tadalafil 20 mg

1 INDICATIONS & 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) 1.1 Pulmonary Arterial Hypertension 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%).

Macleods Pharmaceuticals Limited

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] off label use` `[3] fatigue` `[4] pain` `[5] dyspnoea` `[6] nausea` `[7] arthralgia` `[8] headache` `[9] diarrhoea` `[10] condition aggravated`

1 year ago

TEAR YELLOW L 64

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

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 16.2 Storage 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.

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