Source: FDA, National Drug Code (US) Revision Year: 2021
Tekturna contains aliskiren hemifumarate, adirect renin inhibitor. 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:
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 as film-coated tablets, which contains 165.75 mg or 331.5 mg aliskiren hemifumerate (equivalent to 150 mg or 300 mg aliskiren) and the following excipients: crospovidone; magnesium stearate; microcrystalline cellulose; povidone; silica, colloidal anhydrous; hypromellose; macrogol; talc; iron oxide, black (E172); iron oxide, red (E172); titanium dioxide (E171).
| Dosage Forms and Strengths |
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150 mg light pink biconvex round tablet, imprinted NVR/IL (Side 1/Side 2). 300 mg light red biconvex ovaloid round tablet, imprinted NVR/IU (Side 1/Side 2). |
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Tekturna tablets are supplied as a light-pink, biconvex round tablet containing 150 mg of aliskiren, and as a light-red biconvex ovaloid tablet containing 300 mg of aliskiren. Tablets are imprinted with NVR on one side and IL, IU, on the other side of the 150 mg and 300 mg tablets, respectively. All strengths are packaged in bottles and unit-dose blister packages (10 strips of 10 tablets) as described below in Table 7. Table 7. Tekturna Tablets Supply:
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| Drug | Countries | |
|---|---|---|
| TEKTURNA | United States, South Africa |
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