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. In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability [see Clinical Studies ( 14.2 )] . 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 is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): To improve exercise ability and delay clinical worsening. In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. 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 ).

actavis pharma, inc.

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

4 years ago

OVAL WHITE 5 405

16 HOW SUPPLIED/STORAGE AND HANDLING

AMBRISENtan film - coated tablets are supplied as follows: Tablet Strength Package Configuration NDC No. Description of Tablet; debossed on Tablet; Size 5 mg 30 count bottle 0591 - 2405 - 30 white to off-white; capsule shaped; film- coated tablet; debossed with "5" on one side and "405" on the other side; 8.0 mm x 4.0 mm 10 mg 30 count bottle 0591 - 2406 - 30 white to off-white; capsule shaped; film- coated tablet; debossed with " 10 " on one side and "406" on the other side; 11.00 mm x 5.10 mm Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store

AMBRISENtan tablets in its original packaging.

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actavis pharma, inc.

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