Infacol

1. Name Of The Medicinal Product

INFACOL

2. Qualitative And Quantitative Composition

Simeticone 40mg/ml

3. Pharmaceutical Form

Oral suspension

4. Clinical Particulars

4.1 Therapeutic Indications

An antiflatulent for the relief of griping pain, colic or wind due to swallowed air.

4.2 Posology And Method Of Administration

For adults and elderly:

Not applicable.

For infants:

20mg (0.5ml) administered before each feed. If necessary this may be increased to 40mg (1ml). Treatment with Infacol may provide a progressive improvement in symptoms over several days.

4.3 Contraindications

None stated

4.4 Special Warnings And Precautions For Use

If symptoms persist, seek medical advice.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Levothyroxine may bind to simeticone. Absorption of levothyroxine may be impaired if Infacol is given concurrently to infants treated for thyroid disorders.

4.6 Pregnancy And Lactation

Not applicable

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

None stated

4.9 Overdose

In the event of deliberate or accidental overdose, treat symptoms on appearance.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Physiologically the active ingredient is a chemically inert, non-systemic gastric defoaming agent that works by altering the elasticity of interfaces of mucus-embedded bubbles in the gastrointestinal tract.

The gas bubbles are thus broken down or coalesced and in this form gas is more easily eliminated through eructation or passing flatus.

5.2 Pharmacokinetic Properties

Simeticone is not absorbed from the gastrointestinal tract.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Saccharin Sodium

Hypromellose

Orange flavour

Methyl Hydroxybenzoate (E218)

Propyl Hydroxybenzoate (E216)

Purified Water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

As packaged for sale : 3 years

After first opening : 28 days.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

High-density polyethylene bottle fitted with a low-density polyethylene dropper and evoprene teat containing 50ml of liquid.

6.6 Special Precautions For Disposal And Other Handling

Not stated.

7. Marketing Authorisation Holder

Forest Laboratories UK Limited

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent DA2 6SL

8. Marketing Authorisation Number(S)

PL 0108/0100

9. Date Of First Authorisation/Renewal Of The Authorisation

29^th October 1986 / 26^th November 2001

10. Date Of Revision Of The Text

26th April 2011

11. Legal Category

GSL

Quinoderm Lotio-Gel 5%

1. Name Of The Medicinal Product

QUINODERM™ LOTIO-GEL 5%

2. Qualitative And Quantitative Composition

Benzoyl Peroxide BP	5.0%
Potassium Hydroxyquinoline Sulphate BP	0.5%

3. Pharmaceutical Form

Quinoderm Lotio-gel 5% is a homogeneous astringent gel formulated to give the colour and consistency of a creamy white lotion. It is intended for topical use only.

4. Clinical Particulars

4.1 Therapeutic Indications

Acne

4.2 Posology And Method Of Administration

Route of administration: For topical use only.

Adults, children and the elderly

By gentle massage over all the affected area one to three times daily.

4.3 Contraindications

Patients with known sensitivity to either of the active constituents should not use Quinoderm Lotio-gel 5%.

4.4 Special Warnings And Precautions For Use

Contact with mouth and eyes should be avoided. Care should be taken to avoid contact with dyed fabrics as this product may adversely affect dye fastness.

In a few isolated cases, overreaction to Quinoderm Lotio-gel 5% may occur. To minimise this possibility, select a small area of skin behind the ear, apply the cream and leave for twelve hours. If severe irritation or pronounced redness occurs, do not proceed with treatment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Benzoyl peroxide is an oxidising agent. Hence, Quinoderm Lotio-gel 5% should not be used at the same time as other topical agents which would react with an oxidising agent.

4.6 Pregnancy And Lactation

Quinoderm Lotio-gel 5% is not contra-indicated in pregnancy or lactation.

4.7 Effects on ability to drive and use machine

Not applicable.

4.8 Undesirable Effects

If symptoms persist or if the condition worsens or if irritation, itch or rash occurs, treatment should be discontinued and the Physician or Pharmacist consulted for advice.

4.9 Overdose

If accidentally ingested symptomatic and supportive management is advised.

5. Pharmacological Properties

The main pharmacological action of benzoyl peroxide is considered to be keratolytic and comedolytic. Potassium hydroxyquinoline sulphate has broad spectrum antibacterial activity. This combination is formulated in a specifically researched and developed base and is designed to aid the resolution of the polymorphic lesions of acne.

The base has been developed with the objective of providing a stable pharmaceutical form which maximises the advantages of a gel and lotion in a system which does not employ organic solvents and therefore has a correspondingly lower irritancy, toxicity and abuse potential.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Light Liquid Paraffin BP, Edetic Acid BP, Sodium Acid Phosphate BP, Maize Starch BP, Lactic Acid BP, Cetomacrogol 1000 BP, cetyl stearyl alcohol, sodium cetyl stearyl sulphate, PEG 40 castor oil, Purified Water BP.

6.2 Incompatibilities

Any topical agent that would react with an oxidising agent.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Quinoderm Lotio-gel 5% should be stored in a cool, dry place avoiding extremes of temperature, i.e. not less than 5°C and not more than 30°C.

6.5 Nature And Contents Of Container

Quinoderm Lotio-gel 5% is available in polyethylene bottles with a flip-top cap containing 30 ml of product. Each bottles is cartoned and contains a package insert.

6.6 Special Precautions For Disposal And Other Handling

By gentle massage over all the affected area one to three times daily.

8. Marketing Authorisation Number(S)

0291/0009

10. Date Of Revision Of The Text

September 1995.

Legal category

P.

Vascalpha 10mg Prolonged Release Tablet

1. Name Of The Medicinal Product

VASCALPHA 10 mg PROLONGED RELEASE TABLETS

(FELODIPINE)

2. Qualitative And Quantitative Composition

One prolonged release tablet contains 10mg of felodipine.

Lactose monohydrate 21.45mg

For excipients, see 6.1.

3. Pharmaceutical Form

Prolonged release tablet.

Reddish brown, round, biconvex, film coated prolonged release tablets with imprint 10.

4. Clinical Particulars

4.1 Therapeutic Indications

Essential hypertension

4.2 Posology And Method Of Administration

Vascalpha (felodipine) prolonged release tablets should usually be administered as follows:

The recommended starting dose is 5 mg felodipine once daily.

If necessary, the dose may be increased to 10 mg felodipine once daily or another antihypertensive agent added. Dose increases should occur at intervals of at least 2 weeks. The usual maintenance dose is 5-10mg once daily.

The maximum daily dose is 10 mg felodipine.

The dose should be adjusted to the individual requirements of the patient.

Elderly

The recommended starting dose should be 2.5mg.

Subsequent dose increases should be undertaken with particular caution.

Impaired hepatic function

In patients with mild to moderate hepatic impairment, the recommended starting dose should be lowered to the minimal therapeutic effective dose of felodipine.

The dose should only be increased after carefully balancing the benefits against the risks (see 5.2 Pharmacokinetic properties). It is contraindicated in patients with severe hepatic impairment.

Impaired renal function

The pharmacokinetics are not significantly affected in patients with mild to moderate impaired renal function. Caution should be taken in patients with severe renal impairment (see section 4.4 Special warnings and precautions for use and section 5.2. Pharmacokinetic properties).

Children

Felodipine is not recommended for use in children due to lack of data on safety and efficacy.

Administration

The prolonged release tablets should be taken in the morning with a sufficient amount of fluid (e.g. a glass of water, but it should NOT be taken with grapefruit juice!) (see 4.5 Interaction with other medicinal products and other forms of interaction).

The prolonged release tablets should be swallowed whole and not chewed or crushed. The tablets may be taken on an empty stomach or with a light meal, however a high fat meal should be avoided (see 5.2 Pharmacokinetic properties).

4.3 Contraindications

Felodipine is contra-indicated in patients with:

- hypersensitivity to felodipine (or other dihydropyridines) or to any of the excipients

- cardiogenic shock

- severe aortic and mitral stenosis

- obstructive hyperthrophic cardiomyopathy

- unstable angina pectoris

- acute myocardial infarction (within 4-8 weeks of a myocardial infarction)

- decompensated heart failure

- severe hepatic impairment

- pregnancy (see section 4.6)

4.4 Special Warnings And Precautions For Use

Felodipine should be used with caution in patients with:

- conduction disorders, compensated heart failure, tachycardia and aortic or mitral valve stenosis.

- mild to moderate hepatic impairment, as the anti-hypertensive effect may be enhanced. Adjustment of the dosage should be considered.

- severe renal impairment (GFR <30ml/min)

- AV block of the second or third degree

If treatment with felodipine is discontinued abruptly, a hypertensive crisis may occur in individual cases.

Felodipine could cause significant hypotension (vasodilation effect) with consecutive tachycardia, leading to myocardial ischaemia in sensitive patients, therefore predisposed patients may suffer from myocardial infarction (see section 5.1 Pharmacodynamic properties).

Dihydropyridines may cause acute hypotension. In some cases there is a risk of hypoperfusion accompanied by reflex tachycardia (paradoxical angor) (see section 5.1 Pharmacodynamic properties).

Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Felodipine is a CYP3A4 substrate. Drugs that induce or inhibit CYP3A4 will have large influence on felodipine concentrations.

The anti-hypertensive effect of felodipine may be enhanced by other anti-hypertensives and tricyclic antidepressants.

The concomitant intake of felodipine and drugs which inhibit the cytochrome P450 isoenzyme 3A4 of the liver (such as cimetidine, azole antifungals [itraconazole or ketoconazole], macrolide antibiotics [erythromycin, clarithromycin, telithromycin] or HIV protease inhibitors leads to increased felodipine plasma levels (see section 4.4 Special warnings and precautions for use). Grapefruit juice results in increased peak plasma levels and bioavailability possibly due to interaction with flavanoids in the fruit juice. Therefore grapefruit juice should not be taken together with felodipine.

Cocomitant treatment with drugs such as carbamazepine, phenytoin and barbiturates (e.g. phenobarbital) and rifampicin reduces the plasma levels of felodipine via enzyme induction in the liver (cytochrome P450 System). A similar effect is expected with St John's Wort. Therefore a dose increase of felodipine may be necessary.

Hydrochlorothiazide may enhance the antihypertensive effect of felodipine.

Felodipine can induce an increase of Cmax of ciclosporin. Additionally, ciclosporin may inhibit felodipine metabolism, which may create a potential risk of felodipine toxicity.

Blood levels of digoxin increase during concomitant administration of felodipine. Therefore, decreasing of digoxin dosage should be taken into account when the two drugs are administered concurrently.

4.6 Pregnancy And Lactation

Pregnancy

Felodipine is contra-indicated during the entire duration of pregnancy, as animal experiments have demonstrated foetal damage (see 5.3 Preclinical safety data). Pregnancy must be excluded before starting treatment with felodipine.

Lactation

Felodipine is excreted in breast milk. If the breast-feeding mother is taking therapeutic doses of felodipine, a fully breast-fed infant absorbs only a very low dose of the active substance with the breast milk. There is no experience of the risk this may pose to the newborn, therefore as a precaution breast-feeding should be discontinued during treatment.

4.7 Effects On Ability To Drive And Use Machines

Felodipine can cause dizziness or tiredness. These adverse effects are more likely to occur after initiation of the treatment, after dose increases, or after concomitant ingestion of alcohol. Should they occur, one should refrain from driving and other activities requiring alertness.

4.8 Undesirable Effects

Adverse drug reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (

Nervous system disorders

Very common: Headache (particularly at the beginning of treatment, when the dose is increased or when high doses are administered). Generally, those effects subside on continued treatment.

Uncommon: Paraesthesia, dizziness, fatigue, syncope, restlessness

Ear and labyrinth disorders

Very common: Tinnitus (particularly at the beginning of treatment, when the dose is increased or when high doses are administered). Generally, those effects subside on continued treatment.

Cardiac disorders

Common: Particularly at the beginning of treatment, angina pectoris attacks may occur, or in patients with pre-existing angina pectoris there may be an increase in the frequency, duration and severity of the attacks.

Uncommon: Palpitations, tachycardia, hypotension.

Very rare: Myocardial infarction

Vascular disorders

Rare: Leucocytoclastic vasculitis

Respiratory, thoracic and mediastinal disorders

Uncommon: Dyspnoea

Gastrointestinal disorders

Uncommon: Nausea, vomiting, diarrhoea, constipation.

Hepatobiliary disorders

Very rare: Hepatic function disorders (elevated transaminase levels).

Skin and subcutaneous tissue disorders

Very common: Flushing (particularly at the beginning of treatment, when the dose is increased or when high doses are administered). Generally, those effects subside on continued treatment.

Uncommon: Skin and hypersensitivity reactions such as pruritus, urticaria, exanthema, photosensitisation. Gingival hyperplasia and gingivitis

Very rare: Exfoliative dermatitis

Musculoskeletal and connective tissue disorders

Uncommon: Myalgia, arthralgia, tremors

Renal and urinary disorders

Uncommon: Pollakisuria

Reproductive system and breast disorders

Very rare: Erection disorders, gynaecomastia, menorrhagia.

General disorders and administration site conditions

Common: Peripheral oedema (The degree of ankle swelling is dose related).

Uncommon: Weight gain, sweating

Very rare: Angiooedema, fever

4.9 Overdose

Symptoms of intoxication

Overdose may lead to excessive peripheral vasodilatation with marked hypotension and in rare cases bradycardia.

Management of intoxication

The therapeutic measures should focus on elimination of the active ingredient (e.g. administration of charcoal, bowel irrigation) and monitoring of the vital signs. If severe hypotension occurs, symptomatic treatment should be provided, the patient should be placed supine with the legs elevated. In case of accompanying bradycardia, atropine (0.5 – 1.0 mg) should be given intravenously. Additional intravenous fluids should be cautiously administered under haemodynamic supervision to prevent cardiac overloading. Sympathomimetic drugs with predominant effect on the α₁-adrenoreceptor (such as dobutamine, dopamine, noradrenaline (norepinephrine) or adrenaline (epinephrine)) may also be given. Dosage depends on the efficacy obtained.

Felodipine is only dialysable to a minimal extent (approx. 9%).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotheraputic group: 1,4-didydropyridine derivative/calcium antagonist

ATC code: C08C A02

Felodipine is a calcium antagonist of the dihydropyridine class of calcium channel blockers. Calcium antagonists interfere with the voltage-dependent L-type (slow) calcium channels in the plasma membranes of smooth muscle cells and reduce the inflow of calcium ions. This results in vasodilatation.

Felodipine has a greater selectivity for vascular smooth muscle than myocardial muscle. Felodipine selectively dilates arterioles with no effects on venous vessels. Felodipine leads to a dose-related lowering of blood pressure via vasodilatation and consequently a reduction of peripheral vascular resistance. It reduces both systolic and diastolic blood pressure. The haemodynamic effect of felodipine is accompanied by reflex (baroreceptor-mediated) tachycardia. In therapeutic doses, felodipine has no direct effect on either cardiac contractility or cardiac conduction. Felodipine reduces renal vascular resistance. The glomerular filtration rate remains unchanged.

Felodipine has a weak natriuretic/diuretic effect and does not provoke fluid retention.

Felodipine can be used as a monotherapy but also concomitantly with beta-blockers, diuretics and ACE inhibitors.

5.2 Pharmacokinetic Properties

Absorption

Felodipine is completely absorbed following oral administration. Peak plasma levels are reached with the prolonged release formulation after 3 – 5 hours and result in even felodipine plasma concentrations within the therapeutic range for 24 hours. Steady state is reached approx. 3 days after starting treatment. Due to an extensive first-pass effect, only approx. 15 % of the administered dose is systemically available.

Distribution

The plasma protein binding of felodipine is> 99 %. The volume of distribution is approximately 10 l/kg at steady state, so that felodipine is indicating large tissue distribution. There is no significant accumulation during long-term treatment.

Metabolism

Felodipine is extensively metabolised in the liver by CYP3A4. All identified metabolites are inactive.

Elimination

No unchanged parent substance is detectable in the urine. The average half-life of felodipine in the terminal phase is 25 hours. The inactive hydrophilic metabolites formed by hepatic biotransformation are mainly eliminated renally (to approx. 70 %), and the remainder is excreted in the faeces. The mean plasma clearance is 1100 ml/l and depends on the hepatic blood flow.

Elderly

Increased plasma concentrations have been measured in elderly patients.

Impaired hepatic function

Increased plasma concentrations of up to 100% have been measured in patients with impaired hepatic function.

Impaired renal function

Renal impairment does not affect the pharmacokinetics of felodipine, although accumulation of inactive metabolites occurs in renal failure.

Effect of food

The rate, but not the extent of absorption is affected by the simultaneous ingestion of fatty food. Cmax was 2 to 2.5 times higher following intake of a high-fat meal compared to a fasting state.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. In animal studies with respect to the reproduction, adverse effects were found. Effects in rats (prolonged duration of pregnancy and difficult labour) and rabbits (impaired development of distal phalanges, presumably due to decreased uteroplacental perfusion) revealed no evidence of a direct teratogenic effect, but indicate secondary consequences of the pharmacodynamic effect. In monkeys, an abnormal position of the distal phalanges was found. The significance of these observations for humans is unknown.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

Lactose monohydrate, microcrystalline cellulose, hypromellose, povidone K25, propyl gallate (PhEur), colloidal anhydrous silica, magnesium stearate (PhEur)

Tablet coat:

Hypromellose, talcum, propylene glycol, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

48 months

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

PVC/PE/PVDC aluminium blister.

Pack sizes: 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 250, 500 and 1000 prolonged release tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Actavis UK Limited (Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

8. Marketing Authorisation Number(S)

PL 00142/0542

9. Date Of First Authorisation/Renewal Of The Authorisation

21 July 2003

10. Date Of Revision Of The Text

June 2007

Fulvicin P/G

Generic Name: griseofulvin (GRIS ee oh FUL vin)

Brand Names: Fulvicin P/G, Fulvicin U/F, Grifulvin V, Gris-PEG

What is Fulvicin P/G (griseofulvin)?

Griseofulvin is an antifungal antibiotic that fights infections caused by fungus.

Griseofulvin is used to treat infections such as ringworm, athlete's foot, jock itch, and fungal infections of the scalp, fingernails, or toenails.

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

What is the most important information I should know about Fulvicin P/G (griseofulvin)?

You should not use griseofulvin if you are allergic to it, or if you have liver failure, porphyria, or if you are pregnant.

Before you take griseofulvin, tell your doctor if you have liver disease, heart disease, lupus, or an allergy to penicillin.

Avoid exposure to sunlight or tanning beds. Griseofulvin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Drinking alcohol can increase certain side effects of griseofulvin. 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. Griseofulvin will not treat a viral infection such as the common cold or flu.

What should I discuss with my healthcare provider before taking Fulvicin P/G (griseofulvin)?

You should not use griseofulvin if you are allergic to it, or if you have:

• 
  

  liver failure;

  
  


• 
  

  porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); or

  
  


• 
  

  if you are pregnant.

  
  

To make sure you can safely take griseofulvin, tell your doctor if you have any of the following conditions:

• 
  

  liver disease;

  
  


• 
  

  heart disease;

  
  


• 
  

  lupus; or

  
  


• 
  

  an allergy to penicillin.

  
  

FDA pregnancy category C. It is not known whether griseofulvin 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 griseofulvin 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 take Fulvicin P/G (griseofulvin)?

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.

Griseofulvin works best if you take it with foods that are high in fat. 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. Griseofulvin will not treat a viral infection such as the common cold or flu. Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid 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. If you use this medication long-term, your blood will need to be tested often. Visit your doctor regularly. Store at room temperature away from moisture, heat, and light.

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.

What should I avoid while taking Fulvicin P/G (griseofulvin)?

Avoid exposure to sunlight or tanning beds. Griseofulvin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Drinking alcohol can increase certain side effects of griseofulvin.

Fulvicin P/G (griseofulvin) 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 a serious side effect such as:

• 
  

  fever, chills, flu symptoms;

  
  


• 
  

  white patches or sores inside your mouth or on your lips;

  
  


• 
  

  confusion, trouble with daily activities;

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  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:

• 
  

  flushing (warmth, redness, or tingly feeling);

  
  


• 
  

  nausea, vomiting, or diarrhea;

  
  


• 
  

  headache, dizziness, feeling tired;;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  confusion;

  
  


• 
  

  numbness or tingling in your hands or feet; or

  
  


• menstrual irregularities.

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 Fulvicin P/G (griseofulvin)?

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

• 
  

  birth control pills;

  
  


• 
  

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

  
  

This list is not complete and other drugs may interact with griseofulvin. 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 Fulvicin P/G resources

• Fulvicin P/G Side Effects (in more detail)
• Fulvicin P/G Use in Pregnancy & Breastfeeding
• Drug Images
• Fulvicin P/G Drug Interactions
• Fulvicin P/G Support Group
• 0 Reviews for Fulvicin P/G - Add your own review/rating

• Fulvicin P/G Advanced Consumer (Micromedex) - Includes Dosage Information


• Griseofulvin Prescribing Information (FDA)


• Griseofulvin Professional Patient Advice (Wolters Kluwer)


• Griseofulvin Monograph (AHFS DI)


• Grifulvin V Microsize MedFacts Consumer Leaflet (Wolters Kluwer)


• Gris-PEG Ultramicrosize Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Gris-PEG Prescribing Information (FDA)

Compare Fulvicin P/G with other medications

• Dermatophytosis
• Onychomycosis, Fingernail
• Onychomycosis, Toenail
• Tinea Barbae
• Tinea Capitis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis

Where can I get more information?

• Your pharmacist can provide more information about griseofulvin.

See also: Fulvicin P/G side effects (in more detail)

Tetmodis 25mg tablets

1. Name Of The Medicinal Product

Tetmodis 25 mg tablets

2. Qualitative And Quantitative Composition

Each tablet contains 25 mg Tetrabenazine.

Each tablet contains 60.8 mg lactose.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet

Yellow, round, flat, with a breaking score on one-side.

The tablet can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

Tetmodis is indicated for hyperkinetic motor disorders with Huntington's chorea.

4.2 Posology And Method Of Administration

The tablets are for oral use. The therapy should be supervised by a doctor experienced in treating hyperkinetic disorders.

Adults

Huntington's chorea

Dosage and administration are individual in each patient and therefore only a guide is given.

An initial starting dose of 12.5 mg/day one to three times a day is recommended. This can be increased every three or four days by 12.5 mg until the optimal effect is observed or up to the occurence of intolerance effects (sedation, Parkinsonism, depression).

The maximum daily dose is 200 mg a day.

If there is no improvement at the maximum dose in seven days, it is unlikely that the compound will be of benefit to the patient, either by increasing the dose or by extending the duration of treatment.

Elderly

No specific studies have been performed in the elderly, but tetrabenazine has been administered to elderly patients in standard dosage without apparent ill effect. Parkinson-like adverse reactions are quite common in these patients and could be dose-limiting.

Children

No adequate controlled studies have been performed in children. The treatment is not recommended in children.

Patients with hepatic impairment

In patients with mild and moderate hepatic impairment half the initial dose and a slower up-titration of the dose is recommended. Patients with severe hepatic impairment have not been studied, therefore additional caution is advised in these patients (see also section 4.4 and 5.2).

Patients with renal impairment

No studies have been performed in patients with renal impairment. Caution is advised in the treatment of these patients.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients

Tetrabenazine can block the action of reserpine. Thus these substances should not be taken concomitantly.

Use of monoamine oxidase inhibitors

Presence of a hypokinetic-rigid-syndrome (Parkinsonism)

Depression

Breast feeding

Pheochromocytoma

Pro-lactin-dependent tumours, e.g. pituitary or breast cancer

4.4 Special Warnings And Precautions For Use

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

It is known that dose dependent adverse events such as sedation, depression and the occurrence of a hypokinetic-rigid-syndrome (Parkinsonism) are possible. In such a case, the dose should be reduced and discontinuation of tetrabenazine be considered if events do not resolve.

MAO-inhibitors are contraindicated (see section 4.3) and should be stopped 14 days before the treatment with tetrabenazine starts.

Tetmodis should be used with caution in patients with hepatic impairment (see section 4.2).

A neuroleptic malignant syndrome has been described under the use of tetrabenazine and after abrupt withdrawal.

Neuroleptic malignant syndrome is a rare complication of tetrabenazine therapy. Neuroleptic Malignant Syndrome most often occurs early in treatment, in response to changes in dose or after prolonged treatment. The main symptoms of this condition are mental changes, rigidity, hyperthermia, autonomic dysfunction (sweating and fluctuations in blood pressure) and elevated creatinine phosphokinase levels. If Neuroleptic Malignant syndrome is suspected Tetrabenazine should be withdrawn immediately and appropriate treatment initiated.

Tetrabenazine causes a small increase (up to 8msec) in the corrected QT interval. Tetrabenazine should be used with caution in combination with other drugs known to prolong QTc and in patients with congenital long QT syndromes and a history of cardiac arrythmias (see section 4.5).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Tetmodis should not be used concomitantly with reserpine, MAO inhibitors.

Levodopa should be administered with caution in the presence of Tetmodis.

Concomitant use with tricyclic antidepressants, alcohol, opioids, beta blocking agents, antihypertensive drugs, hypnotics and neuroleptics is not recommended.

No interaction studies with tetrabenazine have been performed in vivo, and metabolising enzymes are partly unknown. In vitro studies indicate that tetrabenazine may be a CYP2D6 inhibitor and therefore cause increased plasma concentrations of medicinal products metabolised by CYP2D6.

Inhibitors of CYP2D6 (e.g. fluoxetine, paroxetine, terbinafine, moclobemide and quinidine) may result in increased plasma concentrations of the active metabolite dihydrotetrabenazine, why they should only be combined with caution. A reduction of the tetrabenazine dose may be necessary.

Tetrabenazine should be used with caution with drugs known to prolong QTc including antipsychotic medications (e.g. chlorpromazine, thioridazine), antibiotics (e.g. gatifloxacin, moxifloxacin) and Class IA and III antiarrythmic medications (e.g. quinidine, procainamide, amiodarone, sotalol).

4.6 Pregnancy And Lactation

Pregnancy

Animal studies are insufficient with respect to effects on pregnancy, embryofetal development, birth, or development post partum (see section 5.3). There are no adequate data from the use of tetrabenazine in pregnant women and the potential risk for humans is unknown. Tetmodis should not be used during pregnancy unless no other treatment is available.

Lactation

Tetrabenazine is contraindicated during lactation (see section 4.3). Breast-feeding must be stopped, if treatment with tetrabenazine is necessary.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised that Tetmodis may cause drowsiness and therefore may modify their performance at skilled tasks (driving ability, operation of machinery, etc.) to a varying degree, depending on dose and individual susceptibility.

4.8 Undesirable Effects

The following undesirable effects are ranked according to system organ class and to their frequency:

Very common (

Common (

Uncommon (

Rare (

Very rare (< 1/10.000)

Psychiatric disorders

Very common:	depression,
Common:	anxiety, insomnia, confusion

Nervous system disorders

Very common:	drowsiness (with higher dosages), Parkinson-like syndrome (with higher dosages)
Uncommon:	altered levels of consciousness
Rare:	Neuroleptic malignant syndrome (NMS) (see section 4.4)

Vascular disorders

Common:

Hypotension

Gastrointestinal disorders

Common:

dysphagia, nausea, vomiting, diarrhoea, constipation

Musculoskeletal and connective tissue disorders

Uncommon:	severe extrapyramidal symptoms including muscular rigidity, autonomic dysfunction
Very rare:	Skeletal muscle damage

General disorders and administration site conditions

Uncommon:

hyperthermia

For the following side-effects, it is not possible to estimate the incidence from available data:

Psychiatric disorders: disorientation, nervousness

Nervous system disorders: ataxia, akathisia, dystonia, dizziness, amnesia

Vascular disorders: bradycardia, epigastric pain, dry mouth

4.9 Overdose

Signs and symptoms of overdosage may include drowsiness, sweating, hypotension and hypothermia. Treatment is symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX06

The central effects of Tetmodis closely resemble those of Reserpine, but it differs from the latter in having less peripheral activity and being much shorter acting.

Animal studies have shown that tetrabenazine disturbs the metabolism of biogenic amines, for instance that of serotonin and noradrenaline, and that this activity is limited to the brain. The supposition is that this effect of tetrabenazine on amines in the brain explains the clinical effects in the brain. Tetrabenazine inhibits the re-uptake of monoamines in the neuroterminal of the presynaptic neurons of the central nervous system. This results in a depletion of monoamines, including dopamine. Dopamine depletion results in hypokinesis leading to a reduction in chorea severity. Tetrabenazine inhibits the re-uptake of monoamines in synaptic nerve terminals by a reversible and short-term binding to the vesicular monoamine transporter (VMAT). VMAT2 transports monoamines especially in peripheral and central neurons, while VMAT1 regulates the transport in peripheral chromaffine tissues. Tetrabenazine has a higher affinity for VMAT2 than for VMAT1. Thus, tetrabenazine has a short, hardly peripheral effect.

5.2 Pharmacokinetic Properties

Tetrabenazine has a low and erratic bioavailability. It appears to be extensively metabolised by first-pass metabolism. The major metabolite, hydroxytetrabenazine, is formed by reduction. Little unchanged Tetrabenazine can be detected in the urine. Since hydroxytetrabenazine is reported to be as active as Tetrabenazine in depleting brain amines, it is likely that this is the major therapeutic agent.

Special populations

Hepatic impairment

Mild and moderate hepatic impairment increases the exposure and prolongs the half-lives of tetrabenazine and hydroxytetrabenazine (4 patients with Child Pugh score 5-6 and 1 patient with Child Pugh score 9.) Severe hepatic impairment has not been studied.

5.3 Preclinical Safety Data

In repeat-dose toxicity studies, the effects observed with orally administered tetrabenazine were related to depletion of central stores of monoamines. Common symptoms were hypoactivity, lethargy, strabismus, or closed eyes. Primarily pharmacological effects such as sedation were observed and considered dose limiting.

The genotoxic potential of tetrabenazine has been studied using a series of conventional tests. In vitro, tetrabenazine was negative for point mutations and positive for chromosomal aberrations in Chinese hamster ovary cells, at cytotoxic concentrations only. Tetrabenazine was not genotoxic in an in vivo chromosomal aberration test; however, carcinogenicity studies have not been performed.

Studies to investigate the effects on fertility have not been conducted. Tetrabenazine was not embryotoxic or teratogenic in the rabbit; however, the observed systemic exposure was lower than that observed clinically. The potential embryotoxic and teratogenic effects were also insufficiently studied in the rat. In a peri/postnatal study in the rat, increased neonatal mortality was observed, the cause of which is unknown.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Pregelatinised maize starch

Lactose monohydrate

Talc

Iron oxide yellow E172

Magnesium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Store in the original package in order to protect from light.

This medicinal product does not require any special temperature storage conditions.

6.5 Nature And Contents Of Container

White round high-density polyethylene (HDPE) tablet container with a child-resistant, tamper-evident polypropylene (PP) screw cap with mounted desiccant containing 112 tablets.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Orpha-Devel Handels und Vertriebs GmbH 3002 Purkersdorf, Austria

8. Marketing Authorisation Number(S)

PL 30414/0005

9. Date Of First Authorisation/Renewal Of The Authorisation

20/07/2010

10. Date Of Revision Of The Text

20/07/2010

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Drug List:

Enfuvirtide

Class: HIV Entry and Fusion Inhibitors
VA Class: AM800
Chemical Name: N - Acetyl - l - tyrosyl - l - threonyl - l - seryl - l - leucyl - l - isoleucyl - l - histidyl - l - seryl - l - leucyl - l - isoleucyl - l - alpha - glutamyl - l - alpha - glutamyl - l - seryl - l
Molecular Formula: C₂₀₄H₃₀₁N₅₁O₆₄
CAS Number: 159519-65-0
Brands: Fuzeon

Introduction

Antiretroviral; HIV fusion inhibitor.¹

Uses for Enfuvirtide

Treatment of HIV Infection

Treatment of HIV-1 infection in treatment-experienced (previously treated) patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy; used in conjunction with other antiretrovirals.¹

Safety and efficacy have not been systematically evaluated in treatment-naive patients (have not previously received antiretroviral therapy).^{1 12} Experts state the drug is not recommended for initial treatment.^{5 13}

Postexposure Prophylaxis following Occupational Exposure to HIV

Postexposure prophylaxis of HIV infection† in health-care workers and others exposed occupationally via percutaneous injury or mucous membrane or nonintact skin contact with blood, tissues, or other body fluids associated with a risk for transmission of the virus.¹⁶ Used in conjunction with other antiretrovirals.¹⁶

Not recommended for routine postexposure prophylaxis, but can be considered with expert consultation.¹⁶

Enfuvirtide Dosage and Administration

Administration

Sub-Q Administration

Administer sub-Q into the upper arm, anterior thigh, or abdomen (avoid the navel).^{1 4 13}

Injection sites should be rotated with each injection (i.e., injections should be made at a site different from the preceding injection site).^{1 4}

Injections should not be made into areas where skin shows signs of a previous injection site reaction and should not be made near anatomical areas where large nerve tracts lie close to the skin (e.g., near the elbow, knee, groin, inferior or medial section of the buttocks).^{1 4} Injections also should not be made directly over blood vessels, near the navel, or into skin abnormalities, moles, scars (including surgical scars), bruises, tattoos, or burn sites.^{1 4}

Refrigerated reconstituted solution should be brought to room temperature before injection.¹

May be self-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug.^{1 4}

Reconstitution

Add 1.1 mL of sterile water for injection diluent provided by the manufacturer to vial containing 108 mg; tap vial gently with a fingertip for 10 seconds and then gently roll between the hands (avoid foaming) to ensure that the drug is in contact with the diluent.^{1 4} Let vial stand until all of the powder goes into solution; reconstitution can take up to 45 minutes.¹ Reconstituted solutions of the drug should not be shaken.⁴

Reconstituted solution contains 90 mg/mL.¹

Dosage

Must be given in conjunction with other antiretrovirals.¹

Pediatric Patients

Treatment of HIV Infection

Sub-Q

Children 6–16 years of age: 2 mg/kg (maximum 90 mg) twice daily.^{1 13}

Adolescents >16 years of age: 90 mg twice daily.^{1 13}

Adults

Treatment of HIV Infection

Sub-Q

90 mg twice daily.^{1 5}

Postexposure Prophylaxis following Occupational Exposure to HIV†

Sub-Q

90 mg twice daily.¹⁶

Use with expert consultation.¹⁶

Initiate postexposure prophylaxis as soon as possible (within hours rather than days) and continue for 4 weeks, if tolerated.¹⁶

Prescribing Limits

Pediatric Patients

Treatment of HIV Infection

Sub-Q

Children 6–16 years of age: Maximum 90 mg twice daily.¹

Special Populations

Hepatic Impairment

Dosage recommendations not available.⁵

Renal Impairment

Treatment of HIV Infection

Dosage adjustments not needed.^{1 5}

Cautions for Enfuvirtide

Contraindications

• 
  

  Known hypersensitivity to enfuvirtide or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Local Reactions

Sub-Q administration associated with injection site reactions (e.g., mild to moderate pain/discomfort, induration, erythema, presence of nodules or cysts, pruritus, ecchymosis) in almost all patients.^{1 2 3}

Injection site reactions persist for >7 days in some patients; injection site reactions at ≥6 sites reported in 23% of patients in phase 3 clinical studies.¹

Infectious Complications

Increased incidence of bacterial pneumonia; has not been directly attributed to the drug.¹ Risk factors included low initial CD4⁺ T-cell counts, high initial viral load, IV drug abuse, smoking, and history of lung disease.¹

Monitor patients (especially those with underlying conditions that may predispose them to pneumonia) carefully for signs and symptoms of pneumonia.¹

Sensitivity Reactions

Hypersensitivity reactions (e.g., rash, fever, nausea and vomiting, chills, rigors, hypotension, elevated serum liver transaminase concentrations) reported; these hypersensitivity reactions have recurred on rechallenge.^{1 2}

Other adverse events that may be immune mediated include primary immune complex reactions, respiratory distress, glomerulonephritis, and Guillain-Barré syndrome.^{1 2}

If hypersensitivity reaction occurs, discontinue and seek immediate medical evaluation.¹

Do not reinitiate enfuvirtide in patients who have experienced a hypersensitivity reaction.¹

General Precautions

Laboratory Test Interferences

Although enfuvirtide has not been studied in non-HIV-infected individuals, the possibility exists that administration of the drug could lead to the production of anti-enfuvirtide antibodies that could cross react with HIV glycoprotein 41(gp41), resulting in a false-positive HIV test using an enzyme-linked immunosorbent assay (ELISA); a confirmatory test (i.e., Western blot) would be expected to be negative.¹

Immune Reconstitution Syndrome

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jiroveci [formerly P. carinii]); this may necessitate further evaluation and treatment.¹

Administration Using Biojector 2000

Neuralgia and/or paresthesia, sometimes lasting up to 6 months, reported following injection into anatomical sites where large nerve tracts lie close to the skin.¹ Bruising and hematomas also reported.¹

Patients receiving anticoagulants and those with hemophilia or other coagulation disorders may be at higher risk for post-injection bleeding.¹

Specific Populations

Pregnancy

Category B.¹

Antiretroviral Pregnancy Registry at 800-258-4263.¹

Some experts state that safety and pharmacokinetic data insufficient to recommend enfuvirtide in pregnant women.¹⁸

Lactation

Enfuvirtide or its metabolites distributed into milk in animals; not known whether distributed into human milk.¹

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.¹

Pediatric Use

Safety and efficacy not established in children <6 years of age.^{1 13}

Limited efficacy data available in pediatric patients 6–16 years of age.^{1 6 13}

Adverse effects in pediatric patients similar to those in adults; however, infections at the injection site (cellulitis, abscess) reported more frequently in adolescents than adults.¹

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.¹

Common Adverse Effects

Injection site reactions; GI effects (diarrhea, nausea); fatigue.¹

Interactions for Enfuvirtide

Does not inhibit CYP-450 isoenzymes.¹

Does not affect metabolism of CYP3A4, CYP2D6, CYP1A2, CYP2C19, or CYP2E1 substrates.¹

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions unlikely.¹

Specific Drugs and Laboratory Tests

Drug	Interaction	Comments
Anticoagulants	Higher risk for postinjection bleeding when enfuvirtide administered using a Biojector needle-free device1
Efavirenz	In vitro evidence of additive or synergistic antiretroviral effects1
Lamivudine	In vitro evidence of additive or synergistic antiretroviral effects1
Indinavir	In vitro evidence of additive or synergistic antiretroviral effects1
Nelfinavir	In vitro evidence of additive or synergistic antiretroviral effects1
Rifampin	Pharmacokinetic interaction unlikely1
Ritonavir	Possible increase in plasma concentrations and AUC of enfuvirtide1	Not considered clinically important1
Saquinavir	Possible increase in AUC of enfuvirtide with ritonavir-boosted saquinavir1	Not considered clinically important1
Test, Enzyme-linked immunosorbent assay (ELISA) for HIV	Possible false-positive in non-HIV-infected individuals given enfuvirtide1	Confirmatory test (i.e., Western blot) expected to be negative1
Tipranavir	In vitro evidence of synergistic antiretroviral effects17
Zidovudine	In vitro evidence of additive or synergistic antiretroviral effects1

Enfuvirtide Pharmacokinetics

Absorption

Bioavailability

Almost completely absorbed following sub-Q administration; absolute bioavailability is 84.3%.¹

Systemic absorption is comparable following injection into the abdomen, thigh, or arm.¹

Systemic absorption in adults is comparable following sub-Q injection using the Biojector 2000 needle-free device or a 27-gauge ½-inch needle and syringe.¹⁹

Special Populations

Plasma concentrations in children 6–16 years of age receiving enfuvirtide 2 mg/kg twice daily (maximum 90 mg twice daily) similar to those reported in adults receiving the recommended dosage.¹

Distribution

Plasma Protein Binding

92%; bound mainly to albumin and, to a lesser extent, α-1 acid glycoprotein.¹

Elimination

Metabolism/Elimination

Expected to undergo catabolism to its constituent amino acids, with subsequent recycling of the amino acids in the body pool.¹

Hemodialysis does not have a clinically important effect on enfuvirtide clearance.¹

Half-life

3.8 hours.¹

Special Populations

Pharmacokinetics not evaluated in hepatic impairment.¹

Clearance not affected in patients with renal impairment with Cl_cr >35 mL/minute.¹ Clearance reduced by 38% in patients with severe renal impairment (Cl_cr 11–35 mL/minute) and 14–28% in patients with end-stage renal disease undergoing dialysis.¹

Stability

Storage

Parenteral

Powder for Injection

25°C (may be exposed to 15–30°C).¹

Store reconstituted solution under refrigeration at 2–8°C; discard 24 hours after reconstitution.¹

Actions and SpectrumActions

• 
  

  Pharmacologically and structurally different from other currently available antiretrovirals.¹

  
  


• 
  

  Active against HIV-1; inactive against HIV-2.¹

  
  


• 
  

  Interferes with entry of HIV-1 into target cells by inhibiting fusion of the viral and cellular membranes.¹

  
  


• 
  

  HIV-1 with reduced susceptibility to enfuvirtide have been selected in vitro and have emerged during therapy with the drug.¹

  
  


• 
  

  Cross-resistance between enfuvirtide and nucleoside reverse transcriptase inhibitors (NRTIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), or HIV protease inhibitors (PIs) is highly unlikely since the drugs have different mechanisms of action.¹²

  
  

Advice to Patients

• 
  

  Critical nature of compliance with HIV therapy.¹ Importance of using enfuvirtide in conjunction with other antiretrovirals—not for monotherapy.¹

  
  


• 
  

  Antiretroviral therapy is not a cure for HIV infection, and opportunistic infections still may occur.¹ HIV transmission via sexual contact or sharing needles is not prevented by antiretrovirals.¹

  
  


• 
  

  Importance of clinicians providing appropriate instruction on use of enfuvirtide to patients and/or their caregivers who are allowed to administer the drug in the home setting.¹

  
  


• 
  

  Importance of administering enfuvirtide into the preferred sites (i.e., upper arm, abdomen, anterior thigh).¹ Injections should not be made near anatomical areas where large nerve tracts lie close to the skin (e.g., near the elbow, knee, groin, inferior or medial section of the buttocks), directly over a blood vessel, near the navel, or into skin abnormalities, moles, scars (including surgical scars), bruises, tattoos, or burn sites.¹

  
  


• 
  

  Importance of reading the patient package insert from the manufacturer.¹

  
  


• 
  

  Importance of monitoring for signs and symptoms of injection site reactions and contacting clinician if such reactions are severe or there are signs of infection such as oozing, increased heat, swelling, redness, or pain.^{1 4}

  
  


• 
  

  Importance of monitoring for signs and symptoms of pneumonia (cough with fever, rapid breathing, shortness of breath) and contacting clinician if these occur.^{1 4}

  
  


• 
  

  Importance of discontinuing enfuvirtide and informing clinician if manifestations of a hypersensitivity reaction (combinations of rash, fever, nausea and vomiting, chills, rigors, and/or hypotension) occur.¹

  
  


• 
  

  Advise that dizziness may occur; necessity of exercising caution when driving or operating machinery.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Enfuvirtide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection	108 mg (to provide 90 mg)	Fuzeon (with sterile water for injection diluent)	Roche

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 01, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Roche. Fuzeon (enfuvirtide) prescribing information. Nutley, NJ; 2008 Dec.

2. Lalezaru JP, Henry K, O’Hearn M et al. Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America. N Engl J Med. 2003; 348:2175-85. [IDIS 498400] [PubMed 12637625]

3. Lalezari JP, Eron JJ, Carlson M et al. A phase II clinical study of the long-term safety and antiviral activity of enfuvirtide-based antiretroviral therapy. AIDS. 2003; 17:691-8. [PubMed 12646792]

4. Roche. Injection instructions: Fuzeon (enfuvirtide). From the Fuzeon web site. (Assessed 2005 Sep 8.)

5. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (November 3, 2008). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

6. Church JA, Cunningham C, Hughes M et al. Safety and antiretroviral activity of chronic subcutaneous administration of T-20 in human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2002; 21:653-9. [IDIS 487366] [PubMed 12237598]

7. Lazzarin A, Clotet B, Cooper D et al for the TORO2 study group. Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia. N Engl J Med. 2003; 348:2186-95. [IDIS 498401] [PubMed 12773645]

8. Chronimed Statscript Pharmacy. Chronimed to be exclusive U.S. distributor of Fuzeon; contract signed with Roche. From the Chronimed web site. (Assessed 2003 May 12.)

9. Fuzeon progressive distribution program. From the Fuzeon web site. (Assessed 2003 May 12.)

10. Wei X, Decker JM, Liu H et al. Emergence of resistant human immunodeficiency virus type 1 in patients receiving fusion inhibitor (T-20) monotherapy. Antimicrob Agents Chemother. 2002; 46:1896-1905. [IDIS 481643] [PubMed 12019106]

11. Zhang X, Nieforth K, Lang JM et al. Pharmacokinetics of plasma enfuvirtide after subcutaneous administration to patients with human immunodeficiency virus: inverse Gaussian density absorption and 2-compartment disposition. Clin Pharmacol Ther. 2002; 72:10-9. [IDIS 484779] [PubMed 12152000]

12. Roche. Nutley, NJ: Personal communication.

13. Working Group on Antiretroviral Therapy and Medical Management of HIV-infected Children of the National Resource Center at the François-Xavier Bagnoud Center, Health Resources and Services Administration (HRSA), and National Institutes of Health (NIH). Guidelines for the use of antiretroviral agents in pediatric HIV infection (February 23, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

14. Hammer SM, Saag MS, Schechter M et al. Treatment of adult HIV infection: 2006 recommendations of the International AIDS Society–USA panel. JAMA. 2006; 296:827-43. [PubMed 16905788]

15. Gazzard B, for the BHIVA Guidelines Writing Committee. British HIV association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy (2005). HIV Med. 2005; 6(Suppl 2):1-61.

16. Center for Disease Control and Prevention. Updated U.S. public health service guidelines for the management of occupational exposures to HIV and recommendations for postexposure prophylaxis. MMWR Recomm Rep. 2005; 54(No. RR-9):1-17.

17. Boehringer Ingelheim. Aptivus (tipranavir) capsules prescribing information. Ridgefield, CT; 2006 Jun 27.

18. Perinatal HIV Guidelines Working Group. US Public Health Service task force recommendations for use of antiretroviral drugs in pregnant HIV-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States (April 29, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

19. True AL, Chiu YY, Demasi RA et al. Pharmacokinetic bioequivalence of enfuvirtide using a needle-free device versus standard needle administration. Pharmacotherapy. 2006; 26: 1679-86. [PubMed 17125431]

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