(vardenafil)
Levitra® (vardenafil) Prescribing Information
(Refer to full Summary of product Characteristics (SmPC) before prescribing)
Presentation: Each tablet contains 5mg / 10mg / 20mg vardenafil (as hydrochloride trihydrate). Indication: Treatment of erectile dysfunction. To be effective, sexual stimulation is required. Not for use by women. Posology and method of administration: Adult men: 10mg approximately 25 to 60 minutes before sexual activity. Based on efficacy and tolerability the dose may be increased to 20mg or decreased to 5mg. The maximum recommended dose is 20mg once per day. Can be taken with or without food, onset of activity may be delayed if taken with a high fat meal. Elderly men: no dosage adjustment required, though increase to a maximum 20mg dose should be carefully considered depending on individual tolerability. Children and adolescents: not indicated for individuals below 18 years of age. Mild and moderate hepatic impairment, severe renal impairment: A starting dose of 5mg should be considered. With other medicinal products: In combination with erythromycin or clarithromycin, the dose of Levitra® should not exceed 5mg. Contra-indications: Hypersensitivity to vardenafil or to any of the excipients; coadministration with nitrates or nitric oxide donors (such as amyl nitrite) in any form; patients who have loss of vision in one eye because of NAION; men for whom sexual activity is inadvisable (e.g. severe cardiovascular disorders); severe hepatic impairment; end-stage renal disease requiring dialysis; hypotension; recent stroke or myocardial infarction; unstable angina; known hereditary retinal degenerative disorders; concomitant use of potent CYP3A4 inhibitors ketoconazole and itraconazole (oral form) in men older than 75 years; concomitant use of potent HIV protease inhibitors such as ritonavir and indinavir. Warnings and Precautions: Medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes. Consider cardiovascular status, since there is a degree of cardiac risk associated with sexual activity. Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure. Use with caution in patients with anatomical deformation of the penis or conditions which predispose to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). Combination with other treatments for erectile dysfunction is not recommended. Patients on stable alpha-blocker therapy: initiate vardenafil therapy at a starting dose of 5mg and consider a time separation of dosing. Concomitant use with potent CYP 3A4 inhibitors should be avoided. A dose of 5mg vardenafil must not be exceeded when given concomitantly with erythromycin or clarithromycin. Avoid grapefruit juice. Prolongation of QTc interval - avoid use in patients with relevant risk factors. Advise patients that in the case of sudden visual defect to stop taking Levitra® and consult a physician. Tolerability of the maximum dose of 20mg may be lower in elderly patients (≥ 65 years old). Administration to patients with bleeding disorders or active peptic ulceration only after careful benefit-risk assessment. Interactions: Effects on vardenafil: inhibitors of CYP 3A4 may reduce vardenafil clearance. Effects of vardenafil: coadministration with nitrates is contraindicated. Concomitant treatment with alpha-blockers should be initiated only if the patient is stable on alpha-blocker therapy. Pregnancy and lactation: not indicated for use in women. Effects on ability to drive and use machines: patients should be aware of how they react to Levitra® before driving or operating machinery. Undesirable Effects: Very common: flushing, headache. Common: dizziness, nasal congestion, dyspepsia, and nausea. Serious side effects: cf. CI/Warnings and Precautions - in addition tachycardia, palpitations, angina pectoris, myocardial ischaemia/infarction, seizure, priapism, NAION, visual field defect, laryngeal oedema, intraocular pressure increased, sudden deafness. Serious cardiovascular events, including cerebrovascular haemorrhage, sudden cardiac death, transient ischaemic attack, unstable angina and ventricular arrhythmia reported post marketing in temporal association with another medicinal product in this class. Prescribers should consult the SmPC in relation to other side effects. Overdose: an increase in undesirable effects may be observed. Legal Category: POM. Package Quantities and Basic NHS Costs: 4 x 5mg (£16.59), 8 x 5mg (£33.19), 4 x 10mg (£22.24), 8 x 10mg (£44.47), 4 x 20mg (£23.50), and 8 x 20mg (£46.99). MA Number(s): EU/1/03/248/001-012. Further information available from: Bayer plc, Bayer Schering Pharma, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom, Telephone: 01635 563000. Date of revision: April 2009.
Levitra® is a registered trademark of Bayer AG.
Date of revision: June 2008
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Bayer Schering Pharma; Tel: 01635 563500, Fax: 01635 563703, E-mail: phdsguk@bayer.co.uk