TADALAFIL tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Aphena Pharma Solutions - Tennessee, LLC

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Tadalafil tablets, USP are indicated for the treatment of erectile dysfunction (ED). Tadalafil tablets, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tadalafil tablets, USP 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® ). Hypersensiti

產品總結:

Tadalafil Tablets, USP are supplied as follows: 2.5 mg: Light yellow to yellow colored, oval-shaped, film-coated tablets, debossed with “T21/2 ” on one side and plain on other side. Bottle of 30 NDC 27241-111-03 Bottle of 500 NDC 27241-111-05 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 30 NDC 27241-112-03 Bottle of 500 NDC 27241-112-05 10 mg: Light yellow to yellow colored, oval-shaped, film-coated tablets, debossed with “T10” on one side and plain on other side. Bottle of 30 NDC 27241-113-03 Bottle of 500 NDC 27241-113-05 20 mg: Light yellow to yellow colored, oval-shaped, film-coated tablets, debossed with “T20” on one side and plain on other side. Bottle of 30 NDC 27241-114-03 Bottle of 500 NDC 27241-114-035 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.

授权状态:

Abbreviated New Drug Application

产品特点

TADALAFIL - TADALAFIL TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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
RECENT MAJOR CHANGES
Warning and Precautions (5.4) 05/2017
INDICATIONS AND USAGE
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the
treatment of:
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)
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:_
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).
_Tadalafil tablets for once daily use:_
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).
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg (3).
CONTRAINDICATIONS
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).
WARNINGS AND PRECAUTIONS
Patients should not use tadalafil if sex is inadvisable due to
cardiovascular status (5.1).
Use of tadalafil with alpha-blockers, ant