Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT)
Aphena Pharma Solutions - Tennessee, LLC
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 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
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.
Abbreviated New Drug Application
TADALAFIL- TADALAFIL TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- 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 read_full_document