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5 mg, 10 mg, 20 mgof vardenafil, as vardenafil hydrochloride.
LEVITRA (vardenafil tablets) is indicated for: Treatment of erectile dysfunction (difficultiesor the inability to achieve or maintain
penile erection sufficient for satisfactory sexual performance).Special Populations
Pregnant and Nursing Women: LEVITRA is not indicated for use in women. There are no trials of
LEVITRA in pregnant women.
Pediatrics (< 18 years of age): LEVITRA is not indicated for use in individuals less than 18 years
Geriatrics ( 65 years of age): A starting dose of 5 mg LEVITRA should be considered in patients
65 years and older. On average, elderly males (65 years and over) had a 52% higher vardenafil AUC
than younger males (18-45 years); however, this difference was not statistically significant.
LEVITRA (vardenafil tablets) can be taken with or without food. LEVITRA is not affected by
moderate amounts of alcohol (0.5 g/kg body weight; approximately 3.4 fluid ounces of 40% alcohol
in a 70 kg person). Sexual stimulation is required to achieve an erection.
Recommended Dose and Dosage Adjustment
The recommended starting dose of LEVITRA is 10 mg, taken orally 25 to 60 minutes before sexual
activity. Sexual activity can be initiated as soon as 15 minutes and as long as 8-10 hours after taking
LEVITRA. The dose may be increased to a maximum recommended dose of 20 mg or decreased to
5 mg based on efficacy and tolerability. (See CLINICAL TRIALS.) In patients with more severe
erectile dysfunction (eg, diabetics) a more rapid titration may be appropriate. The recommended dose
frequency is a maximum of once per day (as desired).
Geriatrics: A starting dose of 5 mg LEVITRA should be considered in patients 65 years or older.
(See WARNINGS AND PRECAUTIONS, ACTION AND CLINICAL PHARMACOLOGY, and
Hepatic Insufficiency: No dose adjustment for patients with mild hepatic impairment is required.
Vardenafil clearance is reduced in patients with moderate hepatic impairment. In patients with
moderate hepatic impairment, a 5 mg starting dose of LEVITRA is recommended, which may
subsequently be increased to a maximum dose of 10 mg, based on tolerability and efficacy. (See
WARNINGS AND PRECAUTIONS, ACTION AND CLINICAL PHARMACOLOGY, and
DETAILED PHARMACOLOGY.) Vardenafil has not been evaluated in patients with severe
hepatic impairment (Child-Pugh C).
Renal Insufficiency: No dose adjustment is required for patients with mild, moderate, or severe renal
impairment. Vardenafil has not been evaluated in patients on dialysis.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
LEVITRA (vardenafil tablets) in single doses up to 80 mg per day was tolerated in healthy male
volunteers without producing serious adverse side effects. A 40 mg once daily dose of LEVITRA
demonstrated mild adverse events while 40 mg twice daily resulted in cases of severe back pain. No
muscle or neurological toxicity was identified.
In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not
expected to accelerate clearance because LEVITRA is highly bound to plasma proteins and is not
significantly eliminated in the urine. For management of a suspected overdose please contact your
regional Poison Control Centre.
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