VARDENAFIL HYDROCHLORIDE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Lannett Company, Inc.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 tablets are not indicated for use in females. There

Tóm tắt sản phẩm:

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].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

VARDENAFIL HYDROCHLORIDE- VARDENAFIL HYDROCHLORIDE TABLET
LANNETT COMPANY, INC.
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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 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 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
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 hepatic impairment
should not e