Rosutor-10 Tablets

Description

ROSUTOR 10 (rosuvastatin calcium) is a synthetic lipid- lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl 2-[methyl (methylsulfonyl) amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enioc acid] calcium salt. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white amorphous power that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is hydrophilic compound with a partition coefficient (octanol/water) of 0. 13 at Ph of 7.0

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Clinical Pharmacology

ROSUTOR 10 is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxyl-3-methyl glutaryl coenzyme-A to mevalonate, a precursor of cholesterol. In vivo studies in an animal, and in vitro studies in cultured animal and human cells have shown rosuvastatin to have a high uptake into, and selectivity for action in the liver, the target organ for cholesterol lowering. In vivo and in vitro studies, rosuvastatin produces it lipid modifying effects in two ways, First, it increases the number of hepatic LDL receptors on the cell- surface to enhance uptake and catabolism of LDL second, rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number VLDL and LDL particles.

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NAFDAC No

B4-0600

Other Info

ROSUTOR 10 can be taken with or without food, at any time of day. Dose range: 5-40 mg 0nce daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg. HoFH: starting dose 20 mg. In pediatric patients, 10 to 17 years of age with HeFH: The usual dose range is 5- 20mg/day.