Proton pump inhibitors

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Proton pump inhibitors act by irreversible inhibition of the H+/K+ ATPase, in the parietal cells of the stomach. It markedly inhibits gastric acid secretion and has a long duration of action. They are used for treatment of gastric and duodenal ulcers, gastroesophageal reflux disease and other excessive gastrointestinal acid secretory disorders.

See also

Medical conditions associated with proton pump inhibitors:

Aspiration PneumoniaBarrett's EsophagusDuodenal UlcerDuodenal Ulcer ProphylaxisErosive EsophagitisGastrointestinal HemorrhageGERDHelicobacter Pylori InfectionIndigestionMultiple Endocrine AdenomasNSAID-Induced Gastric UlcerNSAID-Induced Ulcer ProphylaxisPathological Hypersecretory ConditionsPeptic UlcerStomach UlcerStress Ulcer ProphylaxisSystemic MastocytosisZollinger-Ellison Syndrome Drug List:AciphexNexiumProtonixDexilant-Delayed-Release-CapsulesPrilosec-Otc-Delayed-Release-CapsulesZegerid-OtcPrevacid-OtcProtonix-I-V

Minims Lidocaine & Fluorescein

Minims*

Lidocaine and Fluorescein

4% w/v Lidocaine hydrochloride and 0.25% w/v Fluorescein Sodium

About your eye drops

The name of this medicine is Minims Lidocaine & Fluorescein. Each Minims unit contains a solution of 4% w/v Lidocaine hydrochloride with 0.25% w/v fluorescein sodium.

One of the active ingredients in this medicine is lidocaine hydrochloride. This is the new name for lignocaine hydrochloride. The ingredient itself has not changed.

It also contains purified water, povidone and hydrochloric acid. Each Minims unit is a sterile, single-use container which holds approximately 0.5ml of solution. Each carton holds 20 Minims units. Lidocaine is a local anaesthetic which temporarily numbs the surface of the eye. Fluorescein temporarily colours your eyes orange or green and helps your doctor or eye specialist to examine them.

Who makes your eye drops?

Minims Lidocaine and Fluorescein are manufactured by

Laboratoire Chauvin S.A. ZI Ripotier 07200/Aubenas France

The Marketing Authorisations for Minims Lidocaine and Fluorescein (PL 0033/0073 & PA 118/24/1) are held by

Chauvin Pharmaceuticals Ltd. 106 London Road Kingston-Upon-Thames KT2 6TN England What are your eye drops for?

Your eye drops are used to numb and stain the surface of the eye, for a short time only, to allow the doctor or eye specialist to examine your eye.

Most often, your eye drops are used to allow the pressure inside your eyes to be measured.

Before using your eye drops

You should not use this product if you are allergic to fluorescein or Lidocaine and other similar types of local anaesthetic.

This product should be used with care in eyes that are inflamed (red and painful).

Your eye drops are not intended for long term use. Frequent use of local anaesthetic in the eye over long periods of time may affect your eyesight.

Using your eye drops

The doctor or eye specialist will put the drops in for you. You may be asked to press on the inner corners of your eyes for a minute to stop the solution draining into your nose and throat through the tear ducts.

It is important to protect your eye from dust during the time your eye is numb. Your doctor or eye specialist will make sure that your eye is properly protected.

The Minims unit should be thrown away after a single use, even if some solution remains.

It is unlikely that you will suffer an overdose from Minims Lidocaine & Fluorescein, but if you do suddenly feel unwell after receiving the drops, tell your doctor or eye specialist.

Following administration of Minims Lidocaine & Fluorescein you may experience very rare side effects which includes redness and irriatation of the eye, swelling around the eye, rarely difficulty in breathing and symptoms of shock and itchy skin rash with raised red blotches.

After using your eye drops

Tell your doctor or eye specialist if you suffer from any unwanted effects after using Minims Lidocaine & Fluorescein, that are not mentioned in this leaflet.

Storing your eye drops

The expiry date is printed on each Minims unit overwrap and printed on the carton label. Do not use it after this date.

Your eye drops should be stored below 25°C and in original container to protect from light. Do not allow to freeze.

This leaflet applies only to Minims Lidocaine & Fluorescein, but does not contain all the

If you have any questions or are not sure about anything, ask a doctor, eye specialist or pharmacist.

Date of (Partial) Revision of Text:

August 2005.

* Trade Mark

Chauvin Pharmaceuticals Ltd. 106 London Road Kingston-Upon-Thames KT2 6TN England Tel:020 8781 2900 Fax:020 8781 2901

Art. 76441 0504128/4

Humulin 50/50 Vials
Pronunciation: IN-su-lin EYE-soe-faneGeneric Name: Insulin Isophane (NPH)/Insulin RegularBrand Name: Examples include Humulin 50/50 and Novolin 70/30

Glyceryl Trinitrate Tablets BP 500 micrograms
1. Name Of The Medicinal Product

GLYCERYL TRINITRATE TABLETS BP 500 micrograms

2. Qualitative And Quantitative Composition

Each tablet contains 500 micrograms Glyceryl Trinitrate BP.

3. Pharmaceutical Form

White uncoated tablets.

White, circular, biconvex uncoated tablets, impressed “C” on one face and the identifying letters “GF” on the reverse.

4. Clinical Particulars 4.1 Therapeutic Indications

As a short-acting vasodilator

Relief of angina pectoris

Prophylaxis of angina pectoris

Relief of acute spontaneous coronary artery spasm

4.2 Posology And Method Of Administration

Posology

1-2 tablets (0.5-1.0mg) should be placed under the tongue and allowed to dissolve slowly; this dose should be repeated as required. If pain persists after a total of 3 doses in 15minutes the patient should be advised to seek medical attention.

Dosage should be adjusted according to the response obtained by the individual patient and the severity of the anginal pain.

NB Tolerance may develop with daily use, but withdrawal for a week re-establishes the original sensitivity.

Method of Administration

For sublingual administration

4.3 Contraindications

Known hypersensitivity to nitrates and other ingredients in the tablets. Patients with rare hereditary problems of galactose intolerence, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Marked anaemia, raised intercranial pressure including that caused by head trauma, cerebral haemorrhage, closed angle glaucoma, hypotensive conditions, hypovolaemia, obstructive hypertrophic cardiomyopathy, aortic stenosis, mitral stenosis, cardiac tamponade, obstructive heart failure and constrictive pericarditis.

Phosphodiesterase type-5 inhibitors (eg sildenafil, tadalafil, vardenafil) have been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates, and their co-administration with nitrates or nitric oxide donors is therefore contra-indicated.

4.4 Special Warnings And Precautions For Use

Caution is necessary in patients with severe hepatic or renal impairment, hypothyroidism, hypoxaemia, hypothermia or a recent history of myocardial infaraction and malnutrition.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Some effects of glyceryl trinitrate are enhanced by alcohol. The hypotensive effects of nitrates are potentiated by concurrent administration of phosphodiestrase type-5 inhibitors (eg sildenafil, tadalafil, vardenafil).

Glyceryl trinitrate may potentiate the effects of anti-hypertensive drugs (such as vasodilators, beta-blockers, calcium-channel blockers, diuretics).

There is a potential for drugs that cause dry mouth (eg anticholinergic, antimuscarinics, tricyclic antidepressants) to reduce the effectiveness of sublingual nitrates.

There have been some reports that the anticoagulant effects of heparin may be reduced by the concurrent use of nitrates. The effects of heparin should be monitored and dose adjusted as necessary.

An enhanced hypotensive effect with sublingual apomorphine may occur as a result of concomitant administration with glyceryl trinitrate.

Ergot alkaloids may oppose the coronary vasodilatation of nitrates. Ergot alkaloids can precipitate angina and glyceryl trinitrate can reduce the first pass hepatic metabolism of dihydroergotamine.

4.6 Pregnancy And Lactation

There is no, or inadequate, evidence of safety of nitrates in human pregnancy or lactation; nitrates should not be administered in pregnancy or lactation unless considered essential.

4.7 Effects On Ability To Drive And Use Machines

As Glyceryl trinitrate can cause dizziness patients should make sure they are not affected before driving or operating machinery. This effect appears to be accentuated by alcohol.

4.8 Undesirable Effects

System Organ Class

Very Common

(

Common

(

Uncommon

(

Rare

(

Very Rare

(< 1/10,00)

Frequency not known (cannot be estimated from the available data)

Nervous system disorders

Throbbing headache

Vertigo

       

Eye disorders

         

Increased ocular pressure

Cardiac disorders

     

Tachycardia, bradycardia

 

Syncope, hypoxaemia

Vascular disorders

 

Dizziness

 

Postural hypotension

   

Gastrointestinal disorders

 

Nausea

     

vomiting

Skin and subcutaneous tissue disorders

 

Facial flushing

 

Allergic skin reactions

Exfoliative dermatitis

 

General disorders and administration site complications

 

Weakness

Localised burning sensation

      4.9 Overdose

Toxic effects of glyceryl trinitrate include vomiting, restlessness, hypotension, syncope, cyanosis and methaemoglobinaemia; impairment of respiration, hypoxia, bradycardia and psychosis may ensue.

Overdosage should be treated with gastric lavage, followed by charcoal administration if necessary in case that nitrates were ingested, attention to any respiratory and circulatory symptoms. Oxygen may prove additionally useful.

Effects of hypotension may be minimised by treating the patient in the recumbent position with the head lowered or raised legs. Methaemoglobinaemia may be treated with methylene blue intravenously 1-4mg/kg body-weight. The circulation may be maintained with infusions of plasma or suitable electrolyte solutions.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: CO1D AO2 Organic nitrates

Glyceryl trinitrate is a vasodilator and is used for angina of effort. Vasodilation is achieved by the releasing of free redical nitric oxide which activates guanylate cyclase and increases synthesis of guanosine 3? and 5?-monophosphate with resultant effects on the phosphorylation of proteins in smooth muscle. If taken in excess, its vasodilatory effect can cause headache.

5.2 Pharmacokinetic Properties

Glyceryl trinitrate is readily absorbed from the oral mucosa, but rapidly metabolised so that it only has a fleeting duration of action.

Glyceryl trinitrate is also readily absorbed from the gastrointestinal tract, but owing to extensive first-pass metabolism in the liver its bioavailability is reduced (short plasma half-life).

Glyceryl trinitrate is metabolised by hydrolysis to dinitrates and the mononitrate, which is the main urinary metabolite.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

The tablets also contain: lactose, stearic acid, magnesium stearate, colloidal silicon dioxide, mannitol, acacia.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf-life

Two years from the date of manufacture.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Discard 8 weeks after first opening.

6.4 Special Precautions For Storage

Store below 25°C in a dry place.

Protect from light.

6.5 Nature And Contents Of Container

The product is supplied in amber glass bottles with screw caps lined with aluminium foil.

Pack sizes: 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 200s, 1000s

Product may also be supplied in bulk packs, for reassembly purposes only, in amber glass containers with screw caps lined with aluminium foil, filled with aluminium foil as a cushioning material.

Maximum size of bulk packs: 5,000

6.6 Special Precautions For Disposal And Other Handling

• Your Glyceryl Trinitrate tablets will be presented in a glass airtight container with a foil-lined cap. Keep them in this.

• After use reclose the bottle cap tightly.

• Do not put cotton wool, other drugs, or anything else in the bottle with the tablets.

• Store the tablets below 25oC in a dry place, protected from light. If you need to carry them with you DO NOT carry them close to your body, rather in a purse, wallet or handbag.

If you do not use the tablets within 8 weeks of first opening the bottle, obtain a fresh supply and return the old tablets to your pharmacist. (A fresh tablet should produce a slight burning sensation when placed under the tongue; if this does not occur, obtain a fresh supply). In any event do not use the tablets after the expiry date shown.

Administrative Data 7. Marketing Authorisation Holder

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

8. Marketing Authorisation Number(S)

PL 0142/6296 R

9. Date Of First Authorisation/Renewal Of The Authorisation

February 1986

January 1994, June 1999

10. Date Of Revision Of The Text

16/04/2010

Adrenocortical Insufficiency Medications

Definition of Adrenocortical Insufficiency:

Loss, to varying degrees, of adrenocortical function.

Synonym: hypocorticoidism.

Drugs associated with Adrenocortical Insufficiency

The following drugs and medications are in some way related to, or used in the treatment of Adrenocortical Insufficiency. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Adrenocortical Insufficiency

Micromedex Care Notes:

Addison's DiseaseSecondary Adrenal Insufficiency

Medical Encyclopedia:

Exogenous adrenal insufficiency Drug List:AristocortClinacort-InjectionCortefDe-Sone-La-InjectionDeltasoneDexacort-Phosphate-In-TurbinaireDexasone-InjectionDexpak-Tablets-Dose-PackKen-Jec-40-InjectionMeticortenSolurex-InjectionSterapredTac-3-InjectionTriamcot-InjectionU-Tri-Lone-InjectionZema-Pak-10-Day

Naglazyme

Generic Name: galsulfase (gal SUL fase) Brand Names: Naglazyme

What is galsulfase?

Galsulfase is used to treat some of the symptoms of a genetic condition called Maroteaux-Lamy syndrome. Maroteaux-Lamy syndrome is also called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis).

Maroteaux-Lamy syndrome is a metabolic disorder in which the body lacks the enzyme needed to break down certain sugars and proteins. These substances can build up in the body, causing enlarged organs, abnormal bone structure, changes in facial features, breathing problems, heart problems, vision or hearing loss, and changes in mental or physical abilities.

Galsulfase may improve walking and stair-climbing ability in people with this condition. However, this medication is not a cure for Maroteaux-Lamy syndrome.

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

What is the most important information I should know about galsulfase? Galsulfase may improve walking and stair-climbing ability in people with Maroteaux-Lamy syndrome. However, galsulfase is not a cure for this condition. Some people receiving a galsulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, fever or chills, skin rash, itching, nausea, vomiting, stomach pain, pain in your chest, trouble breathing, or if you feel like you might pass out when galsulfase is injected.

Your name may need to be listed on a patient registry while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that galsulfase has on long-term treatment of Maroteaux-Lamy syndrome.

What should I discuss with my health care provider before receiving galsulfase? You should not use this medication if you are allergic to galsulfase or mouse proteins.

Before receiving galsulfase, tell your doctor if you are allergic to any drugs, or if you have:

sleep apnea (breathing stops during sleep);

a fever; or

flu symptoms, or a common cold.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use galsulfase.

Your name may need to be listed on a patient registry while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that galsulfase has on long-term treatment of Maroteaux-Lamy syndrome.

FDA pregnancy category B. This medication is not expected to 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 galsulfase passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby. How is galsulfase given?

Galsulfase is given as an injection through a needle placed into a vein. You will most likely receive this injection in a clinic or hospital setting. Galsulfase is usually given once per week.

The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.

Your doctor may also prescribe other medications to help prevent an allergic reaction to galsulfase. Take all of your medications as directed.

To be sure this medication is helping your condition and not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your galsulfase injection.

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

Symptoms of a galsulfase overdose are not known.

What should I avoid while receiving galsulfase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are receiving galsulfase.

Galsulfase side effects Some people receiving a galsulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, fever or chills, skin rash, itching, nausea, vomiting, stomach pain, pain in your chest, trouble breathing, or if you feel like you might pass out when galsulfase is injected. 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.

Less serious side effects may include:

headache;

joint pain;

eye redness;

nausea, vomiting, stomach pain, diarrhea;

runny or stuffy nose, sore throat, cough, ear pain; or

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

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 galsulfase?

There may be other drugs that can interact with galsulfase. 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 Naglazyme resources Naglazyme Side Effects (in more detail)Naglazyme Use in Pregnancy & BreastfeedingNaglazyme Support Group0 Reviews for Naglazyme - Add your own review/rating Naglazyme Prescribing Information (FDA) Naglazyme Consumer Overview Naglazyme Advanced Consumer (Micromedex) - Includes Dosage Information Naglazyme MedFacts Consumer Leaflet (Wolters Kluwer) Galsulfase Professional Patient Advice (Wolters Kluwer) Compare Naglazyme with other medications Mucopolysaccharidosis Type VI Where can I get more information? Your pharmacist can provide more information about galsulfase.

See also: Naglazyme side effects (in more detail)

Good Sense Sleep Aid
Dosage Form: tabletPerrigo Sleep Aid Tablets Drug Facts Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Uses helps to reduce difficulty in falling asleep Warnings

Ask a doctor before use if you have

a breathing problem such as asthma, emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Do not give

to children under 12 years of age

Ask a doctor or pharmacist before use if you are

taking any other drugs

When using this product avoid alcoholic beverages take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. 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 of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use Other information store at 68°-77°F (20°-25°C) retain in carton until time of use see carton end panel for lot number and expiration date Inactive ingredients

dibasic calcium phosphate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-800-719-9260

Principal Display Panel

Fall Asleep Fast!

Sleep Aid Tablets

Doxylamine Succinate Tablets, 25 mg

Nighttime Sleep-Aid

Safe, Proven Effective

Just One Tablet Per Dose

Actual Size

Compare to active ingredient of Unisom® SleepTabs®

Sleep Aid Tablets Carton

Menopur injectable

Generic Name: menotropins (injectable) (MEN oh troe pins) Brand Names: Menopur, Repronex

What are menotropins?

Menotropins are an equal mixture of the naturally occurring follicle-stimulating hormone (FSH) and luteinizing hormone (LH). FSH and LH are important for the development of follicles (eggs) produced by the ovaries and for the development of sperm.

Menotropins are used to stimulate ovulation (the release of an egg) when a woman's ovaries can produce a follicle but hormonal stimulation is deficient. Menotropins are also used to stimulate the development of multiple eggs for in vitro fertilization. Likewise, menotropins are used to stimulate the production of sperm in men who have functioning testes but in whom hormonal stimulation is deficient.

Menotropins may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about menotropins?

Menotropins may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

What should I discuss with my healthcare provider before using menotropins?

Menotropins will not induce ovulation or sperm production if your ovaries or testes are not functioning properly.

Do not use menotropins without first taking to your doctor if you

might be pregnant;

have a thyroid problem;

have cancer or a tumor of the breast, ovary, uterus, hypothalamus, or pituitary gland;

have undiagnosed vaginal bleeding;

have ovarian cysts or enlargement; or

have any other serious or chronic medical illness.

You may not be able to use menotropins, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Do not use menotropins if you are pregnant. Menotropins are in the FDA pregnancy category X. This means that they are known to cause birth defects. It is not known whether menotropins pass into breast milk. Do not use menotropins without first talking to your doctor if you are breast-feeding a baby. How should I use menotropins?

Use menotropins exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Formulations of menotropins intended for intramuscular injection (an injection into muscle) must not be administered subcutaneously (under the skin), and vice versa. If you are administering this medication at home, your doctor will give you detailed instructions on how to mix the solution and give yourself the injection. Do not inject menotropins if you are not sure how.

Use the solution immediately after it is mixed. Throw away any medicine that is left over.

Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.

Store menotropins at room temperature or in the refrigerator, away from direct light, moisture, and heat.

What happens if I miss a dose?

Contact your doctor if you miss a dose of menotropins. Do not use a double dose of this medication without first talking to your doctor.

What happens if I overdose? An overdose of menotropins is unlikely to threaten life. Notify your doctor immediately or call an emergency room or poison control center for advice.

Symptoms of a menotropins overdose are not known. Ovarian hyperstimulation syndrome (OHSS) may result with an overdose of menotropins. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal.

What should I avoid while using menotropins?

There are no restrictions on food, beverages, or activity during therapy with menotropins unless your doctor directs otherwise.

Menotropins side effects Stop using menotropins and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Less than 2% of female patients treated with menotropins develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these side effects.

Serious pulmonary (lung and breathing) conditions have been reported in patients using menotropins. Seek medical attention if you experience any sudden changes in your breathing.

Other side effects may also occur. Notify your doctor if you experience

ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;

nausea, vomiting, or diarrhea;

shortness of breath;

pain, warmth, or tenderness centralized in an arm or leg;

fever or chills;

headache or drowsiness;

weakness or aching of muscles or joints;

breast enlargement or tenderness;

pain, swelling, or irritation at the injection site; or

rash.

Menotropins may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

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 menotropins?

It is not known whether other medications will interact with menotropins. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines including vitamins, minerals, and herbal products.

More Menopur resources Menopur Side Effects (in more detail)Menopur Use in Pregnancy & BreastfeedingMenopur Drug InteractionsMenopur Support Group0 Reviews for Menopur - Add your own review/rating Compare Menopur with other medications Female InfertilityFollicle StimulationOvulation Induction Where can I get more information? Your pharmacist can provide more information about menotropins.

See also: Menopur side effects (in more detail)

Vaginal anti-infectives

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Vaginal anti-infectives are available as creams, pessaries (tablets), gels or solutions to treat either bacterial or fungal vaginal infections. Vaginal antifungal products are used to treat vaginal thrush. Antibacterial vaginal products are used for bacterial infections such as bacterial vaginosis. Other products are used to manage irritation or minor soreness.

See also

Medical conditions associated with vaginal anti-infectives:

AcneBacterial VaginitisCutaneous CandidiasisFungal Infection ProphylaxisOral ThrushPerioral DermatitisRosaceaTinea CorporisTinea CrurisTinea PedisTinea VersicolorVaginal Yeast Infection Drug List:Zeasorb-Af-GelLotrimin-Af-PowderVagistat-1ClindesseTerazol-CreamMonistat-5Monistat-1Aloe-Vesta-2-In-1-AntifungalBazaBetadine-Spray-Aerosol-SolutionCleocin-CreamClotrimazole-3Cruex-Prescription-StrengthDesenex-Prescription-StrengthFungoidGyne-Lotrimin-3-CreamM-Zole-Dual-PackMicatin-Cooling-ActionMicatin-Foot-Powder-DeodorantMicatin-Liquid-FootMicro-Guard-TopicalMiranel-Af-LiquidMonistat-Derm-CreamMonistat-3-CreamMycelex-OtcPharmadine-Aerosol-SolutionRecuro-VaginalSultrin-Triple-SulfaTerazol-7Trimo-SanVitazol-TopicalZazole-Cream

atenolol Intravenous

a-TEN-oh-lol

Intravenous route(Solution)

Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction and ventricular arrhythmias have occurred. As with other beta blockers, when discontinuation of atenolol is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. If the angina worsens or acute coronary insufficiency develops, it is recommended that atenolol be promptly reinstituted, at least temporarily. Patients should be warned against interruption or discontinuation of therapy without the physician's advice .

Commonly used brand name(s)

In the U.S.

Tenormin

Available Dosage Forms:

Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Beta-Adrenergic Blocker, Cardioselective

Uses For atenolol

Atenolol injection is used to reduce the risk of death from an acute heart attack. It is given to people who have already had a heart attack .

atenolol is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart .

atenolol is available only with your doctor's prescription .

Before Using atenolol

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 atenolol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to atenolol 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 atenolol injection 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 atenolol injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart disease, which may require caution and an adjustment of dosage in patients receiving atenolol injection .

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. 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 receiving atenolol, 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 atenolol 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.

Albuterol Amiodarone Arformoterol Bambuterol Bitolterol Broxaterol Clenbuterol Clonidine Colterol Diltiazem Dronedarone Fenoldopam Fenoterol Formoterol Hexoprenaline Indacaterol Isoetharine Levalbuterol Metaproterenol Pirbuterol Procaterol Reproterol Rimiterol Ritodrine Salmeterol Terbutaline Tretoquinol Tulobuterol Verapamil

Using atenolol 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.

Acarbose Aceclofenac Acemetacin Acetohexamide Alclofenac Alfuzosin Amlodipine Apazone Arbutamine Benfluorex Benoxaprofen Bromfenac Bufexamac Bunazosin Carprofen Chlorpropamide Clometacin Clonixin Dexketoprofen Diclofenac Diflunisal Digoxin Dipyrone Disopyramide Doxazosin Droxicam Etodolac Etofenamate Felbinac Felodipine Fenbufen Fenoprofen Fentiazac Floctafenine Flufenamic Acid Flurbiprofen Gliclazide Glimepiride Glipizide Gliquidone Glyburide Guar Gum Ibuprofen Indomethacin Indoprofen Insulin Insulin Aspart, Recombinant Insulin Glulisine Insulin Lispro, Recombinant Isoxicam Ketoprofen Ketorolac Lacidipine Lercanidipine Lornoxicam Manidipine Meclofenamate Mefenamic Acid Meloxicam Metformin Mibefradil Miglitol Moxisylyte Nabumetone Naproxen Nicardipine Nifedipine Niflumic Acid Nilvadipine Nimesulide Nimodipine Nisoldipine Nitrendipine Oxaprozin Oxyphenbutazone Phenoxybenzamine Phentolamine Phenylbutazone Pirazolac Piroxicam Pirprofen Pranidipine Prazosin Propyphenazone Proquazone Quinidine Repaglinide St John's Wort Sulindac Suprofen Tamsulosin Tenidap Tenoxicam Terazosin Tiaprofenic Acid Tolazamide Tolbutamide Tolmetin Trimazosin Troglitazone Urapidil Zomepirac 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 atenolol. Make sure you tell your doctor if you have any other medical problems, especially:

Bradycardia (slow heartbeat) or Heart block or Heart failure or Pheochromocytoma (adrenal gland tumor), untreated—Should not use in patients with these conditions . Diabetes or Hyperthyroidism (overactive thyroid) or Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat . Kidney disease—Use with caution. The effects may be increased because of slower removal from the body . Lung disease (e.g., asthma, bronchitis, emphysema)—May cause difficulty with breathing in patients with this condition . Proper Use of atenolol

A nurse or other trained health professional will give you atenolol. atenolol is given through a needle placed in one of your veins .

Precautions While Using atenolol

Your doctor will only give you a few doses of atenolol, and then you will be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor .

atenolol 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 or nurse immediately if any of the following side effects occur:

More common Blurred vision chest pain or discomfort confusion dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly shortness of breath slow or irregular heartbeat sweating unusual tiredness or weakness Less common Anxiety cough difficulty breathing dizziness or lightheadedness fainting fast heartbeat noisy breathing sudden shortness of breath or troubled breathing tightness in chest wheezing Rare Bloody urine decreased frequency or amount of urine increased blood pressure increased thirst loss of appetite lower back or side pain nausea swelling of face, fingers, or lower legs vomiting weight gain Incidence not determined Black, tarry stools bleeding gums blood in urine or stools bone or joint pain disturbed color perception double vision feeling that others are watching you or controlling your behavior feeling that others can hear your thoughts feeling, seeing, or hearing things that are not there fever halos around lights loss of vision night blindness overbright appearance of lights paleness or cold feeling in fingertips and toes pinpoint red or purple spots on skin severe mood or mental changes skin irritation or rash, including rash that looks like psoriasis skin rash, hives, or itching sore throat swollen or painful glands tingling or pain in fingers or toes when exposed to cold tunnel vision unusual behavior unusual bleeding or bruising

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

Symptoms of overdose Anxiety coma cool, pale skin depression dilated neck veins extreme fatigue headache increased hunger irregular breathing nervousness nightmares seizures shakiness slurred speech unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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:

Incidence not determined Decreased interest in sexual intercourse dry mouth inability to have or keep an erection loss in sexual ability, desire, drive, or performance loss of hair, temporary pain of penis on erection

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: atenolol Intravenous 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.

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Prenatal Multivitamins and Minerals with Iron, Folic Acid, Docusate Sodium, and Omega-3 Fatty Acids
Pronunciation: pree-NATE-al VYE-ta-mins/MIN-er-als/EYE-urn/FOE-lik AS-id/DOK-ue-sate SOE-dee-um/oh-MAY-ga 3 FA-tee AS-idsGeneric Name: Prenatal Multivitamins and Minerals with Iron, Folic Acid, Docusate Sodium, and Omega-3 Fatty AcidsBrand Name: PrimaCare One

Fortovase
Generic Name: Saquinavir (sa-KWIN-a-veer)Brand Name: Fortovase

Fortovase cannot be interchanged with saquinavir mesylate ( Invirase) capsules.

Lavoclen-4

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 Lavoclen-4 (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 Lavoclen-4 (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 Lavoclen-4 (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 Lavoclen-4 (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 Lavoclen-4 (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.

Lavoclen-4 (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 Lavoclen-4 (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 Lavoclen-4 resources Lavoclen-4 Side Effects (in more detail)Lavoclen-4 Use in Pregnancy & BreastfeedingLavoclen-4 Drug InteractionsLavoclen-4 Support Group0 Reviews for Lavoclen-4 - 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 Lavoclen-4 with other medications AcnePerioral Dermatitis Where can I get more information? Your pharmacist can provide more information about benzoyl peroxide topical.

See also: Lavoclen-4 side effects (in more detail)

Ampyra

Generic Name: dalfampridine (dal FAM pri deen) Brand Names: Ampyra

What is dalfampridine?

Dalfampridine is a potassium channel blocker.

Dalfampridine is used to improve walking in patients with multiple sclerosis (MS).

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

What is the most important information I should know about dalfampridine? You should not use dalfampridine if you are allergic to it, or if you have moderate to severe kidney disease, if you have ever had a seizure (convulsions), or if you are also taking another multiple sclerosis drug called Fampridine.

Before you take dalfampridine, tell your doctor if you have kidney disease.

Do not take more than 2 tablets in a 24-hour period. Do not use a tablet that has been broken or crushed. A broken tablet can release too much of the drug at one time. This can increase your risk of having a seizure. Stop taking dalfampridine and call your doctor at once if you a seizure, pain or burning when you urinate, problems with your balance, numbness or tingly feeling, or a relapse of your MS symptoms. What should I discuss with my health care provider before taking dalfampridine? You should not use dalfampridine if you are allergic to it, or if you have:

moderate to severe kidney disease;

if you have ever had a seizure (convulsions); or

if you are also taking another MS drug called Fampridine (4-aminopyridine).

To make sure you can safely take dalfampridine, tell your doctor if you have kidney disease.

FDA pregnancy category C. It is not known whether dalfampridine 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 dalfampridine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using dalfampridine. Do not give this medication to anyone under 18 years old without the advice of a doctor. How should I take dalfampridine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Dalfampridine is usually taken once every 12 hours. Follow your doctor's instructions.

Do not take more than 2 tablets in a 24-hour period.

Dalfampridine may be taken with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Do not dissolve the tablet in liquid. Breaking or dissolving the pill may cause too much of the drug to be released at one time. Do not use a dalfampridine tablet that has been accidentally crushed or broken. This can increase your risk of having a seizure. Store at room temperature away from moisture and heat.

Throw away any leftover medicine after the expiration date on the label has passed.

See also: Ampyra dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take 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.

Overdose can cause confusion, problems with thinking or memory, tremors, sweating, or seizures.

What should I avoid while taking dalfampridine?

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

Dalfampridine 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 taking dalfampridine and call your doctor at once if you have a serious side effect such as:

seizure (convulsions);

pain or burning when you urinate;

problems with balance;

numbness, burning pain, or tingly feeling;

relapse or worsening of MS symptoms;

Less serious side effects may include:

headache, dizziness;

sleep problems (insomnia);

nausea, constipation, upset stomach;

weakness;

stuffy nose, sinus pain, sore throat; or

back pain.

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 dalfampridine?

There may be other drugs that can interact with dalfampridine. 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 Ampyra resources Ampyra Side Effects (in more detail)Ampyra DosageAmpyra Use in Pregnancy & BreastfeedingAmpyra Drug InteractionsAmpyra Support Group17 Reviews for Ampyra - Add your own review/rating Ampyra Prescribing Information (FDA) Ampyra Monograph (AHFS DI) Ampyra Advanced Consumer (Micromedex) - Includes Dosage Information Ampyra Consumer Overview Ampyra MedFacts Consumer Leaflet (Wolters Kluwer) Dalfampridine Professional Patient Advice (Wolters Kluwer) Compare Ampyra with other medications Multiple Sclerosis Where can I get more information? Your pharmacist can provide more information about dalfampridine.

See also: Ampyra side effects (in more detail)

Hytrin BPH 2mg Tablets
1. Name Of The Medicinal Product

Hytrin Tablets 2mg

Terazosin Tablets 2mg

2. Qualitative And Quantitative Composition     mg/tablet

Active:

Terazosin

as monohydrochloride dihydrate

2.0 3. Pharmaceutical Form

Yellow, round, flat bevelled tablets embossed with logo and triangular facets on one face and plain on the other.

4. Clinical Particulars 4.1 Therapeutic Indications

Orally administered Hytrin is indicated in the treatment of mild to moderate hypertension. It may be used in combination with thiazide diuretics and/or other antihypertensive drugs or as sole therapy where other agents are inappropriate or ineffective. The hypotensive effect is most pronounced on the diastolic pressure. Although the exact mechanism of the hypotensive action of terazosin is not established, the relaxation of peripheral blood vessels appears to be produced mainly by competitive antagonism of post-synaptic alpha1 - adrenoceptors. Hytrin usually produces an initial gradual decrease in blood pressure followed by a sustained antihypertensive action.

Orally administered Hytrin is also indicated as a therapy for the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH). Terazosin is a selective post synaptic alpha-1 -adrenoreceptor antagonist. Antagonism of alpha-i -receptors on prostatic and urethral smooth muscle has been shown to improve urinary tract flow and relieve the urinary obstruction caused by BPH.

4.2 Posology And Method Of Administration

Hypertension.

Adults

Initial dose

1 mg before bedtime is the starting dose for all patients and should not be exceeded. Compliance with this initial dosage recommendation should be strictly observed to minimise potential for acute first-dose hypotensive episodes.

Subsequent doses

The single daily dosage may be increased by approximately doubling the dosage at weekly intervals to achieve the desired blood pressure response.

The usual maintenance dose is 2mg to 10mg once daily. Doses over 20mg rarely improve efficacy and doses over 40mg have not been studied.

BPH

Adults Only:

The dose of terazosin should be adjusted according to the patient's response. The following is a guide to administration:

Initial dose

1 mg before bedtime is the starting dose for all patients and should not be exceeded. Strict compliance with this recommendation should be observed to minimise acute first-dose hypotensive episodes.

Subsequent dose

The dose may be increased by approximately doubling at weekly or bi-weekly intervals to achieve the desired reduction in symptoms. The maintenance dose is usually 5 to 10mg once daily. Improvements in symptoms have been detected as early as two weeks after starting treatment with terazosin.

At present there are insufficient data to suggest additional symptomatic relief with doses above 10mg once daily.

Treatment should be initiated using the BPH Starter Pack and response to treatment reviewed at four weeks. Transient side effects may occur at each titration step. If any side effects persist, consideration should be given to reducing the dose.

Use in renal insufficiency

Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in the recommended dosages.

Use in Children

Safety and efficacy in children has not been established.

Use in the Elderly

Pharmacokinetic studies in the elderly indicate that no alteration in dosage recommendation is required.

Postural Hypotension

Postural hypotension has been reported to occur in patients receiving terazosin for the symptomatic treatment of urinary obstruction caused by BPH. In these cases, the incidence of postural hypotensive events was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%)

Use with thiazide diuretics and other antihypertensive agents

When adding a thiazide diuretic or another antihypertensive agent to a patient's regimen the dose of Hytrin should be reduced and retitration carried out if necessary. Caution should be observed when Hytrin is administered with thiazides or other antihypertensive agents as hypotension may develop.

4.3 Contraindications

Known sensitivity to alpha-adrenoceptor antagonists.

4.4 Special Warnings And Precautions For Use

As with other alpha adrenoreceptor antagonists, terazosin is not recommended in patients with a history of micturition syncope.

In clinical trials, the incidence of postural hypotension was greater in BPH patients than those with hypertension. In these cases, the incidence of postural hypotension events was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%).

If administration is discontinued for more than several days, therapy should be re-instituted using the initial dosing regimen.

Concomitant use of phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) and terazosin may lead to symptomatic hypotension in some patients. In order to minimise the risk for developing postural hypotension the patient should be stable on the alpha-blocker therapy before initiating use of phosphodiesterase-5-inhibitors.

The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In patients receiving terazosin plus ACE inhibitors or diuretics the proportion reporting dizziness or related side effects was greater than in the total population of terazosin treated patients from clinical trials.

Caution should be observed when terazosin is administered with other antihypertensive agents, to avoid the possibility of significant hypotension. When adding terazosin to a diuretic or other antihypertensive agent, dosage reduction and retitration may be necessary.

Terazosin has been given without interaction with analgesics/anti-inflammatories, cardiac glycosides, hypoglycemics, antiarrhythmics, anxiolytics/sedatives, antibacterials, hormones/steroids and drugs used for gout.

Phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) (see section 4.4).

4.6 Pregnancy And Lactation

Although no teratogenic effects were seen in animal testing, the safety of Hytrin use during pregnancy or during lactation has not yet been established. Hytrin should not be used therefore in pregnancy unless the potential benefit outweighs the risk.

4.7 Effects On Ability To Drive And Use Machines

Dizziness, light-headedness or drowsiness may occur with the initial dose or in association with missed doses and subsequent reinitiation of Hytrin therapy. Patients should be cautioned about these possible adverse effects and the circumstances in which they may occur and advised to avoid driving or hazardous tasks for approximately 12 hours after initial dose or when the dose is increased.

4.8 Undesirable Effects

Hytrin in common with other alpha-adrenoceptor antagonists may cause syncope. Syncopal episodes have occurred within 30 to 90 minutes of the initial dose of the drug. Syncope has occasionally occurred in association with rapid dosage increases or the introduction of another antihypertensive agent.

In clinical trials in hypertension, the incidence of syncopal episodes was approximately one percent. In most cases this was believed to be due to an excessive postural hypotensive effect although occasionally the syncopal episode has been preceded by a bout of tachycardia with heart rates of 120 to 160 beats per minute.

If syncope occurs the patient should be placed in a recumbent position and supportive treatment applied as necessary.

Dizziness, light-headedness or fainting may occur when standing up quickly from a lying or sitting position. Patients should be advised of this possibility and instructed to lie down if these symptoms appear and then sit for a few minutes before standing to prevent their recurrence.

These adverse effects are self limiting and in most cases do not recur after the initial period of therapy or during subsequent re-titration.

Adverse events reported with terazosin

The most common events were asthenia, palpitations, nausea, peripheral oedema, dizziness, somnolence, nasal congestion/rhinitis and blurred vision/amblyopia.

In addition, the following have been reported: back pain; headache; tachycardia; postural hypotension; syncope; oedema; weight gain; pain in extremities; decreased libido; depression; nervousness; paraesthesia; vertigo; dyspnoea; sinusitis and impotence.

Additional adverse reactions reported in clinical trials or reported during marketing experience but not clearly associated with the use of terazosin include the following:

chest pain; facial oedema; fever; abdominal pain; neck pain; shoulder pain; vasodilation; arrhythmia; constipation; diarrhoea; dry mouth; dyspepsia; flatulence; vomiting; gout; arthralgia; arthritis; joint disorders; myalgia; anxiety; insomnia; bronchitis; epistaxis; flu symptoms; pharyngitis; rhinitis; cold symptoms; pruritis; rash; increased cough; sweating; abnormal vision; conjunctivitis; tinnitus; urinary frequency; urinary tract infection and urinary incontinence primarily reported in post-menopausal women.

At least two cases of anaphylactoid reactions have been reported with the administration of terazosin.

Post marketing experience: Thrombocytopenia and priapism have been reported. Atrial fibrillation has been reported: however, a cause and effect relationship has not been established.

Laboratory tests: Small but statistically significant decreases in haematocrit, haemoglobin, white blood cells, total protein and albumin were observed in controlled clinical trials. These laboratory findings suggest the possibility of haemodilution. Treatment with terazosin for up to 24 months had no significant effect on prostate specific antigen (PSA) levels.

4.9 Overdose

Should administration of Hytrin lead to acute hypotension, cardiovascular support is of first importance. Restoration of blood pressure and normalisation of heart rate may be accomplished by keeping the patient in a supine position. If this measure is inadequate, shock should first be treated with volume expanders and if necessary, vasopressors could then be used. Renal function should be monitored and general supportive measures applied as required. Dialysis may not be of benefit since laboratory data indicate that terazosin is highly protein bound.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Although the exact mechanism of the hypotensive action is not established, the relaxation of peripheral blood vessels appears to be produced mainly by competitive antagonism of post-synaptic alpha-adrenoceptors. Hytrin usually produces an initial gradual decrease in blood pressure followed by a sustained antihypertensive action.

Clinical experience indicates that a 2-5% decrease in total cholesterol plasma concentration and a 3-7% decrease in the combined LDLC + VLDLC fraction plasma concentration from pretreatment values are associated with the administration of therapeutic doses of terazosin.

In clinical trials, plasma concentrates of total cholesterol and combined low density and very low density lipoproteins were found to be slightly reduced following Hytrin administration. Additionally, the increase in total cholesterol seen with other hypertensive agents did not occur when these were used in combination with Hytrin.

Studies suggest that alpha-1 -adrenoreceptor antagonism is useful in improving the urodynamics in patients with chronic bladder obstruction such as in benign prostatic hyperplasia (BPH).

The symptoms of BPH are caused mainly by the presence of an enlarged prostate and by the increased smooth muscle tone of the bladder outlet and prostate, which is regulated by alpha-1 -adrenergic receptors.

In in-vitro experiments, terazosin has been shown to antagonise phenylephrine-induced contractions of human pro static tissue. In clinical trials terazosin has been shown to improve the urodynamics and symptomatology in patients with BPH.

5.2 Pharmacokinetic Properties

The plasma concentration of the parent drug is a maximum about 1 hour post administration and declines with a half-life of approximately 12 hours. Food has little or no effect on bioavailability. Approximately 40% of the administered dose is eliminated in the urine and 60% in the faeces. The drug is highly bound to plasma proteins.

5.3 Preclinical Safety Data

Carcinogenicity: Hytrin has been shown to produce tumours in male rats when administered at a high dose over a long period of time. No such occurrences were seen in female rats or in a similar study in mice. The relevance of these findings with respect to the clinical use of the drug in man is unknown.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose

Maize starch

Pregelatinised starch

Purified talc

Magnesium stearate

Purified water

Dye yellow (quinolone yellow, E104)

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Tablets in a blister original pack. The 2mg tablets are supplied in a pack of 28 tablets. Blisters are packaged in a carton with a package insert.

Starter Pack for Hypertension:

The 2mg tablets form part of a starter pack of 28 tablets which also contains 7 x 1mg tablets. Blisters are packaged in a carton with a package insert.

Starter pack for BPH:

Tablets in a blister pack. The starter pack consists of 7 x 1mg, 14 x 2mg and 7 x 5mg tablets. The blisters, of PVC/PVdC, are heat sealed with 20 micron hard tempered aluminium foil and packaged in a carton with a pack insert.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Amdipharm plc

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

8. Marketing Authorisation Number(S)

PL 20072/0029

9. Date Of First Authorisation/Renewal Of The Authorisation

13/05/97

10. Date Of Revision Of The Text

June 2009

Truvada
Generic Name: emtricitabine and tenofovir disoproxil fumarate Dosage Form: tablet, film coatedFULL PRESCRIBING INFORMATION WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of Truvada, in combination with other antiretrovirals [See Warnings and Precautions (5.1)].

Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Truvada have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Truvada. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Truvada. If appropriate, initiation of anti-hepatitis B therapy may be warranted [See Warnings and Precautions (5.2)].

Indications and Usage for Truvada

 Truvada®, a combination of EMTRIVA® and VIREAD®, is indicated in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

The following points should be considered when initiating therapy with Truvada for the treatment of HIV-1 infection:

It is not recommended that Truvada be used as a component of a triple nucleoside regimen. Truvada should not be coadministered with ATRIPLA®, EMTRIVA, VIREAD or lamivudine-containing products [See Warnings and Precautions (5.4)]. In treatment experienced patients, the use of Truvada should be guided by laboratory testing and treatment history [See Clinical Pharmacology (12.4)]. Truvada Dosage and Administration Recommended Dose

 The dose of Truvada for adults and pediatric patients 12 years of age and older with body weight greater than or equal to 35 kg (greater than or equal to 77 lb) is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

Dose Adjustment for Renal Impairment

Significantly increased drug exposures occurred when EMTRIVA or VIREAD were administered to subjects with moderate to severe renal impairment [see EMTRIVA or VIREAD Package Insert]. Therefore, the dosing interval of Truvada should be adjusted in patients with baseline creatinine clearance 30–49 mL/min using the recommendations in Table 1. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients [See Warnings and Precautions (5.3)].

No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in patients with mild renal impairment [See Warnings and Precautions (5.3)].

Table 1 Dosage Adjustment for Patients with Altered Creatinine Clearance Creatinine Clearance (mL/min)* ?50 30–49 <30

Nevirapine Suspension
Pronunciation: ne-VIR-a-peenGeneric Name: NevirapineBrand Name: Viramune

Schistosoma japonicum Medications

Definition of Schistosoma japonicum: A species of trematode worm that parasitises humans and that

Drugs associated with Schistosoma japonicum

The following drugs and medications are in some way related to, or used in the treatment of Schistosoma japonicum. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:Biltricide

methimazole

meth-IM-a-zole

Commonly used brand name(s)

In the U.S.

Tapazole

Available Dosage Forms:

Tablet

Therapeutic Class: Antithyroid Agent

Chemical Class: Thionamide

Uses For methimazole

Methimazole is used to treat hyperthyroidism, a condition where the thyroid gland produces too much thyroid hormone. It is also used before thyroid surgery or radioactive iodine treatment.

Methimazole is an antithyroid medicine. It works by making it harder for the body to use iodine to make thyroid hormone. It does not block the effects of a thyroid hormone that was made by the body before its use was begun.

methimazole is available only with your doctor's prescription.

Before Using methimazole

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 methimazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to methimazole 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methimazole in children.

Geriatric

No information is available on the relationship of age to the effects of methimazole in geriatric patients.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. 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 methimazole, 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 methimazole 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.

Acenocoumarol Anisindione Dicumarol Phenindione Phenprocoumon Warfarin 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 methimazole. Make sure you tell your doctor if you have any other medical problems, especially:

Blood or bone marrow problems (e.g., agranulocytosis, aplastic anemia, thrombocytopenia)—Use with caution. May make these conditions worse. Liver disease—Effects may be increased because of slower removal of the medicine from the body. Proper Use of methimazole

Take methimazole only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

methimazole works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, if you are taking more than one dose a day, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 3 doses a day, the doses should be spaced about 8 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your doctor.

Food in your stomach may change the amount of methimazole that is able to enter the bloodstream. To make sure that you always get the same effects, try to take methimazole at the same time in relation to meals every day. That is, always take it with meals or always take it on an empty stomach.

Dosing

The dose of methimazole 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 methimazole. 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 oral dosage form (tablets): For treatment of hyperthyroidism (overactive thyroid): Adults—At first, 15 to 60 milligrams (mg) daily, divided into 3 equal doses and given every 8 hours. The maintenance dose is 5 to 15 mg daily. Children—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.4 mg per kilogram (kg) of body weight per day, divided into 3 equal doses and given every 8 hours. The maintenance dose is 0.2 mg/kg of body weight per day. Missed Dose

If you miss a dose of methimazole, 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 methimazole

It is very important that your doctor check your progress at regular visits to make sure that methimazole is working properly. Blood tests may be needed to check for unwanted effects.

Using methimazole while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking methimazole. If you think you have become pregnant while using the medicine, tell your doctor right away.

Methimazole can temporarily lower the number of white blood cells in your blood, 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 the 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.

Liver problems may occur while you are using methimazole. Stop using methimazole and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

While you are being treated with methimazole, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Methimazole 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 or have recently taken 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. 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.

Before having any kind of surgery, tell the medical doctor in charge that you are using methimazole. Taking methimazole together with medicines used during surgery may increase the risk of side effects.

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.

methimazole 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 Black, tarry stools chest pain chills cough fever painful or difficult urination shortness of breath sore throat sores, ulcers, or white spots on the lips or in the mouth swollen glands unusual bleeding or bruising unusual tiredness or weakness Rare Backache increase or decrease in urination swelling of the feet or lower legs Incidence not known Abdominal or stomach pain bleeding gums bleeding under the skin blood in the urine or stools burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings cough or hoarseness dark urine difficulty with moving fever with or without chills general feeling of discomfort, illness, or weakness general feeling of tiredness or weakness headache joint pain light-colored stools loss of appetite and weight lower back or side pain muscle aching or cramping muscle pain or stiffness nausea and vomiting numbness or tingling of the hands, feet, or face pinpoint red spots on the skin soreness of the muscles sores, ulcers, or white spots on the lips or in the mouth swollen joints swollen salivary glands swollen, painful, or tender lymph glands in the neck, armpit, or groin tightness in the chest upper right abdominal pain wheezing yellow eyes and skin

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

Symptoms of overdose Cloudy or bloody urine cracks in the skin high blood pressure loss of heat from the body red, swollen skin scaly skin sensation of pins and needles stabbing pain

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:

Incidence not known Abnormal loss of hair dizziness or lightheadedness feeling of constant movement of self or surroundings heartburn hives or welts itching loss of taste pain or discomfort in the chest, upper stomach, or throat redness of the skin sensation of spinning skin rash sleepiness vomiting

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: methimazole side effects (in more detail)

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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 methimazole resources Methimazole Side Effects (in more detail)Methimazole DosageMethimazole Use in Pregnancy & BreastfeedingDrug ImagesMethimazole Drug InteractionsMethimazole Support Group0 Reviews for Methimazole - Add your own review/rating methimazole Concise Consumer Information (Cerner Multum) Methimazole Prescribing Information (FDA) Methimazole Monograph (AHFS DI) Methimazole Professional Patient Advice (Wolters Kluwer) Methimazole MedFacts Consumer Leaflet (Wolters Kluwer) Tapazole Prescribing Information (FDA) Compare methimazole with other medications Hyperthyroidism

SonoVue 8 microlitres / ml, powder and solvent for dispersion for injection
1. Name Of The Medicinal Product

SonoVue 8 microlitres / ml powder and solvent for dispersion for injection

2. Qualitative And Quantitative Composition

One ml contains 8µl of sulphur hexafluoride microbubbles

On reconstitution as directed, 1 ml of the resulting dispersion contains 8 µl sulphur hexafluoride in the microbubbles, equivalent to 45 microgrammes.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Powder and solvent for dispersion for injection.

SonoVue is a kit including

1 vial containing 25 mg of lyophilised powder

1 pre-filled syringe containing 5 ml sodium chloride

1 Mini-Spike transfer system

Information on the appearance of the reconstituted solution is given in section 6.6.

4. Clinical Particulars 4.1 Therapeutic Indications

This medicinal product is for diagnostic use only.

SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, which results in an improved signal to noise ratio.

SonoVue should only be used in patients where study without contrast enhancement is inconclusive.

Echocardiography

SonoVue is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation.

Doppler of macrovasculature

SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteriesby improving the Doppler signal to noise ratio.

SonoVue increases the quality of the Doppler flow image and the duration of clinically-useful signal enhancement in portal vein assessment.

Doppler of microvasculature

SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography, leading to more specific lesion characterisation.

4.2 Posology And Method Of Administration

This product should only be used by physicians experienced in diagnostic ultrasound imaging.

The recommended doses of SonoVue are:

B-mode imaging of cardiac chambers, at rest or with stress: 2 ml.

Vascular Doppler imaging: 2.4 ml.

During a single examination, a second injection of the recommended dose can be made when deemed necessary by the physician.

Elderly Patients

The dosage recommendations also apply to elderly patients.

Paediatric Patients

The safety and effectiveness of SonoVue in patients under 18 years old has not been established and the product should not be used in these patients.

The microbubble dispersion is prepared before use by injecting through the septum 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to the contents of the vial. The vial is then shaken vigorously for a few seconds until the lyophilisate is completely dissolved. The desired volume of the dispersion can be drawn into a syringe any time up to six hours after reconstitution. Just before drawing into the syringe, the vial should be agitated to re-suspend the microbubbles. SonoVue should be administered immediately after drawing into the syringe by injection into a peripheral vein. Every injection should be followed by a flush with 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.

For instructions for preparation see section 6.6.

4.3 Contraindications

SonoVue should not be administered to patients with known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue.

SonoVue is contraindicated for use in patients with recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders.

SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure>90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome.

The safety and efficacy of SonoVue have not been established in pregnant and lactating women therefore, SonoVue should not be administered during pregnancy and lactation (see Section 4.6).

4.4 Special Warnings And Precautions For Use

ECG monitoring should be performed in high-risk patients as clinically indicated.

It should be emphasised that stress echocardiography, which can mimic an ischaemic episode, could potentially increase the risk of SonoVue utilisation. Therefore, if SonoVue is to be used in conjunction with stress echocardiography patients must have a stable condition verified by absence of chest pain or ECG modification during the two preceding days.

Moreover, ECG and blood pressure monitoring should be performed during SonoVue-enhanced echocardiography with a pharmacological stress (e.g. with dobutamine).

Care should be taken in patients with ischaemic cardiac disease because in these patients allergy-like and/or vasodilatory reactions may lead to life-threatening conditions.

Emergency equipment and personnel trained in its use must be readily available. Caution is advised when SonoVue is administered to patients with clinically significant pulmonary disease, including severe chronic obstructive pulmonary disease.

It is recommended to keep the patient under close medical supervision during and for at least 30 minutes following the administration of SonoVue.

Numbers of patients with the following conditions who were exposed to SonoVue in the clinical trials were limited, and therefore, caution is advisable when administering the product to patients with: acute endocarditis, prosthetic valves, acute systemic inflammation and/or sepsis, hyperactive coagulation states and/or recent thromboembolism, and end-stage renal or hepatic disease.

SonoVue is not suitable for use in ventilated patients, and those with unstable neurological diseases.

In animal studies, the application of echo-contrast agents revealed biological side effects (e.g. endothelial cell injury, capillary rupture) by interaction with the ultrasound beam. Although these biological side effects have not been reported in humans, the use of a low mechanical index is recommended.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No specific interaction studies have been performed. There was no apparent relationship with respect to occurrence of adverse events in the clinical studies for patients receiving various categories of the most common concomitant medications.

4.6 Pregnancy And Lactation

No clinical data on exposed pregnancies are available. Animal studies do not indicate harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development

(see section 5.3 Preclinical safety data). Caution should be exercised when prescribing to pregnant women. It is not known if sulphur hexafluoride is excreted in human milk. Therefore, caution should be exercised when SonoVue is administered to breast-feeding women.

4.7 Effects On Ability To Drive And Use Machines

On the basis of the pharmacokinetic and pharmacodynamic profiles, no or negligible influence is expected with the use of SonoVue on the ability to drive or use machines.

4.8 Undesirable Effects

The undesirable effects reported with SonoVue were, in general, non-serious, transient and resolved spontaneously without residual effects.

In clinical trials, the most commonly reported adverse reactions are headache (2.3%), injection site reaction including bruising, burning and paraesthesia at the injection site (1.7%) and injection site pain (1.4%).

There were changes in ECG, blood pressure and in some laboratory parameters measured, but these were not deemed to be of clinical significance.

The adverse reactions reported among 1788 adult patients in clinical studies are:

Body system

Common >1/100, <1/10)

Uncommon >1/1,000 - <1/100)

Metabolism and nutrition disorders

 

Hyperglycaemia

Nervous system disorders

Headache

Paraesthesia, dizziness, insomnia, taste perversion

Eye disorders

 

Vision blurred

Vascular disorder

 

Vasodilatation

Respiratory, thoracic and mediastinal disorders

 

Pharyngitis, sinus pain

Gastrointestinal disorders

Nausea

Abdominal pain

Skin and subcutaneous tissue disorders

 

Pruritus, rash erythematous

Musculoskeletal, connective tissue and bone disorders

 

 

Back pain

General disorders and administration site conditions

Injection site pain, injection site reaction, including bruising, burning and paraesthesia at the injection site

Chest pain, pain no organ system, asthenia

One case of sensory-motor paresis was reported.

Post marketing

Rare cases suggestive of hypersensitivity, which could include skin erythema, bradycardia, hypotension or anaphylactic shock have been reported following the injection of SonoVue. In some of these cases, in patients with underlying coronary artery disease, bradycardia and hypotension were accompanied by myocardial ischemia and/or myocardial infarctions.

In very rare cases, fatal outcomes have been reported in temporal association with the use of SonoVue. In all these patients there was a high underlying risk for major cardiac complications, which could have led to the fatal outcome.

4.9 Overdose

Since there have been no cases of overdose reported to date, neither signs nor symptoms of overdose have been identified. In a Phase I study doses up to 56 ml of SonoVue were administered to normal volunteers without serious adverse events being reported. In the event of overdose occurring, the patient should be observed and treated symptomatically.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Ultrasound contrast media

ATC code: VO8DA.

The addition of sodium chloride 9 mg/ml (0.9%) solution for injection to the lyophilised powder followed by vigorous shaking results in the production of the microbubbles of sulphur hexafluoride. The microbubbles have a mean diameter of about 2.5µm, with 90% having a diameter less than 6µm and 99% having a diameter less than 11µm. Each millilitre of SonoVue contains 8µl of the microbubbles.The interface between the sulphur hexafluoride bubble and the aqueous medium acts as a reflector of the ultrasound beam thus enhancing blood echogenicity and increasing contrast between the blood and the surrounding tissues.

The intensity of the reflected signal is dependent on concentration of the microbubbles and frequency of the ultrasound beam. At the proposed clinical doses, SonoVue has been shown to provide marked increase in signal intensity of more than 2 minutes for B-mode imaging in echocardiography and of 3 to 8 minutes for Doppler imaging of the macrovasculature and microvasculature.

Sulphur hexafluoride is an inert, innocuous gas, poorly soluble in aqueous solutions. There are literature reports of the use of the gas in the study of respiratory physiology and in pneumatic retinopexy.

5.2 Pharmacokinetic Properties

The total amount of sulphur hexafluoride administered in a clinical dose is extremely small, (in a 2 ml dose the microbubbles contain 16 µl of gas). The sulphur hexafluoride dissolves in the blood and is subsequently exhaled.

After a single intravenous injection of 0.03 or 0.3 ml of SonoVue/kg (approximately 1 and 10 times the maximum clinical dose) to human volunteers, the sulphur hexafluoride was cleared rapidly. The mean terminal half-life was 12 minutes (range 2 to 33 minutes). More than 80% of the administered sulphur hexafluoride was recovered in exhaled air within 2 minutes after injection and almost 100% after 15 minutes.

In patients with diffuse interstitial pulmonary fibrosis, the percent of dose recovered in expired air averaged 100% and the terminal half-life was similar to that measured in healthy volunteers.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and toxicity to reproduction. Caecal lesions observed in some repeat- dose studies with rats, but not in monkeys, are not relevant for humans under normal conditions of administration.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Powder:

Macrogol 4000

Distearoylphosphatidylcholine

Dipalmitoylphosphatidylglycerol Sodium

Palmitic acid

Solvent:

Sodium chloride 9 mg/ml (0.9%) solution for injection

6.2 Incompatibilities

In the absence of compatibility studies, SonoVue should not be admixed with any other medicinal product except the solvent provided.

6.3 Shelf Life

2 years.

Once reconstituted, chemical and physical stability has been demonstrated for 6 hours. From a microbiological point of view, the product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user.

6.4 Special Precautions For Storage

The medicinal product does not require any special storage conditions.

For storage conditions of the reconstituted medicinal product, see section 6.3.

6.5 Nature And Contents Of Container

Presentation 02 (with separate MiniSpike transfer system):-

25 mg of dry, lyophilised powder in an atmosphere of sulphur hexafluoride in a colourless

Type I glass vial, with elastomeric closure.

Separate transfer system.

Type I glass pre-filled syringe containing 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection.

6.6 Special Precautions For Disposal And Other Handling

Before use examine the product to ensure that the container and closure have not been damaged.

SonoVue must be prepared before use by injecting through the septum 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to the contents of the vial. The vial is then shaken vigorously for twenty seconds after which the desired volume of the dispersion can be drawn into a syringe as follows, depending on the presentation:

)

Presentation 02 ( with separate MiniSpike transfer system )

1. Connect the plunger rod by screwing it clockwise into the syringe.

2. Open the MiniSpike transfer system blister and remove syringe tip cap.

3. Open the transfer system cap and connect the syringe to the transfer system by screwing it in clockwise.

4. Remove Flipcap glass protective disk from the vial. Slide the vial into the transparent sleeve of the transfer system and press firmly to lock the vial in place.

5. Empty the contents of the syringe into the vial by pushing on the plunger rod.

6. Shake vigorously for 20 seconds to mix all the contents in the vial (white milky liquid).

7. Invert the system and carefully withdraw SonoVue into the syringe.

8. Unscrew the syringe from the transfer system.

SonoVue should be administered immediately by injection into a peripheral vein.

After reconstitution, a homogeneous white milky liquid is obtained. If solid parts of the lyophilisate are seen or the suspension is not homogeneous, the product should be discarded. If SonoVue is not used immediately after reconstitution the microbubble dispersion should be shaken again before being drawn up into a syringe. Chemical and physical stability of the microbubble dispersion has been demonstrated for 6 hours.

The vial is for a single examination only. Any unused dispersion remaining at the end of an examination or waste material must be discarded in accordance with local requirements.

7. Marketing Authorisation Holder

Bracco International B.V.

Strawinskylaan 3051

NL - 1077 ZX Amsterdam

The Netherlands

8. Marketing Authorisation Number(S)

EU/1/01/177/002

9. Date Of First Authorisation/Renewal Of The Authorisation

26 March 2001/ 24 April 2006

10. Date Of Revision Of The Text

24 April 2006

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