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%).

Mylan Pharmaceuticals Inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] pain` `[4] dyspnoea` `[5] headache` `[6] nausea` `[7] diarrhoea` `[8] off label use` `[9] toxicity to various agents` `[10] rash`

4 years ago

ROUND YELLOW T9DI 20

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tadalafil Tablets, USP are available containing 20 mg of tadalafil, USP. The 20 mg tablets are yellow, film-coated, round, unscored tablets debossed with T9DI over 20 on one side of the tablet and plain on the other side. They are available as follows: NDC 0378-6976-91 bottles of 60 tablets 16.2 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep out of reach of children.

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Pulmonary Hypertension tadalafil 20 MG Oral Tablet

FDA Reported Adverse Reactions [1] drug ineffective [2] fatigue [3] pain [4] dyspnoea [5] headache [6] nausea [7] diarrhoea [8] off label use [9] toxicity to various agents [10] rash

ROUND YELLOW T9DI 20

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] pain` `[4] dyspnoea` `[5] headache` `[6] nausea` `[7] diarrhoea` `[8] off label use` `[9] toxicity to various agents` `[10] rash`