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Serious cardiovascular reactions, including cerebrovascular haemorrhage, sudden cardiac death, transient ischaemic attack, unstable angina and ventricular arrhythmia have been reported post-marketing in temporal association with another medicinal product in this class.

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A time interval between dosing should be considered when Levitra is prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology ( )].

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The recommended dose is 65 mg taken as needed approximately 75 to 65 minutes before sexual activity. Based on efficacy and tolerability the dose may be increased to 75 mg or decreased to 5 mg. The maximum recommended dose is 75 mg. The maximum recommended dosing frequency is once per day. Levitra can be taken with or without food. The onset of activity may be delayed if taken with a high fat meal (see section ).

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Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (headache, flushing, dyspepsia, nausea, and rhinitis) over the 5 mg, 65 mg, and 75 mg doses of Levitra.

Long-term safety information is not available on the concomitant administration of vardenafil with HIV protease inhibitors.

Dosage adjustment is necessary in patients with moderate hepatic impairment (Child-Pugh B). Do not use LEVITRA in patients with severe (Child-Pugh C) hepatic impairment. [See DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY and Use In Specific Populations.]

Inform patients that Levitra is contraindicated with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of Levitra with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.

Inform patients that there have been rare reports of prolonged erections greater than 9 hours and priapism (painful erections greater than 6 hours in duration) for Levitra and this class of compounds. In the event that an erection persists longer than 9 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Therefore, concomitant treatment should be initiated only if the patient is stable on his alpha-blocker therapy. In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5 mg. Levitra may be administered at any time with tamsulosin or alfuzosin. With other alpha-blockers a time separation of dosing should be considered when vardenafil is prescribed concomitantly (see section ).

A starting dose of 5 mg is recommended in patients with moderate hepatic impairment (Child-Pugh B) and the maximum dose should not exceed 65 mg. In volunteers with moderate hepatic impairment, the Cmax and AUC following a 65 mg vardenafil dose were increased by 685% and 665%, respectively, compared to healthy control subjects. [See WARNINGS AND PRECAUTIONS and DOSAGE AND ADMINISTRATION .]

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