SPL Set ID: 32549c43-f8ff-422c-b42d-ca0877e661cf

1 drug(s) with this SPL Set ID

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Ambrisentan AMBRISENTAN
5 mg Tablet
ACTAVIS PHARMA, INC. FDA Rx Only

Ambrisentan is an endothelin receptor antagonist. The chemical name of ambrisentan is (+)-(2 S )-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid. It has a molecular formula of C 22 H 22 N 2 O 4 and a molecular weight of 378.42 and has the following structural formula: Figure 1: Ambrisentan Structural Formula Ambrisentan is a white to light yellow, crystalline powder. It is a carboxylic acid with a pKa of 4.0. Ambrisentan is practically insoluble in water and in aqueous solutions at low pH. Solubility increases in aqueous solutions at higher pH. In the solid state ambrisentan is very stable, is not hygroscopic, and is not light sensitive. Ambrisentan is available as 5 mg and 10 mg film-coated tablets for once daily oral administration. The tablets include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Each 5 mg ambrisentan film-coated tablet is white to off-white and capsule shaped. Each 10 mg ambrisentan film-coated tablet is white to off-white and capsule shaped. Ambrisentan tablets are unscored. Figure 1 Ambrisentan Structural Formula

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