TADALAFIL tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Proficient Rx LP

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). 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 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 tablets 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 tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets or ADCIRCA

Огляд продуктів:

Tadalafil tablets, USP 10 mg are available for oral administration as yellow coloured, almond shaped, biconvex, film coated tablets, debossed with “FJ3” on one side and plain on other side Bottles of 4 count comes in a child-resistant package (NDC 71205-720-04) Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

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
INDICATIONS AND USAGE
Tadalafil is 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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ADVERSE REACTIONS
Most common adverse reactions (≥2%) include headache, dyspepsia,
back pain, myalgia, nasal
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:_
o
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:_
o
o
o
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 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
rioc