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Friday, 16 March 2012

Levobunolol 0.5% w / v Eye Drops, Solution

1. Name Of The Medicinal Product

LEVOBUNOLOL 0.5% eye drops, solution

2. Qualitative And Quantitative Composition

Levobunolol Hydrochloride : 5 mg per ml.

For excipients, see 6.1.

3. Pharmaceutical Form

Eye drops, solution.

4. Clinical Particulars

4.1 Therapeutic Indications

• Ocular hypertension.

• Chronic open-angle glaucoma.

4.2 Posology And Method Of Administration

Ophthalmic route

One drop of levobunolol 0.5% in the affected eye twice a day.

In some cases, only 1 drop of levobunolol 0.5% daily may be sufficient, particularly when the intraocular pressure is maintained at satisfactory levels.

Nasolacrimal occlusion or gently closing the eyelid for 3 minutes after instillation of the drops is recommended. This may reduce the systemic absorption of medications administered via the ocular route and result in a decrease in systemic side effects.

If deemed necessary, the ophthalmologist can associate levobunolol eye drops to one or more anti-glaucoma medications (by local and/or systemic routes).

However, it is not advisable to combine 2 of beta-adrenergic blocking agent eye drops (see precaution for use).

Other eye drops have to be instilled at least 15 minutes before or after levobunolol.

However, normalisation of the intraocular pressure with levobunolol eye drops may require several weeks; consequently, the treatment monitoring should include a measurement of intraocular pressure after approximately 4 weeks of therapy.

Substitution therapy

When levobunolol eye drops is substituted for another anti-glaucoma agents, this eye drops has to be discontinued at the end of a complete day and one drop of levobunolol eye drops should be applied in the affected eye twice a day on the following day.

When levobunolol eye drops is substituted for several anti-glaucoma agents administered simultaneously, only one medication should be discontinued at a time.

When levobunolol eye drops is substituted for miotic agents, a monitoring of the patient's refraction can be necessary when the effects of miotics have disappeared.

The medical prescription should be accompanied by the monitoring of the intraocular pressure, particularly at the onset of therapy.

Use in children:

No clinical studies have been performed in children with levobunolol eye drops. Consequently, its use is not recommended.

4.3 Contraindications

It is necessary to keep in mind the contraindications of the systemic administration of beta-adrenergic blocking agents. Systemic side effects may occur after topical administration:

-asthma or chronic obstructive pulmonary diseases

-heart failure when not adequately controlled,

-cardiogenic shock,

-second and third degree atrioventricular block (without cardiac pacemaker),

-Prinzmetal's angina,

-sick sinus syndrome (including sinoatrial block),

-bradycardia (< 45 to 50 beats per minute),

-Raynaud's disease and peripheral circulatory disorders,

-untreated phaeochromocytoma,

-hypotension,

-hypersensitivity to any component of the medication,

Combination with floctafenine (see 4.5 Interactions with other medicinal products and other forms of interactions).

Combination with sultopride (see 4.5 Interactions with other medicinal products and other forms of interactions).

4.4 Special Warnings And Precautions For Use

This medicinal product contains sodium metabisulphite and benzalkonium chloride.

Ocular

-The effect on intraocular pressure or the known effects of systemic beta

-The combination of two eye drops of beta-adrenergic blocking agents is not recommended (see 4-2 Posology and method of administration).

-When this eye drops is used to lower intraocular pressure in patients with angle-closure glaucoma, it should be given in combination with a miotic.

In these patients, the immediate treatment objective is to reopen the angle by constriction of the pupil with a miotic agent, since levobunolol has no or little effect on the pupil.

-With anti-glaucoma agents decreasing the aqueous humour secretion (described with timolol and acetazolamide), choroidal detachments and ocular hypotension were reported further to surgical treatment of glaucoma.

Wearing contact lenses:

There is a risk of contact lenses intolerance due to the decrease of lachrymal secretion linked in general to the use of beta-adrenergic blocking agents.

Patients should be instructed to wait at least15 minutes after instillation of Levobunolol Alcon before inserting contact lenses. Levobunolol Alcon should not be administered while wearing contact lenses. Benzalkonium chloride may cause eye irritation and is known to discolour soft contact lenses.

-A decrease of levobunolol sensitivity may appear with a prolonged treatment. The absence of tachyphylaxis should be checked every year in long term treatment.

General

It is necessary to keep in mind the special warnings and precautions of the systemic administration of beta-adrenergic blocking agents. Systemic side effects may occur after topical administration:

The concomitant use of a beta-blocker with certain calcium antagonists (bepridil, verapamil, diltiazem) or beta-blockers used to treat cardiac insufficiency is not recommended (see 4.5 Interactions with other medicinal products and other forms of interactions).

Athletes: athletes should be warned that this medicine contains an active component that may induce a positive analytical result in antidoping controls.

Discontinuation of treatment

Systemic treatment with beta-adrenergic blocking agents should not be directly discontinued particularly in patients with angina: a sudden discontinuation may induce serious rhythm disorders, myocardial infarction or sudden death.

The dosage should be lowered gradually, i.e. over 1-2 weeks.

Bradycardia

If the heart rate decreases to less than 50-55 beats per minute at rest and the patient experiences symptoms related to bradycardia, the dosage should be reduced.

Heart failure

Special care should be taken in patients with controlled heart failure

First degree atrioventricular block

Due to the negative dromotropic effect of beta-adrenergic blocking agents, levobunolol should be administered with caution to patients having first degree atrioventricular block.

Phaeochromocytoma

When beta-adrenergic blocking agents are used in the treatment of hypertension due to a treated phaeochromocytoma, blood pressure should be closely monitored.

Patients with renal failure and/or hepatic failure

In these at risk patients, dosage adjustments are often needed when beta-adrenergic blocking agents are used systemically.

Diabetic patients

Patients should be advised to reinforce self-monitoring of their glycaemia at the beginning of treatment.

Signs and symptoms of hypoglycaemia, especially tachycardia, palpitations and sweating may be masked.

Psoriasis

As worsening of the disease have been reported with beta-adrenergic blocking agent, treatment should be weighed up in this indication.

Allergic reactions

In patients who may present a severe anaphylactic reaction of any origin, in particular those associated with iodine contrast products or floctafenine (see interactions), or during a desensitisation treatment, treatment with a beta-adrenergic blocking agent may exacerbate the reaction and a resistance to the usual dosages of epinephrine.

General anaesthesia

Beta-adrenergic blocking agents may reduce the sympathetic reflex mechanism. Continuation of treatment with beta-adrenergic blocking agents throughout surgery reduces the risk for cardiac arrhythmia, ischemia and acute blood pressure increases. The anaesthetist should be informed when the patient is receiving a beta-adrenergic blocking agent.

-If discontinuation of the treatment is necessary, 48 hours may be necessary to re-establish the sensitivity to catecholamines.

-In some cases, treatment with beta-adrenergic blocking agents cannot be discontinued :

.in patients with coronary heart failure, it is advisable to continue the treatment until surgery, due to the risk associated with sudden withdrawal of beta-adrenergic blocking agents.

.in emergency or when the treatment cannot be discontinued, the patient should be protected from vagal dominance by an adequate pre-administration of atropine, renewed if necessary. The anaesthetist should use the least cardioplegic products possible and should compensate for blood losses.

-The increase of anaphylactic risk linked to beta-adrenergic blocking agents should be taken into account.

Thyrotoxicosis

Beta-adrenergic blocking agents may mask some signs, in particular cardiovascular signs.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

1 ) Eye drops

Ophthalmic monitoring is required in patients with concomitant use of eye drops containing epinephrine (risk of mydriasis).

2 ) Other drugs

Even if there is little systemic passage of beta-adrenergic blocking agents after topical administration, interactions with other medicinal products may occur.

Consideration should be given to the interactions observed with beta-adrenergic blocking agents administered systemically.

Contraindicated association

+ Floctafenine

Beta-adrenergic blocking agents may affect the cardiovascular regulating mechanisms which counterbalance shock or hypotension caused by floctafenine.

+ Sultopride

Increased risk of ventricular rhythm disorders, notably torsade de pointes (atypical rapid ventricular tachycardia).

Associations not recommended

+ Calcium antagonists (bepridil, diltiazem and verapamil)

Automatism disorders (excessive bradycardia, sinusal arrest), sinoatrial and atrioventricular conduction disorders, and heart failure (synergy of effects).

If necessary the combination may be made under strict clinical and ECG monitoring, in particular in elderly subjects or at the start of treatment.

+ Beta blockers used in cardiac insufficiency

Risk of increase of undesirable side effects of beta-blockers, notably with excessive risk of bradycardia.

Associations requiring precautions for use

+ Halogen volatile anaesthetic drugs

Beta-adrenergic blocking agents may affect the cardiovascular regulating mechanisms (the beta-adrenergic inhibition may be reversed during surgery with the use of beta-stimulating agents).

Treatment with beta-adrenergic blocking agents should not generally be discontinued and, in all cases, abrupt withdrawal should be avoided. The anaesthetist should be aware of such a treatment.

+ Anticholinesterases: donezepil, galantamine, rivastigmine, neostigmine, pyridostigmine, tacrine, ambenonium

Risk of excessive bradycardia (addition of bradycardiogenic effects).

Regular clinical monitoring.

+An increase of the systemic effects of topical beta-adrenergic blocking agent and an increase of the blood concentrations of beta-adrenergic blocking agent were reported with the combination of topical beta-adrenergic blocking agent and quinidine, probably due to the inhibition of the metabolism of the beta-adrenergic blocking agent by quinidine (described with timolol).

+ Baclofen

Increased antihypertensive effect.

Blood pressure should be monitored and the dosage of the antihypertensive drug should be adjusted, if required.

+ Clonidine and other central antihypertensives (alphamethyldopa, guanfacine, moxonidine, rilmenidine)

Significant increase in arterial pressure in the event of sudden discontinuation of the treatment by the central antihypertensive.

Avoid the sudden discontinuation of the central antihypertensive. Clinical monitoring.

+ -Insulin, hypoglycaemic sulphonic agents, and glinides

Beta-adrenergic blocking agents may mask the signs and symptoms of acute hypoglycaemia: palpitations, tachycardia.

The patient should be informed and instructed to monitor his glycaemia, in particular when the treatment is initiated.

+ Lidocaine :

With lidocaine intravenous route, increase of lidocaine blood levels and possibly increased risk of neurologic and cardiac undesirable effects (decrease of lidocaine hepatic metabolism).

The dosage of lidocaine should be adjusted accordingly.

Clinical, electrocardiographic and possibly lidocaine blood levels monitoring are advised during treatment with a beta-adrenergic blocking agent, and after its withdrawal.

+ Medicinal products causing torsade de pointes

Class Ia antiarrhythmics (quinidine, hydroquinidine, disopyramide) and class III antiarrhythmics (amiodarone, dofetilide, ibutilide, sotalol), certain neuroleptics: phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, tiapride), butyrophenones (droperidol, haloperidol), other neuroleptics (pimozide), and other medicinal products such as: bepridil, cisapride, diphenamil, erythromycin IV, vincamine IV, mizolastrine, halofantrine, sparfloxacine, petamidine, moxifloxacine…

Increased risk of ventricular rhythm disorders, notably torsade de pointes.

Clinical and electrocardiographic monitoring.

+Amiodarone

Abnormal contractility, automatism and conduction (inhibition of the sympathetic mechanisms regulating the cardiac function).

A clinical monitoring should be made when both drugs, amiodarone and the beta-bloquant are combined.

+ Propafenone

Contractility, automatism and conduction disorders (suppression of compensatory sympathetic mechanisms).

Clinical and ECG monitoring.

Associations to Consider :

+ NSAIDs (general route) including selective cox-2 inhibitors

Decrease of antihypertensive effect (inhibition of the vasodilating prostaglandins by NSAIDs and sodium retention with pyrazoled NSAIDs).

+ Alpha blockers for urological purposes: alfuzosine, doxazosine, prazosine, tamsulosine, terazosine

Increase in the hypotensive effect, risk of increased orthostatic hypotension.

+ Amifostine

Increase in the antihypertensive effect.

+ Calcium antagonists (dihydropyridines)

Hypotension, left ventricular failure in patients with latent or uncontrolled cardiac failure (in-vitro negative inotropic effects, of drug-related intensity, have been shown with dihydropyridines compounds, and may add up to the negative inotropic effects of beta-adrenergic blocking agents). Moreover, treatment with beta-adrenergic blocking agents could minimise the reflex sympathetic reaction in case of excessive haemodynamic changes.

+ Imipraminic antidepressants (tricyclic), neuroleptics

Hypotensive effect with increased risk of orthostatic hypotension (additive effect).

+ Mefloquine

Risk of excessive bradycardia (addition of bradycardiogenic effects).

+ Dipyridamole (IV)

Increase of the antihypertensive effect.

4.6 Pregnancy And Lactation

The systemic passage of topical beta-adrenergic blocking agents exists but it is smaller than with systemic agents.

Pregnancy

Studies in animals have not revealed any teratogenic effect.

In clinical practice, no teratogenic effect has been reported to date, and results of controlled prospective studies with some beta-adrenergic blocking agents have not revealed malformations at birth.

In neonate of treated mothers, the action of beta-adrenergic blocking agents persists during several days after birth and could result in bradycardia, respiratory distress, hypoglycaemia; generally, the persistence of effect is without clinical consequence. Nevertheless, a cardiac failure may occur by reduction of the cardiovascular compensation reaction, requiring hospitalisation and intensive-care treatment (see overdose) and avoiding filling solutes (risk of acute pulmonary oedema).

This drug may be prescribed during pregnancy if necessary.

In case of treatment until delivery, close monitoring of the neonate (heart rate and glycaemia for the first 3 to 5 day of life) is recommended.

Lactation

Beta-adrenergic blocking agents are excreted in human milk.

The risk of hypoglycaemia and bradycardia has been described for some beta-adrenergic blocking agents with little binding to plasmatic proteins. Therefore, breast-feeding is not recommended when treatment is needed.

4.7 Effects On Ability To Drive And Use Machines

There are undesirable effects associated with this eye drops (particularly visual disturbances) which may affect the ability to drive and use machines.

4.8 Undesirable Effects

The most frequently reported undesirable effects with levobunolol eye drops are local ocular reactions. Like other topically applied ophthalmic drugs, levobunolol eye drops may be absorbed systemically and adverse reactions seen with oral beta blockers may also occur.

Cardiac Disorders:

Bradycardia (occasionally severe), atrioventricular block (heart block; slowing of atrioventricular conduction or worsening or an existing atrioventricular block), syncope, palpitations, arrhythmia.

Vascular Disorders:

hypotension, peripheral coldness, intermittent claudication, Raynaud's phenomena.

Eye Disorders:

Conjunctivitis, eye irritation, blepharitis, conjunctival hyperaemia, keratoconjunctivitis sicca, ocular pruritus, keratitis, corneal disorder (decreased corneal sensitivity), vision blurred, visual disturbance (including refractive changes due to withdrawal of miotic therapy in some cases), diplopia, eyelid ptosis, choroidal detachment (following filtration surgery).

Gastrointestinal Disorders:

Abdominal pain upper, dyspepsia, dry mouth, nausea, vomiting, diarrhea,

General Disorders and Administration Site Disorders:

asthenia, fatigue, lethargy, chest pain.

Immune System Disorders:

allergic reactions including anaphylaxis, angioedema, urticaria, rash (localized and generalized; see also Skin and Subcutaneous Tissue Disorders).

Investigations:

antinuclear antibody positive (with extremely rare clinical relevance, such as symptoms of lupus erythematosus, which regress at treatment discontinuation).

Metabolism and Nutrition Disorders:

hypoglycaemia.

Nervous System Disorders:

headache, ataxia, dizziness, increase in signs and symptoms of myasthenia gravis.

Psychiatric Disorders:

hallucination, confusion, nightmare, depression, insomnia, sleep disorder, libido decreased.

Reproductive System and Breast Disorders:

erectile dysfunction.

Respiratory, Thoracic, and Mediastinal disorders:

dyspnea, cough, bronchospasm (predominantly in patients with pre-existing bronchospastic disease).

Skin and Subcutaneous Tissue Disorders:

Urticaria, angioneurotic oedema (angio-oedema), alopecia, rash, rash psoriasiform, psoriasis (exacerbation).

4.9 Overdose

Although systemic passage of beta-adrenergic blocking agents administered topically is low, overdoses are possible.

Should accidental ocular overdosage occur, flush the eye(s) with sterile water or sodium chloride solution 0.9%.

Symptoms and management of overdose are similar to that of systemically administered beta-adrenergic blocking agents.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code : S01ED03

ANTIGLAUCOMA

BETA-ADRENERGIC BLOCKING AGENT.

(S = Sensory organ)

The three pharmacological characteristics of the levobunolol are:

• non cardioselective beta-adrenergic blocking agent,

• absence of partial agonist potency [or absence of intrinsic sympathomimetic activity (ISA)],

• no significant membrane stabilising effect (local anaesthetic or quinidine-like).

Levobunolol hydrochloride eye drops lowers intraocular pressure, whether or not associated with glaucoma by decreasing aqueous humour secretion.

5.2 Pharmacokinetic Properties

As with other eye drops, levobunolol may pass in systemic circulation.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzalkonium chloride, disodium edetate, polyvinyl alcohol, sodium metabisulphite (E223), disodium phosphate dodecahydrate (E339), potassium dihydrogen phosphate (E340), sodium chloride, hydrochloric acid and/or sodium hydroxide, purified water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

Keep the container in the outer carton in order to protect from light. Do not freeze. Discard the product 28 days after first opening.

6.5 Nature And Contents Of Container

Opaque polyethylene bottle and dropper tip with white polypropylene cap, containing 5 ml or 10 ml of eye drops.

6.6 Special Precautions For Disposal And Other Handling

No special precautions.

7. Marketing Authorisation Holder

Cusi (UK) Ltd.,

Pentagon Park,

Boundary Way,

Hemel Hempstead,

Herts.,

HP2 7UD, UK

8. Marketing Authorisation Number(S)

PL 16020/0010

9. Date Of First Authorisation/Renewal Of The Authorisation

July 1999/

2004

10. Date Of Revision Of The Text

November 2004

Wednesday, 14 March 2012

Mycamine 50mg and 100mg powder for solution for infusion

1. Name Of The Medicinal Product

Mycamine^®

2. Qualitative And Quantitative Composition

Each vial contains 50 mg micafungin (as sodium).

After reconstitution each ml contains 10 mg micafungin (as sodium).

Each vial contains 100 mg micafungin (as sodium).

After reconstitution each ml contains 20 mg micafungin (as sodium).

Excipients:

Each 50 mg vial contains 200 mg lactose.

Each 100 mg vial contains 200 mg lactose.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for solution for infusion.

White compact powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Mycamine is indicated for:

Adults, adolescents

- Treatment of invasive candidiasis.

- Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate.

- Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells / μl) for 10 or more days.

Children (including neonates) and adolescents < 16 years of age:

- Treatment of invasive candidiasis.

The decision to use Mycamine should take into account a potential risk for the development of liver tumours (see section 4.4). Mycamine should therefore only be used if other antifungals are not appropriate.

4.2 Posology And Method Of Administration

Consideration should be given to official/national guidance on the appropriate use of antifungal agents.

Treatment with Mycamine should be initiated by a physician experienced in the management of fungal infections.

Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

The dose regimen of Mycamine depends on the body weight of the patient as given in the following tables:

Use in adults, adolescents

Indication
	Body weight > 40 kg	Body weight
Treatment of invasive candidiasis	100 mg/day*	2 mg/kg/day*
Treatment of oesophageal candidiasis	150 mg/day	3 mg/kg/day
Prophylaxis of Candida infection	50 mg/day	1 mg/kg/day

*If the patient's response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients

Treatment duration

Invasive candidiasis: The treatment duration of Candida infection should be a minimum of 14 days. The antifungal treatment should continue for at least one week after two sequential negative blood cultures have been obtained and after resolution of clinical signs and symptoms of infection.

Oesophageal candidiasis: For the treatment of oesophageal candidiasis, Mycamine should be administered for at least one week after resolution of clinical signs and symptoms.

Prophylaxis of Candida infections: For prophylaxis of Candida infection, Mycamine should be administered for at least one week after neutrophil recovery.

Use in children (including neonates) and adolescents < 16 years of age

Indication
	Body weight > 40 kg	Body weight
Treatment of invasive candidiasis	100 mg/day*	2 mg/kg/day*
Prophylaxis of Candida infection	50 mg/day	1 mg/kg/day

Treatment duration

Prophylaxis of Candida infections: For prophylaxis of Candida infection, Mycamine should be administered for at least one week after neutrophil recovery. Experience with Mycamine in patients less than 2 years of age is limited.

Gender/Race

No dose adjustment is necessary based on gender or race (see section 5.2).

Use in patients with hepatic impairment

No dose adjustment is necessary in patients with mild or moderate hepatic impairment (see section 5.2). There are currently insufficient data available for the use of Mycamine in patients with severe hepatic impairment and its use is not recommended in these patients (see section 4.4 and 5.2).

Use in patients with renal impairment

No dose adjustment is necessary in patients with renal impairment (see section 5.2).

After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour. More rapid infusions may result in more frequent histamine mediated reactions.

For reconstitution instructions see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substance, to other echinocandins or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Hepatic effects:

The development of foci of altered hepatocytes (FAH) and hepatocellular tumours after a treatment period of 3 months or longer were observed in rats. The assumed threshold for tumour development in rats is approximately in the range of clinical exposure. The relevance of this finding for the therapeutic use in patients can not be excluded. Liver function should be carefully monitored during micafungin treatment. To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/AST is recommended. Micafungin treatment should be conducted on a careful risk/benefit basis, particularly in patients having severe liver function impairment or chronic liver diseases known to represent preneoplastic conditions, such as advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects, or receiving a concomitant therapy including hepatotoxic and/or genotoxic properties.

Micafungin treatment was associated with significant impairment of liver function (increase of ALT, AST or total bilirubin > 3 times ULN) in both healthy volunteers and patients. In some patients more severe hepatic dysfunction, hepatitis, or hepatic failure including fatal cases have been reported. Paediatric patients < 1 year of age might be more prone to liver injury (see section 4.8).

During administration of micafungin, anaphylactic/anaphylactoid reactions including shock may occur. If these reactions occur, micafungin infusion should be discontinued and appropriate treatment administered.

Exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. If patients develop a rash they should be monitored closely and micafungin discontinued if lesions progress.

Rare cases of haemolysis including acute intravascular haemolysis or haemolytic anaemia have been reported in patients treated with micafungin. Patients who develop clinical or laboratory evidence of haemolysis during micafungin therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing micafungin therapy.

Micafungin may cause kidney problems, renal failure, and abnormal renal function test. Patients should be closely monitored for worsening of renal function.

Co-administration of micafungin and amphotericin B desoxycholate should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see section 4.5).

Patients receiving sirolimus, nifedipine or itraconazole in combination with Mycamine should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary (see section 4.5).

The incidence of some adverse reactions was higher in paediatric patients than in adult patients (see section 4.8).

This medicinal product for intravenous use contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Micafungin has a low potential for interactions with medicines metabolised via CYP3A mediated pathways.

Drug interaction studies in healthy human subjects were conducted to evaluate the potential for interaction between micafungin and mycophenolate mofetil, ciclosporin, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, ritonavir, rifampicin, itraconazole, voriconazole and amphotericin B. In these studies, no evidence of altered pharmacokinetics of micafungin was observed. No micafungin dose adjustments are necessary when these medicines are administered concomitantly. Exposure (AUC) of itraconazole, sirolimus and nifedipine was slightly increased in the presence of micafungin (22%, 21% and 18% respectively).

Co-administration of micafungin and amphotericin B desoxycholate was associated with a 30% increase in amphotericin B desoxycholate exposure. Since this may be of clinical significance this co-administration should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see section 4.4).

4.6 Pregnancy And Lactation

There are no data from the use of micafungin in pregnant women. In animal studies micafungin crossed the placental barrier and reproductive toxicity was seen (see section 5.3). The potential risk for humans is unknown.

Mycamine should not be used during pregnancy unless clearly necessary.

It is not known whether micafungin is excreted in human breast milk. Animal studies have shown excretion of micafungin in breast milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Mycamine should be made taking into account the benefit of breast-feeding to the child and the benefit of Mycamine therapy to the mother.

Testicular toxicity was observed in animal studies (see section 5.3). Micafungin may have the potential to affect male fertility in humans.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed. However, adverse reactions may occur, which may influence the ability to drive and use machines (see section 4.8).

4.8 Undesirable Effects

The safety profile of micafungin is based on 3028 patients treated with micafungin in clinical studies: 2.002 patients with Candida infections (including candidaemia, invasive candidiasis and oesophageal candidiasis), 375 with invasive aspergillosis (primarily refractory infections) and 651 for prophylaxis of systemic fungal infections.

The patients treated with micafungin in clinical studies represent a critically ill patient population that requires multiple medicinal products including antineoplastic chemotherapy, potent systemic immunosuppressants and broad spectrum antibiotics. These patients had a wide variety of complex underlying conditions such as haematological malignancies and HIV-infection or were transplant recipients and/or treated in intensive care. Patients treated prophylactically with micafungin were those undergoing haematopoetic stem cell transplantation (HSCT) who were at high risk for fungal infections.

Overall 32.2% of the patients experienced adverse drug reactions. The most frequently reported adverse reactions were nausea (2.8%), blood alkaline phosphatase increased (2.7%), phlebitis (2.5%, primarily in HIV infected patients with peripheral lines), vomiting (2.5%), and aspartate aminotransferase increased (2.3%). No clinically significant differences were seen when the safety data were analysed by gender or race.

In the following table adverse reactions are listed by system organ class and MedDRA preferred term. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ Class	Common	Uncommon	Rare	Not known (frequency cannot be estimated from available data)
Blood and lymphatic system disorders	leukopenia, neutropenia, anaemia	pancytopenia, thrombocytopenia, eosinophilia, hypoalbuminaemia	haemolytic anaemia, haemolysis (see section 4.4)	disseminated intravascular coagulation
Immune system disorders		anaphylactic / anaphylactoid reaction (see section 4.4), hypersensitivity
Endocrine disorders		hyperhidrosis
Metabolism and nutritional disorders	hypokalaemia, hypomagnesaemia, hypocalcaemia	hyponatraemia, hyperkalaemia, hypophosphataemia, anorexia
Psychiatric disorders		insomnia, anxiety, confusion
Nervous system disorders	headache	somnolence, tremor, dizziness, dysgeusia
Cardiac disorders		tachycardia, palpitations, bradycardia
Vascular disorders	phlebitis	hypotension, hypertension, flushing		shock
Respiratory, thoracic and mediastinal disorders		dyspnoea
Gastrointestinal disorders	nausea, vomiting, diarrhoea, abdominal pain	dyspepsia, constipation
Hepatobiliary disorders	blood alkaline phosphatase increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased (including hyperbilirubinaemia), liver function test abnormal	hepatic failure (see section 4.4), gamma-glutamyltransferase increased, jaundice, cholestasis, hepatomegaly, hepatitis		hepatocellular damage including fatal cases (see section 4.4)
Skin and subcutaneous tissue disorders	rash	urticaria, pruritus, erythema		toxic skin eruption, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (see section 4.4)
Renal and urinary disorders		blood creatinine increased, blood urea increased, renal failure aggravated		renal impairment (see section 4.4), acute renal failure
General disorders and administration site conditions	pyrexia, rigors	injection site thrombosis, infusion site inflammation, injection site pain, peripheral oedema
Investigations		blood lactate dehydrogenase increased

Possible allergic-like symptoms

Symptoms such as rash and rigors have been reported in clinical studies. The majority were of mild to moderate intensity and not treatment limiting. Serious reactions (e.g. anaphylactoid reaction 0.2%, 6/3028) were uncommonly reported during therapy with micafungin and only in patients with serious underlying conditions (e.g. advanced AIDS, malignancies) requiring multiple co-medications.

Hepatic adverse reactions

The overall incidence of hepatic adverse reactions in the patients treated with micafungin in clinical studies was 8.6% (260/3028). The majority of hepatic adverse reactions were mild and moderate. Most frequent reactions were increase in AP (2.7%), AST (2.3%), ALT (2.0%), blood bilirubin (1.6%) and liver function test abnormal (1.5%). Few patients (1.1%; 0.4% serious) discontinued treatment due to a hepatic event. Cases of serious hepatic dysfunction occurred uncommonly (see section 4.4).

Injection-site reactions

None of the injection-site adverse reactions were treatment limiting.

Paediatric patients

The incidence of some adverse reactions (listed in the table below) was higher in paediatric patients than in adult patients. Additionally, paediatric patients < 1 year of age experienced about two times more often an increase in ALT, AST and AP than older paediatric patients (see section 4.4). The most likely reason for these differences were different underlying conditions compared with adults or older paediatric patients observed in clinical studies. At the time of entering the study, the proportion of paediatric patients with neutropenia was several-fold higher than in adult patients (40.2% and 7.3% of children and adults, respectively), as well as allogeneic HSCT (29.4% and 13.4%, respectively) and haematological malignancy (29.1% and 8.7%, respectively).

Blood and lymphatic system disorders
common	thrombocytopenia
Cardiac disorders
common	tachycardia
Vascular disorders
common	hypertension, hypotension
Hepatobiliary disorders
common	hyperbilirubinaemia, hepatomegaly
Renal and urinary disorders
common	acute renal failure, blood urea increased

4.9 Overdose

Repeated daily doses up to 8 mg/kg (maximum total dose 896 mg) in adult patients have been administered in clinical trials with no reported dose-limiting toxicity. One case of mis-dosage of 7.8 mg/kg/day for 7 days was reported in a newborn patient. No adverse reactions associated with this high dose were noted.

There is no experience with overdoses of micafungin. In case of overdose, general supportive measures and symptomatic treatment should be administered. Micafungin is highly protein-bound and not dialysable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other antimycotics for systemic use, ATC code: J02AX05

Mode of action

Micafungin non-competitively inhibits the synthesis of 1,3-β-D-glucan, an essential component of the fungal cell wall. 1,3-β-D-glucan is not present in mammalian cells.

Micafungin exhibits fungicidal activity against most Candida species and prominently inhibits actively growing hyphae of Aspergillus species.

PK/PD relationship

An additive or synergistic pharmacodynamic interaction of micafungin and amphotericin B was found in a mouse model of pulmonary aspergillosis (immunosuppression with hydrocortisone, intranasal infection with Aspergillus fumigatus).

Mechanism(s) of resistance

As for all antimicrobial agents, cases of reduced susceptibility and resistance have been reported and cross-resistance with other echinocandins cannot be excluded. Reduced susceptibility to echinocandins has been associated with mutations in the Fks1 gene coding for a major subunit of glucan synthase.

Breakpoints

Susceptibility testing was performed with modifications according to the Clinical and Laboratory Standards Institute (CLSI) methods M27-A2 (Candida species) and M38-A (Aspergillus species), respectively. To date, standardised techniques for susceptibility testing for 1,3-β-D-glucan synthesis inhibitors have not been established and results of susceptibility testing do not necessarily correlate with clinical outcome.

Although no MIC breakpoints for echinocandins have been established, a MIC of Candida spp. without bisecting any species group and represents a concentration that is easily maintained throughout the dosing interval. Infections due to Candida spp. in this MIC range are likely to respond to therapy.

The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. This information is only a guide to the probabilities of whether micro-organisms will be susceptible to micafungin or not. Where applicable the information on the European range of acquired resistance for the individual micro-organisms is indicated in brackets.

Commonly susceptible species [MIC ranges in Europe, mg/l]

Candida albicans [0.007 - 0.25]

Candida glabrata [0.007 - 0.12]

Candida tropicalis [0.007 - 0.12]

Candida krusei [0.015 - 0.12]

Candida kefyr [0.03 - 0.06]

Candida parapsilosis [0.12 - 2]

Candida guilliermondii [0.5]

Candida lusitaniae [0.12 - 0.25]

Candida spp. [0.015 - 0.5]

(incl. C. famata, C. dubliniensis, C. lipolytica, C. pelliculosa, C. rugosa, C. stellatoidea and C. zeylanoides)

Aspergillus fumigatus

Aspergillus flavus

Aspergillus niger

Aspergillus terreus

Aspergillus nidulans

Aspergillus versicolor

The mycelial form of dimorphic fungi (e.g. Histoplasma capsulatum, Blastomyces dermatitidis, Coccidioides immitis)

Species for which acquired resistance may be a problem

None

Inherently resistant organisms

Cryptococcus spp.

Pseudallescheria spp.

Scedosporium spp.

Fusarium spp.

Trichosporon spp.

Zygomycetes spp.

Information from clinical studies

Candidaemia and Invasive Candidiasis: Micafungin (100 mg/day or 2 mg/kg/day) was as effective as and better tolerated than liposomal amphotericin B (3 mg/kg) as first-line treatment of candidaemia and invasive candidiasis in a randomised, double-blind, multinational non-inferiority study. Micafungin and liposomal amphotericin B were received for a median duration of 15 days (range, 4 to 42 days in adults; 12 to 42 days in children).

Non-inferiority was proven for adult patients, and similar findings were demonstrated for the paediatric subpopulations (including neonates and premature infants). Efficacy findings were consistent, independent of the infective Candida species, primary site of infection and neutropenic status (see Table). Micafungin demonstrated a smaller mean peak decrease in estimated glomerular filtration rate during treatment (p<0.001) and a lower incidence of infusion-related reactions (p=0.001) than liposomal amphotericin B.

Overall Treatment Success in the Per Protocol Set, Invasive Candidiasis Study

	Micafungin	Liposomal Amphotericin B	% Difference [95% CI]
N	n (%)	N	n (%)
Adult Patients
Overall Treatment Success	202	181 (89.6)	190	170 (89.5)	0.1 [-5.9, 6.1] †
Overall Treatment Success by Neutropenic Status
Neutropenia at baseline	24	18 (75.0)	15	12 (80.0)	0.7 [-5.3, 6.7] ‡
No neutropenia at baseline	178	163 (91.6)	175	158 (90.3)
Paediatric Patients
Overall Treatment Success	48	35 (72.9)	50	38 (76.0)	-2.7 [-17.3, 11.9] §
< 2 years old	26	21 (80.8)	31	24 (77.4)
Premature Infants	10	7 (70.0)	9	6 (66.7)
Neonates (0 days to < 4 weeks)	7	7 (100)	5	4 (80)
2 to 15 years old	22	14 (63.6)	19	14 (73.7)
Adults and Children Combined, Overall Treatment Success by Candida Species
Candida albicans	102	91 (89.2)	98	89 (90.8)
Non-albicans species ¶: all	151	133 (88.1)	140	123 (87.9)
C. tropicalis	59	54 (91.5)	51	49 (96.1)
C. parapsilosis	48	41 (85.4)	44	35 (79.5)
C. glabrata	23	19 (82.6)	17	14 (82.4)
C. krusei	9	8 (88.9)	7	6 (85.7)

† Micafungin rate minus the liposomal amphotericin B rate, and 2-sided 95% confidence interval for the difference in overall success rate based on large sample normal approximation.

‡ Adjusted for neutropenic status; primary endpoint.

§ The paediatric population was not sized to test for non-inferiority.

¶ Clinical efficacy was also observed (< 5 patients) in the following Candida species: C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua and C. dubliniensis.

Oesophageal Candidiasis: In a randomised, double-blind study of micafungin versus fluconazole in the first-line treatment of oesophageal candidiasis, 518 patients received at least a single dose of study drug. The median treatment duration was 14 days and the median average daily dose was 150 mg for micafungin (N=260) and 200 mg for fluconazole (N=258). An endoscopic grade of 0 (endoscopic cure) at the end of treatment was observed for 87.7% (228/260) and 88.0% (227/258) of patients in the micafungin and fluconazole groups, respectively (95% CI for difference: [-5.9%, 5.3%]). The lower limit of the 95% CI was above the predefined non-inferiority margin of -10%, proving non-inferiority. The nature and incidence of adverse events were similar between treatment groups.

Prophylaxis: Micafungin was more effective than fluconazole in preventing invasive fungal infections in a population of patients at high risk of developing a systemic fungal infection (patients undergoing haematopoietic stem cell transplantation [HSCT] in a randomised, double-blind, multicentre study). Treatment success was defined as the absence of a proven, probable, or suspected systemic fungal infection through the end of therapy and absence of a proven or probable systemic fungal infection through the end of study. Most patients (97%, N=882) had neutropenia at baseline (< 200 neutrophils/μL). Neutropenia persisted for a median of 13 days. There was a fixed daily dose of 50 mg (1.0 mg/kg) for micafungin and 400 mg (8 mg/kg) for fluconazole. The mean period of treatment was 19 days for micafungin and 18 days for fluconazole in the adult population (N=798) and 23 days for both treatment arms in the paediatric population (N=84).

The rate of treatment success was statistically significantly higher for micafungin than fluconazole (1.6%

Tuesday, 13 March 2012

Pernox Lotion

Pronunciation: sal-ih-SILL-ik AS-id/SULL-fer
Generic Name: Salicylic Acid/Sulfur
Brand Name: Pernox

Pernox Lotion is used for:

Treating acne. It may also be used for other conditions as determined by your doctor.

Pernox Lotion is a topical salicylate. It works by causing the skin to swell, soften, and then slough or peel in areas where it is applied.

Do NOT use Pernox Lotion if:

you are allergic to any ingredient in Pernox Lotion

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pernox Lotion:

Some medical conditions may interact with Pernox Lotion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)

if you have liver or kidney problems, a skin infection, skin irritation, eczema, diabetes, or poor blood circulation

Some MEDICINES MAY INTERACT with Pernox Lotion. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, heparin, warfarin), aspirin, methotrexate, or sulfonylureas (eg, glipizide) because the risk of side effects may be increased by Pernox Lotion

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pernox Lotion may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pernox Lotion:

Use Pernox Lotion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Shake well before each use.

Apply a small amount of medicine to the affected area. Rub in gently.

Wash hands after you have applied Pernox Lotion, unless your hands are a part of the treated area.

If you miss a dose of Pernox Lotion, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Pernox Lotion.

Important safety information:

Pernox Lotion is for external use only. Avoid getting Pernox Lotion in your eyes, nose, or mouth, or on the genitals. If contact with your eyes occurs, flush with water for 15 minutes. Do not inhale the vapors of Pernox Lotion.

Overuse of topical products may worsen your condition.

Do not use Pernox Lotion longer or more often than recommended by your doctor or on the package label.

Check with your doctor before use if you have a condition that covers a large area of the body.

Be sure to apply Pernox Lotion only to the affected area and not to normal healthy skin.

Do not use Pernox Lotion on skin that is irritated, infected, or reddened.

Do not use Pernox Lotion on open skin wounds, moles, birthmarks, genital warts, warts on the face, or warts growing hair.

Do not use any other medicines or products on your skin unless your doctor instructs you otherwise.

Do not use a topical medicine containing mercury on the same area where Pernox Lotion is used. The combination may cause a foul odor, may be irritating to the skin, or may stain the skin black.

Pernox Lotion may interfere with certain lab test results. Make sure your doctor and lab personnel know you are using Pernox Lotion.

Pernox Lotion is extremely flammable. Do not store or use Pernox Lotion near a fire or other open flame.

Pernox Lotion may be harmful if swallowed. If you may have taken Pernox Lotion by mouth, contact your local poison control center or emergency room immediately.

Pernox Lotion contains a salicylate, which has been linked to Reye syndrome. Do not use Pernox Lotion on children or teenagers during or after chickenpox, flu, or other viral infections without checking with your doctor or pharmacist.

Use Pernox Lotion with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.

Caution is advised when using Pernox Lotion in CHILDREN because they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Pernox Lotion during pregnancy. It is unknown if Pernox Lotion is excreted in breast milk. Do not breast-feed while you are using Pernox Lotion.

Possible side effects of Pernox Lotion:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry, peeling, red, or scaling skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pernox side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; diarrhea; dizziness; loss of appetite; loss of hearing; mental disturbances; nausea; rapid or difficult breathing; ringing in the ears; seizures; sluggishness; vomiting; yellowing of the skin or eyes.

Proper storage of Pernox Lotion:

Store Pernox Lotion at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Pernox Lotion out of the reach of children and away from pets.

General information:

If you have any questions about Pernox Lotion, please talk with your doctor, pharmacist, or other health care provider.

Pernox Lotion is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pernox Lotion. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Pernox resources

Pernox Side Effects (in more detail)
Pernox Use in Pregnancy & Breastfeeding
Pernox Drug Interactions
Pernox Support Group
1 Review for Pernox - Add your own review/rating

Sastid Soap Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Pernox with other medications

Acne
Dandruff

Monday, 12 March 2012

Staxyn

Generic Name: vardenafil (var DEN a fil)

Brand Names: Levitra, Staxyn

What is vardenafil?

Vardenafil relaxes muscles and increases blood flow to particular areas of the body.

Vardenafil is used to treat erectile dysfunction (impotence).

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

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

Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems (such as nitroglycerin). Taking vardenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure. During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of vardenafil. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis. Stop using vardenafil and get emergency medical help if you have sudden vision loss.

What should I discuss with my healthcare provider before taking vardenafil?

Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking vardenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

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

heart disease, heart rhythm problems;

a recent history (in the past 6 months) of a heart attack, stroke, or congestive heart failure;

a personal or family history of "Long QT syndrome";

high or low blood pressure;

seizures;

liver disease, kidney disease (or if you are on dialysis);

a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

a bleeding disorder such as hemophilia;

a stomach ulcer;

hearing or vision problems, history of vision loss;

an eye disorder such as retinitis pigmentosa (an inherited condition of the eye);

a physical deformity of the penis (such as Peyronie's disease); or

if you have been told you should not have sexual intercourse for health reasons.

Vardenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking vardenafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether vardenafil is the actual cause of vision loss. Stop using vardenafil and get emergency medical help if you have sudden vision loss. FDA pregnancy category B: Although vardenafil is not for use in women, this medication is not expected to be harmful to an unborn baby. Although vardenafil is not for use in women, it is not known if vardenafil 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.

Staxyn may contain phenylalanine. Talk to your doctor before using this form of vardenafil if you have phenylketonuria (PKU).

How should I take vardenafil?

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.

Vardenafil can be taken with or without food.

Vardenafil is usually taken only when needed, about 60 minutes before sexual activity. The medication can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

To take the orally disintegrating tablet (Staxyn):

Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.

Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.

Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Swallow several times as the tablet dissolves. Do not take Staxyn with liquid.

Do not take vardenafil more than once a day. Allow 24 hours to pass between doses. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since vardenafil is used as needed, you are not likely to be on a dosing schedule.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include back pain, muscle pain, or vision problems.

What should I avoid while taking vardenafil?

Drinking alcohol can increase certain side effects of vardenafil.

Grapefruit and grapefruit juice may interact with vardenafil and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Do not use any other drug to treat impotence, such as alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others), unless your doctor tells you to.

Vardenafil 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 sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of vardenafil. Stop using vardenafil and call your doctor at once if you have any of these serious side effects:

sudden vision loss;

ringing in your ears, or sudden hearing loss;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

irregular heartbeat;

swelling in your hands, ankles, or feet;

shortness of breath;

vision changes;

feeling light-headed, fainting;

penis erection that is painful or lasts 4 hours or longer; or

seizure (convulsions).

Less serious side effects may include:

warmth or redness in your face, neck, or chest;

runny or stuffy nose;

headache, dizziness;

upset stomach; or

back pain.

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

What other drugs will affect vardenafil?

Do not take vardenafil with similar medications such as sildenafil (Viagra) or tadalafil (Cialis).

Before taking vardenafil, tell your doctor about all other medications you use for erectile dysfunction, or if you are using any of the following medications:

conivaptan (Vaprisol);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

an antidepressant such as nefazodone;

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

antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);

heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), or verapamil (Calan, Covera, Isoptin, Verelan);

heart rhythm medicine such as amiodarone (Cordarone, Pacerone), quinidine (Quin-G), procainamide (Procan, Pronestyl), or sotalol (Betapace); or

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

This list is not complete and other drugs may interact with vardenafil. 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 Staxyn resources

Staxyn Side Effects (in more detail)
Staxyn Use in Pregnancy & Breastfeeding
Staxyn Drug Interactions
Staxyn Support Group
1 Review for Staxyn - Add your own review/rating

Staxyn Prescribing Information (FDA)

Staxyn Advanced Consumer (Micromedex) - Includes Dosage Information

Staxyn Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Staxyn Consumer Overview

Levitra Prescribing Information (FDA)

Levitra Monograph (AHFS DI)

Levitra MedFacts Consumer Leaflet (Wolters Kluwer)

Levitra Consumer Overview

Compare Staxyn with other medications

Erectile Dysfunction

Where can I get more information?

Your pharmacist can provide more information about vardenafil.

See also: Staxyn side effects (in more detail)