Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT)
Mylan Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Citiți documentul complet