TADALAFIL tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

medsource pharmaceuticals

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 Tablet

Produktsammanfattning:

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: 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.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

TADALAFIL- TADALAFIL TABLET, FILM COATED
MEDSOURCE PHARMACEUTICALS
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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:
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 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).
WARNINGS AND PRECAUTIONS
Patients should not use Tadalafil Tablets if sex is inadvisable due to
cardio