Imidapril Hydrochloride

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Flecainide Acetate Tablets 50mg, 100mg (Actavis UK Ltd)

Flecainide Acetate 50mg and 100mg tablets

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. Index 1 What Flecainide Acetate tablets are and what they are used for 2 Before you take 3 How to take 4 Possible side effects 5 How to store 6 Further information What Flecainide Acetate tablets are and what they are used for

Flecainide Acetate tablets belong to a group of medicines called anti-arrhythmics. They work by regulating the heart rate.

Flecainide Acetate tablets may be used to treat the following conditions when other drugs are not effective: irregular beats of the upper heart chambers (atria) including Wolff-Parkinson-White Syndrome irregular beats of the lower heart chambers (ventricles). Before you take

Do not take Flecainide Acetate tablets and tell your doctor if you:

are allergic (hypersensitive) to flecainide acetate or any of the other ingredients (see section 6) suffer from conduction problems of the heart, such as a slow or fast heart beat or heart block suffer from heart failure have severely low blood pressure have had a heart attack (myocardial infarction) are in shock due to heart problems (cardiogenic shock) have rapid and irregular heart beat (atrial fibrillation) are taking disopyramide (medicine to treat irregular heart rhythms).

Take special care with Flecainide Acetate tablets and tell your doctor if you:

suffer from low or high levels of potassium in the blood have liver or kidney disease have a pacemaker have any heart disease or an enlarged heart have rapid or irregular heart beats after heart surgery have been told you have disturbances in heart rhythm known as sick sinus syndrome. Taking other medicines

Before taking Flecainide Acetate tablets, tell your doctor if you are taking or have recently taken the following medicines, or are taking any non-prescribed medicines:

verapamil or beta blockers (e.g. propranolol to treat heart diseases) laxatives (to treat constipation) diuretics (‘water tablets’) steroids (e.g. betamethasone, hydrocortisone or prednisolone) sodium channel blockers (e.g. lidocaine to treat irregular heartbeat (arrhythmia) or as a local anaesthetic) phenytoin, phenobarbital or carbamazepine (to treat epilepsy) digoxin (to treat heart conditions) amiodarone, quinidine or disopyramide (to treat irregular heart rhythms) cimetidine (to treat stomach ulcers) fluoxetine or tricyclic antidepressants (e.g. amitriptyline to treat depression) terfenadine or astemizole (to treat allergic reactions) quinine or halfantrine (to treat or prevent malaria) Pregnancy and breast-feeding

Your doctor will only prescribe Flecainide Acetate tablets if it is absolutely necessary. Breast feeding is not recommended whilst taking Flecainide Acetate tablets. Check with your doctor if you are unsure.

Driving and using machines

Flecainide Acetate tablets may cause dizziness or affect your vision. Make sure you are not affected before you drive or operate machinery.

Tests

Your doctor will monitor your progress on a regular basis with ECG (electrocardiogram) and blood tests, and may alter the dose if necessary.

If you see another doctor or go into hospital, let them know what medicines you are taking.

How to take

Always take Flecainide Acetate tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Treament may be started in hospital.

Swallow these tablets whole with water on an empty stomach or one hour before food.

Doses: Adults and adolescents (13-17 years of age) treatment of irregular beats of the upper heart chambers (atria) : starting dose is 50mg twice a day up to a maximum dose of 300mg per day. treatment of irregular heart beats of the lower heart chambers (ventricular) : starting dose is 100mg twice a day up to a maximum dose of 400mg per day. Children under 12 years of age - not recommended Elderly patients or those fitted with pacemakers, with kidney or liver problems or taking amiodarone or cimetidine - a lower dose of flecainide may be given. If you take more Flecainide Acetate tablets than you should

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once.

If you forget to take Flecainide Acetate tablets

If you forget to take a dose take it as soon as you remember, unless it is nearly time to take the next dose. Then go on as before. Never double up on the next dose to make up for the one missed.

If you stop taking the tablets

Talk to your doctor before you stop taking the tablets and follow their advice.

Possible side effects

Like all medicines, Flecainide Acetate tablets can cause side effects, although not everybody gets them.

Stop taking Flecainide Acetate tablets and contact your doctor at once if the following allergic reaction happens: skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Very common (occurs in more than 1 in 10 users): dizziness, giddiness, light headedness, headache, double or blurred vision

Common (occurs in less than 1 in 10 users): signs of your heart condition getting worse or development of new heart symptoms, a change in heart beat pattern (especially in patients with existing heart problems)

Uncommon (occurs in less than 1 in 100 users): changes in the numbers and types of your blood cells, difficulty breathing, feeling or being sick

Rare (occurs in less than 1 in 1,000 users): affects on your immune system which may be associated with inflammation, hallucinations, depression, confusion, memory loss, nervousness, anxiety, disturbances of movement, convulsions, ‘pins and needles’ or numbness, problems with co-ordination, raised liver enzyme levels or jaundice (yellow skin and/or whites of the eyes)

Very rare (occurs in less than 1 in 10,000 users): particles in the front of the eye (corneal deposits), lung disease (pneumonitis), sensitivity of the skin to light, flushing or increased sweating, allergic skin reactions (which may be itchy), dry mouth, impairment of taste, joint and muscle pain, impotence.

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

How to store

Keep out of the reach and sight of children.

Do not store the tablets above 25°C and store in the original packaging.

Do not use Flecainide Acetate tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information What Flecainide Acetate tablets contain The active substance (the ingredient that makes the tablets work) is flecainide acetate. Each tablets contains either 50mg or 100mg of the active ingredient. The other ingredients are croscarmellose sodium, magnesium stearate, maize starch, pregelatinised maize starch, microcrystalline cellulose (E460). What Flecainide Acetate tablets look like and contents of the pack

Flecainide Acetate tablets are white, uncoated tablets.

Pack sizes are 60 tablets

Marketing Authorisation Holder and Manufacturer Actavis Barnstaple EX32 8NS UK

Date of last revision: July 2008.

If you would like a leaflet with larger text, please contact 01271 311257.

Actavis Barnstaple EX32 8NS UK

50134525

NIOPAM 300
1. Name Of The Medicinal Product

NIOPAM 300 , solution for injection

2. Qualitative And Quantitative Composition

61.2% w/v Iopamidol equivalent to 300mg iodine/ml.

Each ml contains 612 mg iopamidol.

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for injection.

Clear aqueous solution filled into colourless glass ampoules or bottles.

4. Clinical Particulars 4.1 Therapeutic Indications

X-ray contrast medium for use in lumbar and thoraco-cervical myelography, cerebral angiography, peripheral angiography, venography, computer tomography enhancement, urography and arthrography.

4.2 Posology And Method Of Administration

Route of administration:

Intra-ventricular

Intra-arterial

Intra-venous

Intra-articular

Intra-thecal

Intra-cisternal

Dosage

NIOPAM 300 : DOSAGE SCHEDULE

Procedure

Dosage

Lumbar Myelography

Adults 5 - 10 ml

Thoraco-Cervical Myelography

Adults 5 - 10 ml

Cerebral Angiography

Adults 5 - 10 ml *

Children **

Peripheral Arteriography

 

Venography

Adults 20 - 50 ml *

Children **

Adults 20 - 50 ml *

Children **

Do not exceed 250 ml

Computer Tomography Enhancement

Adults: Brain scanning 50 - 100ml

Whole body scanning 40-100ml

Intravenous Urography

Adults 40 - 80 ml

In severe renal failure the usual high dose methods should be employed. (up to 1.5 mg/kg)

Children 1 - 2.5 mg/kg or **

Arthrography

Adults 1 - 10 ml according to the joint being examined.

* repeat as necessary; ** according to body size and age;

Single injection volume depends on the vascular area to be examined.

Elderly: dosage as for adults. The lowest effective dose should be used.

Method of administration

No other drugs should be mixed with the contrast medium.

Lumbar myelography

A slow sub-arachnoid injection is made through a fine lumbar puncture needle into one of the lower lumbar interspinous spaces (L3-L4 or L4-L5). Optimum contrast appears immediately after injections and films should be obtained promptly.

Thoraco-cervical myelography

Following a slow sub-arachnoid injection the patient should be turned on his side and tilted 10°-20° head down under fluoroscopic control. In this manner it is possible to control movement of the contrast medium column into the dorsal region.

If the cervical region is to be examined, the contrast medium should be run into the cervical region first, before the examination of the dorsal areas where it is progressively diluted.

Niopam may also be injected sub-occipitally or by lateral cervical puncture technique. Care should be taken to ensure that the contrast medium does not move intracranially.

Following intrathecal use, the patient should rest with the head and chest elevated for one hour and be kept well hydrated. Thereafter, he/she may ambulate carefully but bending down be avoided. If remaining in bed, the head and chest should be kept elevated for 6 hours. Patients suspected of having a low seizure threshold should be observed during this period.

Cerebral angiography

Any of the current techniques is suitable for radiological visualisation of the cerebral vasculature with Niopam 300. Carotid and vertebral angiography, performed by catheterisation or percutaneous injection techniques, require rapid injection, which, if necessary may be repeated.

Peripheral arteriography and phlebography (venography)

Percutaneous injection into the appropriate blood vessel is used for visualisation of peripheral arteries and veins.

Computer tomography enhancement

Contrast enhancement for brain scans can be achieved between one and three minutes after i.v. injection. Niopam 200, 300 and 340 are also used for total body scanning examinations after i.v. administration as a bolus, as a drip infusion or by a combination of the two methods.

Urography

The contrast medium is injected intravenously and rapidly eliminated through the kidneys. In patients with severe renal failure, high dose urography should be used.

Arthrography

Visualisation of joint cavities and articular surfaces can be achieved by either single or double contrast examination.

4.3 Contraindications

Use in patients with proven or suspected hypersensitivity to iodine containing preparations of this type.

Because of overdosage considerations, immediate repeat myelography in the event of technical failure is contraindicated.

4.4 Special Warnings And Precautions For Use

A positive history of allergy, asthma or untoward reaction during previous similar investigations indicates a need for extra caution; the benefit should clearly outweigh the risk in such patients. Appropriate resuscitative measures should be immediately available.

X-ray examination of women should if possible be conducted during the pre-ovulation phase of the menstrual cycle and should be avoided during pregnancy.

When examining small children or babies, do not limit fluid intake before administering a hypertonic contrast solution. Also, correct any existing water and electrolyte imbalance.

Care should be exercised in carrying out radiographic procedures with contrast media in patients with severe functional impairment of the liver or myocardium, severe systemic disease and in myelomatosis (including Waldenstr?ms macroglobulinemia, multiple myeloma). In the latter condition patients should not be exposed to dehydration; similarly abnormalities of fluid or electrolyte balance should be corrected prior to use.

Particular care should also be exercised in patients with moderate to severe impairment of renal function (as reflected by a raised blood urea) or in diabetes. Substantial deterioration in renal function is minimised if the patient is well hydrated. Renal function parameters should be monitored after the procedure in these patients.

Patients with severe hepato-renal insufficiency should not be examined unless absolutely indicated. Re-examination should be delayed for 5-7 days.

Niopam should be administered with caution in elderly patients and patients with increased intracranial pressure or suspicion of intracranial tumour, abscess or haematoma, and in those with a history of epilepsy, severe cardiovascular disease, renal impairment, chronic alcoholism or multiple sclerosis.

Patients with these conditions have an increased risk of neurological complications.

General anaesthesia may be indicated in selected patients. However, a higher incidence of adverse reactions has been reported in these patients, probably due to the hypotensive effect of the anaesthetic.

Contrast media may promote sickling in individuals who are homozygous for sickle cell disease when injected intravenously and intra-arterially.

Patients with phaeochromocytoma may develop severe hypertensive crisis following intravascular Niopam. Premedication with ?-receptor blockers is recommended.

The administration of iodinated contrast media may aggravate the symptoms of myasthenia gravis.

Patients with congestive heart failure should be observed for several hours following the procedure to detect delayed haemodynamic disturbances, which may be associated with a transitory increase in the circulating osmotic load. All other patients should be observed for at least one hour after the procedure, as most of the adverse events occur in this period. The patient should also be informed that allergic reactions may develop up to several days after the procedure; in such case, a physician should be consulted immediately.

In neonates, and particularly in premature neonates, it is recommended that tests of thyroid function (typically TSH and T4), should be checked 7-10 days and 1 month after the administration of iodinated contrast media because of the risk of hypothyroidism due to iodine overload.

In patients scheduled for thyroid examination with a radioactive iodine tracer, one must take into consideration that iodine uptake in the thyroid gland will be reduced for several days (up to two weeks) after dosing with an iodinized contrast medium that is eliminated through the kidneys.

Local tissue irritation can occur as an event of perivascular infiltration.

Neuroradiology

In patients who are known epileptics or have a history of epilepsy, anticonvulsant therapy should be maintained before and following myelographic procedures. In some instances anticonvulsant therapy may be increased for 48 hours before the examination.

Neuroleptics must be absolutely avoided because they lower the seizure threshold. The same applies to analgesics, antiemetics, antihistamines and sedatives of the phenothiazine group. Whenever possible, treatment with such drugs should be discontinued at least 48 hours before administration of the contrast medium and not be resumed less than 12 hours after completion of the procedure.

Angiography

In patients undergoing angiocardiographic procedures special attention should be paid to the status of the right heart and pulmonary circulation. Right heart insufficiency and pulmonary hypertension may precipitate bradycardia and systemic hypotension, when the organic iodine solution is injected. Right heart angiography should be carried out only when absolutely indicated.

In angiographic procedures, the possibility of dislodging plaque or damaging or perforating the vessel wall should be considered during catheter manipulation and contrast medium injection. Test injections to ensure proper catheter placements are recommended.

Angiography should be avoided whenever possible in patients with homocystinuria due to an increased risk of thrombosis and embolism.

In patients undergoing peripheral angiography, there should be pulsation in the artery into which the X-ray contrast medium will be injected. In patients with thromboangiitis obliterans or ascending infections in combination with serious ischemia the angiography should be performed, if at all, with special caution.

In patients undergoing venography, special caution should be exercised in patients with suspected phlebitis, serious ischaemia, local infections, or a complete venous occlusion. Serious neurological events have been observed following direct injection of contrast media into cerebral arteries or vessels supplying the spinal cord or in angiocardiography due to inadvertent filling of the carotids.

In paediatric roentgenology, one should proceed with great caution when injecting the contrast medium into the right heart chambers of cyanotic neonates with pulmonary hypertension and impaired cardiac function.

In examinations of the aortic arch the tip of the catheter should be positioned carefully to avoid hypotension, bradycardia and CNS injury due to excess pressure transmitted from the injector pump to the brachiocephalic branches of the aorta.

Urography

Care should be exercised in patients with moderate to severe impairment of renal function (as reflected by a raised blood urea). Substantial deterioration in renal function is minimized if the patient is well hydrated. Renal function parameters, especially urinary output should be monitored after the examination in these patients.

Re-examination should be delayed 5-7 days.

Non-ionic contrast media have less anti-coagulant activity in-vitro than ionic media. Meticulous attention should therefore be paid to angiographic technique. Non-ionic media should not be allowed to remain in contact with blood in the syringe and intravascular catheters should be flushed frequently, to minimise the risk of clotting, which rarely has led to serious thromboembolic complications after procedures.

Niopam should be used with caution in patients with hyperthyroidism. It is possible that hyperthyroidism may recur in patients previously treated for Graves' disease.

The presence of renal damage in diabetic patients is one of the factors predisposing to renal impairment following contrast media administration. This may precipitate lactic acidosis in patients who are taking metformin. As a precaution, metformin should be discontinued at the time of, or prior to, the procedure and withheld for 48 hours subsequent to the procedure and re-instituted only after renal function has been re-evaluated and found to be normal.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Thyroid function tests: use of iodinated contrast media may interfere with tests for thyroid function which depend on iodine estimations, such as Protein Binding Iodine and radioactive iodine uptake. As a consequence they will not accurately reflect thyroid function for up to 16 days following administration of iodinated contrast media. Thyroid function tests not depending on iodine estimations, e.g. T3 resin uptake and total or free thyroxine (T4) assays are not affected.

No other specific interference with physiological functions have been noted.

The administration of an X-ray contrast medium in diabetic patients with nephropathy who are taking biguanides may precipitate lactic acidosis.

Arterial thrombosis has been reported when iopamidol was given following papaverine.

The administration of vasopressors strongly potentiate the neurological effect of the intra-arterial contrast media.

Contrast media may interfere with laboratory tests for bilirubin, proteins or inorganic substances (eg iron, copper, calcium, phosphate). These substances should not be assayed during the same day following the administration of contrast media.

4.6 Pregnancy And Lactation

X-ray examination of women should if possible be conducted during the pre-ovulation phase of the menstrual cycle and should be avoided during pregnancy ; also, since it has not been demonstrated that Niopam is safe for use in pregnant women, it should be administered only if the procedure is considered essential by the physician.

Niopam is poorly excreted in human milk. From animal experience, Niopam is non toxic in animals after oral administration. Although, no serious adverse reactions have been reported in nursing infants, Niopam should be administered to lactating women only if considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

There is no known effect on the ability to drive and operate machines. However, because of the risk of early reactions, driving or operating machinery is not advisable for one hour following the last injection.

4.8 Undesirable Effects

The use of iodinated contrast media may cause untoward side effects. They are usually mild to moderate and transient in nature. However , severe and life threatening reactions sometimes leading to death have been reported.

Anaphylaxis (anaphylactoid reactions/hypersensitivity) may manifest with: mild localized or more diffuse angioneurotic oedema, tongue oedema, laryngospasm or laryngeal oedema, dysphagia, pharyngitis and throat tightness, pharyngolaryngeal pain, cough, conjunctivitis, rhinitis, sneezing, feeling hot, sweating increased, asthenia, dizziness, pallor, dyspnoea, wheezing, bronchospasm, and moderate hypotension. Skin reactions may occur in the form of various types of rash, diffuse erythema, diffuse blisters, urticaria, and pruritus. These reactions, which occur irrespective of the dose administered and the route of administration, may represent the first signs of incipient state of shock. Administration of the contrast medium must be discontinued immediately and – if necessary – specific treatment initiated via a venous access.

More severe reactions involving the cardiovascular system such as vasodilatation with pronounced hypotension, tachycardia, dyspnoea, agitation, cyanosis and loss of consciousness (syncope) may require emergency treatment.

Intravascular administration –Adults

The safety of Iopamidol injection through intravascular administration was evaluated in 2,548 adult patients involved in clinical trials.

The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (

System Organ Class

Adverse Reactions

     

Clinical Trials

Post-marketing Surveillance

     

Common

(

Uncommon

(

Rare

(

Frequency unknown

 

Blood and lymphatic system disorders

     

Thrombocytopenia

Immune system disorders

     

Anaphylaxis, Anaphylactoid reaction

Psychiatric disorders

   

Confusional state

 

Nervous system disorders

Headache

Dizziness, Taste alteration

Paraesthesia

Coma, Transient ischaemic attack, Syncope, Depressed level of consciousness or loss of consciousness, Convulsion,

Eye disorders

     

transient blindness, Visual disturbance, Conjunctivitis, Photophobia

Cardiac disorders

 

Cardiac dysrhythmias such as extrasystoles, atrial fibrillation, ventricular tachycardia and ventricular fibrillation*

Bradycardia

Myocardial ischaemia or infarction, Cardiac failure, Cardio-respiratory arrest, Tachycardia

Vascular disorders

 

Hypotension, Hypertension, Flushing

 

Circulatory collapse or shock

Respiratory, thoracic and mediastinal disorders

   

Pulmonary oedema, Asthma, Bronchospasm

Respiratory arrest, Respiratory failure, Acute respiratory distress syndrome, Respiratory distress, Apnoea, Laryngeal oedema, Dyspnoea

Gastrointestinal disorders

Nausea

Vomiting, Diarrhea, Abdominal pain, Dry mouth

 

Salivary hypersecretion, Salivary gland enlargement

Skin and subcutaneous tissue disorders

 

Rash, Urticaria, Pruritus, Erythema, Sweating increased

 

Face oedema, muco-cutaneous syndromes **

Musculoskeletal and connective tissue disorders

 

Back pain

Muscle spasms

Musculoskeletal pain, Muscular weakness

Renal and urinary disorders

 

Acute renal failure

   

General disorders and administration site conditions

Feeling hot

Chest pain, Injection site pain***, Pyrexia, Feeling cold

 

Rigors, Pain, Malaise

Investigations

 

Blood creatinine increased

 

Electrocardiogram change including ST segment depression

* Cardiac reactions may occur as consequences of the coronary catheterization procedural hazard: these complications include coronary artery thrombosis and coronary artery embolism.

** As with other iodinated contrast media, very rare cases of muco-cutaneous syndromes, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome) and erythema multiforme, have been reported following the administration of Iopamidol

*** Injection site pain and swelling may occur. In the majority of cases it is due to extravasation of contrast medium. These reactions are usually transient and result in recovery without sequelae. However, inflammation and even skin necrosis have been seen on very rare occasions. In isolated reports extravasation led to the development of compartment syndrome

Intravascular administration – Pediatric Population

Frequency type and severity of adverse reactions in children are similar to those in adults.

Intrathecal administration - Adults

The safety of Iopamidol injection through intrathecal administration was evaluated in 132 adult patients .

System Organ Class

Adverse Reactions

     

Clinical Trials

Post-marketing Surveillance

     

Very common

(

Common

(

Uncommon

(

Frequency unknown

 

Infections and infestations

     

Meningitis aseptic, Meningitis bacterial as consequence of the procedural hazard

Immune system disorders

     

Anaphylaxis, Anaphylactoid reaction*

Psychiatric disorders

     

Confusional state, Disorientation, Agitation, Restlessness

Nervous system disorders

Headache

   

Coma, Paralysis, Convulsion, Syncope, Depressed level of consciousness or loss of consciousness, Meningism,Dizziness, Paraesthesia, Hypoaesthesia

Eye disorders

     

Transient blindness

Cardiac disorders

     

Arrhythmia

Vascular disorders

 

Flushing

 

Hypertension

Respiratory, thoracic and mediastinal disorders

     

Respiratory arrest, Dyspnoea

Gastrointestinal disorders

 

Nausea, Vomiting

   

Skin and subcutaneous tissue disorders

   

Rash

 

Musculoskeletal and connective tissue disorders

 

Back pain, Neck pain, Pain in extremity, Sensation of heaviness

   

General disorders and administration site conditions

     

Pyrexia, Malaise, Rigors

* Anaphylaxis (anaphylactoid reactions/hypersensitivity) may occur. Anaphylactoid reactions with circulatory disturbances such as severe blood pressure decrease leading to syncope or cardiac arrest and life threatening shock are much less common after intrathecal administration than after intravascular administration.

Body cavity administration

The majority of the reactions occur some hours after the contrast administration due to the slow absorption from the area of administration and distribution in the whole organism.

The reactions reported in cases of arthrography usually represent irritative manifestations superimposed on existing tissue inflammation.

Systemic hypersensitivity is rare, generally mild and in the form of skin reactions. However, the possibility of severe anaphylactoid reactions cannot be excluded.

4.9 Overdose

Treatment of overdosage is directed toward the support of all vital functions and the elimination of the contrast medium while maintaining the patient well hydrated.

If needed, hemodyalisis can be used to eliminate iopamidol from the body.

5. Pharmacological Properties

Pharmacotherapeutic group; ATC code: V08A B04

5.1 Pharmacodynamic Properties

Iopamidol is contrast medium belonging to the new generation of non-ionic compound whose solubility is due to the presence of hydrophilic substitutes in the molecule. This results in a solution of low osmolality when compared with ionic media.

Iopamidol has been shown to be effective as an X-ray contrast medium in neuroradiology, angiography, venography, arthrography, urography, cerebral angiography and left ventriculography and coronary arteriography. Its toxicity particularly cardiac and CNS toxicity are less than those of ionic contrast media.

5.2 Pharmacokinetic Properties

The pharmacokinetics of iopamidol conform to an open two compartment pharmacokinetic model with first order elimination.

Distribution volume is equivalent to extracellular fluid.

Elimination is almost completely through the kidneys. Less that 1% of the administered dose has been recovered in the faeces up to 72 hours after dosing. Elimination is rapid; up to half the administered dose may be recovered in the urine in the first two hours of dosing.

There is no evidence of biotransformation.

Serum protein binding is negligible.

5.3 Preclinical Safety Data

No adverse effects can be predicted from animal toxicology studies other than those documented from human use of iopamidol.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Excipients are trometamol, hydrochloric acid and edetate calcium disodium.

6.2 Incompatibilities

No other drug should be mixed with the contrast medium.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Protect from light.

6.5 Nature And Contents Of Container

10ml clear, colourless Type I glass ampoules.

20 and 30ml clear, colourless Type I or Type II glass vials with rubber closures and aluminium caps.

20, 50, 70, 100, 200 and 250ml clear, colourless Type I or Type II glass bottles with rubber closures and aluminium caps.

6.6 Special Precautions For Disposal And Other Handling

Discard if the solution is not clear of particulate matter.

Exceptionally, the event of crystallisation of Niopam could occur. It has been shown that such a phenomenon is caused by a damaged or defective container and therefore the product should not be used in this case.

The bottle, once opened, must be used immediately.

Any residue of contrast medium must be discarded.

Niopam, as other iodinated contrast media, can react with metallic surfaces containing copper (e.g. brass), therefore the use of equipment, in which the product comes into direct contact with such surfaces, should be avoided.

7. Marketing Authorisation Holder

Bracco U.K. Ltd,

Bracco House, Mercury Park,

Wycombe Lane, Wooburn Green,

Buckinghamshire HP10 OHH

8. Marketing Authorisation Number(S)

PL 18920/0009

9. Date Of First Authorisation/Renewal Of The Authorisation

22nd March 1982/ 9th January 2002

10. Date Of Revision Of The Text

15 November 2011

MiraLax Powder for Oral Solution
Pronunciation: pol-ee-ETH-il-een GLIE-colGeneric Name: Polyethylene Glycol-3350Brand Name: Examples include GlycoLax and MiraLax

Pacnex

Generic Name: benzoyl peroxide topical (BEN zoyl per OX ide) Brand Names: Acne Treatment, Acne-Clear, Benzac AC, Benzac W, Benzashave 10, Benzashave 5, BenzEFoam, Benziq, Benziq Wash, BPO Foaming Cloths, Brevoxyl, Brevoxyl Acne Wash Kit, Brevoxyl-4 Creamy Wash Complete Pack, Brevoxyl-8 Creamy Wash Complete Pack, Breze, Clearplex, Clearskin, Clinac BPO, Desquam-E, Desquam-X 10, Desquam-X 5, Desquam-X Wash, Fostex Bar 10%, Fostex Gel 10%, Fostex Wash 10%, Inova, Lavoclen-4, Lavoclen-8, Loroxide, NeoBenz Micro, Neutrogena Acne Mask, Neutrogena On Spot Acne Treatment, Oscion, Oscion Cleanser, Oxy 10 Balance, Oxy Balance, Oxy Daily Wash Chill Factor, Oxy-10, Pacnex, PanOxyl, Panoxyl 10, Panoxyl 5, Panoxyl Aqua Gel, PanOxyl Maximum Strength Foaming Acne Wash, Persa-Gel, Seba-Gel, SoluCLENZ Rx, Triaz, Triaz Cleanser, Zaclir

What is Pacnex (benzoyl peroxide topical)?

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin.

Benzoyl peroxide topical (for the skin) is used to treat acne.

Benzoyl peroxide topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Pacnex (benzoyl peroxide topical)?

There are many brands and forms of benzoyl peroxide available and not all brands are listed on this leaflet.

Do not use benzoyl peroxide topical while you are also using tretinoin (Altinac, Avita, Renova, Retin-A, Tretin-X). Using these medications together could cause severe skin irritation.

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use benzoyl peroxide topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using benzoyl peroxide topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

What should I discuss with my healthcare provider before using Pacnex (benzoyl peroxide topical)? Do not use benzoyl peroxide topical while you are also using tretinoin (Altinac, Avita, Renova, Retin-A, Tretin-X). Using these medications together could cause severe skin irritation. FDA pregnancy category C. It is not known whether benzoyl peroxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether benzoyl peroxide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Pacnex (benzoyl peroxide topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Wash your hands before and after applying this medication. Shake the lotion well just before each use.

Clean and pat dry the skin to be treated. Apply benzoyl peroxide in a thin layer and rub in gently.

Do not cover the treated skin area unless your doctor has told you to.

Benzoyl peroxide topical is usually applied one to three times daily. Follow your doctor's instructions.

Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Pacnex (benzoyl peroxide topical)? Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use benzoyl peroxide topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using benzoyl peroxide topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Avoid using sunscreen containing PABA on the same skin treated with benzoyl peroxide, or skin discoloration may occur.

Pacnex (benzoyl peroxide topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using benzoyl peroxide and call your doctor at once if you have severe stinging or burning of your skin.

Less serious side effects may include:

mild stinging or burning;

itching or tingly feeling;

skin dryness, peeling, or flaking; or

redness or other irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Pacnex (benzoyl peroxide topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzoyl peroxide topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Pacnex resources Pacnex Side Effects (in more detail)Pacnex Use in Pregnancy & BreastfeedingPacnex Drug InteractionsPacnex Support Group0 Reviews for Pacnex - Add your own review/rating Acne Treatment Cream MedFacts Consumer Leaflet (Wolters Kluwer) BenzEFoam Foam MedFacts Consumer Leaflet (Wolters Kluwer) Benzac Topical Advanced Consumer (Micromedex) - Includes Dosage Information Benzac AC Wash MedFacts Consumer Leaflet (Wolters Kluwer) Benzefoam Prescribing Information (FDA) Benzefoam Ultra Prescribing Information (FDA) Brevoxyl Gel MedFacts Consumer Leaflet (Wolters Kluwer) Brevoxyl Creamy Wash Prescribing Information (FDA) Desquam-X Wash Prescribing Information (FDA) Inova Pads MedFacts Consumer Leaflet (Wolters Kluwer) NeoBenz Micro Wash Plus Pack Cream MedFacts Consumer Leaflet (Wolters Kluwer) Neobenz Micro SD Prescribing Information (FDA) Neobenz Micro Wash Plus Pack Prescribing Information (FDA) Oxy Balance Topical Advanced Consumer (Micromedex) - Includes Dosage Information Pacnex LP Prescribing Information (FDA) PanOxyl Bar MedFacts Consumer Leaflet (Wolters Kluwer) Triaz Cloths MedFacts Consumer Leaflet (Wolters Kluwer) Triazolam Monograph (AHFS DI) Compare Pacnex with other medications AcnePerioral Dermatitis Where can I get more information? Your pharmacist can provide more information about benzoyl peroxide topical.

See also: Pacnex side effects (in more detail)

Topcare Complete Acid Reducer plus Antacid
Dosage Form: tablet, chewableTopco Complete Acid Reducer plus Antacid Drug Facts Active ingredient (in each chewable tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purpose

Acid reducer

Antacid

Uses

relieves heartburn associated with acid indigestion and sour stomach

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions adults and children 12 years and over: do not swallow tablet whole: chew completely to relieve symptoms, chew 1 tablet before swallowing do not use more than 2 chewable tablets in 24 hours children under 12 years: ask a doctor Other information each tablet contains: calcium 320 mg; magnesium 65 mg Phenylketonurics: Contains Phenylalanine 2.2 mg per tablet read the directions and warnings before use read the bottle label. It contains important information. store at 20°-25°C (68°-77°F) protect from moisture Inactive ingredients

aspartame, D&C red no. 7 calcium, dextrates, FD&C blue no. 1 lake, FD&C red no. 40 lake, flavor, glyceryl monostearate, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

Questions or comments?

1-888-423-0139

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Dual Action

Complete

Famotidine 10 mg/Calcium Carbonate 800 mg/Magnesium Hydroxide 165 mg Tablets

Acid Reducer plus Antacid

Just One Tablet

Relieves Heartburn Due to Acid Indigestion

Berry Flavor

Actual Size

Compare to Pepcid® Complete active ingredients

Complete Acid Reducer plus Antacid Label

Nitrodur 0.6

Generic Name: nitroglycerin (Transdermal route)

nye-troe-GLIS-er-in

Commonly used brand name(s)

In the U.S.

Minitran Nitrek Nitro-Bid Nitro-Dur

In Canada

Nitrodur 0.2 Nitro-Dur 0.2 Nitro-Dur 0.3 Nitrodur 0.4 Nitro-Dur 0.4 Nitrodur 0.6 Nitro-Dur 0.6 Nitro-Dur 0.8 Transderm-Nitro Trinipatch 0.2 Trinipatch 0.4 Trinipatch 0.6

Available Dosage Forms:

Ointment Patch, Extended Release

Therapeutic Class: Antianginal

Chemical Class: Nitrate

Uses For Nitrodur 0.6

Nitroglycerin transdermal is used to prevent angina (chest pain) caused by coronary artery disease. It does not work fast enough to relieve the pain of an angina attack that has already started.

Nitroglycerin transdermal belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. When used regularly on a long-term basis, this helps prevent angina attacks from occurring.

This medicine is available only with your doctor's prescription.

Before Using Nitrodur 0.6

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of nitroglycerin transdermal in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nitroglycerin transdermal in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving nitroglycerin transdermal.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Sildenafil Tadalafil Vardenafil

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alteplase, Recombinant

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetylcysteine Aspirin Dihydroergotamine Pancuronium Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Cardioversion (medical heart procedure) or Defibrillation (medical heart procedure)—Use with caution. The patch should be removed before having these procedures. Congestive heart failure or Heart attack, recent or Hypertrophic cardiomyopathy (a heart disease) or Hypotension (low blood pressure) or Hypovolemia (low amount of blood)—Use with caution. May make these conditions worse. Proper Use of nitroglycerin

This section provides information on the proper use of a number of products that contain nitroglycerin. It may not be specific to Nitrodur 0.6. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. It will only work if applied correctly.

This form of nitrate is used to reduce the number of angina attacks over a long time. It will not relieve an attack that has already started because it works too slowly. The ointment and patch forms release medicine gradually to provide an effect for 7 to 10 hours. Check with your doctor if you also need a fast-acting medicine to relieve the pain of an angina attack.

You should use this medicine first thing in the morning and follow the same schedule each day. This medicine works best if you have a "drug-free" period of time every day when you do not use it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

For patients using the ointment:

Before applying a new dose of ointment, remove any ointment remaining on the skin from a previous dose. This will allow the fresh ointment to release the nitroglycerin properly. This medicine comes with papers to help measure the dose. Use them to measure the length of ointment squeezed from the tube and to apply the ointment to the skin. Do not rub or massage the ointment into the skin. Spread it in a thin, even layer, and cover an area of skin that is the same size each time it is applied. Apply the ointment to skin with little or no hair that is free of scars, cuts, or irritation. Apply each dose of ointment to a different area of skin to prevent irritation. If your doctor has ordered an airtight covering or dressing (such as plastic kitchen wrap) be placed over this medicine, make sure you know how to apply it. Airtight dressings will increase the amount of medicine absorbed through the skin and may cause more side effects. Use them only as directed and check with your doctor if you have any questions about this.

For patients using the patch system:

Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands. Do not try to trim or cut the adhesive patch to adjust the dosage. Check with your doctor if you think the medicine is not working as it should. Apply the patch to a clean, dry skin area with little or no hair that is free of scars, cuts, or irritation. Always remove a previous patch before applying a new one. Apply a new patch if the first one becomes loose or falls off. Apply each patch to a different area to prevent skin irritation. Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For angina prevention: For transdermal dosage form (ointment): Adults—At first, 7.5 milligrams (mg), one-half inch of ointment, two times a day. Apply the first dose in the morning right after you wake up, and the second dose 6 hours later. Your doctor may increase your dose as needed. Children—Use and dose must be determined by your doctor. For transdermal dosage form (skin patch): Adults—Apply one patch once a day in the morning. Leave the patch in place for a total of 12 to 14 hours. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After removing a used patch, fold it in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

Precautions While Using Nitrodur 0.6

If you will be taking this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using this medicine. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you experience an angina attack, you must go to the hospital right away.

This medicine may cause headaches. These headaches are a sign that the medicine is working. Do not stop using the medicine or change the time you use it in order to avoid the headaches. If you have severe pain, talk with your doctor.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking this medicine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

Do not stop using this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Tell the doctor in charge that you are using this medicine before having a magnetic resonance imaging (MRI) scan. Skin burns may occur at the site where the patch is worn during this procedure. Ask your doctor if the patch should be removed before having an MRI scan. You might need to put on a new patch after the procedure.

Nitrodur 0.6 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Lightheadedness Less common Arm, back, or jaw pain blurred vision chest pain or discomfort chest tightness or heaviness confusion dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly fainting fast or irregular heartbeat nausea shortness of breath sweating unusual tiredness or weakness Rare Bluish-colored lips, fingernails, or palms dark urine difficulty with breathing fever headache pale skin rapid heart rate sore throat unusual bleeding or bruising Incidence not known Blistering, burning, crusting, dryness, or flaking of the skin cough difficulty with swallowing hives itching, scaling, severe redness, soreness, or swelling of the skin puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue skin rash wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose Blurred or loss of vision bulging soft spot on the head of an infant change in consciousness change in the ability to see colors, especially blue or yellow cold, clammy skin disturbed color perception double vision feeling of constant movement of self or surroundings halos around lights headache, severe and throbbing loss of consciousness night blindness overbright appearance of lights paralysis sensation of spinning tunnel vision

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare Burning, itching, redness, skin rash, swelling, or soreness at the application site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Nitrodur 0.6 side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Nitrodur 0.6 resources Nitrodur 0.6 Side Effects (in more detail)Nitrodur 0.6 Use in Pregnancy & BreastfeedingNitrodur 0.6 Drug InteractionsNitrodur 0.6 Support Group0 Reviews for Nitrodur 0.6 - Add your own review/rating Compare Nitrodur 0.6 with other medications AnginaAngina Pectoris ProphylaxisHeart AttackHeart FailureHigh Blood Pressure

Verelan

Generic Name: verapamil (Oral route)

ver-AP-a-mil

Commonly used brand name(s)

In the U.S.

Calan Calan SR Covera-HS Isoptin SR Verelan Verelan PM

Available Dosage Forms:

Tablet, Extended Release Capsule, Extended Release Tablet Tablet, Extended Release, 24 HR Capsule, Extended Release, 24 HR

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Phenylalkylamine

Uses For Verelan

Verapamil is used alone or together with other medicines to treat heart rhythm problems, severe chest pain (angina), or high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

Verapamil is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. As a result, verapamil relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload .

This medicine is available only with your doctor's prescription .

Before Using Verelan

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of verapamil in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of verapamil in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require an adjustment of dose in patients receiving verapamil .

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol Adenosine Alprenolol Amiodarone Atazanavir Atenolol Atorvastatin Betaxolol Bevantolol Bisoprolol Bucindolol Bupivacaine Carteolol Carvedilol Celiprolol Clonidine Clozapine Colchicine Crizotinib Dantrolene Digoxin Dilevalol Dronedarone Eplerenone Erythromycin Esmolol Everolimus Labetalol Levobunolol Lovastatin Mepindolol Mepivacaine Metipranolol Metoprolol Nadolol Nebivolol Oxprenolol Penbutolol Pindolol Propranolol Ranolazine Simvastatin Sotalol Talinolol Tertatolol Timolol Tizanidine Tolvaptan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aspirin Buspirone Carbamazepine Clarithromycin Cyclosporine Dalfopristin Digitoxin Dutasteride Flecainide Fosphenytoin Indinavir Itraconazole Lithium Midazolam Nevirapine Oxcarbazepine Pancuronium Phenobarbital Phenytoin Quinidine Quinupristin Rifapentine Ritonavir Sirolimus St John's Wort Tedisamil Telithromycin Tubocurarine Vecuronium Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol Grapefruit Juice Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Congestive heart failure or Muscle disease (e.g., Duchenne's muscular dystrophy, myasthenia gravis) or Pulmonary edema (fluid in the lungs)—Use with caution. May make these conditions worse . Heart block (type of abnormal heart rhythm) or Heart problems (e.g., Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome) or Low blood pressure (hypotension) or Sick sinus syndrome (heart rhythm problem, can use if have a pacemaker that works properly)—Should not be used in patients with these conditions . Kidney problems or Liver problems—Use with caution. The effects may be increased because of slower removal of the medicine from the body . Proper Use of verapamil

This section provides information on the proper use of a number of products that contain verapamil. It may not be specific to Verelan. Please read with care.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet .

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well .

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease .

Swallow the extended-release tablet whole with a full glass of water. Do not break, crush, or chew it. It is best to take this medicine with food .

If you cannot swallow the verapamil extended-release capsules, you may open it and sprinkle the pellets contained in the capsule on one tablespoon of applesauce. This mixture must be swallowed immediately with a glass of cool water. The applesauce should not be hot and should be soft enough to be swallowed without chewing. Do not chew or crush the pellets .

If you are taking the extended-release tablets, you may sometimes notice what looks like a tablet in your stool. This is the empty tablet shell that is left after the medicine has been absorbed .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For chest pain: For oral dosage form (tablets): Adults—The usual dose is 80 to 120 milligrams (mg) three times a day. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor . For oral dosage form (extended-release tablets, 24 hr): Adults—At first, 180 milligrams (mg) once daily at bedtime. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor . For heart rhythm problems: For oral dosage form (tablets): Adults—The total usual dose is 240 to 480 milligrams (mg) divided in three or four equal doses per day. Children—Use and dose must be determined by your doctor . For high blood pressure: For oral dosage form (tablets): Adults—At first, 80 milligrams (mg) three times a day. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor . For oral dosage form (extended-release capsules): Adults—At first, 200 milligrams (mg) once daily at bedtime. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor . For oral dosage form (extended-release tablets): Adults—At first, 180 milligrams (mg) once daily in the morning. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor . For oral dosage form (extended-release tablets, 24 hr): Adults—At first, 180 milligrams (mg) once daily at bedtime. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor . Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Verelan

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

Low blood pressure (hypotension) may occur while taking this medicine. Check with your doctor right away if you have the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness .

While you are taking this medicine be careful to limit the amount of alcohol that you drink. Alcohol increases dizziness and drowsiness and also lowers blood pressure .

Verelan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common Blue lips and fingernails blurred vision burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings chest pain confusion coughing that sometimes produces a pink frothy sputum difficult, fast, noisy breathing, sometimes with wheezing dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly increased sweating lightheadedness, dizziness, or fainting pale skin shortness of breath slow or irregular heartbeat sore throat sweating swelling in legs and ankles unusual tiredness or weakness Rare Chills cold sweats feeling of warmth redness of the face, neck, arms and occasionally, upper chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Difficulty having a bowel movement (stool) headache Less common Acid or sour stomach belching difficulty in moving heartburn indigestion joint pain muscle aching or cramping muscle pains or stiffness nausea rash stomach discomfort, upset, or pain trouble sleeping unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Verelan side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Verelan resources Verelan Side Effects (in more detail)Verelan Use in Pregnancy & BreastfeedingDrug ImagesVerelan Drug InteractionsVerelan Support Group0 Reviews for Verelan - Add your own review/rating Verelan Prescribing Information (FDA) Verelan Sustained-Release Pellet-Filled Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Verelan Concise Consumer Information (Cerner Multum) Verapamil Prescribing Information (FDA) Calan MedFacts Consumer Leaflet (Wolters Kluwer) Calan Prescribing Information (FDA) Calan SR Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Calan SR Prescribing Information (FDA) Covera-HS Prescribing Information (FDA) Covera-HS Sustained-Release Tablets (Controlled Onset) MedFacts Consumer Leaflet (Wolters Kluwer) Isoptin Concise Consumer Information (Cerner Multum) Isoptin SR Prescribing Information (FDA) Verapamil Hydrochloride Monograph (AHFS DI) Verelan PM Prescribing Information (FDA) Verelan PM Sustained-Release Capsules Controlled Onset MedFacts Consumer Leaflet (Wolters Kluwer) Compare Verelan with other medications AnginaArrhythmiaBipolar DisorderCluster HeadachesHigh Blood PressureIdiopathic Hypertrophic Subaortic StenosisMigraine PreventionNocturnal Leg CrampsSupraventricular Tachycardia

Azopt

Generic Name: brinzolamide ophthalmic (brin ZOE la mide off THAL mik) Brand Names: Azopt

What is Azopt (brinzolamide ophthalmic)?

Brinzolamide reduces the amount of fluid in the eye, which decreases pressure inside the eye.

Brinzolamide ophthalmic (for the eyes) is used to treat certain types of glaucoma and other causes of high pressure inside the eye.

Brinzolamide ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Azopt (brinzolamide ophthalmic)? Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using the eye drops before putting your contact lenses in.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have narrow-angle glaucoma.

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using brinzolamide ophthalmic. Do not use the medications at the same time.

Brinzolamide ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly. What should I discuss with my healthcare provider before using Azopt (brinzolamide ophthalmic)? You should not use this medication if you are allergic to brinzolamide.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have narrow-angle glaucoma.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether brinzolamide ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Azopt (brinzolamide ophthalmic)? Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using the eye drops before putting your contact lenses in.

Use brinzolamide ophthalmic exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Wash your hands before using the eye drops.

To apply the eye drops:

Tilt your head back slightly and pull down on the lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper. Squeeze out a drop and close your eye. Gently press your finger to the inside corner of the eye (near the nose) for about 1 minute to keep the liquid from draining into your tear duct.

If you use the drops in both eyes, repeat the steps above in your other eye. Also wait at least 10 minutes before using any other eye drops that your doctor has prescribed.

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye. Do not use this medicine if it has changed colors or has particles in it.

Tell your doctor right away if you have an eye infection, injury, or plan to have any type of eye surgery. You may need to stop using the medicine for a short time.

Store this medication at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of brinzolamide ophthalmic is not expected to produce life-threatening symptoms.

What should I avoid while using Azopt (brinzolamide ophthalmic)? Brinzolamide ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using brinzolamide ophthalmic. Do not use the medications at the same time.

Azopt (brinzolamide ophthalmic) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

swelling or redness of your eyelids;

eye redness, discomfort, or sensitivity to light;

drainage, crusting, or oozing of your eyes or eyelids;

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

pain in your upper stomach, jaundice (yellowing of your skin or eyes);

pale skin, easy bruising or bleeding; or

chest pain.

Less serious side effects may include:

blurred vision, double vision, drooping eyelid;

burning or stinging in your eye;

bitter or unusual taste in your mouth;

stomach or back pain;

dry eyes, feeling that something is in your eye;

headache; or

nausea, diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Azopt (brinzolamide ophthalmic)?

Before using brinzolamide ophthalmic, tell your doctor if you are using any of the following drugs:

salicylates such as aspirin, Novasal, Doan's Extra Strength, Salflex, Tricosal, and others;

This list is not complete and there may be other drugs that can interact with brinzolamide ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Azopt resources Azopt Side Effects (in more detail)Azopt DosageAzopt Use in Pregnancy & BreastfeedingAzopt Drug InteractionsAzopt Support Group0 Reviews for Azopt - Add your own review/rating Azopt Prescribing Information (FDA) Azopt Monograph (AHFS DI) Azopt Advanced Consumer (Micromedex) - Includes Dosage Information Azopt Drops MedFacts Consumer Leaflet (Wolters Kluwer) Compare Azopt with other medications Glaucoma, Open AngleIntraocular Hypertension Where can I get more information? Your pharmacist can provide more information about brinzolamide ophthalmic.

See also: Azopt side effects (in more detail)

CellCept Solution
Pronunciation: MYE-koe-FEN-oh-late MOE-fe-tilGeneric Name: Mycophenolate MofetilBrand Name: CellCept

Totect

Generic Name: dexrazoxane (dex ray ZOX ane) Brand Names: Totect, Zinecard

What is dexrazoxane?

Dexrazoxane is used to protect the heart and other tissues from harmful side effects caused by certain cancer medications.

The Zinecard brand of dexrazoxane is used in women who are receiving doxorubicin for metastatic breast cancer.

The Totect brand of dexrazoxane is used in men or women to treat a condition called extravasation (es-TRA-va-ZAY-shun). Extravasation happens when an injected medicine escapes from the blood vessels and circulates into tissues in the body. Serious tissue damage can occur when extravasation happens during injection of certain cancer medications.

Dexrazoxane may also be used for purposes not listed in this medication guide.

What is the most important information I should know about dexrazoxane? You should not receive Totect if you are pregnant. It could harm the unborn baby. If possible before you receive Totect, tell your doctor if you are pregnant. It is not known whether Zinecard will harm an unborn baby. You should not receive this medication if your chemotherapy does not include doxorubicin or a similar medication such as daunorubicin (Cerubidine), epirubicin (Ellence), idarubicin (Idamycin), or mitoxantrone (Novantrone).

Before you receive dexrazoxane, tell your doctor if you have liver or kidney disease, or if you are pregnant or breast-feeding.

Tell your doctor at once if you have serious side effects such as fever, chills, body aches, flu symptoms, easy bruising or bleeding, or sores your mouth or throat.

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows that you have received Totect.

What should I discuss with my health care provider before receiving dexrazoxane? You should not receive Zinecard if your chemotherapy does not include doxorubicin or a similar medication such as:

daunorubicin (Cerubidine);

epirubicin (Ellence);

idarubicin (Idamycin); or

mitoxantrone (Novantrone);

If possible before you receive dexrazoxane, tell your doctor if you have:

liver disease;

kidney disease; or

if you are pregnant or breast-feeding.

Zinecard is rated as FDA pregnancy category C. It is not known whether Zinecard will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Totect is rated as FDA pregnancy category D. Do not use Totect if you are pregnant. It could harm the unborn baby. If possible before you receive Zinecard, tell your doctor if you are pregnant. It is not known whether dexrazoxane passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using dexrazoxane. In an emergency situation, it may not be possible before you are treated with Totect to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication. How is dexrazoxane given?

Dexrazoxane is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

Totect is usually started within 6 hours after extravasation, and continued once daily for 3 days.

Zinecard is usually started 30 minutes before you receive your doxorubicin injection.

Dexrazoxane can add to the bone marrow lowering effects of chemotherapy. This can weaken your immune system, making it easier for you to get sick from being around others who are ill.

To be sure this medication is not causing harmful effects, your blood cells and kidney function will need to be tested often. Do not miss any follow up visits to your doctor for blood or urine tests. What happens if I miss a dose?

Since dexrazoxane is given by a healthcare professional as part of your chemotherapy treatment, you are not likely to miss a dose.

Call your doctor if you miss a chemotherapy appointment.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid after receiving dexrazoxane?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Dexrazoxane side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your doctor at once if you have any of these serious side effects:

fever, chills, body aches, flu symptoms, sores in your mouth and throat;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

bruising, swelling, warmth, redness, oozing, or bleeding of any surgical incision.

Less serious side effects may include:

swelling in your hands or feet;

hair loss;

nausea, vomiting, diarrhea, loss of appetite;

sore throat, trouble swallowing;

dizziness, tired feeling; or

pain, swelling, or redness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect dexrazoxane?

Some cancer medications may be less effective if they are used with dexrazoxane. Tell your doctor if your chemotherapy medications include:

fluorouracil (5-FU, Adrucil);

cyclophosphamide (Cytoxan, Neosar).

This list is not complete and other drugs may interact with dexrazoxane. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Totect resources Totect Side Effects (in more detail)Totect Use in Pregnancy & BreastfeedingTotect Support Group0 Reviews for Totect - Add your own review/rating Totect Consumer Overview Totect Prescribing Information (FDA) Totect Advanced Consumer (Micromedex) - Includes Dosage Information Dexrazoxane Prescribing Information (FDA) Dexrazoxane Professional Patient Advice (Wolters Kluwer) Dexrazoxane MedFacts Consumer Leaflet (Wolters Kluwer) Dexrazoxane Hydrochloride Monograph (AHFS DI) Zinecard Prescribing Information (FDA) Compare Totect with other medications Extravasation Where can I get more information? Your doctor or pharmacist can provide more information about dexrazoxane.

See also: Totect side effects (in more detail)

Neutrogena Lotion

Generic Name: topical emollients (TOP i kal ee MOL i ents) Brand Names: Aloe Vesta Cream, AlphaSoft, AmeriPhor, Aqua Glycolic, Aqua Lube, Aquaphor, Aveeno, Baby Lotion, Baby Oil, Bag Balm, Baza-Pro, Beta Care, Blistex Lip Balm, Carmex, CarraKlenz, CeraVe, CeraVe AM, Cetaphil Lotion, Chap Stick, Citraderm, CoolBottoms, Corn Huskers Lotion, Curel Moisture Lotion, Derma Soothe, Dr Scholl's Essentials Cracked Skin Repair, Eucerin, Herpecin-L, K-Y Jelly, Keri Lotion, Lamisilk Heel Balm, Lubri-Soft, Lubriderm, Mederma, Moisturel, Natural Ice, NeutrapHor, NeutrapHorus Rex, Neutrogena Cleansing, Neutrogena Lotion, Nivea, Nutraderm, Pacquin, Phisoderm, Pretty Feet & Hands, Proshield Skincare Kit, Remedy 4-in-1 Cleansing Lotion, Replens, Secura, Sensi-Care, Soft Sense, St. Ives, Theraplex Lotion, Vaseline Intensive Care

What are Neutrogena Lotion (topical emollients)?

Emollients are substances that moisten and soften your skin.

Topical (for the skin) emollients are used to treat or prevent dry skin. Topical emollients are sometimes contained in products that also treat acne, chapped lips, diaper rash, cold sores, or other minor skin irritation.

There are many brands and forms of topical emollients available and not all are listed on this leaflet.

Topical emollients may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Neutrogena Lotion (topical emollients)? You should not use a topical emollient if you are allergic to it. Topical emollients will not treat or prevent a skin infection.

Ask a doctor or pharmacist before using this medication if you have deep wounds or open sores, swelling, warmth, redness, oozing, bleeding, large areas of skin irritation, or any type of allergy.

What should I discuss with my healthcare provider before using Neutrogena Lotion (topical emollients)? You should not use a topical emollient if you are allergic to it. Topical emollients will not treat or prevent a skin infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

deep wounds or open sores;

swelling, warmth, redness, oozing, or bleeding;

large areas of skin irritation;

any type of allergy; or

if you are pregnant or breast-feeding. How should I use Neutrogena Lotion (topical emollients)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Clean the skin where you will apply the topical emollient. It may help to apply this product when your skin is wet or damp. Follow directions on the product label.

Shake the product container if recommended on the label.

Apply a small amount of topical emollient to the affected area and rub in gently.

If you are using a stick, pad, or soap form of topical emollient, follow directions for use on the product label.

Do not use this product over large area of skin. Do not apply a topical emollient to a deep puncture wound or severe burn without medical advice.

If your skin appears white or gray and feels soggy, you may be applying too much topical emollient or using it too often.

Some forms of topical emollient may be flammable and should not be used near high heat or open flame, or applied while you are smoking.

Store as directed away from moisture, heat, and light. Keep the bottle, tube, or other container tightly closed when not in use.

What happens if I miss a dose?

Since this product is used as needed, it does not have a daily dosing schedule. Seek medical advice if your condition does not improve after using a topical emollient.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking Neutrogena Lotion (topical emollients)? Avoid getting topical emollients in your eyes, nose, or mouth. If this does happen, rinse with water. Avoid exposure to sunlight or tanning beds. Some topical emollients can make your skin more sensitive to sunlight or UV rays. Neutrogena Lotion (topical emollients) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using the topical emollient and call your doctor if you have severe burning, stinging, redness, or irritation where the product was applied.

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Neutrogena Lotion (topical emollients)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied products. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Neutrogena Lotion resources Neutrogena Lotion Use in Pregnancy & BreastfeedingNeutrogena Lotion Support Group0 Reviews for Neutrogena - Add your own review/rating Biafine Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Campath Monograph (AHFS DI) Campral Monograph (AHFS DI) Camptosar Monograph (AHFS DI) Diabinese Monograph (AHFS DI) Kinerase Cream MedFacts Consumer Leaflet (Wolters Kluwer) Neosalus Foam MedFacts Consumer Leaflet (Wolters Kluwer) Promiseb Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Neutrogena Lotion with other medications Dry Skin Where can I get more information? Your pharmacist can provide more information about topical emollients.

Hemoban
Dosage Form: solutionHemoban

DIRECTIONS FOR USE

REF 10808 – Hemoban – 1oz/30mL

Trexall

Generic Name: methotrexate (Oral route, Injection route)

meth-oh-TREX-ate

Injection route(Powder for Solution;Solution)

Only for life-threatening neoplastic disease or severe rheumatoid arthritis and psoriasis unresponsive to other therapies. Death, fetal death and/or congenital anomalies, lung disease, tumor lysis syndrome, fatal skin reactions, and Pneumocystis carinii pneumonia have been reported. Monitor for bone marrow, liver, lung, and kidney toxicities. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs). Hepatotoxicity, fibrosis, and cirrhosis occur with prolonged use. Diarrhea and ulcerative stomatitis require interruption of therapy. Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Increased risk of soft tissue necrosis and osteosarcoma with concomitant radiotherapy. Malignant lymphoma may occur. Use extreme caution with high dose regimen for osteosarcoma. Do not use formulations/diluents with preservatives for intrathecal or high dose therapy .

Oral route(Tablet)

Only for life-threatening neoplastic disease or severe rheumatoid arthritis and psoriasis unresponsive to other therapies. Death, fetal death and/or congenital anomalies, lung disease, tumor lysis syndrome, fatal skin reactions, and Pneumocystis carinii pneumonia have been reported. Monitor for bone marrow, liver, lung, and kidney toxicities. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs). Hepatotoxicity, fibrosis, and cirrhosis occur with prolonged use. Diarrhea and ulcerative stomatitis require interruption of therapy. Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Increased risk of soft tissue necrosis and osteosarcoma with concomitant radiotherapy. Malignant lymphoma may occur .

Commonly used brand name(s)

In the U.S.

Rheumatrex Dose Pack Trexall

Available Dosage Forms:

Tablet Solution Powder for Solution Injectable

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

Uses For Trexall

Methotrexate belongs to the group of medicines known as antimetabolites. It is used to treat cancer of the breast, head and neck, lung, blood, bone, and lymph, and tumors in the uterus. It may also be used to treat other kinds of cancer, as determined by your doctor.

Methotrexate blocks an enzyme needed by the cell to live. This interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by methotrexate, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with methotrexate, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Methotrexate is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, methotrexate is used in certain patients with the following medical conditions:

Acute nonlymphocytic leukemia (a type of cancer of the blood and lymph system) Cancer in the membranes that cover and protect the brain and spinal cord (the meninges) Cancer of the bladder Cancer of the brain (lymphoma) Cancer of the cervix Cancer of colon and rectum Cancer of the esophagus Cancer of the ovaries Cancer of the pancreas Cancer of the penis Cancers of the soft tissues of the body, including the muscles, connective tissues (tendons), vessels that carry blood or lymph, or fat Cancer of the stomach Hodgkin's lymphoma (a cancer of the lymph system, a part of the body's immune system) Before Using Trexall

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Newborns and other infants may be more sensitive to the effects of methotrexate. However, in other children it is not expected to cause different side effects or problems than it does in adults.

Geriatric

Side effects may be more likely to occur in the elderly, who are usually more sensitive to the effects of methotrexate.

Pregnancy Pregnancy Category Explanation All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adenovirus Vaccine Type 4, Live Adenovirus Vaccine Type 7, Live Alclofenac Amoxicillin Apazone Asparaginase Aspirin Bacillus of Calmette and Guerin Vaccine, Live Benoxaprofen Bentiromide Bismuth Subsalicylate Carprofen Dantrolene Dexlansoprazole Diclofenac Diflunisal Dipyrone Doxycycline Droxicam Esomeprazole Etodolac Fenbufen Fenoprofen Flurbiprofen Ibuprofen Indomethacin Indoprofen Influenza Virus Vaccine, Live Isoxicam Ketoprofen Ketorolac Leflunomide Measles Virus Vaccine, Live Meclofenamate Mefenamic Acid Mezlocillin Mumps Virus Vaccine, Live Nabumetone Naproxen Nimesulide Omeprazole Oxaprozin Pantoprazole Penicillin G Penicillin V Phenylbutazone Phenytoin Piperacillin Pirazolac Piroxicam Pirprofen Pristinamycin Probenecid Proquazone Pyrimethamine Rabeprazole Rotavirus Vaccine, Live Rubella Virus Vaccine, Live Salsalate Smallpox Vaccine Sulfamethizole Sulfamethoxazole Sulfapyridine Sulfisoxazole Sulindac Suprofen Tamoxifen Tenidap Tenoxicam Tiaprofenic Acid Tolmetin Triamterene Trimethoprim Typhoid Vaccine Varicella Virus Vaccine Warfarin Yellow Fever Vaccine Zomepirac

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amiodarone Cyclosporine Eltrombopag Mercaptopurine Procarbazine Rofecoxib Theophylline Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Alcohol abuse (or history of)—Increased risk of unwanted effects on the liver Chickenpox (including recent exposure) or Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body Colitis Disease of the immune system Gout (history of) or Kidney stones (or history of)—Methotrexate may increase levels of a chemical called uric acid in the body, which can cause gout or kidney stones Infection—Methotrexate can reduce immunity to infection Intestine blockage or Kidney disease or Liver disease—Effects may be increased because of slower removal of methotrexate from the body Mouth sores or inflammation or Stomach ulcer—May be worsened Proper Use of methotrexate

This section provides information on the proper use of a number of products that contain methotrexate. It may not be specific to Trexall. Please read with care.

Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Methotrexate is often given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

While you are using methotrexate, your doctor may want you to drink extra fluids so that you will pass more urine. This will help the drug to pass from the body, and will prevent kidney problems and keep your kidneys working well.

Methotrexate commonly causes nausea and vomiting. Even if you begin to feel ill, do not stop using this medicine without first checking with your doctor. Ask your health care professional for ways to lessen these effects.

If you vomit shortly after taking a dose of methotrexate, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Trexall

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not drink alcohol while using this medicine. Alcohol can increase the chance of liver problems.

Some patients who take methotrexate may become more sensitive to sunlight than they are normally. When you first begin taking methotrexate, avoid too much sun and do not use a sunlamp until you see how you react to the sun, especially if you tend to burn easily. In case of a severe burn, check with your doctor.

Do not take medicine for inflammation or pain (aspirin or other salicylates, diclofenac, diflunisal, fenoprofen, ibuprofen, indomethacin, ketoprofen, meclofenamate, mefenamic acid, naproxen, phenylbutazone, piroxicam, sulindac, suprofen, tolmetin) without first checking with your doctor. These medicines may increase the effects of methotrexate, which could be harmful.

While you are being treated with methotrexate, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Methotrexate may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Methotrexate can lower the number of white blood cells in your blood temporarily, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination. Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin. Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done. Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime. Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur. Trexall Side Effects

Along with their needed effects, medicines like methotrexate can sometimes cause unwanted effects such as blood problems, kidney problems, stomach or liver problems, loss of hair, and other side effects. These and others are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Black, tarry stools blood in urine or stools bloody vomit diarrhea joint pain reddening of skin stomach pain swelling of feet or lower legs Less common Blurred vision confusion convulsions (seizures) cough pinpoint red spots on skin shortness of breath unusual bleeding or bruising

Check with your doctor as soon as possible if any of the following side effects occur:

More common Sores in mouth and on lips Less common Back pain cough or hoarseness accompanied by fever or chills dark urine dizziness drowsiness fever or chills headache lower back or side pain accompanied by fever or chills painful or difficult urination accompanied by fever or chills unusual tiredness or weakness yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Loss of appetite nausea or vomiting Less common Acne boils pale skin skin rash or itching

This medicine may cause a temporary loss of hair in some people. After treatment with methotrexate has ended, normal hair growth should return.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Back pain blurred vision confusion convulsions (seizures) dizziness drowsiness fever headache unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Trexall side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Trexall resources Trexall Side Effects (in more detail)Trexall Use in Pregnancy & BreastfeedingDrug ImagesTrexall Drug InteractionsTrexall Support Group0 Reviews for Trexall - Add your own review/rating Trexall Prescribing Information (FDA) Trexall MedFacts Consumer Leaflet (Wolters Kluwer) Trexall Concise Consumer Information (Cerner Multum) Methotrexate Prescribing Information (FDA) Methotrexate Monograph (AHFS DI) Methotrexate MedFacts Consumer Leaflet (Wolters Kluwer) Methotrexate Sodium, Preservative Free injection Concise Consumer Information (Cerner Multum) Compare Trexall with other medications Acute Lymphoblastic LeukemiaAcute Lymphocytic LeukemiaAcute Nonlymphocytic LeukemiaBladder CancerBrain TumorBreast CancerBullous PemphigoidCervical CancerChoriocarcinomaCogan's SyndromeColorectal CancerDermatomyositisEctopic PregnancyEczemaEsophageal CarcinomaGastric CancerGraft-versus-host diseaseHead and Neck CancerHodgkin's LymphomaLymphomaMeningeal LeukemiaMycosis FungoidesNeoplastic DiseasesNon-Hodgkin's LymphomaNon-Small Cell Lung CancerOsteosarcomaOvarian CancerPancreatic CancerPemphigoidPemphigusPsoriasisPsoriatic ArthritisRheumatoid ArthritisSmall Cell Lung CancerSoft Tissue SarcomaSolid TumorsSystemic SclerosisTrophoblastic DiseaseUveitis

Miacalcin Ns

Generic Name: calcitonin (Nasal route)

kal-si-TOE-nin (SA-man)

Commonly used brand name(s)

In the U.S.

Fortical Miacalcin

In Canada

Miacalcin Ns

Available Dosage Forms:

Spray

Therapeutic Class: Calcium Regulator

Pharmacologic Class: Calcitonin

Uses For Miacalcin Ns

Calcitonin nasal is used together with calcium and vitamin D to treat bone loss in women with postmenopausal osteoporosis who have been postmenopause for at least 5 years.

This medicine is available only with your doctor's prescription.

Before Using Miacalcin Ns

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of calcitonin nasal in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of calcitonin nasal in the elderly. However, elderly patients are more likely to have unwanted side effects (e.g., irritation or redness of the nose, stuffy or runny nose), which may require caution in patients receiving calcitonin nasal.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Lithium Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Paget's disease—Use with caution. Some medicines used for this condition (e.g., alendronate, etidronate, or risedronate) may keep calcitonin nasal from working properly. Proper Use of calcitonin (salmon)

This section provides information on the proper use of a number of products that contain calcitonin (salmon). It may not be specific to Miacalcin Ns. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off with water right away.

Each spray bottle contains 30 doses of the medicine. Keep track of the doses you use and throw away any unused medicine after 30 doses, even if the bottle is not completely empty.

This medicine usually comes with patient instructions. Read the instructions carefully before using this medicine. If you have any questions about using the pump spray, ask your doctor.

To assemble the pump:

If your medicine and its pump were not already assembled by the pharmacist, carefully follow the instructions provided with the container. Remove the bottle of solution from the refrigerator and let it slowly warm up to room temperature (less than 77 degrees F). Lift the plastic tab and pull the metal safety seal off the bottle. Hold the bottle upright and carefully pull the rubber stopper out of the bottle. Hold the spray pump unit and remove the plastic cap from the bottom of the unit. Hold the bottle upright and place the spray pump unit into the bottle. Turn the spray pump unit clockwise and tighten it until it is securely fastened.

To prepare this medicine:

Before you use a new bottle of calcitonin spray, the spray pump will need to be primed (started). If your pharmacist assembled the unit for you, check to see if it has already been primed by pumping the unit once. If a full spray comes out, the unit has already been primed; if not, you must prime the pump. To prime a new bottle, hold the bottle upright and away from you, then pump it several times until you see a faint spray. Do not prime the pump again before each daily use.

To use the nose spray:

Before using the spray, blow your nose gently to clear the nostrils. Keeping your head in an upright position, carefully place the nozzle into one nostril. Press the pump toward the bottle one time. Do not spray more than once. Do not inhale while spraying. To keep the nosepiece clean, wipe it with a clean tissue and replace the dust cap after use. Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For nasal dosage form (nose spray): For postmenopausal osteoporosis: Adults—One spray into one nostril per day. It is best to change which nostril you use each day. As an example, you should spray into the left side on the first day, then into the right side on the second day, and back to the left side on the third day. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the unopened bottle in the refrigerator. Do not freeze. You may store the opened bottle in an upright position at room temperature, away from heat and direct light. An opened bottle of Miacalcin® can be stored for up to 35 days, and an opened bottle of Fortical® can be stored for up to 30 days. Throw away any unused medicine after 30 or 35 days based on the brand you are using.

Precautions While Using Miacalcin Ns

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Your doctor may also want to check your nose before and during treatment with this medicine.

Your doctor might give you an allergy skin test to see if you are allergic to calcitonin before using this medicine.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause irritation in the nose that can be painful and serious. Stop using this medicine and check with your doctor right away if you have more than one of the following symptoms: sneezing; runny or stuffy nose; shortness of breath; troubled breathing; or heavy nosebleeds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Miacalcin Ns Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Crusting, patches, or sores inside the nose dryness, itching, redness, swelling, tenderness, or other signs of nasal irritation not present before use of this medicine headaches (severe or continuing) nosebleeds runny nose stuffy nose sneezing Less common Bloody or cloudy urine difficult, burning, or painful urination difficulty with breathing or wheezing (severe) dizziness frequent urge to urinate loss of sense of smell swollen glands upper respiratory infection, with chest pain, chills, cough, ear congestion or pain, fever, head congestion, hoarseness or other voice changes, nasal congestion, runny nose, sneezing, or sore throat Rare Hair loss hives, itching, or skin rash increased thirst taste disturbances

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Back pain joint pain Less common or rare Abdominal or stomach pain burning, dry, or itching eyes constipation diarrhea flu-like symptoms (fever with or without chills, headache, body ache) flushing mental depression muscle pain nausea unusual tearing of the eyes unusual tiredness or weakness upset stomach

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Miacalcin Ns side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Miacalcin Ns resources Miacalcin Ns Side Effects (in more detail)Miacalcin Ns Use in Pregnancy & BreastfeedingMiacalcin Ns Drug InteractionsMiacalcin Ns Support Group1 Review for Miacalcin Ns - Add your own review/rating Compare Miacalcin Ns with other medications HypercalcemiaOsteogenesis ImperfectaOsteoporosisPaget's Disease

Gonal-f RFF Pen

Generic Name: follicle stimulating hormone (FOL ik al STIM ue lay ting HOR mone) Brand Names: Follistim AQ, Follistim AQ Cartridge, Gonal-F, Gonal-f RFF, Gonal-f RFF Pen

What is Gonal-f RFF Pen (follicle stimulating hormone)?

Follicle stimulating hormone is a man-made form of a hormone that occurs naturally in the body. This hormone regulates ovulation, the growth and development of eggs in a woman's ovaries.

Follicle stimulating hormone is used to treat infertility in women who cannot ovulate and do not have primary ovarian failure. Follicle stimulating hormone is also used to stimulate sperm production in men.

Follicle stimulating hormone is often used together with another medication called human chorionic gonadotropin (hCG).

Follicle stimulating hormone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Gonal-f RFF Pen (follicle stimulating hormone)? Do not use this medication if you are already pregnant. Your doctor may give you a pregnancy test to make sure you are not pregnant before you receive follicle stimulating hormone.

Follicle stimulating hormone is not effective in women with primary ovarian failure or in men with primary testicular failure.

You should not use this medicine if you are allergic to follicle stimulating hormone, neomycin (Mycifradin, Neo-Fradin) or streptomycin, or if you have an untreated or uncontrolled endocrine disorder (thyroid, pituitary gland, or adrenal gland), heavy or abnormal vaginal bleeding that has not been checked by a doctor, an ovarian cyst, or cancer of the breast, ovary, uterus, or testicle.

Before using follicle stimulating hormone, tell your doctor if you have polycystic ovary disease, asthma, or a history of stroke or blood clot.

You should not breast-feed while you are using follicle stimulating hormone. Avoid having sex and call your doctor right away if you have any of the following symptoms of a fluid buildup in your stomach or chest area: severe pain in your lower stomach, nausea, vomiting, diarrhea, bloating, feeling short of breath, swelling or weight gain, or urinating less than usual.

Fertility treatment may increase your chance of having twins, triplets, etc (multiple births). These are high-risk pregnancies both for the mother and the babies. Talk to your doctor if you have concerns about this risk.

What should I discuss with my healthcare provider before using Gonal-f RFF Pen (follicle stimulating hormone)?

This medication is not effective in women with primary ovarian failure (when the ovaries are unable to produce an egg).

This medication is not effective in men with primary testicular failure (when the testicles are unable to produce sperm).

You should not use follicle stimulating hormone if you are allergic to it, if you are already pregnant, or if you have:

an untreated or uncontrolled disorder of the thyroid, pituitary gland, or adrenal glands;

heavy or abnormal vaginal bleeding that has not been checked by a doctor;

an ovarian cyst;

cancer of the breast, ovary, uterus, testicle, hypothalamus, or pituitary gland; or

if you are allergic to neomycin (Mycifradin, Neo-Fradin) or streptomycin.

To make sure you can safely use follicle stimulating hormone, tell your doctor if you have:

polycystic ovary disease;

asthma; or

a history of stroke or blood clot.

FDA pregnancy category X. Follicle stimulating hormone can harm an unborn baby or cause birth defects. Do not use this medication if you are already pregnant. Your doctor may give you a pregnancy test to make sure you are not pregnant before you receive follicle stimulating hormone. Tell your doctor right away if you become pregnant during treatment.

Fertility treatment may increase your chance of having twins, triplets, etc (multiple births). These are high-risk pregnancies both for the mother and the babies. Talk to your doctor if you have concerns about this risk.

It is not known whether follicle stimulating hormone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using follicle stimulating hormone. How should I use Gonal-f RFF Pen (follicle stimulating hormone)? You must remain under the care of a doctor while using follicle stimulating hormone.

Follicle stimulating hormone is injected under the skin or into a muscle. You will be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

The cartridge and injection pen are used only for an injection under the skin. Follicle stimulating hormone in a vial (bottle) is for injection into a muscle using a syringe.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Your doctor may occasionally change your dose to make sure you get the best results.

Prepare your syringe or injection pen only when you are ready to give yourself an injection. Do not use the medication if it looks cloudy or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

If you use follicle stimulating hormone to get pregnant, you may need to have sex daily for several days in a row. The timing of sex within your dosing schedule is important for this treatment to work.

To be sure this medication is helping your condition, your blood may need to be tested often. You may also need ultrasound exams. Visit your doctor regularly.

Storing unopened vials, cartridges, or injection pens: Keep in the carton and store in a refrigerator or at room temperature. Do not freeze. Protect from light and use within 3 months.

Storing after your first use: Keep the vial, cartridge, or injection pen at room temperature or in the refrigerator and use within 28 days. Protect from light.

Take the injection pen out of the refrigerator and allow it to reach room temperature before giving the injection. Do not heat the medicine before using.

Throw away any unused vial, cartridge, or pen after the expiration date on the label has passed.

Do not share this medication with another person, even if they have the same symptoms you have. What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of follicle stimulating hormone.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using Gonal-f RFF Pen (follicle stimulating hormone)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Gonal-f RFF Pen (follicle stimulating hormone) side effects Some women using this medicine have developed a sudden buildup of fluid in the stomach or chest area. This condition is called ovarian hyperstimulation syndrome (OHSS), and can be a life-threatening. Avoid having sex and call your doctor right away if you have any of the following symptoms of OHSS:

severe pain in your lower stomach;

nausea, vomiting, diarrhea, bloating;

feeling short of breath;

swelling in your hands or legs;

weight gain;

urinating less than usual.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using follicle stimulating hormone and call your doctor at once if you have a serious side effect such as:

sudden numbness or weakness (especially on one side of the body);

pain, swelling, warmth, or redness in your arms or legs; or

severe pelvic pain on one side.

Less serious side effects may include:

headache;

mild nausea or stomach pain;

mild numbness or tingly feeling;

mild pelvic pain, tenderness, or discomfort;

runny or stuffy nose, sore throat;

breast swelling or tenderness;

acne;

mild skin rash; or

pain, bruising, redness, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Gonal-f RFF Pen (follicle stimulating hormone)?

There may be other drugs that can interact with follicle stimulating hormone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Gonal-f RFF Pen resources Gonal-f RFF Pen Side Effects (in more detail)Gonal-f RFF Pen Use in Pregnancy & BreastfeedingGonal-f RFF Pen Drug InteractionsGonal-f RFF Pen Support Group0 Reviews for Gonal-f RFF Pen - Add your own review/rating Gonal-f RFF Pen Solution MedFacts Consumer Leaflet (Wolters Kluwer) Follistim Consumer Overview Follistim Advanced Consumer (Micromedex) - Includes Dosage Information Follistim AQ Consumer Overview Follistim AQ MedFacts Consumer Leaflet (Wolters Kluwer) Follistim AQ Prescribing Information (FDA) Gonal-F Prescribing Information (FDA) Gonal-F Advanced Consumer (Micromedex) - Includes Dosage Information Gonal-f Powder MedFacts Consumer Leaflet (Wolters Kluwer) Gonal-f RFF Prescribing Information (FDA) Compare Gonal-f RFF Pen with other medications Follicle StimulationHypogonadism, MaleOvulation Induction Where can I get more information? Your doctor or pharmacist can provide more information about follicle stimulating hormone.

See also: Gonal-f RFF Pen side effects (in more detail)

Ocular Tuberculosis Medications

There are currently no drugs listed for "Ocular Tuberculosis".

Definition of Ocular Tuberculosis: Tuberculosis infection of the eye(s).

Learn more about Ocular Tuberculosis

Micromedex Care Notes:

Tuberculosis

Medical Encyclopedia:

Disseminated tuberculosis Drug List:

Ceretec
Dosage Form: injection, powder, lyophilized, for solution

Diagnostic Radiopharmaceutical

For intravenous use only

Ceretec Description

The Ceretec kit is supplied as a pack of 5 vials for use in the preparation of a technetium Tc99m exametazime intravenous injection as a diagnostic radiopharmaceutical for use as an adjunct in the detection of altered regional cerebral perfusion and for the radiolabeling of autologous leukocytes. Each vial of Ceretec contains a pre-dispensed sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime [(RR,SS)-4.8-diaza-3,6,6,9-tetramethylundecane-2, 10-dione bisoxime], 7.6 µg stannous chloride dihydrate (minimum stannous tin 0.6 µg; maximum total stannous and stannic tin 4.0 µg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative.

Prior to publication of the USAN, exametazime was formerly known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications.

The structural formula of exametazime is:

When sterile pyrogen-free sodium pertechnetate Tc99m in isotonic saline is added to the vial of Ceretec, a Tc99m complex of exametazime is formed.

Administration is by intravenous injection for diagnostic use.

Physical Characteristics

Technetium Tc99m decays by isomeric transition with a physical half-life of 6.03 hours.(1) Photons that are useful for imaging studies are listed in Table 1.

Table 1. Principal Radiation Emission Data-technetium Tc99m Radiation Mean %/

Cafergot oral/rectal

Generic Name: caffeine and ergotamine (oral/rectal) (KAF een and er GOT a meen) Brand Names: Cafergot, Migergot

What is caffeine and ergotamine?

Caffeine is a stimulant that causes narrowing of blood vessels (vasoconstriction).

Ergotamine is in a group of drugs called ergot alkaloids (ER-got AL-ka-loids). It works by narrowing the blood vessels around the brain. Ergotamine also affects blood flow patterns that are associated with certain types of headaches.

The combination of caffeine and ergotamine is used to treat or prevent a migraine type headache.

This medication will only treat a headache that has already begun. It will not prevent migraine headaches or reduce the number of attacks.

Caffeine and ergotamine should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches.

Caffeine and ergotamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about caffeine and ergotamine? This medication can harm an unborn baby or a nursing baby. Do not use caffeine and ergotamine if you are pregnant or breast-feeding. Do not use this medication if you are allergic to caffeine and ergotamine or other ergot medicines, or if you have a history of heart disease, angina (chest pain), blood circulation problems, history of a heart attack or stroke, coronary artery disease, uncontrolled high blood pressure, severe liver or kidney disease, or a serious infection. Using certain medications together with caffeine and ergotamine can cause even greater decreases in blood flow than caffeine and ergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Tell your doctor about all other medications you are using, especially antibiotics, antidepressants, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Also tell your doctor about all of your medical conditions, especially breathing problems, high blood pressure, liver or kidney disease, or risk factors for coronary artery disease (diabetes, high blood pressure or cholesterol, menopause or hysterectomy, smoking, taking birth control pills, being overweight, having a family history of coronary artery disease, or being a man older than 40).

This medication will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Never use more than your prescribed dose of caffeine and ergotamine. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. An overdose of caffeine and ergotamine can be fatal. What should I discuss with my healthcare provider before using caffeine and ergotamine ? Do not use this medication if you are allergic to caffeine or ergotamine, or other ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert).

Do not use caffeine and ergotamine if you are pregnant or breast-feeding, or if you have:

a history of heart disease, angina (chest pain), blood circulation problems, or history of a heart attack or stroke;

coronary artery disease or "hardening of the arteries";

uncontrolled high blood pressure;

severe liver disease; severe kidney disease; or

a serious infection called sepsis.

Using certain medications together with caffeine and ergotamine can cause even greater decreases in blood flow than caffeine and ergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Do not use caffeine and ergotamine if you are also using any of the following medications:

conivaptan (Vaprisol);

diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), telithromycin (Ketek), or troleandomycin (Tao);

an antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

an antidepressant such as nefazodone;

heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan); or

HIV/AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir).

Caffeine and ergotamine can cause rare but serious side effects on the heart, including heart attack or stroke. If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using caffeine and ergotamine, tell your doctor if you have:

breathing problems;

high blood pressure;

liver disease;

kidney disease; or

coronary artery disease (or risk factors that include diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category X. This medication can cause birth defects. Do not use caffeine and ergotamine if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using caffeine and ergotamine. Caffeine and ergotamine passes into breast milk and may be harmful to a nursing infant. Do not use caffeine and ergotamine without telling your doctor if you are breast-feeding a baby. How should I use caffeine and ergotamine?

Use this medication exactly as prescribed by your doctor. Never use more than your prescribed dose of caffeine and ergotamine. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. Caffeine and ergotamine is not for daily use.

To use caffeine and ergotamine tablets: Take 2 tablets of caffeine and ergotamine as soon as you notice headache symptoms, or after an attack has already begun.

If your headache does not completely go away, you may take 1 more tablet after at least 30 minutes have passed. If additional medication is needed, you may take 1 tablet every 30 minutes up to a total of 6 tablets for one migraine attack.

If you still have migraine symptoms after taking a total of 6 tablets, call your doctor. Do not take more than a total of 6 tablets in any 24-hour period. Do not take more than a total of 10 tablets over a period of 7 days.

To use caffeine and ergotamine rectal suppositories: Insert 1 suppository at the first sign of migraine headache symptoms, or after an attack has already begun. If your headache does not completely go away, use 1 more suppository after at least 1 hour has passed.

Do not take a rectal suppository by mouth. It is for use only in your rectum.

Try to empty your bladder just before using the suppository. Remove the outer wrapper from the suppository and insert it gently into the rectum, pointed tip first. Avoid handling the suppository too long or it will melt in your hands.

For best results, lie down after inserting the suppository and hold it in for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after you have inserted the suppository.

If you still have migraine symptoms after using a total of 2 rectal suppositories, call your doctor. Do not use more than a total of 2 suppositories per headache. Do not use more than a total of 5 suppositories over a period of 7 days. Do not give this medication to anyone else, even if they have the same headache symptoms you have. Caffeine and ergotamine can be dangerous if it is used to treat headache in a person who has not been diagnosed by a doctor as having true migraine headaches. Store caffeine and ergotamine at room temperature away from moisture, heat, and light. Do not use any stored caffeine and ergotamine if the expiration date on the label has passed. What happens if I miss a dose?

Since caffeine and ergotamine is used only when needed, you are not likely to miss a dose.

Do not take more than 6 caffeine and ergotamine tablets per day or more than 10 tablets per week. Do not use more than 2 suppositories per headache or 5 suppositories per week. What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. An overdose of caffeine and ergotamine can be fatal.

Overdose can cause vomiting, confusion, drowsiness, weak pulses in your arms and legs, numbness and tingling or pain in your hands or feet, blue-colored fingers or toes, fainting, and seizure (convulsions).

What should I avoid while using caffeine and ergotamine? Do not use caffeine and ergotamine within 24 hours before or after using another migraine headache medicine, including:

dihydroergotamine (D.H.E. 45, Migranal), caffeine and ergotamine (Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), methysergide (Sansert); or

almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), sumatriptan (Imitrex), rizatriptan (Maxalt, Maxalt-MLT), or zolmitriptan (Zomig).

Grapefruit and grapefruit juice may interact with caffeine and ergotamine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Caffeine and ergotamine side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using caffeine and ergotamine and call your doctor at once if you have a serious side effect such as:

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance;

fast or slow heart rate;

muscle pain in your arms or legs;

leg weakness;

numbness or tingling and a pale or blue-colored appearance in your fingers or toes;

severe pain in your stomach or lower back;

urinating less than usual or not at all;

painful sores on your rectum after using the rectal suppositories;

swelling or itching in any part of your body;

cough with stabbing chest pain and trouble breathing; or

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

dizziness, spinning sensation;

weakness;

nausea, vomiting; or

mild itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect caffeine and ergotamine?

Many drugs can interact with caffeine and ergotamine. Below is just a partial list. Talk with your doctor before using caffeine and ergotamine if you are also taking:

birth control pills;

zileuton (Zyflo);

cold or allergy medications;

nicotine (Nicoderm, Nicorette);

diet pills, stimulants, or medication to treat ADHD (such as Ritalin or Adderall);

an antidepressant such fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), nefazodone (Serzone), paroxetine (Paxil), sertraline (Zoloft), and others;

nitroglycerin or other nitrate medicines such as isosorbide (Isordil, Dilatrate, Imdur, Monoket); or

heart or blood pressure medication such as atenolol (Tenormin), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and there may be other drugs that can interact with caffeine and ergotamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Cafergot resources Cafergot Side Effects (in more detail)Cafergot Use in Pregnancy & BreastfeedingDrug ImagesCafergot Drug InteractionsCafergot Support Group5 Reviews for Cafergot - Add your own review/rating Compare Cafergot with other medications Cluster HeadachesMigraine Where can I get more information? Your pharmacist can provide more information about caffeine and ergotamine.

See also: Cafergot side effects (in more detail)

Vetrimec Plus
Dosage Form: FOR ANIMAL USE ONLYVETone™

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