देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT)
REMEDYREPACK 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 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 tablets are contraindic
Tadalafil Tablets USP, 5 mg are supplied as yellow colored, round, biconvex, film-coated tablets debossed with “A13” on one side and plain on the other. NDC: 70518-3001-00 NDC: 70518-3001-01 PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 12 in 1 BOTTLE PLASTIC Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Keep this and all medications out of reach of children. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
TADALAFIL- TADALAFIL TABLET, FILM COATED REMEDYREPACK 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 INDICATIONS AND USAGE Tadalafil is 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 is 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). (2) DOSAGE FORMS AND STRENGTHS Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg ( 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 tablets or ADCIRCA ( 4.2). Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3). WARNINGS AND PRECAUTIONS Patients should not use tadalafil if sex is inadvisable due to cardiovascular status ( 5.1). Use of tadalafil with alpha-blockers, antihypertensives or substantial amounts of alcohol पूरा दस्तावेज़ पढ़ें