Pulmonary Hypertension tadalafil 20 MG Oral Tablet

1 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 ) 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%).

Lupin Pharmaceuticals, Inc.

FDA Reported Adverse Reactions
`[1] dyspnoea` `[2] drug ineffective` `[3] nausea` `[4] headache` `[5] diarrhoea` `[6] fatigue` `[7] pain` `[8] dizziness` `[9] vomiting` `[10] hypotension`

4 years ago

ROUND ORANGE L 124

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

TADALAFIL Tablets USP are supplied as follows: 20 mg orange colored, round shaped, biconvex film coated tablets debossed with 'L 124' on one side and plain on other side. Bottles of 30 NDC 68180-914-06 Bottles of 60 NDC 68180-914-07 16.2 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

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Pulmonary Hypertension tadalafil 20 MG Oral Tablet

FDA Reported Adverse Reactions [1] dyspnoea [2] drug ineffective [3] nausea [4] headache [5] diarrhoea [6] fatigue [7] pain [8] dizziness [9] vomiting [10] hypotension

ROUND ORANGE L 124

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FDA Reported Adverse Reactions
`[1] dyspnoea` `[2] drug ineffective` `[3] nausea` `[4] headache` `[5] diarrhoea` `[6] fatigue` `[7] pain` `[8] dizziness` `[9] vomiting` `[10] hypotension`