VARDENAFIL tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Aphena Pharma Solutions - Tennessee, LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. Administration of vardenafil 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, may potentiate the hypotensive effects of nitrates. A suitable time interval following dosing of vardenafil for the safe administration of nitrates or nitric oxide donors has not been determined.  Do not use vardenafil in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including vardenafil may potentiate the hypotensive effects of GC stimulators. Pregnancy Category B vardenafil is not indicated for use in women. There are no studies of vardenafil use in pregnant women. No evidence of specific potential for teratogenicity, embryotoxicity or fe

Produkt oppsummering:

Vardenafil Hydrochloride Tablets, 20 mg are light yellow to orange colored, round, biconvex, bevel edged, film-coated tablets, debossed with "10" on one side and "71" on other side and are supplied as: NDC 51407-174-30 in bottle of 30 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

VARDENAFIL- VARDENAFIL TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
VARDENAFIL HYDROCHLORIDE TABLETS
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 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 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 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 is 5 mg ( 2.4,
5.6)
The recommended starting dose of vardenafil 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
Vardenafil hydrochloride tablets 2.5 mg (equivalent to