Tekturna
Tekturna®
(aliskiren)
Tablets
150 mg and 300 mg
USE IN PREGNANCY: When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Tekturna should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.
DRUG DESCRIPTION
Aliskiren, the active component of Tekturna® Tablets, is an orally active, nonpeptide, potent renin inhibitor. Aliskiren is present in Tekturna Tablets as its hemifumarate salt. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-Carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is
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Molecular formula: C30H53N3O6 • 0.5 C4H4O4
Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-Octanol, and highly soluble in water. Tekturna is available for oral administration as film-coated tablets containing 150 mg, and 300 mg of aliskiren base and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide colorants, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.
Generic Name: Aliskiren Tablets
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Tekturna
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