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:

Northwind Pharmaceuticals, LLC

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 tablets, USP 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 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 tabl

Resumo do produto:

Tadalafil Tablets USP, 20 mg are yellow colored, oval shape, biconvex with bevel edge, film-coated tablets debossed '899' on one side and plain on the other side and are supplied as follows: NDC 51655-063-87 in bottle of 6 tablets NDC 51655-063-54 in bottle of 15 tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

TADALAFIL- TADALAFIL TABLET, FILM COATED
NORTHWIND PHARMACEUTICALS, 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
INDICATIONS AND USAGE
Tadalafil tablets, USP are 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 tablets are 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, antihypertensives or su