Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT)
Macleods Pharmaceuticals Limited
ORAL
PRESCRIPTION DRUG
Tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). Tadalafil tablet is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. Do not use nitrates within 48 hours of the last dose of tadalafil tablet. Tadalafil tablet potentiates the hypotensive effect of nitrates. This potentiation is thought to result from the combined effects of nitrates and tadalafil tablet on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)]. Coadministration of GC stimulators such as riociguat with tadalafil tablet is contraindicated. Tadalafil tablet may potentiate the hypotensive effects of GC stimulators. Tadalafil tablet is contraindicated in patients with a known serio
Tadalafil tablets USP is supplied as follows: 20 mg yellow colored, almond shaped, biconvex film coated tablets having ‘L 64’ debossed on one side and plain on other side Bottles of 30 NDC 33342-278-07 Bottles of 60 NDC 33342-278-09 Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
Abbreviated New Drug Application
TADALAFIL - TADALAFIL TABLET, FILM COATED MACLEODS PHARMACEUTICALS LIMITED ---------- 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 ADMINISTRATION INITIAL U.S. APPROVAL: 2003 INDICATIONS AND USAGE Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (1.1) DOSAGE AND ADMINISTRATION 40 mg once daily, with or without food. (2.1) Dividing the dose (40 mg) over the course of the day is not recommended. (2.1) Use with ritonavir requires dosage adjustments. (2.4) (2) DOSAGE FORMS AND STRENGTHS Tablets (not scored): 20 mg (3) CONTRAINDICATIONS Concomitant organic nitrates (4.1) Concomitant Guanylate Cyclase (GC) Stimulators (4.2) History of known serious hypersensitivity reaction to tadalafil or CIALIS (4.3) WARNINGS AND PRECAUTIONS Hypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of tadalafil tablets. Not recommended in patients with pulmonary veno-occlusive disease. (5.1, 5.2) Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent. (5.3) Hearing impairment: Cases of sudden decrease or loss of hearing have been reported with CIALIS. (5.4) Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors. (5.5) Prolonged erection: Advise patients to seek emergency treatment if an erection lasts >4 hours. (5.6) ADVERSE REACTIONS The most common adverse reaction is headache. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTAC Belgenin tamamını okuyun