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:

Amneal Pharmaceuticals NY LLC

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. Administration of vardenafil hydrochloride 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 may potentiate the hypotensive effects of nitrates. A suitable time interval following dosing of vardenafil hydrochloride for the safe administration of nitrates or nitric oxide donors has not been determined. Do not use vardenafil hydrochloride in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including vardenafil hydrochloride 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 pregnant women to inform any drug-associat

Обзор продуктов:

Vardenafil hydrochloride tablets, 5 mg, 10 mg or 20 mg contain 5 mg, 10 mg or 20 mg of vardenafil equivalent to 5.926 mg, 11.852 mg or 23.704 vardenafil hydrochloride trihydrate respectively which is equivalent to 5.373 mg, 10.746 mg or 21.492 mg of vardenafil hydrochloride respectively. Vardenafil Hydrochloride Tablets, 5 mg are supplied as orange, round, film-coated tablet, free from physical defects, debossed with “AC” & “18” on one side and plain on other side. They are available as follows: Bottles of 30:               NDC 69238-1151-3 Vardenafil Hydrochloride Tablets, 10 mg are supplied as orange, round, film-coated tablet, free from physical defects, debossed with “AC” & “19” on one side and plain on other side. They are available as follows: Bottles of 30:               NDC 69238-1152-3 Vardenafil Hydrochloride Tablets, 20 mg are supplied as orange, round, film-coated tablet, free from physical defects, debossed with “AC” & “20” on one side and plain on other side. They are available as follows: Bottles of 30:               NDC 69238-1153-3 Store at 20° to 25°C (68° to 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
AMNEAL PHARMACEUTICALS NY LLC
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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) 03/2023
INDICATIONS AND USAGE
Vardenafil hydrochloride is 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 strong 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.
Cobicistat: 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
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 patients with
moderate hepatic impairment
should n