TADALAFIL tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Preferred Pharmaceuticals Inc.

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Tadalafil tablets, USP are supplied as follows: Four strengths of almond-shaped tablets are available in different sizes, and supplied in the following package sizes: 5 mg tablets debossed with “049” Store at 20o C to 25o C (68o F to 77o F); excursions permitted to 15o C to 30o C (59o F to 86o F) [see USP Controlled Room Temperature]. Keep out of reach of children.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

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
RECENT MAJOR CHANGES
Warnings and Precautions (5.4) 05/2017
INDICATIONS AND USAGE
Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated
for the treatment of:
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If tadalafil tablets are used with finasteride to initiate BPH
treatment, such use is recommended for up to
26 weeks (1.4).
DOSAGE AND ADMINISTRATION
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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)
_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).
Administration of tadalafil tablets to patients using any form of
organic nitrate is contraindicated.
Tadalafil tablets were shown to potentiate the hypotensive effect of
nitrates (4.1).
History of known serious hypersensitivity reaction to tadalafil
tablets or ADCIRCA
(4.2).
®
Administration with guanylate cyclase (GC) stimulators, such as
riociguat (4.3).
Patients should not use tad