TADALAFIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

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 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 tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil

Product summary:

Tadalafil Tablets, USP are available containing 2.5 mg, 10 mg or 20 mg of tadalafil, USP. The 2.5 mg tablets are light yellow, film-coated, round, unscored tablets debossed with M on one side of the tablet and TL over 1 on the other side. They are available as follows: NDC 0378-6970-93 bottles of 30 tablets NDC 0378-6970-77 bottles of 90 tablets NDC 0378-6970-01 bottles of 100 tablets NDC 0378-6970-85 carton of 30 tablets (two blister cards x 15 tablets) The 10 mg tablets are light yellow, film-coated, round, unscored tablets debossed with M on one side of the tablet and TL3 on the other side. They are available as follows: NDC 0378-6972-93 bottles of 30 tablets NDC 0378-6972-77 bottles of 90 tablets NDC 0378-6972-01 bottles of 100 tablets The 20 mg tablets are light yellow, film-coated, round, unscored tablets debossed with M on one side of the tablet and TL4 on the other side. They are available as follows: NDC 0378-6973-93 bottles of 30 tablets NDC 0378-6973-91 bottles of 60 tablets NDC 0378-6973-77 bottles of 90 tablets NDC 0378-6973-80 bottles of 180 tablets NDC 0378-6973-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep out of reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TADALAFIL- TADALAFIL TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
----------
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:
•
•
•
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
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 10 mg, 20 mg (3).
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
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:_
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).
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).
Patients sho