Country: United States
Language: English
Source: NLM (National Library of Medicine)
VARDENAFIL HYDROCHLORIDE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H)
PD-Rx Pharmaceuticals, Inc.
VARDENAFIL HYDROCHLORIDE
VARDENAFIL 20 mg
ORAL
PRESCRIPTION DRUG
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 recei
LEVITRA (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed “BAYER” cross on one side and “20” on the other side equivalent to 20 mg of vardenafil, respectively. Bottles of 6 tablets (NDC 55289-193-06) Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
New Drug Application
LEVITRA- VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED PD-RX PHARMACEUTICALS, INC. ---------- 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 LEVITRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1) DOSAGE AND ADMINISTRATION 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): 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) DOSAGE FORMS AND STRENGTHS LEVITRA tablets 2.5 mg, 5 mg, 10 mg, 20 mg ( 3) CONTRAINDICATIONS Administration with nitrates and nitric oxide donors ( 2.4, 4.1) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 2.4, 4.2) WARNINGS AND PRECAUTIONS Cardiovascular Effects: Patients should not use LEVITRA if sex Read the complete document