TADALAFIL tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

Tadalafil (UNII: 742SXX0ICT) (Tadalafil - UNII:742SXX0ICT)

Fáanlegur frá:

Proficient Rx LP

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 or ADCIRCA®

Vörulýsing:

Tadalafil Tablets, USP are supplied as follows: Four strengths of round, pale yellow to yellow tablets are available in different sizes, and supplied in the following package sizes: 20 mg tablets debossed with “47”      Bottles of 10 NDC 71205-400-10 Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

TADALAFIL- TADALAFIL TABLET, FILM COATED
PROFICIENT RX LP
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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:_
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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:_
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•
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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 Tada