VARDENAFIL HYDROCHLORIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

VARDENAFIL (UNII: UCE6F4125H) (VARDENAFIL - UNII:UCE6F4125H)

Tilgjengelig fra:

QYK BRANDS LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Vardenafil Hydrochloride tablets 2.5 mg 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side and are available as follows: Bottles of 30 tablets                  NDC 33342-151-07 Bottles of 100 tablets                NDC 33342-151-11 Unit dose blister pack of 100 tablets                            NDC 33342-151-12 Vardenafil Hydrochloride tablets 5 mg 5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side and are available as follows: Bottles of 30 tablets                     NDC 33342-152-07 Bottles of 100 tablets                   NDC 33342-152-11 Unit dose blister pack of 100 tablets                                   NDC 33342-152-12 Vardenafil Hydrochloridetablets 10 mg 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side and are available as follows: Bottles of 30 tablets                     NDC 33342-153-07 Bottles of 100 tablets                   NDC 33342-153-11 Unit dose blister pack of 100 tablets                                   NDC 33342-153-12 Vardenafil Hydrochloride tablets 20 mg 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side and are available as follows: Bottles of 30 tablets                     NDC 33342-154-07 Bottles of 100 tablets                   NDC 33342-154-11 Unit dose blister pack of 50 tablets                                     NDC 33342-154-31 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

VARDENAFIL HYDROCHLORIDE- VARDENAFIL HYDROCHLORIDE TABLET
QYK BRANDS LLC
----------
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
INDICATIONS AND USAGE
Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5)
inhibitor indicated for the treatment of
erectile dysfunction. (1) (1)
DOSAGE AND ADMINISTRATION
V ARDENAFIL is 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 v ARDENAFIL hydrochloride tablets should be
considered in patients ≥ 65 years
of age. (2.3)
V ARDENAFIL is taken orally, approximately 60 minutes before sexual
activity. (2.1)
The maximum recommended dosing frequency is one tablet per day. (2.1)
V ARDENAFIL hydrochloride tabletsmay be taken with or without food.
(2.2)
If taking potent or moderate inhibitors of CYP3A4, the dose of V
ARDENAFIL 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 Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily,
itraconazole 400 mg daily, clarithromycin:
No more than 2.5 mg in a 24-hour period (2)
o Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin:
No more than 5 mg in a 24-hour
period. (2)
In patients on stable alpha-blocker therapy the recommended starting
dose of v ARDENAFIL
HYDROCHLORIDE is 5 mg (2.4, 5.6)
The recommended starting dose of v ARDENAFIL 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
V ARDENAFIL hydrochloride tablets 2.5 mg, 5 mg, 10 mg, 20 mg (3)
CONTRAINDICATIONS
Administration with nitrates and nitric oxid