LEVITRA- vardenafil hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VARDENAFIL HYDROCHLORIDE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H)

Available from:

GlaxoSmithKline LLC

INN (International Name):

VARDENAFIL HYDROCHLORIDE

Composition:

VARDENAFIL 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LEVITRA® is indicated for the treatment of erectile dysfunction. Administration of LEVITRA with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2)] . Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including LEVITRA, may potentiate the hypotensive effects of nitrates. A suitable time interval following dosing of LEVITRA for the safe administration of nitrates or nitric oxide donors has not been determined. Do not use LEVITRA in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including LEVITRA may potentiate the hypotensive effects of GC stimulators. LEVITRA is not indicated for use in women. There are no studies of LEVITRA use in pregnant women. No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis. Th

Product summary:

LEVITRA (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed “BAYER” cross on one side and “5”, “10”, and “20” on the other side equivalent to 5 mg, 10 mg, and 20 mg of vardenafil, respectively. Package Strength NDC Code Bottles of 30 5 mg 0173-0829-13 10 mg 0173-0830-13 20 mg 0173-0831-13 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

LEVITRA- VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVITRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVITRA
LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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LEVITRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the
treatment of erectile dysfunction.
(1)
LEVITRA is taken as needed: For most patients, the starting dose is 10
mg, up to once daily. Increase
to 20 mg or decrease to 5 mg based on efficacy/tolerability. (2.1)
A starting dose of 5 mg LEVITRA should be considered in patients ≥
65 years of age. (2.3)
LEVITRA is taken orally, approximately 60 minutes before sexual
activity. (2.1)
The maximum recommended dosing frequency is one tablet per day. (2.1)
LEVITRA may be taken with or without food. (2.2)
If taking potent or moderate inhibitors of CYP3A4, the dose of LEVITRA
should be adjusted as follows
(2.4, 5.2, 7.2):
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Ritonavir: No more than 2.5 mg in a 72-hour period
Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily,
itraconazole 400 mg daily,
clarithromycin: No more than 2.5 mg in a 24-hour period
Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No
more than 5 mg in a 24-hour
period.
In patients on stable alpha-blocker therapy the recommended starting
dose of LEVITRA is 5 mg (2.4,
5.6)
The recommended starting dose of LEVITRA is 5 mg in patients with
moderate hepatic impairment
(Child-Pugh B). The maximum dose in patients with moderate hepatic
impairment should not exceed
10 mg. (2.3, 8.6)
LEVITRA tablets 5 mg, 10 mg, 20 mg (3)
Administration with nitrates and nitric oxide donors (2.4, 4.1)
Administration with guanylate cyclase (GC) stimulators, such as
riociguat (2.4, 4.2)
Cardiovascu