Depixol Injection and Conc Injection
1. Name Of The Medicinal Product

Depixol Injection

Depixol® Conc. Injection

2. Qualitative And Quantitative Composition

Depixol Injection:

20 mg/mL (2% w/v) cis(Z)-flupentixol decanoate in thin vegetable oil.

Ampoules 1mL and 2 mL, Syringes 1 mL and 2 mL and Vial 10 mL.

Depixol Conc Injection:

100 mg/mL (10%w/v) cis (Z)-flupentixol decanoate in thin vegetable oil.

Ampoules 0.5 mL and 1 mL and Vial 5 mL.

3. Pharmaceutical Form

Oily solution for deep intramuscular injection.

4. Clinical Particulars 4.1 Therapeutic Indications

The treatment of schizophrenia and other psychoses.

Use of Depixol should be restricted to those stabilised on oral therapy.

4.2 Posology And Method Of Administration

Route of administration

Deep intramuscular injection into the upper outer buttock or lateral thigh.

Dosage and dosage interval should be adjusted according to the patients' symptoms and response to treatment.

Note: As with all oil-based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular entry does not occur.

Adults

The usual dosage of flupentixol decanoate lies between 50 mg every 4 weeks and 300 mg every 2 weeks, but some patients may require up to 400 mg weekly. Other patients may be adequately maintained on dosages of 20-40 mg flupentixol decanoate every 2-4 weeks. In patients who have not previously received depot antipsychotic, treatment is usually started with a small dose (e.g. 20 mg) to assess tolerability. An interval of at least one week should be allowed before the second injection is given at a dose consistent with the patients' condition.

Depixol Injection 20 mg/ml is not intended for use in patients requiring doses of greater than 60 mg (3 mL) of flupentixol. Injection volumes of 2 – 3 mL should be distributed between two injection sites.

More concentrated solutions of flupentixol decanoate (Depixol Conc Injection or Depixol Low Volume Injection) should be used if doses greater than 3 mL (60 mg) are required.

The injection volumes selected for Depixol Conc Injection or Depixol Low Volume Injection should not exceed 2 mL.

Adequate control of severe psychotic symptoms may take up to 4 to 6 months at high enough dosage. Once stabilised lower maintenance doses may be considered, but must be sufficient to prevent relapse.

Elderly

In accordance with standard medical practice, initial dosage may need to be reduced to a quarter or half the normal starting dose in the frail or elderly.

Children

Depixol is not indicated for children.

Reduced renal function

Flupentixol has not been studied in renal impairment. Increased cerebral sensitivity to antipsychotics has been noted in severe renal impairment (see section 4.4).

Reduced hepatic function

Flupentixol has not been studied in hepatic impairment. It is extensively metabolised by the liver and particular caution should be used in this situation and serum level monitoring is advised (see section 4.4). Depixol should be initiated at low doses orally to check for tolerability before switching to the depot formulation.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients (see section 6.1). Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma.

Not recommended for excitable or agitated patients.

4.4 Special Warnings And Precautions For Use

Caution should be exercised in patients having: liver disease; cardiac disease or arrhythmias; severe respiratory disease; renal failure; epilepsy (and conditions predisposing to epilepsy e.g. alcohol withdrawal or brain damage); Parkinson's disease; narrow angle glaucoma; prostatic hypertrophy; hypothyroidism; hyperthyroidism; myasthenia gravis; phaeochromocytoma and patients who have shown hypersensitivity to thioxanthenes or other antipsychotics.

The elderly require close supervision because they are specially prone to experience such adverse effects as sedation, hypotension, confusion and temperature changes.

The possibility of development of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, fluctuating consciousness, instability of the autonomous nervous system) exists with any neuroleptic. The risk is possibly greater with the more potent agents. Patients with pre-existing organic brain syndrome, mental retardation, and opiate and alcohol abuse are overrepresented among fatal cases.

Treatment: Discontinuation of the neuroleptic. Symptomatic treatment and use of general supportive measures. Dantrolene and bromocriptine may be helpful.

Symptoms may persist for more than a week after oral neuroleptics are discontinued and somewhat longer when associated with the depot forms of the drugs.

Blood dyscrasias, including thrombocytopenia, have been reported rarely. Blood counts should be carried out if a patient develops signs of persistent infection.

As described for other psychotropics flupentixol may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients.

Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. The plasma concentrations of the Depixol Injection gradually decrease over several weeks which makes gradual dosage tapering unnecessary.

When transferring patients from oral to depot antipsychotic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection.

An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations.

Flupentixol should be used with caution in patients with risk factors for stroke.

As with other drugs belonging to the therapeutic class of antipsychotics, flupentixol may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, flupentixol should be used with caution in susceptible individuals (with hypokalaemia, hypomagnesia or genetic predisposition) and in patients with a history of cardiovascular disorders, e.g. QT prolongation, significant bradycardia (<50 beats per minute), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia.

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Depixol and preventive measures undertaken.

Concomitant treatment with other antipsychotics should be avoided (see section 4.5).

Suicide/suicidal thoughts or clinical worsening

Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.

It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Other psychiatric conditions for which flupentixol is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders. Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

Increased Mortality in Elderly people with Dementia

Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.

Depixol is not licensed for the treatment of dementia-related behavioural disturbances.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In common with other antipsychotics, flupentixol enhances the response to alcohol the effects of barbiturates and other CNS depressants. Flupentixol may potentiate the effects of general anaesthetics and anticoagulants and prolong the action of neuromuscular blocking agents.

The anticholinergic effects of atropine or other drugs with anticholinergic properties may be increased. Concomitant use of drugs such as metoclopramide, piperazine or antiparkinson drugs may increase the risk of extrapyramidal effects such as tardive dyskinesia. Combined use of antipsychotics and lithium or sibutramine has been associated with an increased risk of neurotoxicity.

Antipsychotics may enhance the cardiac depressant effects of quinidine; the absorption of corticosteroids and digoxin. The hypotensive effect of vasodilator antihypertensive agents such as hydralazine and ?-blockers (e.g. doxazosin), or methyl-dopa may be enhanced.

Increases in the QT interval related to antipsychotic treatment may be exacerbated by the co-administration of other drugs known to significantly increase the QT interval.

Co-administration of such drugs should be avoided. Relevant classes include:

• class Ia and III antiarrhythmics (e.g. quinidine, amiodarone, sotalol, dofetilide)

• some antipsychotics (e.g. thioridazine)

• some macrolides (e.g. erythromycin)

• some antihistamines

• some quinolone antibiotics (e.g. moxifloxacin)

The above list is not exhaustive and other individual drugs known to significantly increase QT interval (e.g. cisapride, lithium) should be avoided.

Drugs known to cause electrolyte disturbances such as thiazide diuretics (hypokalaemia) and drugs known to increase the plasma concentration of flupentixol should also be used with caution as they may increase the risk of QT prolongation and malignant arrythmias (see section 4.4).

Antipsychotics may antagonise the effects of adrenaline and other sympathomimetic agents, and reverse the antihypertensive effects of guanethidine and similar adrenergic-blocking agents. Antipsychotics may also impair the effect of levodopa, adrenergic drugs and anticonvulsants.

The metabolism of tricyclic antidepressants may be inhibited and the control of diabetes may be impaired.

4.6 Pregnancy And Lactation

As the safety of this drug during pregnancy has not been established, use during pregnancy, especially the first and last trimesters, should be avoided, unless the expected benefit to the patient outweighs the potential risk to the foetus.

Flupentixol is excreted into the breast milk. If the use of Depixol is considered essential, nursing mothers should be advised to stop breast feeding.

The newborn of mothers treated with antipsychotics in late pregnancy, or labour, may show signs of intoxication such as lethargy, tremor and hyperexcitability, and have a low Apgar score.

4.7 Effects On Ability To Drive And Use Machines

Alertness may be impaired, especially at the start of treatment, or following the consumption of alcohol; patients should be warned of this risk and advised not to drive or operate machinery until their susceptibility is known. Patients should not drive if they have blurred vision.

4.8 Undesirable Effects

Cases of suicidal ideation and suicidal behaviours have been reported during flupentixol therapy or early after treatment discontinuation (see section 4.4).

Undesirable effects are for the majority dose dependent. The frequency and severity are most pronounced in the early phase of treatment and decline during continued treatment.

Extrapyramidal reactions may occur, especially in the early phase of treatment. In most cases these side effects can be satisfactorily controlled by reduction of dosage and/or use of antiparkinsonian drugs. The routine prophylactic use of antiparkinsonian drugs is not recommended. Antiparkinsonian drugs do not alleviate tardive dyskinesia and may aggravate them. Reduction in dosage or, if possible, discontinuation of flupentixol therapy is recommended. In persistent akathisia a benzodiazepine or propranolol may be useful.

Cardiac disorders

Tachycardia, palpitations.

Electrocardiogram QT prolonged.

Blood and lymphatic system disorders

Thrombocytopenia, neutropenia, leukopenia, agranulocytosis

Nervous system disorders

Somnolence, akathisia, hyperkinesia, hypokinesia.

Tremor, dystonia, dizziness, headache, disturbance in attention.

Tardive dyskinesia, dyskinesia, parkinsonism, speech disorder, convulsion.

Neuroleptic malignant syndrome.

Eye disorders

Accommodation disorder, vision abnormal.

Oculogyration.

Respiratory, thoracic and mediastinal disorders

Dyspnoea.

Gastrointestinal disorders

Dry mouth.

Salivary hypersecretion, constipation, vomiting, dyspepsia, diarrhoea.

Abdominal pain, nausea, flatulence.

Renal and urinary disorders

Micturition disorder, urinary retention.

Skin and subcutaneous tissue disorders

Hyperhidrosis, pruritus.

Rash, photosensitivity reaction, dermatitis.

Musculoskeletal and connective tissue disorder

Myalgia.

Muscle rigidity.

Endocrine disorder

Hyperprolactinaemia.

Metabolism and nutrition disorders

Increased appetite, weight increased.

Decreased appetite.

Hyperglycaemia, glucose tolerance abnormal.

Vascular disorders

Hypotension, hot flush.

General disorders and administration site conditions

Asthenia, fatigue.

Injection site reaction1.

Immune system disorders

Hypersensitivity, anaphylactic reaction.

Hepatobiliary disorders

Liver function test abnormal.

Jaundice

Reproductive system and breast disorders

Ejaculation failure, erectile dysfunction.

Gynaecomastia, galactorrhoea, amenorrhoea.

Psychiatric disorders

Insomnia, depression, nervousness, agitation, libido decreased.

Confusional state.

1For injectable flupentixol presentations.

As with other drugs belonging to the therapeutic class of antipsychotics, rare cases of QT prolongation, ventricular arrhythmias - ventricular fibrillation, ventricular tachycardia, Torsade de Pointes and sudden unexplained death have been reported for flupentixol (see section 4.4).

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- Frequency unknown.

Abrupt discontinuation of flupentixol may be accompanied by withdrawal symptoms. The most common symptoms are nausea, vomiting, anorexia, diarrhoea, rhinorrhoea, sweating, myalgias, paraesthesias, insomnia, restlessness, anxiety, and agitation. Patients may also experience vertigo, alternate feelings of warmth and coldness, and tremor. Symptoms generally begin within 1 to 4 days of withdrawal and abate within 7 to 14 days.

4.9 Overdose

Overdosage may cause somnolence or even coma, extrapyramidal symptoms, convulsions, hypotension, shock, hyper or hypothermia. ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular arrhythmias have been reported when administered in overdose together with drugs known to affect the heart.

Treatment is symptomatic and supportive, with measures aimed at supporting the respiratory and cardiovascular systems. The following specific measures may be employed if required.

- Anticholinergic antiparkinson drugs if extrapyramidal symptoms occur

- Sedation (with benzodiazepines) in the unlikely event of agitation or excitement or convulsions

- Noradrenaline in saline intravenous drip if the patient is in shock. Adrenaline must not be given.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Flupentixol is a non-sedating antipsychotic drug of the thioxanthene group. Its primary pharmacological action is dopamine blockade. Flupentixol has a high affinity for D1 and D2 receptors. Depixol Injection contains the deconoic ester of flupentixol in thin vegetable oil.

5.2 Pharmacokinetic Properties

After intramuscular injection, the ester is slowly released from the oil depot and is rapidly hydrolysed to release flupentixol. Flupentixol is widely distributed in the body and extensively metabolized in the liver. Peak circulating levels occur around 7 days after administration.

5.3 Preclinical Safety Data

Nil of relevance

6. Pharmaceutical Particulars 6.1 List Of Excipients

Thin vegetable oil "Viscoleo" (fractionated coconut oil).

6.2 Incompatibilities

This product may be mixed in the same syringe with other products in the Depixol Injection range. It should not be mixed with any other injection fluids.

6.3 Shelf Life

Depixol Injection:

Ampoules 1 mL and 2 mL : 4 years

Syringes 1 mL and 2 mL : 2 years

Vial 10 mL : 3 years (shelf-life after opening : 1 day)

Depixol Conc Injection:

Ampoule 0.5 mL : 2 years

Ampoule 1 mL : 4 years

Vial 5 mL : 3 years

6.4 Special Precautions For Storage

Store at or below 25°C. Protect from light.

6.5 Nature And Contents Of Container

Depixol Injection:

Ampoules containing 1 mL and 2 mL of 20 mg/mL (2% w/v) cis (Z)-flupentixol decanoate in thin vegetable oil. Pack size = 10 ampoules per box.

Syringes containing 1 mL and 2 mL of 20 mg/mL (2%w/v) cis (Z)-flupentixol decanoate in thin vegetable oil. Pack size = 5 syringes per box.

Vial containing 10 mL of 20 mg/mL (2%w/v) cis (Z)-flupentixol decanoate in thin vegetable oil. Pack size = 1 vial per box.

Depixol Conc Injection:

Ampoules containing 0.5 mL and 1 mL of 100 mg/ml (10% w/v) cis(Z)-flupentixol decanoate in thin vegetable oil. Pack size = 10 ampoules per box.

Vial containing 5 mL of 100 mg/ml (10%) cis(Z)- flupentixol decanoate in thin vegetable oil. Pack size = 1 vial per box.

6.6 Special Precautions For Disposal And Other Handling

Nil.

7. Marketing Authorisation Holder

Lundbeck Ltd

Lundbeck House

Caldecotte Lake Business Park

Milton Keynes

Buckinghamshire

MK7 8LF

United Kingdom

8. Marketing Authorisation Number(S)

Depxiol Injection - PL 0458/0007R

Depixol Conc Injection - PL 00458/0015R

9. Date Of First Authorisation/Renewal Of The Authorisation

28 January 1987 / 17 March 2002

10. Date Of Revision Of The Text

02/012/2010

Ibuleve Gel 50g

Information for the user

IBULEVETM GEL

ibuprofen 5% w/w

Read all of this leaflet carefully before using this product.

Keep this leaflet. You may need to read it again.

Ask your doctor or pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve after a few weeks.

If any of the side effects get serious or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

In this leaflet: 1. What Ibuleve is and what it is used for 2. Before you use Ibuleve 3. How to use Ibuleve 4. Possible side effects 5. How to store Ibuleve 6. Further information What Ibuleve Is And What It Is Used For Ibuleve is an anti-inflammatory painkiller applied to, and absorbed through, the skin. It is for the treatment of the following conditions involving the musculoskeletal system: backache rheumatic or muscular pain sprains strains neuralgia. It is also for pain relief in common arthritic conditions. Ibuleve is recommended for use by adults, the elderly and children over the age of 12 years. Children under the age of 12 may also use it if recommended by their doctor. The active ingredient in this product is ibuprofen. This is one of a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen works by: relieving pain reducing swelling and inflammation. Before You Use Ibuleve Do not use Ibuleve: if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of Ibuleve listed in section 6; if you are asthmatic, or suffer from rhinitis (allergic runny nose) or urticaria (hives) and have ever had a bad reaction to aspirin, ibuprofen or other NSAIDs in the past; if you are pregnant or breast-feeding; on broken, damaged, infected or diseased skin.

Before applying this product for the first time, make sure it is suitable for you to use:

Because Ibuleve is delivered through the skin, directly over the painful area, there is less risk of the complications that sometimes occur when ibuprofen (or a similar anti-inflammatory painkiller) is taken by mouth. However, in rare cases you may be at risk:

if you have a stomach ulcer (also called a peptic or gastric ulcer); if you have ever had kidney problems; if you have ever had asthma; if you have ever had a bad reaction to aspirin or ibuprofen taken by mouth.

If any of the above apply to you, only use this product on advice from your doctor or pharmacist.

Take special care when using this product: Use it only on the skin. Do not use it on children under 12 years old unless advised by a doctor. Do not apply it to broken or irritated skin. Keep the gel away from the eyes, nose and mouth. Using other medicines Interaction between Ibuleve and blood pressure lowering drugs and anticoagulants is possible, in theory, although very unlikely. If you would like more advice about this, speak to your doctor or pharmacist. If you are also taking aspirin or other NSAIDs by mouth, discuss this beforehand with your doctor or pharmacist because these may increase the risk of undesirable effects. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including other medicines obtained without prescription. Pregnancy and breast-feeding

You should not use Ibuleve if you are pregnant or breast-feeding.

Driving and using machinery

Using this product is not known to affect your ability to drive or use machinery.

Important information about one of the ingredients of Ibuleve

The product contains a small amount of propylene glycol. This ingredient may cause skin irritation in a small number of people who are intolerant to it. If your doctor has told you that you have an intolerance to propylene glycol, please talk to your doctor before using this product.

How To Use Ibuleve Before using this tube of gel for the first time, open it as follows: Unscrew the cap, turn it upside down and then use the sharp point of the cap to pierce the membrane in the neck of the tube. The tube squeezer key:

To make Ibuleve easier and more economical to use, a tube squeezer key has been provided. Once fitted to the tube, simply turning the key will dispense the gel more easily for patients who experience difficulties in squeezing tubes.For economy, the key will also help expel the last few grams of Ibuleve when the tube is nearly empty.

To fit the tube squeezer key: Ensure that the tube nozzle has been pierced using the point of the cap. Slide the slit of the key over the folded end of the tube. Carefully turn the key to roll up the tube until the required amount of gel has been expelled. Always replace the cap after use, leaving the key in place on the end of the tube. To use the gel (for adults, the elderly and children over 12 years old): Use the gel up to three times a day, or as often as advised by your doctor. Lightly apply the gel to intact skin over the painful area. Apply only enough gel to thinly cover the affected area, then massage gently until absorbed. Wash hands after use, unless treating them. Carry on using the gel in this way until your condition gets better (you may find you need to use it for a few weeks, and your doctor may want you to continue using it for longer than this). If your symptoms worsen or continue for more than a few weeks, discuss this with your doctor before continuing treatment. If the gel comes into contact with broken skin or gets into the eyes, nose or mouth The product may cause irritation if it comes into contact with broken skin or gets into the eyes, nose or mouth. If this happens, rinse the affected areas with plenty of water. If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists, tell your doctor or pharmacist. If the gel is accidentally swallowed Symptoms may include headache, vomiting, drowsiness and low blood pressure. If you experience any of these symptoms contact a doctor or hospital straight away. If you forget to use this product

Do not worry if you occasionally forget to use this product, just carry on using it when you remember.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Ibuleve can cause side effects, although not everybody gets them.

Occasionally, mild skin rashes, itching or irritation can sometimes occur at the site of application.

If this is unacceptable, or persists, stop using the product and tell your doctor or pharmacist.

Very rarely, the following side effects can happen with ibuprofen, although these are extremely uncommon with products such as Ibuleve that are applied to the skin.

If you experience any of the following, stop using Ibuleve immediately and tell your doctor: Allergic reactions (particularly in people who have a history of asthma or allergic problems), such as: unexplained runny nose and watery eyes, or, in more serious cases asthma or aggravated asthma involving breathing difficulties, wheezing or chest tightness; generalised allergic skin reactions involving itch, swelling, inflammation, redness and perhaps blistering and light sensitivity; other more serious generalised allergic reactions possibly involving unexplained nausea and vomiting, swollen eyes, face or tongue, difficulty swallowing, dizziness or light-headedness.Unconsciousness could perhaps occur in the most serious cases. Kidney problems (particularly in people who have a history of kidney disease), such as: decreased urine volume; loss of appetite / weight loss; swelling to abdomen. Problems with the digestive system (particularly in people who have a history of stomach ulcers etc), such as: stomach pain; heartburn / indigestion.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Ibuleve Keep it out of the reach and sight of children. Always replace the cap tightly after use. Do not store the product above 25°C. Do not use after the expiry date shown on the fold of the tube and the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Further Information About Ibuleve What Ibuleve contains:

The active ingredient is ibuprofen (5% w/w).

The other ingredients are industrial methylated spirit, carbomers, propylene glycol, diethylamine and purified water.

What Ibuleve looks like and contents of the pack The product is a clear, colourless gel that contains no fragrance. The gel is available in tubes containing 30g, 50g and 100g. The 50g and 100g packs also contain a tube key. The Marketing Authorisation holder is Diomed Developments Limited Tatmore Place Gosmore Hitchin Herts SG4 7QR UK The Manufacturer is DDD Limited 94 Rickmansworth Road Watford Herts WD18 7JJ UK The Distributor is DDD Limited 94 Rickmansworth Road Watford Herts WD18 7JJ UK

This leaflet was last approved in June 2008.

To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information: Ibuleve 00173/0060.

This is a service provided by the Royal National Institute of Blind People (RNIB).

KD8/08/1

Micatin Foot Powder Deodorant

Generic Name: miconazole topical (my CON a zole) Brand Names: Aloe Vesta, Aloe Vesta 2 in 1 Antifungal, Baza, Cruex Prescription Strength, Desenex Prescription Strength, Fungoid, Fungoid Kit, Micatin, Micatin Cooling Action, Micatin Foot Powder, Micatin Foot Powder Deodorant, Micatin Jock Itch, Micatin Liquid Foot, Mitrazol, Monistat Derm, Ony-Clear, Zeasorb-AF

What is Micatin Foot Powder Deodorant (miconazole topical)?

Miconazole topical is an antifungal medication. Miconazole topical prevents fungus from growing on your skin.

Miconazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections.

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

What is the most important information I should know about Micatin Foot Powder Deodorant (miconazole topical)? Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth. Who should not use Micatin Foot Powder Deodorant (miconazole topical)?

Do not use miconazole topical if you have had an allergic reaction to it in the past.

It is not known whether miconazole topical will harm an unborn baby. Do not use miconazole topical without first talking to your doctor if you are pregnant. It is not known whether miconazole passes into breast milk. Do not use miconazole topical without first talking to your doctor if you are breast-feeding a baby. How should I use Micatin Foot Powder Deodorant (miconazole topical)? Use miconazole topical exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the cream, lotion, spray, or powder once or twice daily as directed for 2 to 4 weeks.

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 2 weeks (or 4 weeks for athlete's foot), or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth. Store miconazole topical at room temperature away from moisture and heat. What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of miconazole topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of miconazole topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that miconazole topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using Micatin Foot Powder Deodorant (miconazole topical)?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Micatin Foot Powder Deodorant (miconazole topical) side effects

Serious side effects of miconazole topical use are not expected. Stop using miconazole topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Micatin Foot Powder Deodorant (miconazole topical)?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of miconazole topical.

More Micatin Foot Powder Deodorant resources Micatin Foot Powder Deodorant Side Effects (in more detail)Micatin Foot Powder Deodorant Use in Pregnancy & BreastfeedingMicatin Foot Powder Deodorant Drug Interactions0 Reviews for Micatin Foot Deodorant - Add your own review/rating Baza Antifungal Topical Advanced Consumer (Micromedex) - Includes Dosage Information Cruex Prescription Strength Topical Advanced Consumer (Micromedex) - Includes Dosage Information Lotrimin AF Lotion MedFacts Consumer Leaflet (Wolters Kluwer) Micatin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Monistat 3 Cream MedFacts Consumer Leaflet (Wolters Kluwer) Monistat 3 Prescribing Information (FDA) Monistat 7 Cream MedFacts Consumer Leaflet (Wolters Kluwer) Zeasorb-AF Gel MedFacts Consumer Leaflet (Wolters Kluwer) Compare Micatin Foot Powder Deodorant with other medications Cutaneous CandidiasisTinea CorporisTinea CrurisTinea PedisTinea Versicolor Where can I get more information? Your pharmacist has additional information about miconazole topical written for health professionals that you may read.

See also: Micatin Foot Deodorant side effects (in more detail)

Macrodantin Capsules 100mg B.P.
1. Name Of The Medicinal Product

Macrodantin® Capsules 100mg

2. Qualitative And Quantitative Composition

Macrodantin capsules containing 100 mg Nitrofurantoin Ph Eur in macrocrystalline form.

3. Pharmaceutical Form

The 100 mg hard gelatin capsule has an opaque yellow cap and opaque white body with the Logo 'Eaton 009' divided between the body and the cap.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures.

Nitrofurantoin is specifically indicated for the treatment of infections when due to susceptible strains of Escherichia coli, enterococci, staphylococci, Citrobacter, Klebsiella and Enterobacter.

4.2 Posology And Method Of Administration

Dosage:

Adults

Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for seven days.

Severe chronic recurrence (UTIs): 100 mg four times daily for seven days.

Long term suppression: 50-100 mg once a day.

Prophylaxis: 50 mg four times daily for the duration of procedure and for three days thereafter.

Children and Infants over three months of age

Acute Urinary Tract Infections: 3mg/kg day in four divided doses for seven days.

Suppressive - 1mg/kg, once a day.

For children under 25 kg body weight consideration should be given to the use of Furadantin® Suspension.

Elderly

Provided there is no significant renal impairment, in which Nitrofurantoin is contraindicated, the dosage should be that for any normal adult. See precaution and risks to elderly patients associated with long-term therapy (Section 4.8).

4.3 Contraindications

Patients suffering from renal dysfunction with a creatinine clearance of less than 60 ml/minute or elevated serum creatinine.

In infants under three months of age as well as pregnant patients at term (during labour and delivery) because of the theoretical possibility of haemolytic anaemia in the foetus or in the newborn infant due to immature erythrocyte enzyme systems.

Patients with a known hypersensitivity to nitrofurantoin or other nitrofurans.

4.4 Special Warnings And Precautions For Use

Nitrofurantoin is not effective for the treatment of parenchymal infections of unilaterally nonfunctioning kidney. A surgical cause for infection should be excluded in recurrent or severe cases.

Since pre-existing conditions may mask adverse reactions, Nitrofurantoin should be used with caution in patients with pulmonary disease, hepatic dysfunction, neurological disorders, and allergic diathesis.

Peripheral neuropathy and susceptibility to peripheral neuropathy which may become severe or irreversible has occurred and may be life threatening. Therefore, treatment should be stopped at the first signs of neural involvement (paraesthesiae).

Nitrofurantoin should be used in caution with patients with anaemia, diabetes mellitus, electrolyte imbalance, debilitating conditions and vitamin B (particularly folate) deficiency.

Acute, subacute and chronic pulmonary reactions have been observed in patients treated with nitrofurantoin. If these reactions occur, nitrofurantoin should be discontinued immediately.

Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis ) can develop insidiously, and may occur commonly in elderly patients. Close monitoring of the pulmonary conditions of patients receiving long-term therapy is warranted (especially in the elderly).

Patient should be monitored closely for signs of hepatitis (particularly in long term use). Urine may be coloured yellow or brown after taking Nitrofurantoin. Patients on Nitrofurantoin are susceptible to false positive urinary glucose (if tested for reducing substances).

Nitrofurantoin should be discontinued at any sign of haemolysis in those with suspected glucose-6-phosphate dehydrogenase deficiency.

Gastrointestinal reactions may be minimised by taking the drug with food or milk, or by adjustment of dosage.

For long-term treatment, monitor patients closely for evidence of hepatitis or pulmonary symptoms or other evidence of toxicity.

Discontinue treatment with Nitrofurantoin if otherwise unexplained pulmonary, hepatic, haematological or neurological syndromes occur.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

1. Increased absorption with food or agents delaying gastric emptying.

2. Decreased absorption with magnesium trisilicate.

3. Decreased renal excretion of Nitrofurantoin by probenecid and sulphinpyrazone.

4. Decreased anti-bacterial activity by carbonic anhydrase inhibitors and urine alkalisation.

5. Anti-bacterial antagonism by quinolone anti-infectives.

6. Interference with some tests for glucose in urine

4.6 Pregnancy And Lactation

Animal studies with Nitrofurantoin have shown no teratogenic effects. Nitrofurantoin has been in extensive clinical use since 1952, and its suitability in human pregnancy has been well documented. However, as with all other drugs, the maternal side effects may adversely affect course of pregnancy. The drug should be used at the lowest dose as appropriate for a specific indication, only after careful assessment.

Nitrofurantoin is however contraindicated in infants under three months of age and in pregnant women during labour and delivery, because of the possible risk of haemolysis of the infants' immature red cells. Caution should be exercised while breast feeding an infant known or suspected to have an erythrocyte enzyme deficiency, since Nitrofurantoin is detected in trace amounts in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Nitrofurantoin may cause dizziness and drowsiness and the patient should not drive or operate machinery if affected this way.

4.8 Undesirable Effects

Respiratory

If any of the following reactions occur the drug should be discontinued.

Acute pulmonary reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnoea, pulmonary infiltration with consolidation or pleural effusion on chest x-ray, and eosinophilia. In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form.

Chronic pulmonary reactions occur rarely in patients who have received continuous therapy for six months or longer and are more common in elderly patients. Changes in ECG have occurred, associated with pulmonary reactions.

Minor symptoms such as fever, chills, cough and dyspnoea may be significant. Collapse and cyanosis have been reported rarely. The severity of chronic pulmonary reactions and their degree of resolution appear to be related to the duration of therapy after the first clinical signs appear. It is important to recognise symptoms as early as possible. Pulmonary function may be impaired permanently, even after cessation of therapy.

Hepatic

Hepatic reactions including cholestatic jaundice and chronic active hepatitis occur rarely.

Fatalities have been reported. Cholestatic jaundice is generally associated with short-term therapy (usually up to two weeks). Chronic active hepatitis, occasionally leading to hepatic necrosis is generally associated with long-term therapy (usually after six months). The onset may be insidious. Treatment should be stopped at the first sign of hepatotoxicity.

Neurological

Peripheral neuropathy (including optical neuritis) with symptoms of sensory as well as motor involvement, which may become severe or irreversible, has been reported infrequently. Less frequent reactions of unknown causal relationship are depression, euphoria, confusion, psychotic reactions, nystagmus, vertigo, dizziness, asthenia, headache and drowsiness. Treatment should be stopped at the first sign of neurological involvement.

Gastrointestinal

Nausea and anorexia have been reported. Emesis, abdominal pain and diarrhoea are less common gastrointestinal reactions.

Haematological

Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia and megaloblastic anaemia, glucose-6-phosphate dehydrogenase deficiency anaemia, and eosinophilia have been reported. Aplastic anaemia has been reported rarely. Cessation of therapy has generally returned the blood picture to normal.

Hypersensitivity

Allergic skin reactions manifesting as angioneurotic oedema, maculopapular, erythematous or eczematous eruptions, urticaria, and pruritus have occurred.

Lupus-like syndrome associated with pulmonary reaction to Nitrofurantoin has been reported.

Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson Syndrome) have been reported rarely.

Other hypersensitivity reactions include anaphylaxis, sialadenitis, pancreatitis, drug fever, and arthralgia.

Miscellaneous

Transient alopecia and benign intracranial hypertension. As with other antimicrobial agents, superinfections by fungi or resistant organisms such as Pseudomonas may occur. However, these are limited to the genito-urinary tract because suppression of normal bacterial flora does not occur elsewhere in the body

4.9 Overdose

Symptoms and signs of overdose include gastric irritation, nausea and vomiting. There is no known specific antidote. However, Nitrofurantoin can be haemodialysed in cases of recent ingestion. Standard treatment is by induction of emesis or by gastric lavage. Monitoring of full blood count, liver function, and pulmonary function tests are recommended. A high fluid intake should be maintained to promote urinary excretion of the drug.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Macrodantin is a broad spectrum antibacterial agent, active against the majority of urinary pathogens. The wide range of organisms sensitive to the bactericidal activity include:

Escherichia coli

Enterococcus Faecalis

Klebsiella Species

Enterobacter Species

Staphylococcus Species, e.g. S.Aureus, S.Saprophyticus, S.Epidermidis

Citrobacter Species

Clinically most common urinary pathogens are sensitive to Nitrofurantoin.

Most strains of proteus and serratia are resistant. All pseudomonas strains are resistant.

5.2 Pharmacokinetic Properties

The Nitrofurantoin macrocrystals of Macrodantin are specially formulated. The controlled crystal size is designed to control the speed of absorption and thus reduce the incidence of nausea. Clinical and animal studies indicate that Macrodantin therapy decreases the likelihood of nausea in patients who might experience these symptoms on Nitrofurantoin therapy. This special formulation of Nitrofurantoin had not caused any decrease in antibacterial efficacy.

Orally administered Macrodantin is readily absorbed in the upper gastrointestinal tract at a slower rate and to reduced extent when compared to microcrystalline Nitrofurantoin. Blood concentrations at therapeutic dosage are usually low with an elimination half-life of about 30 minutes or less.

Maximum urinary excretion usually occurs 4-5 hours after administration of macrocrystalline Nitrofurantoin. Urinary drug dose recoveries of about 25-30% are obtained

5.3 Preclinical Safety Data

Carcinogenic effect of nitrofurantoin in animal studies was observed. However, human data and extensive use of nitrofurantoin over 50 years do not support such observations.

6. Pharmaceutical Particulars 6.1 List Of Excipients

The capsule fill contains lactose monohydrate, maize starch and purified talc. The capsule shell contains quinoline yellow (E104), titanium dioxide (E171), gelatin, sodium lauryl sulphate. The printing ink contains shellac and black iron oxide (E172).

6.2 Incompatibilities

Not known.

6.3 Shelf Life

Three years

6.4 Special Precautions For Storage

Storage temperature must not exceed 30oC.

6.5 Nature And Contents Of Container

Macrodantin 100 mg capsules are supplied in a PVC/aluminium foil blister pack of 30. Each pack comprises 3 blister cards containing 10 capsules on each card.

6.6 Special Precautions For Disposal And Other Handling

Macrodantin should be used as directed by physician.

A patient information leaflet is provided with details of use and handling of the product.

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Ltd

NLA Tower

12-16 Addiscombe Road

Croydon

CR0 0XT

United Kingdom

8. Marketing Authorisation Number(S)

PL 12762/0049

9. Date Of First Authorisation/Renewal Of The Authorisation

31/03/2000 / 24/05/2002

10. Date Of Revision Of The Text

13/08/2010

Vibramycin Monohydrate

Generic Name: doxycycline (DOX i SYE kleen) Brand Names: Adoxa, Adoxa CK, Adoxa TT, Alodox, Avidoxy, Doryx, Monodox, Oracea, Oraxyl, Periostat, Vibramycin, Vibramycin Calcium, Vibramycin Monohydrate

What is Vibramycin Monohydrate (doxycycline)?

Doxycycline is a tetracycline antibiotic. It fights bacteria in the body.

Doxycycline is used to treat many different bacterial infections, such as urinary tract infections, acne, gonorrhea, and chlamydia, periodontitis (gum disease), and others.

Doxycycline is also used to treat blemishes, bumps, and acne-like lesions caused by rosacea. Doxycycline will not treat facial redness caused by rosacea.

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

What is the most important information I should know about Vibramycin Monohydrate (doxycycline)? Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Doxycycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using doxycycline.

You should not take this medicine if you are allergic to doxycycline or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

Before taking doxycycline, tell your doctor if you have liver disease, kidney disease, asthma, or if you are allergic to sulfites.

Drink plenty of liquids while you are taking doxycycline. Children should not use doxycycline. Doxycycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. What should I discuss with my healthcare provider before taking Vibramycin Monohydrate (doxycycline)? You should not take this medicine if you are allergic to doxycycline or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

To make sure you can safely take doxycycline, tell your doctor if you have any of these other conditions:

liver disease;

kidney disease; or

asthma or sulfite allergy.

If you are using doxycycline to treat gonorrhea, your doctor may test you to make sure you do not also have syphilis, another sexually transmitted disease.

FDA pregnancy category D. Do not use doxycycline if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Tell your doctor right away if you become pregnant during treatment.

Doxycycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using doxycycline.

Doxycycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking doxycycline. Children should not use doxycycline. Doxycycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old. How should I take Vibramycin Monohydrate (doxycycline)?

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.

Take doxycycline with a full glass of water. Drink plenty of liquids while you are taking doxycycline.

Different brands of doxycycline may have different instructions about taking them with or without food.

Most brands of doxycyline may be taken with food or milk if the medicine upsets your stomach. Take Oracea or Periostat on an empty stomach, at least 1 hour before or 2 hours after a meal.

You may open a Doryx capsule or break up a Doryx tablet and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Drink a full glass (8 ounces) of cool water right away.

Do not crush, break, or open a delayed-release capsule. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time. The enteric coated pill has a special coating to protect your stomach. Breaking the pill will damage this coating.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Doxycycline will not treat a viral infection such as the common cold or flu.

If you need surgery, tell the surgeon ahead of time that you are using doxycycline. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat. Throw away any unused medicine after the expiration date on the label has passed. Using expired doxycycline can cause damage to your kidneys. 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 symptoms may include nausea, vomiting, and diarrhea.

What should I avoid while taking Vibramycin Monohydrate (doxycycline)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking doxycycline and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Doxycycline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking doxycycline. Vibramycin Monohydrate (doxycycline) 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. Call your doctor at once if you have a serious side effect such as:

severe headache, dizziness, blurred vision;

fever, chills, body aches, flu symptoms, swollen glands, rash or itching, joint pain, or general ill feeling;

urinating less than usual or not at all;

diarrhea that is watery or bloody

pale or yellowed skin, dark colored urine, fever, confusion or weakness;

severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

loss of appetite, jaundice (yellowing of the skin or eyes); or

severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

mild nausea, mild diarrhea;

upset stomach;

mild skin rash or itching; or

vaginal itching or discharge.

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 Vibramycin Monohydrate (doxycycline)?

Tell your doctor about all other medicines you use, especially:

cholesterol-lowering medications such as cholestyramine (Prevalite, Questran) or colestipol (Colestid);

isotretinoin (Accutane);

tretinoin (Renova, Retin-A, Vesanoid);

an antacid such as Tums, Rolaids, Milk of Magnesia, Maalox, and others;

a product that contains bismuth subsalicylate such as Pepto-Bismol;

minerals such as iron, zinc, calcium, magnesium, and over-the-counter vitamin and mineral supplements;

a blood thinner such as warfarin (Coumadin, Jantoven); or

a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin, Dispermox, Moxatag), ampicillin (Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Bicillin L-A, PC Pen VK, Pfizerpen).

This list is not complete and other drugs may interact with doxycycline. 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 Vibramycin Monohydrate resources Vibramycin Monohydrate Side Effects (in more detail)Vibramycin Monohydrate Use in Pregnancy & BreastfeedingDrug ImagesVibramycin Monohydrate Drug InteractionsVibramycin Monohydrate Support Group3 Reviews for Vibramycin Monohydrate - Add your own review/rating Vibramycin Monohydrate Advanced Consumer (Micromedex) - Includes Dosage Information Doxycycline Professional Patient Advice (Wolters Kluwer) Doxycycline Prescribing Information (FDA) Doxycycline Monograph (AHFS DI) Doxycycline MedFacts Consumer Leaflet (Wolters Kluwer) Adoxa MedFacts Consumer Leaflet (Wolters Kluwer) Alodox Prescribing Information (FDA) Doryx Prescribing Information (FDA) Doryx Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Doxycycline Calcium Monograph (AHFS DI) Monodox Prescribing Information (FDA) Ocudox Convenience Kit MedFacts Consumer Leaflet (Wolters Kluwer) Oracea Consumer Overview Oracea Prescribing Information (FDA) Periostat Prescribing Information (FDA) Periostat MedFacts Consumer Leaflet (Wolters Kluwer) Vibra-Tabs MedFacts Consumer Leaflet (Wolters Kluwer) Vibramycin Prescribing Information (FDA) Compare Vibramycin Monohydrate with other medications AcneActinomycosisAmebiasisAnthraxAnthrax ProphylaxisBacterial InfectionBartonellosisBronchitisBrucellosisBullous PemphigoidChlamydia InfectionCholeraCutaneous Bacillus anthracisEhrlichiosisEnterocolitisEpididymitis, Sexually TransmittedGastroenteritisGranuloma InguinaleInclusion ConjunctivitisLyme DiseaseLyme Disease, ArthritisLyme Disease, CarditisLyme Disease, Erythema Chronicum MigransLyme Disease, NeurologicLymphogranuloma VenereumMalariaMalaria PreventionMelioidosisMycoplasma PneumoniaNongonococcal UrethritisOcular RosaceaOrnithosisPelvic Inflammatory DiseasePemphigoidPemphigusPeriodontitisPlaguePleural EffusionPneumoniaProctitisProstatitisPsittacosisRabbit FeverRickettsial InfectionRosaceaSkin InfectionSTD ProphylaxisSyphilis, EarlySyphilis, LatentTertiary SyphilisTrachomaUpper Respiratory Tract InfectionUrinary Tract Infection Where can I get more information? Your pharmacist can provide more information about doxycycline.

See also: Vibramycin Monohydrate side effects (in more detail)

Sentry AV Ornacyn
Dosage Form: FOR ANIMAL USE ONLYBroad-spectrum, antibiotic for use in drinking water as an aid in the treatment of respiratory diseases of pet birds. INDICATIONS & USAGE Treatment of respiratory diseases of pet birds.

Diprobase Cream
1. Name Of The Medicinal Product

Diprobase Cream

2. Qualitative And Quantitative Composition

No pharmacologically active components.

3. Pharmaceutical Form

Cream

4. Clinical Particulars 4.1 Therapeutic Indications

Diprobase Cream is an emollient, moisturising and protective cream for the follow-up treatment with topical steroids or in spacing such treatment. It may also be used as diluent for topical steroids. Diprobase Cream is recommended for the symptomatic treatment of red inflamed, damaged, dry or chapped skin, the protection of raw skin areas and as a pre-bathing emollient for dry/eczematous skin to alleviate drying areas.

4.2 Posology And Method Of Administration

Adults and Children:

The cream should be applied to the dry skin areas as often as is required and rubbed well into the skin.

4.3 Contraindications

There are no absolute contraindications to the use of the cream other than hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

None stated.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

None stated.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Skin reactions including pruritus, rash, erythema, skin exfoliation, burning sensation, hypersensitivity, pain, dry skin and bullous dermatitis have been reported with product use.

4.9 Overdose

None stated.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Diprobase Cream contains no active ingredients and has no pharmacological action. The ingredients provide emollient, moisturising action on dry or chapped skin.

5.2 Pharmacokinetic Properties

Not applicable due to topical administration and direct action on the skin.

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 SmPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Chlorocresol

Macrogol Cetostearyl Ether (Cetomacrogol)

Cetostearyl alcohol

Liquid paraffin

White soft paraffin

Phosphoric acid

Sodium dihydrogen phosphate

Sodium hydroxide

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

15, 50 and 100gm aluminium tubes - 60 months

500gm pump presentations – 36 months

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

50, 100 and 15gm aluminium epoxy lined membrane tubes with plastic caps.

500gm polypropylene piston pack with polyethylene cap and daplen pump, disc and tube or PVC cap, polypropylene pump, polyolefin disc and HDPE tube or

500gm polypropylene jar (container) with a polypropylene dispenser head and cover, the pump system consists of a polyethylene follower plate, a polypropylene pump cylinder, a polyethylene piston with a glass and a polypropylene valve.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU, UK

8. Marketing Authorisation Number(S)

PL 00025/0575

9. Date Of First Authorisation/Renewal Of The Authorisation

12 April 1996 / 12 April 2001

10. Date Of Revision Of The Text

21 March 2011

11 LEGAL CATEGORY

GSL

© Merck Sharp & Dohme Limited 2011. All rights reserved.

DipCrm/UK/03-11/7

Chorex

Generic Name: chorionic gonadotropin (Subcutaneous route, Intramuscular route, Injection route)

kor-ee-ON-ok goe-nad-oh-TROE-pin

Commonly used brand name(s)

In the U.S.

Chorex Novarel Ovidrel Pregnyl Profasi

In Canada

Chorionic Gonadotropin

Available Dosage Forms:

Powder for Solution Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Gonadotropin

Uses For Chorex

Chorionic gonadotropin is a drug whose actions are almost the same as those of luteinizing hormone (LH), which is produced by the pituitary gland. It is a hormone also normally produced by the placenta in pregnancy. Chorionic gonadotropin has different uses for females and males.

In females, chorionic gonadotropin is used to help conception occur. It is usually given in combination with other drugs such as menotropins and urofollitropin. Many women being treated with these drugs usually have already tried clomiphene alone (e.g., Serophene) and have not been able to conceive yet. Chorionic gonadotropin is also used in in vitro fertilization (IVF) programs.

In males, LH and chorionic gonadotropin stimulate the testes to produce male hormones such as testosterone. Testosterone causes the enlargement of the penis and testes and the growth of pubic and underarm hair. It also increases the production of sperm.

Although chorionic gonadotropin has been prescribed to help some patients lose weight, it should never be used this way. When used improperly, chorionic gonadotropin can cause serious problems.

Chorionic gonadotropin is to be administered only by or under the immediate supervision of your doctor.

Before Using Chorex

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

Allergies

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

Pediatric

Chorionic gonadotropin, when used for treating cryptorchidism (a birth defect where the testes remain inside the body), has caused the sexual organs of some male children to develop too rapidly.

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

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

Asthma or Epilepsy (seizures) or Heart problems or Kidney problems or Migraine headaches—This medication may worsen these conditions. Cancer of the prostate or Precocious puberty (a condition that causes early puberty in boys before 9 years of age)—Increases in the amount of testosterone in the bloodstream may make these conditions worse. Cyst on ovary or Fibroid tumors of the uterus—Chorionic gonadotropin can cause further growth of cysts on the ovary or fibroid tumors of the uterus Unusual vaginal bleeding—Irregular vaginal bleeding is a sign that the endometrium is growing too much, of endometrial cancer, or of other hormone imbalances; the increases in estrogen production caused by ovulation can aggravate these problems of the endometrium. If other hormone imbalances are present, they should be treated before beginning ovulation induction Proper Use of chorionic gonadotropin

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

Dosing

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

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

For injection dosage form: For treating men with problems related to low levels of male hormones: Adults—1000 to 4000 Units injected into the muscle two to three times a week. You may need to receive this medicine for several weeks, months, or longer. If you are being treated for a low sperm count and have been on this medicine for six months, your doctor may give you another hormone medicine (menotropin or urofollitropin injection). You may need to receive both of these medicines together for up to twelve more months. To help pregnancy occur in women: Adults—5000 to 10,000 Units injected into the muscle on a day chosen by your doctor. The dose and day will depend on your hormone levels and the other medicines that you have been using. For the treatment of cryptorchidism (condition where testes do not develop properly): Children—1000 to 5000 Units injected into the muscle two to three times a week for up to ten doses. Precautions While Using Chorex

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

For women taking this medicine to become pregnant :

Record your basal body temperature every day if told to do so by your doctor, so that you will know if you have begun to ovulate. It is important that intercourse take place around the time of ovulation to give you the best chance of becoming pregnant. Your doctor will likely want to monitor the development of the ovarian follicle(s) by measuring the amount of estrogen in your bloodstream and by checking the size of the follicle(s) with ultrasound examinations. Chorex 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 as soon as possible if any of the following side effects occur:

For females onlyMore common Bloating (mild) stomach or pelvic pain Less common or rare Abdominal or stomach pain (severe) bloating (moderate to severe) decreased amount of urine feeling of indigestion nausea, vomiting, or diarrhea (continuing or severe) pelvic pain (severe) shortness of breath swelling of feet or lower legs weight gain (rapid) For boys onlyLess common Acne enlargement of penis and testes growth of pubic hair increase in height (rapid) Frequency not determined difficult or labored breathing difficulty breathing flushing of skin hives or welts itching of skin large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs pain in chest, groin, or legs, especially the calves redness of skin severe, sudden headache skin rash slurred speech sudden loss of coordination sudden, severe weakness or numbness in arm or leg sudden, unexplained shortness of breath tightness in chest unusually warm skin vision changes wheezing

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:

Less common Discouragement enlargement of breasts feeling sad or empty headache irritability lack of appetite loss of interest or pleasure pain at place of injection trouble concentrating trouble sleeping tiredness

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

For females onlyLess common or rare Abdominal or stomach pain (severe) bloating (moderate to severe) decreased amount of urine feeling of indigestion nausea, vomiting, or diarrhea (continuing or severe) pelvic pain (severe) shortness of breath weight gain (rapid)

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: Chorex side effects (in more detail)

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

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

More Chorex resources Chorex Side Effects (in more detail)Chorex Use in Pregnancy & BreastfeedingChorex Drug InteractionsChorex Support Group0 Reviews for Chorex - Add your own review/rating Hcg Consumer Overview Novarel MedFacts Consumer Leaflet (Wolters Kluwer) Novarel Prescribing Information (FDA) Ovidrel Prescribing Information (FDA) Ovidrel Monograph (AHFS DI) Ovidrel MedFacts Consumer Leaflet (Wolters Kluwer) Pregnyl Prescribing Information (FDA) Compare Chorex with other medications Female InfertilityHypogonadism, MaleOvulation InductionPrepubertal Cryptorchidism

Cortomycin Eye Ointment
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP (Sterile) DESCRIPTION:

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP is a sterile antimicrobial and anti-inflammatory ointment for ophthalmic use.

Each Gram Contains: ACTIVES: Neomycin sulfate (equivalent to 3.5 mg neomycin base), Polymyxin B Sulfate equivalent to 10,000 polymyxin B units, Bacitracin Zinc equivalent to 400 bacitracin units, Hydrocortisone 10 mg (1%); INACTIVES: White Petrolatum, Mineral Oil.

Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis.

The structural formulae are:

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis.

The structural formulae are:

Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg.

The structural formula is:

Hydrocortisone, 11?, 17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone.

Its structural formula is:

CLINICAL PHARMACOLOGY:

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body’s defense mechanism against infection, concomitant antimicrobial drugs may be used when this inhibition is considered to be clinically significant in a particular case.

When a decision to administer both a corticosteroid and antimicrobials is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of all drugs is administered. When each type of drug is in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained.

The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.

Microbiology:

The anti-infective components in neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment are included to provide action against specific organisms susceptible to it. Neomycin sulfate and polymyxin B sulfate are active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against Serratia marcescens (see INDICATIONS AND USAGE).

INDICATIONS AND USAGE:

Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.

Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see CLINICAL PHARMACOLOGY: Microbiology).

The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.

CONTRAINDICATIONS:

Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

This product is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.

WARNINGS:

NOT FOR INJECTION INTO THE EYE. Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing. Prolonged use of corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.

Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.

If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma.

The use of corticosteroids after cataract surgery may delay healing and increase the incidence of filtering blebs.

Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.

Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).

PRECAUTIONS: General:

The initial prescription and renewal of the medication order beyond 8 grams should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate.

If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS).

There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients).

Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Information for Patients:

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.

Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General).

If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.

Keep tightly closed when not in use. Keep out of the reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 mcg /mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity or mutagenicity attributable to oral administration of corticosteroids. Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical corticosteroids. Studies to determine mutagenicity with hydrocortisone have revealed negative results.

Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, litter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet. Long-term animal studies have not been performed to evaluate the effect on fertility of topical corticosteroids.

Pregnancy: Teratogenic Effects:

Pregnancy Category C. Corticosteroids have been found to be teratogenic in rabbits when applied topically at concentrations of 0.5% on days 6 to 18 of gestation and in mice when applied topically at a concentration of 15% on days 10 to 13 of gestation. There are no adequate and well-controlled studies in pregnant women. Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS:

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. The exact incidence is not known.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitization reactions including itching, swelling and conjunctival erythema (see WARNINGS). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection:

The development of secondary infection has occurred after use of combinations containing corticosteroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of a corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.

Local irritation on instillation has also been reported.

DOSAGE AND ADMINISTRATION:

Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.

Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS: above.

HOW SUPPLIED:

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP is supplied in a tube with ophthalmic tip applicator in the following size:

3.5 g - Prod. No. 03934.

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

FOR OPHTHALMIC USE ONLY

Storage:

Store between 15° - 30°C (59°- 86°F).

KEEP OUT OF REACH OF CHILDREN.

Rx only

Revised November 2007

Bausch & Lomb Incorporated

terbutaline inhalation

Generic Name: terbutaline inhalation (ter BYOO ta leen) Brand Names: Brethaire

What is terbutaline inhalation?

Terbutaline is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Terbutaline inhalation is used to treat conditions such as asthma, bronchitis, and emphysema.

Terbutaline inhalation may also be used for conditions other than those listed in this medication guide.

What is the most important information I should know about terbutaline inhalation?

It is very important that you use the terbutaline inhaler properly, so that the medicine gets into your lungs. You doctor may want you to use a spacer with the inhaler. Talk to your doctor about proper inhaler use.

Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

What should I discuss with my healthcare provider before using terbutaline inhalation?

Before using terbutaline inhalation, tell your doctor if you have

heart disease or high blood pressure;

epilepsy or another seizure disorder;

diabetes;

an overactive thyroid (hyperthyroidism); or

liver or kidney disease.

You may require a dosage adjustment or special monitoring during treatment with terbutaline inhalation if you have any of the conditions listed above.

Terbutaline is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use terbutaline inhalation without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether terbutaline passes into breast milk. Do not use terbutaline inhalation without first talking to your doctor if you are breast-feeding a baby. Terbutaline inhalation is not approved for use by children younger than 12 years of age. How should I use terbutaline inhalation?

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

Shake the inhaler several times and uncap the mouthpiece. Breathe out fully. For best results, hold the inhaler 1 to 2 inches in front of your open mouth or attach a spacer to the inhaler and place the spacer in your mouth, above your tongue and past your teeth. Take a deep, slow breath as you push down on the canister. Hold your breath for 10 seconds, then exhale slowly. If you place the inhaler directly into your mouth, you may not receive the correct amount of medicine because it will be propelled onto the back of your tongue and/or throat. If you do use the inhaler directly in your mouth, be sure that it is above your tongue and past your teeth.

If you take more than one dose at a time, wait for at least 1 full minute, then repeat the procedure.

If you also use a steroid inhaler, use the terbutaline inhaler first to open up your airways, then use the steroid inhaler as directed.

It is very important that you use the terbutaline inhaler properly, so that the medicine gets into your lungs. Your doctor may want you to use a spacer with the inhaler. Talk to your doctor about proper inhaler use.

It is important to use terbutaline inhalation regularly to get the most benefit.

Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

Your doctor may want you to have lung function test or other medical evaluations during treatment with terbutaline inhalation to monitor progress and side effects.

Keep the inhaler clean and dry. Keep the mouthpiece capped to avoid getting dirt inside it. The inhaler can be cleaned by removing the canister and immersing the mouthpiece in warm water or alcohol. Allow the parts to dry, then reassemble the inhaler.

Carry the inhaler with you at all times in case of emergencies. Get a refill before you run out of medicine and before going on vacation.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.

What happens if I overdose? Seek emergency medical attention if an overdose is suspected.

Symptoms of a terbutaline overdose include angina or chest pain, irregular heartbeats or a fluttering heart, seizures, tremor, weakness, headache, nausea, and vomiting.

What should I avoid while using terbutaline inhalation?

Avoid situations that may trigger an asthma attack such as exercising in cold, dry air; smoking; breathing in dust; and exposure to allergens such as pet fur.

Terbutaline inhalation side effects Stop using terbutaline inhalation and seek emergency medical attention if you experience any of the following serious side effects:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or

chest pain or irregular heartbeats.

Other, less serious side effects may be more likely to occur. Continue to use terbutaline inhalation and talk to your doctor if you experience

headache, dizziness, lightheadedness, or insomnia;

tremor or nervousness;

sweating;

nausea, vomiting, or diarrhea; or

dry mouth.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Terbutaline inhalation Dosing Information

Usual Adult Dose for Asthma -- Maintenance:

Tablets: 5 mg orally 3 times a day at 6 hour intervals during waking hours. May decrease to 2.5 mg/dose if side effects are pronounced. Do not exceed 15 mg in 24 hours.Inhalation aerosol: 2 inhalations separated by 60 seconds every 4 to 6 hours. Do not repeat more often than every 4 to 6 hours.

Usual Adult Dose for Premature Labor:

Tablets: 2.5 to 7.5 mg orally every 6 hours. Therapy should be continued until 36 to 37 weeks gestation.

Tolmetin Sodium

Class: Other Nonsteroidal Anti-inflammatory AgentsVA Class: MS120Chemical Name: Sodium 1-methyl-5-(4-methylbenzoyl)-1H-pyrrole-2-acetate dihydrate

Striant

Generic Name: testosterone buccal system (tes TOSS ter one) Brand Names: Striant

What is testosterone buccal system?

Testosterone is a naturally occurring "male" sex hormone necessary for many processes in the body.

Testosterone buccal system is used to treat men with low testosterone levels.

Testosterone buccal system may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about testosterone buccal system? Notify your doctor if you experience nausea; vomiting; swelling of the ankles; changes in skin color; too frequent or prolonged erections; breathing disturbances, including those associated with sleep; yellowing of the skin or eyes; dark colored urine; or problems with urination. Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

What should I discuss with my healthcare provider before using testosterone buccal system? Do not use testosterone buccal system if you have cancer of the breast or prostate. Testosterone may worsen some cancers of these types.

Before using testosterone buccal system, tell your doctor if you have

had a previous allergic reaction to testosterone;

diabetes;

sleep apnea (brief periods of not breathing during sleep) or if you have risk factors for sleep apnea (e.g., obesity, chronic lung disease);

difficulty with urination due to enlargement of the prostate;

heart disease; or

liver disease or kidney disease.

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

Testosterone buccal system is not approved for use by women and must not be used by women. Testosterone buccal system is in the FDA pregnancy category X. This means that testosterone is known to cause birth defects in an unborn baby. Do not use testosterone buccal system if you are pregnant or could become pregnant during treatment. Testosterone buccal system is not approved for use by women and must not be used by women. It is not known whether testosterone from the buccal system will pass into breast milk.Do not use testosterone buccal system if you are breast-feeding a baby. Men over 65 years of age that use testosterone buccal system may be at increased risk for the development of prostatic enlargement or cancer. You may not be able to use buccal system testosterone, or you may require a lower dose or special monitoring. How should I use testosterone buccal system?

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

To use the testosterone buccal system (Striant):

Hold one buccal system with the flat side on your fingertip. Place the curved side onto your gum, as high as possible above the left or right incisor tooth. Hold your finger on the outside of your lip over the system for 30 seconds to ensure the system is attached to the gum. If the system sticks to the cheek and not the gum, this is acceptable.

The buccal system should remain in place for 12 hours. To remove the system, move it slightly toward the back or front of the mouth then slide it toward the teeth from removal. With each new application, rotate to alternate sides of the mouth. This avoids scratching the gum. Check to see that the system is in place after eating, drinking, brushing the teeth, or using mouthwash.

As the buccal system absorbs moisture from the mouth, it will begin to soften and will mold to the shape of the gum. The system does not dissolve completely, but will remain in place. It will not move until you remove it.

If a buccal system falls off before 8 hours of use, remove it and replace it with a new system in the same place.

Change the buccal system and alternate sides of the mouth 12 hours after application of the original system. If a buccal system falls off after 8 hours but before 12 hours of use, remove the system and replace it with a new system above the opposite incisor. This will serve as the second dose for the day.

Do not chew or swallow the testosterone buccal system.

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

Your doctor may want to perform tests to monitor the amount of testosterone in the body, liver function, prostate function, cholesterol levels, or other factors during treatment with testosterone buccal system.

It is important to use testosterone buccal system regularly to get the most benefit.

Dispose of all used systems properly, out of the reach of children and pets.

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

Apply the next system as soon as you remember. Do not use two doses simultaneously, unless otherwise directed by your doctor.

What happens if I overdose? An overdose of testosterone buccal system is not likely to threaten life. If you do suspect an overdose, or if a system has been ingested, call an emergency room or poison control center for advice. What should I avoid while using testosterone buccal system?

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

Testosterone buccal system side effects If you experience any of the following serious side effects, stop using testosterone buccal system and seek emergency medical attention or contact your doctor immediately:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

nausea or vomiting;

changes in skin color;

swelling of the ankles or legs;

breathing disturbances, including those associated with sleep;

too frequent or prolonged erections;

liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue); or

dark colored urine or problems with urination.

Other, less serious side effects may be more likely to occur. Continue to use testosterone buccal system and talk to your doctor if you experience

irritation or changes in the gum at the system application site;

bitter or unusual taste in the mouth;

headache;

emotional changes;

increased blood pressure;

decreased interest in sex;

changes in blood cholesterol or number of red blood cells (detected by blood tests);

prostate changes or difficulty urinating;

enlarged, swollen or tender breasts; or

acne.

Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect testosterone buccal system?

Before using testosterone buccal system, tell your doctor if you are taking any of the following medicines:

warfarin (Coumadin);

insulin or an oral diabetes medication such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), repaglinide (Prandin), rosiglitazone (Avandia), pioglitazone (Actos), and others;

propranolol (Inderal, Inderal LA, others); or

a corticosteroid such as hydrocortisone (Cortef, Hydrocortone, Solu-Cortef), dexamethasone (Decadron, Hexadrol others), methylprednisolone (Depo-Medrol, Medrol, Solu-Medrol), prednisolone (Prelone, Pediapred), prednisone (Deltasone, Orasone, others), and others.

You may not be able to use testosterone buccal system, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with testosterone buccal system. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

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See also: Striant side effects (in more detail)

Naratriptan
Pronunciation: NAR-a-TRIP-tanGeneric Name: NaratriptanBrand Name: Amerge

Synvisc

Generic Name: hylan G-F 20 (HI lan G F 20) Brand Names: Synvisc, Synvisc-One

What is hylan G-F 20?

Hylan G-F 20 is similar to the fluid that surrounds the joints in your body. This fluid acts as a lubricant and shock absorber for the joints.

Hylan G-F 20 is used to treat knee pain caused by osteoarthritis.

Hylan G-F 20 is usually given after other arthritis medications have been tried without successful treatment of symptoms.

Hylan G-F 20 may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hylan G-F 20? You should not receive hylan G-F 20 if you are allergic to it, or if you have an infection in your knee or in the skin around your knee.

Before you receive a hylan G-F 20 injection, tell your doctor if you have blood clots or circulation problems in your legs, or an allergy to birds, feathers, or egg products.

For at least 48 hours after your injection, avoid jogging, strenuous activity, high-impact sports, or standing for longer than 1 hour at a time.

Call your doctor at once if you have severe pain or swelling around the knee after the injection. What should I discuss with my health care provider before receiving hylan G-F 20? You should not receive hylan G-F 20 if you are allergic to it, or if you have an infection in your knee or in the skin around your knee.

To make sure you can safely receive hylan G-F 20, tell your doctor if you have:

blood clots or circulation problems in your legs; or

an allergy to birds, feathers, or egg products.

It is not known whether hylan G-F 20 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 hylan G-F 20 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. Hylan G-F 20 is generally not used in anyone younger than 21 years old. How is hylan G-F 20 given?

Hylan G-F 20 is injected directly into your knee joint. A healthcare provider will give you this injection.

Hylan G-F 20 is usually given once every week for 3 weeks. Follow your doctor's dosing instructions very carefully.

To prevent pain and swelling, your doctor may recommend resting your knee or applying ice for a short time after your injection.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your hylan G-F 20 injection.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving hylan G-F 20?

For at least 48 hours after your injection, avoid jogging, strenuous activity, or high-impact sports such as soccer or tennis. Also avoid weight-bearing activity or standing for longer than 1 hour at a time. Ask your doctor how long to wait before you resume these activities.

Hylan G-F 20 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. Call your doctor at once if you have severe pain or swelling around the knee after the injection.

Less serious side effects may include:

warmth, pain, stiffness, swelling, or puffiness where the medicine was injected;

muscle pain, trouble walking;

fever, chills, nausea;

numbness or tingly feeling;

headache, dizziness;

tired feeling; or

itching or skin irritation around the knee.

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 hylan G-F 20?

There may be other drugs that can interact with hylan G-F 20. 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 Synvisc resources Synvisc Side Effects (in more detail)Synvisc Use in Pregnancy & BreastfeedingSynvisc Drug InteractionsSynvisc Support Group6 Reviews for Synvisc - Add your own review/rating Synvisc Advanced Consumer (Micromedex) - Includes Dosage Information Synvisc Solution MedFacts Consumer Leaflet (Wolters Kluwer) Synvisc Consumer Overview Hylan G-F 20 Compare Synvisc with other medications Osteoarthritis Where can I get more information? Your doctor can provide more information about hylan G-F 20.

See also: Synvisc side effects (in more detail)

Ocufen
1. Name Of The Medicinal Product

Ocufen®

2. Qualitative And Quantitative Composition

Flurbiprofen sodium 0.03% w/v

3. Pharmaceutical Form

Eye drops.

4. Clinical Particulars 4.1 Therapeutic Indications

Ocufen is indicated for

1) the inhibition of intraoperative miosis. Ocufen does not have intrinsic mydriatic properties and does not replace mydriatic agents.

2) the management of post-operative and post-laser trabeculoplasty inflammation in the anterior segment of the eye in patients in whom steroid therapy is not recommended.

4.2 Posology And Method Of Administration

Adult dosage: For the inhibition of intraoperative miosis, 1 drop is instilled every half hour starting 2 hours before surgery. The final drop should be given not less than 30 minutes before surgery.

To control post-operative and post-laser trabeculoplasty inflammation the dosing regimen above should be followed. Beginning twenty-four hours after surgery, one drop is administered four times daily for at least one week after laser trabeculoplasty or for two to three weeks after other surgery.

In accordance with standard practice, other topical medication should not be co-administered with Ocufen. When administering other topical medications, a minimum interval of 5 minutes between instillations is recommended.

Use in children: Safety and effectiveness in children have not been established.

Administration: Topical by instillation into the conjunctival sac.

4.3 Contraindications

Ocufen is contra-indicated in epithelial herpes simplex keratitis (dendritic keratitis) and in individuals hypersensitive to any component of the medication.

The potential exists for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Ocufen is contra-indicated in individuals who have previously exhibited sensitivities to these drugs.

Use of Ocufen is contra-indicated in patients with known haemostatic defects or who are receiving other medications which may prolong bleeding time. Ocufen is contra- indicated for intraocular use during surgical procedures.

4.4 Special Warnings And Precautions For Use

Wound healing may be delayed with the use of Ocufen.

There have been reports that Ocufen may cause an increased bleeding tendency of ocular tissues in conjunction with surgery.

Patients with a history of herpes simplex keratitis should be monitored closely.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in some surgical patients treated with Ocufen.

4.6 Pregnancy And Lactation

Use in pregnancy: Safety of use in pregnant women has not been established. Ocufen should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

The most frequent adverse reactions reported with the use of Ocufen are transient burning and stinging on instillation, and other minor signs of ocular irritation.

4.9 Overdose

No adverse effects are likely to be experienced following overdosage.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Flurbiprofen sodium is a non steroidal anti inflammatory agent which inhibits prostaglandin synthesis by inhibition of the cyclo-oxygenase enzyme.

Ophthalmic surgery causes prostaglandin release, with the effect that prostaglandin- mediated miosis may occur.

Treatment with Ocufen prior to surgery has been shown to inhibit intra-operative miosis and it is believed that this is brought about by inhibition of ocular prostaglandin release.

The sympathetic nervous system is not affected by this mechanism and acetylcholine- induced miosis has not been found to be inhibited in clinical trials.

Prostaglandins have also been shown to be mediators of certain kinds of intraocular inflammatory processes. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humour barrier, vasodilation, increased vascular permeability, leukocytosis and increased intraocular pressure.

5.2 Pharmacokinetic Properties

Flurbiprofen concentrations of 213 ng/ml in aqueous humour have been reported following half hourly treatment for two hours preceding surgery.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Liquifilm® (polyvinyl alcohol)

Potassium chloride

Sodium chloride

Sodium citrate dihydrate

Citric acid monohydrate

Sodium hydroxide or

Hydrochloric acid (to adjust pH)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

The shelf life is 24 months for the unopened vial. The vial should be discarded after a single dose.

6.4 Special Precautions For Storage

Store at or below 25oC.

6.5 Nature And Contents Of Container

Clear, plastic unit dose vial, each containing 0.4 ml of solution.

6.6 Special Precautions For Disposal And Other Handling

Each vial of Ocufen should be used for a single dose and discarded after use.

7. Marketing Authorisation Holder

Allergan Limited

Marlow International

The Parkway

Marlow

Buckinghamshire SL7 1YL

United Kingdom

8. Marketing Authorisation Number(S)

PL 00426/0069

9. Date Of First Authorisation/Renewal Of The Authorisation

28th June 1991/17th May 2005

10. Date Of Revision Of The Text

24th November 2006

Insulin Penmix 50

Insulin Penmix 50 may be available in the countries listed below.

Ingredient matches for Insulin Penmix 50 Insulin Injection, Biphasic Isophane

Insulin Injection, Biphasic Isophane human (a derivative of Insulin Injection, Biphasic Isophane) is reported as an ingredient of Insulin Penmix 50 in the following countries:

Greece New Zealand

International Drug Name Search

adapalene and benzoyl peroxide topical

Generic Name: adapalene and benzoyl peroxide (topical) (a DAP a leen and BEN zoyl per OX ide) Brand names: Epiduo, Epiduo Pump

What is adapalene and 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.

Adapalene is a medication similar to vitamin A. It helps the skin renew itself.

The combination of adapalene and benzoyl peroxide topical (for the skin) is used to treat acne in people who are at least 12 years old.

Adapalene and benzoyl peroxide topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about adapalene and benzoyl peroxide topical?

Before using this medication, tell your doctor about all other medicated skin products you are using. Using more than one acne medication at a time could cause severe skin irritation.

Avoid getting this medication in your mouth, nose, or eyes, or on your lips. If it does get into any of these areas, rinse with water. Do not use adapalene and benzoyl peroxide topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using adapalene and 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 dryness or irritation, such as harsh soaps, shampoos, or skin cleansers, 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. What should I discuss with my healthcare provider before using adapalene and benzoyl peroxide topical? You should not use this medication if you are allergic to adapalene (Differin) or benzoyl peroxide.

Before using this medication, tell your doctor about all other medicated skin products you are using. Using more than one acne medication at a time could cause severe skin irritation.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using adapalene and benzoyl peroxide topical, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether adapalene and 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 adapalene and benzoyl peroxide topical?

Use adapalene and benzoyl peroxide topical exactly as your doctor has prescribed it for you. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects. Do not use this medication for longer than your doctor has prescribed.

Wash your hands before and after applying this medication.

Adapalene and benzoyl peroxide topical is usually applied one time per day. Follow your doctor's instructions.

Clean and pat dry the skin to be treated. Use a pea-sized amount of the gel for each treatment area (chin, forehead, and each cheek). Apply the medicine in a thin layer and rub in gently.

Do not apply any other skin products unless your doctor has told you to.

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

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to apply the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

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

An overdose of adapalene and benzoyl peroxide applied to the skin is not likely to cause life-threatening symptoms.

What should I avoid while using adapalene and benzoyl peroxide topical? Avoid getting this medication in your mouth, nose, or eyes, or on your lips. If it does get into any of these areas, rinse with water. Do not use adapalene and benzoyl peroxide topical on sunburned, irritated, or broken skin. Also avoid using adapalene and 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 contain salicylic acid, sulfur, or resorcinol while you are using adapalene and benzoyl peroxide topical.

Avoid using skin products that can cause dryness or irritation, such as harsh soaps, shampoos, or skin cleansers, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Avoid exposure to sunlight, sunlamps, or tanning beds. This medication can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors. Adapalene and 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.

During your first 4 weeks of using adapalene and benzoyl peroxide topical, your skin may be dry, red, or scaly. You may also feel some burning or stinging. Call your doctor if these side effects are severe.

Less serious side effects may include mild itching.

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

Adapalene and benzoyl peroxide Dosing Information

Usual Adult Dose for Acne:

Adapalene and benzoyl peroxide topical should be applied to affected areas of the face and/or trunk once daily after washing. A pea-size amount is applied to each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips, and mucous membranes.

What other drugs will affect adapalene and benzoyl peroxide topical? Do not use other medicated skin products unless your doctor has told you to.

It is not likely that other drugs you take orally or inject will have an effect on topically applied adapalene and benzoyl peroxide. But many drugs can interact with each other. 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 adapalene and benzoyl peroxide resources Adapalene and benzoyl peroxide DosageAdapalene and benzoyl peroxide Use in Pregnancy & BreastfeedingAdapalene and benzoyl peroxide Drug InteractionsAdapalene and benzoyl peroxide Support Group29 Reviews for Adapalene and benzoyl peroxide - Add your own review/rating Compare adapalene and benzoyl peroxide with other medications Acne Where can I get more information? Your pharmacist can provide more information about adapalene and benzoyl peroxide topical.

Accupril

Generic Name: quinapril (KWIN a pril) Brand Names: Accupril

What is quinapril?

Quinapril is an ACE inhibitor. ACE stands for angiotensin converting enzyme.

Quinapril is used to treat high blood pressure (hypertension) and heart failure.

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

What is the most important information I should know about quinapril? FDA pregnancy category D. Do not use quinapril if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of quinapril. Do not use salt substitutes or potassium supplements while taking quinapril, unless your doctor has told you to. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting. If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. What should I discuss with my healthcare provider before taking quinapril? You should not use this medication if you are allergic to quinapril or to any other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), ramipril (Altace), or trandolapril (Mavik).

To make sure you can safely take quinapril, tell your doctor if you have any of these other conditions:

kidney disease (or if you are on dialysis);

liver disease;

heart disease or congestive heart failure;

diabetes; or

a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, lupus, scleroderma, or rheumatoid arthritis.

FDA pregnancy category D. Do not use quinapril if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Quinapril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking quinapril. Quinapril can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take quinapril?

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.

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

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting. Drink plenty of water while you are taking quinapril.

Your blood pressure will need to be checked often. To be sure this medication is not causing harmful effects, your kidney or liver function will need to be checked with blood tests. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using quinapril. You may need to stop using the medicine for a short time. If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture, heat, and light.

See also: Accupril 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 symptoms may include extreme dizziness or fainting.

What should I avoid while taking quinapril? Do not use salt substitutes or potassium supplements while taking quinapril, unless your doctor has told you to. Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of quinapril. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Quinapril side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

feeling like you might pass out;

fever, chills, body aches, flu symptoms;

pale or yellowed skin, dark colored urine, fever, confusion or weakness;

high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

chest pain;

urinating more or less than usual, or not at all;

swelling, rapid weight gain; or

jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

headache;

cough;

muscle pain, back pain;

dizziness, tired feeling;

nausea, vomiting, diarrhea, stomach discomfort; or

mild skin itching or rash.

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 quinapril?

Tell your doctor about all other medicines you use, especially:

gold injections to treat arthritis;

lithium (Lithobid, Eskalith);

tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);

a potassium supplement such as K-Dur, Klor-Con;

salt substitutes that contain potassium;

a diuretic (water pill); or

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with quinapril. 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 Accupril resources Accupril Side Effects (in more detail)Accupril DosageAccupril Use in Pregnancy & BreastfeedingDrug ImagesAccupril Drug InteractionsAccupril Support Group2 Reviews for Accupril - Add your own review/rating Accupril Prescribing Information (FDA) Accupril Monograph (AHFS DI) Accupril Advanced Consumer (Micromedex) - Includes Dosage Information Accupril Consumer Overview Accupril MedFacts Consumer Leaflet (Wolters Kluwer) Quinapril Prescribing Information (FDA) Compare Accupril with other medications Diabetic Kidney DiseaseHeart FailureHigh Blood PressureLeft Ventricular Dysfunction Where can I get more information? Your pharmacist can provide more information about quinapril.

See also: Accupril side effects (in more detail)

Vitamin D3

Generic Name: cholecalciferol (vitamin D3) (KOE le kal SIF e role) Brand Names: D 1000 IU, D3-5, D3-50, Delta D3, Vitamin D3

What is cholecalciferol?

Cholecalciferol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Cholecalciferol is used to treat or prevent many conditions caused by a lack of vitamin D, especially conditions of the skin or bones.

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

What is the most important information I should know about cholecalciferol? Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have high levels of calcium or vitamin D in your blood, or if you have any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

Before taking cholecalciferol, tell your doctor if you are allergic to any drugs, or if you have heart disease, kidney disease, or an electrolyte imbalance.

Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends. 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.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamin D can cause serious or life-threatening side effects.

Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, severe pain in your upper stomach spreading to your back, or fainting.

What should I discuss with my healthcare provider before taking cholecalciferol? Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have:

high levels of calcium in your blood (hypercalcemia);

high levels of vitamin D in your body (hypervitaminosis D); or

any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use cholecalciferol:

heart disease;

kidney disease; or

an electrolyte imbalance.

Your cholecalciferol dose needs may change if you are pregnant or breast-feeding. Tell your doctor if you are pregnant or plan to become pregnant during treatment, or if you are breast-feeding a baby. How should I take cholecalciferol?

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

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

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Cholecalciferol is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

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

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamin D can cause serious or life-threatening side effects.

Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, severe pain in your upper stomach spreading to your back, or fainting.

What should I avoid while taking cholecalciferol? Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends.

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

thinking problems, changes in behavior, feeling irritable;

urinating more than usual;

chest pain, feeling short of breath; or

early signs of vitamin D overdose (weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting).

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 cholecalciferol?

Before taking cholecalciferol, tell your doctor if you are taking any of the following medicines:

seizure medication;

cholestyramine (Prevalite, Questran);

colestipol (Colestid);

steroids (prednisone and others);

digoxin (digitalis, Lanoxin); or

a diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.

This list is not complete and there may be other drugs that can interact with cholecalciferol. 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 Vitamin D3 resources Vitamin D3 Side Effects (in more detail)Vitamin D3 Use in Pregnancy & BreastfeedingVitamin D3 Drug InteractionsVitamin D3 Support Group0 Reviews for Vitamin D3 - Add your own review/rating Delta D3 Advanced Consumer (Micromedex) - Includes Dosage Information Compare Vitamin D3 with other medications Prevention of FallsPrevention of FracturesVitamin D DeficiencyVitamin D Insufficiency Where can I get more information? Your pharmacist can provide more information about cholecalciferol.

See also: Vitamin D3 side effects (in more detail)

Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets
Pronunciation: VYE-ta-min/FOE-lik AS-id/EYE-urnGeneric Name: Vitamin B Complex/Vitamin C/Folic Acid/Brand Name: Examples include Foli-Iron and I-Fol Plus

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