TADALAFIL tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT)

Tilgjengelig fra:

Preferred Pharmaceuticals Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown [see Clinical Studies (14.3)] .  Administration of tadalafil to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology (12.2)] . Tadalafil is contraindicated in patients with a known serious hypersensitivity to tadalafil (Tadalafil tablets or ADCIRCA® ). Hypersensitivity reactions

Produkt oppsummering:

Tadalafil Tablets, USP are supplied as follows: 5 mg: Light yellow to yellow colored, oval-shaped, film-coated tablets, debossed with “T5” on one side and plain on other side. Bottle of 15 tablets NDC 68788-8299-1 Bottle of 20 tablets NDC 68788-8292-2 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].Keep out of reach of children.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TADALAFIL- TADALAFIL TABLET
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TADALAFIL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TADALAFIL
TABLETS.
TADALAFIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the
treatment of:
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If tadalafil is used with finasteride to initiate BPH treatment, such
use is recommended for up to 26 weeks
(1.4).
DOSAGE AND ADMINISTRATION
_Tadalafil tablets for use as needed:_
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_Tadalafil tablets for once daily use:_
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DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg (3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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erectile dysfunction (ED) (1.1)
the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2)
ED and the signs and symptoms of BPH (ED/BPH) (1.3)
ED: Starting dose: 10 mg as needed prior to sexual activity. Increase
to 20 mg or decrease to 5 mg
based upon efficacy/tolerability. Improves erectile function compared
to placebo up to 36 hours post
dose. Not to be taken more than once per day (2.1).
ED: 2.5 mg taken once daily, without regard to timing of sexual
activity. May increase to 5 mg based
upon efficacy and tolerability (2.2).
BPH: 5 mg, taken at approximately the same time every day (2.3)
ED and BPH: 5 mg, taken at approximately the same time every day (2.3,
2.4)
Tadalafil tablets may be taken without regard to food (2.5).
Administration of tadalafil to patients using any form of organic
nitrate is contraindicated. Tadalafil
was shown to potentiate the hypotensive effect of nitrates (4.1).
History of known serious hypersensitivity reaction to Tadalafil or
ADCIRCA (4.2). Administration with
guanylate cyclase (GC) stimulators, such as riociguat (4.3).
®
Patients should not use tadalafil if sex is inadvisable due to
cardiovascular status (5.1).
Use of tadalafil with alpha-blockers, antihy