SUMMARY PRODUCT INFORMATION

5 mg, 10 mg, 20 mgof vardenafil, as vardenafil hydrochloride.

 

INDICATIONS AND CLINICAL USE

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

old.

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.

 

DOSAGE AND ADMINISTRATION

Dosing Considerations

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

DETAILED PHARMACOLOGY.)

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.

OVERDOSAGE

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.