Rosuvastatin Calcium Tablets
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The company has production licenses for tablets, capsules, granules, suppositories, powders, injections, oral solutions, dry suspensions, and eye drops.
Product Description
Approval Number:
H20203501
Indications:
1.It is suitable for primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) in patients whose dyslipidemia cannot be appropriately controlled by diet control and other non-pharmacological treatments (such as exercise therapy and weight loss).
2.It is also suitable for patients with homozygous familial hypercholesterolemia as an adjuvant therapy to diet control and other lipid-lowering measures (such as LDL apheresis) or when these measures are not applicable.
Administration:
Patients should be given a standard cholesterol-lowering diet before treatment and maintain dietary control during treatment. The use of this product should follow the principle of individualization, taking into comprehensive consideration the patient's individual cholesterol level, expected cardiovascular risk, and potential risk of adverse reactions.
Oral administration. The usual starting dose is 5 mg once daily. The choice of starting dose should comprehensively consider the patient's individual cholesterol level, expected cardiovascular risk, and potential risk of adverse reactions. For patients who need more effective reduction of low-density lipoprotein cholesterol (LDL-C), a starting dose of 10 mg once daily can be considered, which can control the lipid levels of most patients. If necessary, the dose can be adjusted to the next higher level after 4 weeks of treatment. The maximum daily dose of this product is 20 mg.
It can be administered at any time of the day, with or without food.
Patients with renal Insufficiency
No dose adjustment is required for patients with mild and moderate renal impairment. All doses of this product are contraindicated in patients with severe renal impairment.
Patients with hepatic Insufficiency
In subjects with a Child-Pugh score of ≤7, the systemic exposure of rosuvastatin does not increase; in subjects with a Child-Pugh score of 8-9, increased systemic exposure is observed, and renal function evaluation should be considered in these patients.
It is contraindicated in patients with active liver disease, and there is no experience in using this product in patients with a Child-Pugh score >9.
Ethnic Differences
Increased systemic exposure has been observed in Asian subjects. This factor should be considered when determining the dosage for patients of Asian descent.
Patients with Risk Factors for Myopathy
The recommended starting dose for patients with risk factors for myopathy is 5 mg.
Specifications:
10mg × 14 tablets
The company has production licenses for tablets, capsules, granules, suppositories, powders, injections, oral solutions, dry suspensions, and eye drops.
The main products cover cardiovascular diseases, diabetic complications, anti-tumor, calcium supplementation, digestive system, respiratory system, and orthopedics.
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