TADALAFIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 is contraindicated in patients with a known serious hypersensitivity to tadalafil (Tadalafil tablets or ADCIRCA® ). Hypersensitiv

Product summary:

Tadalafil tablets USP 2.5 mg are light-orange yellow colored, oval shaped, biconvex beveled edge, film coated tablets with debossing "A9" on one side and "2.5" on other side. Bottles of 30                                                   13668-565-30 Bottles of 500                                                 13668-565-05 Carton of 100 (10x10) Unit dose Tablets       13668-565-74                                                                Tadalafil tablets USP 5 mg are yellow colored, oval shaped, biconvex beveled edge, film coated tablets with debossing "B1" on one side and "5" on other side. Bottles of 30                                                   13668-566-30 Bottles of 500                                                 13668-566-05 Carton of 100 (10x10) Unit dose Tablets       13668-566-74                                                      Tadalafil tablets USP 10 mg are yellow colored, oval shaped, biconvex beveled edge, film coated tablets with debossing "A15" on one side and "10" on other side. Bottles of 30                                                   13668-567-30 Bottles of 500                                                 13668-567-05 Carton of 100 (10x10) Unit dose Tablets       13668-567-74                                                          Tadalafil tablets USP 20 mg are yellow colored, oval shaped, biconvex beveled edge, film coated tablets with debossing "A16" on one side and "20" on other side. Bottles of 30                                                   13668-568-30 Bottles of 500                                                 13668-568-05 Carton of 100 (10x10) Unit dose Tablets       13668-568-74                                                      Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature] . Keep this and all medication out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TADALAFIL- TADALAFIL TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, 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
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: (1)
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). (1)
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). (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 tablets if sex is inadvisable due to
cardiovascular status (5.1).
Us