Rosuvastatin Calcium

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Rosuvastatin Calcium API

 

Haorui supplies high quality Rosuvastatin Calcium API produced by our GMP facility that has been successfully inspected by the FDA. We offer competitive prices and support our products with reliable technical and regulatory services.  Rosuvastatin Calcium API is available from R&D to commercial quantities. Please contact us for more details.

The following information is provided for general information purposes ONLY.

Rosuvastatin Calcium Description

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)?,5- dihydroxyhept-6-enoic acid] Calcium salt with the following structural formula:

CRESTOR (rosuvastatin Calcium) Structural Formula Illustration

The empirical formula for rosuvastatin Calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin Calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin Calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.

Inactive Ingredients: Each tablet contains: microcrystalline cellulose NF, lactose monohydrate NF, tribasic Calcium phosphate NF, crospovidone NF, magnesium stearate NF, hypromellose NF, triacetin NF, titanium dioxide USP, yellow ferric oxide, and red ferric oxide NF.

Rosuvastatin Calcium Indications

Hyperlipidemia and Mixed Dyslipidemia

Rosuvastatin Calcium is indicated as adjunctive therapy to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate.

Adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at least one year post- menarche, 10-17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL-C > 190 mg/dL or > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors.

Hypertriglyceridemia

Rosuvastatin Calcium is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.

Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)

Rosuvastatin Calcium is indicated as an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).

Homozygous Familial Hypercholesterolemia

Rosuvastatin Calcium is indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.

Slowing of the Progression of Atherosclerosis

Rosuvastatin Calcium is indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.

Limitations of Use

The effect of Rosuvastatin Calcium on cardiovascular morbidity and mortality has not been determined.

Rosuvastatin Calcium has not been studied in Fredrickson Type I and V dyslipidemias.
Rosuvastatin Calcium Dosage and Administration
The dose range for Rosuvastatin Calcium is 5 to 40 mg orally once daily.

Rosuvastatin Calcium can be administered as a single dose at any time of day, with or without food.

When initiating Rosuvastatin Calcium therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate Rosuvastatin Calcium starting dose should first be utilized, and only then titrated according to the patient's response and individualized goal of therapy.

The 40 mg dose of Rosuvastatin Calcium should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose
Rosuvastatin Calcium Important Information

Rosuvastatin Calcium is prescribed only if diet, exercise, and weight loss fail to lower your cholesterol levels. It's important to remember that Crestor is meant to supplement to replace hese lifestyle changes. To get the full benefit of Rosuvastatin Calcium, you need to stick to the diet and exercise program prescribed by your doctor. All of these efforts to keep your cholesterol levels normal are important because they may lower your risk of heart disease.
Rosuvastatin Calcium Side Effects

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe to continue using Rosuvastatin Calcium.

It's especially important to tell your doctor if you have unusual muscle pain, tenderness, or weakness that's accompanied by fever or a general feeling of illness and fatigue.

Side effects may include:
Abdominal pain, constipation, diarrhea, headache, indigestion, nausea, sore throat
Rosuvastatin Calcium Clinical Trials 1 Rosuvastatin Calcium Clinical Trials 2
Rosuvastatin Calcium Clinical Trials 3 Rosuvastatin Calcium Clinical Trials 4
Rosuvastatin Calcium Patents 1  Rosuvastatin Calcium Patents 2
Rosuvastatin Calcium Patents 3 Rosuvastatin Calcium Patents 4 
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