VARDENAFIL HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. Administration of vardenafil hydrochloride tablets 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 vardenafil hydrochloride tablets, may potentiate the hypotensive effects of nitrates. A suitable time interval following dosing of vardenafil hydrochloride tablets for the safe administration of nitrates or nitric oxide donors has not been determined. Do not use vardenafil hydrochloride tablets in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including vardenafil hydrochloride tablets may potentiate the hypotensive effects of GC stimulators. Pregnancy Category B vardenafil hydrochlor

Product summary:

Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with "2.5", "5", "10" or "20" on one side equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively Store at 25°C (77°F); excursions permitted within15-30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VARDENAFIL HYDROCHLORIDE- VARDENAFIL HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
VARDENAFIL HYDROCHLORIDE TABLETS
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VARDENAFIL HYDROCHLORIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
VARDENAFIL HYDROCHLORIDE TABLETS.
VARDENAFIL HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Warnings and Precautions, Effects on the Eye ( 5.4)
08/2017
INDICATIONS AND USAGE
Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5)
inhibitor indicated for the treatment of erectile
dysfunction. ( 1)
DOSAGE AND ADMINISTRATION
Vardenafil hydrochloride tablets are 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 vardenafil hydrochloride tablets should be
considered in patients ≥ 65 years of age. ( 2.3)
Vardenafil hydrochloride tablets are taken orally, approximately 60
minutes before sexual activity. ( 2.1)
The maximum recommended dosing frequency is one tablet per day. ( 2.1)
Vardenafil hydrochloride tablets may be taken with or without food. (
2.2)
If taking potent or moderate inhibitors of CYP3A4, the dose of
vardenafil hydrochloride tablets 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 vardenafil hydrochloride tablets is 5 mg (
2.4, 5.6)
The recommended starting dose of vardenafil hydrochloride tablets is 5
mg in patients with moderate hepatic
impairment (Child-Pugh B). The maximum dose in patients with moderate
hepat