ambrisentan 5 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 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 ).

Zydus Pharmaceuticals (USA) Inc.

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

4 years ago

ROUND PINK 1179

16 HOW SUPPLIED/STORAGE AND HANDLING

AMBRISENtan Tablets, 5 mg are pink-colored, round shaped, film-coated tablets debossed with "1179" on one side and plain on the other side and are supplied as follows: NDC 70710-1179-3 in bottle of 30 tablets with child-resistant closure NDC 70710-1179-9 in bottle of 90 tablets with child-resistant closure NDC 70710-1179-1 in bottle of 100 tablets with child-resistant closure NDC 70710-1179-7 in unit-dose blister cartons of 10 tablets (1 x 10 unit-dose) NDC 70710-1179-8 in unit-dose blister cartons of 30 tablets (3 x 10 unit-dose)

AMBRISENtan Tablets, 10 mg are white to off-white, oval shaped, film-coated tablets debossed with "1180" on one side and plain on the other side and are supplied as follows: NDC 70710-1180-3 in bottle of 30 tablets with child-resistant closure NDC 70710-1180-9 in bottle of 90 tablets with child-resistant closure NDC 70710-1180-1 in bottle of 100 tablets with child-resistant closure NDC 70710-1180-7 in unit-dose blister cartons of 10 tablets (1 x 10 unit-dose) NDC 70710-1180-8 in unit-dose blister cartons of 30 tablets (3 x 10 unit-dose) Store at 20° to 25° C (68° to 77° F); excursions permitted to 15 to 30° C (59 to 86° F) [see USP Controlled Room Temperature]. Store

AMBRISENtan tablets in its original packaging.

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ambrisentan 10 MG Oral Tablet

Zydus Pharmaceuticals (USA) Inc.

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