ambrisentan 10 MG Oral Tablet

1 INDICATIONS AND USAGE Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): • To improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%). Ambrisentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): To improve exercise ability and delay clinical worsening. Studies establishing effectiveness included trials predominantly in patients with WHO Functional Class II-III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%) ( 1 ).

Mylan Pharmaceuticals Inc.

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

4 years ago

OVAL PINK M AN1

16 HOW SUPPLIED/STORAGE AND HANDLING

AMBRISENtan Tablets are available containing 5 mg or 10 mg of

AMBRISENtan. The 5 mg tablets are pink, film-coated, round, unscored tablets debossed with M on one side of the tablet and AN on the other side. They are available as follows: NDC 0378-4270-93 bottles of 30 tablets The 10 mg tablets are pink, film-coated, capsule shaped, unscored tablets debossed with M on one side of the tablet and AN1 on the other side. They are available as follows: NDC 0378-4271-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store

AMBRISENtan tablets in their original packaging. Dispense only in original container. PHARMACIST: Dispense a Medication Guide with each prescription.

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ambrisentan 5 MG Oral Tablet

Mylan Pharmaceuticals Inc.

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