TADALAFIL tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Proficient Rx LP

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 decrease 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 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 (or ADCIRCA® ). Hypers

Resumo do produto:

Tadalafil tablets USP are available as follows: 10 mg: yellow, oval-shaped, film-coated tablets, debossed with “TEVA” on one side of the tablet and with “3018” on the other side, in bottles of 30 (NDC NDC 0093-3018-56). Bottles of 30 (NDC 71205-418-30) Bottles of 60 (NDC 71205-418-60) Bottles of 90 (NDC 71205-418-90) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

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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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 or
ADCIRCA (4.2).
®
Administration with guanylate cyclase (GC) stimulators, such as
riociguat (4.3).
Patients should not use tadalafil