VARDENAFIL HYDROCHLORIDE tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Alembic Pharmaceuticals Inc.

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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. Risk Summary Vardenafil hydrochloride is not indicated for use in females. There are no data with the use of vardenafil hydrochloride in p

Обзор продуктов:

Vardenafil hydrochloride tablets 2.5 mg are light orange to orange, film-coated round tablets debossed with “L” on one side and “04” on other side. NDC 62332-236-30    with child resistant closure, bottle of 30 tablets NDC 62332-236-31    with child resistant closure, bottle of 100 tablets Vardenafil hydrochloride tablets 5 mg are light orange to orange, film-coated round tablets debossed with “L” on one side and “05” on other side. NDC 62332-237-30    with child resistant closure, bottle of 30 tablets NDC 62332-237-31    with child resistant closure, bottle of 100 tablets Vardenafil hydrochloride tablets 10 mg are light orange to orange, film-coated round tablets debossed with ‘480’ on one side and plain on the other side. NDC 62332-238-30    with child resistant closure, bottle of 30 tablets NDC 62332-238-31    with child resistant closure, bottle of 100 tablets Vardenafil hydrochloride tablets 20 mg are light orange to orange, film-coated round tablets debossed with ‘481’ on one side and plain on the other side. NDC 62332-239-30    with child resistant closure, bottle of 30 tablets NDC 62332-239-31    with child resistant closure, bottle of 100 tablets Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

VARDENAFIL HYDROCHLORIDE - VARDENAFIL HYDROCHLORIDE TABLET, FILM
COATED
ALEMBIC PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
Dosage and Administration (2.4) 3/2023
INDICATIONS AND USAGE
• Vardenafil hydrochloride is a phosphodiesterase 5 (PDE5) inhibitor
indicated for the treatment of erectile
dysfunction. (1) (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 tablet 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 strong or moderate inhibitors of CYP3A4, the dose of
vardenafil hydrochloride tablets should be
adjusted as follows (2.4, 5.2, 7.2):
o Ritonavir: No more than 2.5 mg in a 72-hour period (2)
o Cobicistat: No more than 2.5 mg in a 72-hour period
o Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily,
itraconazole 400 mg daily,
clarithromycin: No more than 2.5 mg in a 24-hour period
o 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
tablet is 5 mg (2.4, 5.6)
• The recommended starting dose of vardenafil hydrochloride tablet
is 5 mg in patients with moderate
hepatic impairment (Child-Pugh B). The maximum dose in patient