Rosuvastatin calcium dispersible tablets

The inhibitory effect of this product on HMG-CoA reductase has been studied in rat human liver microsomes and cloned and purified human HMG, CoA reductase fragments. The I of the latter are: pravastatin, fluvastatin, simvastatin 11.2nmol?L-1, atorvastatin, rosuvastatin, indicating that this product is more potent than existing statins, and the results of studies in rat and human liver microsomes are similar. The active site of this product shows a high affinity for the human enzyme. The enzyme inhibition is reversible and competes with the substrate HMG-CoA, but not with the common substrate nicotinamide-adenine dinucleotide phosphate (NADPH). Rosuvastatin is a selective and competitive HMG-CoA reductase inhibitor. HMG-CoA reductase is the rate-limiting enzyme in the conversion of 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, which is a precursor of cholesterol. The results of animal and cell culture experiments show that rosuvastatin has a high and selective uptake rate by the liver, and the liver is the target organ for lowering cholesterol. The results of in vivo and in vitro experiments show that rosuvastatin can increase the number of liver LDL receptors on the cell surface, thereby enhancing the uptake and catabolism of LDL, and inhibiting liver VLDL synthesis, thereby reducing the total number of VLDL and LDL particles. For patients with homozygous and heterozygous familial hypercholesterolemia, non-familial hypercholesterolemia, and mixed dyslipidemia, rosuvastatin can reduce total cholesterol, LDL-C, ApoB, and non-HDL-C levels. Rosuvastatin can also reduce TG and increase HDL-C levels. For patients with simple hypertriglyceridemia, rosuvastatin can reduce total cholesterol, LDL-C, VLDL-C, ApoB, non-HDL-C, TG levels, and increase HDL-C levels. The effect of rosuvastatin on cardiovascular morbidity and mortality has not yet been determined.

The main ingredient of this product is rosuvastatin calcium. Molecular weight: C22H27FN3O6S

This product is a film-coated tablet, which appears white or off-white after removing the coating.

1. This product is suitable for primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) whose dyslipidemia cannot be properly controlled by diet control and other non-drug treatments (such as exercise therapy, weight loss). 2. This product is also suitable for patients with homozygous familial hypercholesterolemia as an adjuvant treatment for diet control and other lipid-lowering measures (such as LDL removal therapy), or when these methods are not applicable.

Oral. The usual starting dose of this product is 5 mg, once a day. The selection of the starting dose should take into account the individual patient's cholesterol level, expected cardiovascular risk, and the potential risk of adverse reactions. For patients who need to more effectively lower low-density lipoprotein cholesterol (LDL-C), 10 mg once a day can be considered as the starting dose, which can control the blood lipid level of most patients. If necessary, the dose can be adjusted to a higher dose level after 4 weeks of treatment. The maximum daily dose of this product is 20 mg.

Endocrine disorders (diabetes): nervous system abnormalities (headache, dizziness): gastrointestinal abnormalities (constipation, nausea, abdominal pain); skeletal muscle, joint and bone abnormalities (myalgia): systemic abnormalities (weakness).

1. Patients who are allergic to rosuvastatin or any of the ingredients in this product. 2. Patients with active liver disease, including patients with unexplained persistent elevation of serum aminotransferase and any elevation of serum aminotransferase exceeding 3 times the upper limit of normal (ULN). 3. Patients with severe renal impairment (creatinine clearance 30ml/min). 4. Patients with myopathy. 5. Patients who are taking cyclosporine at the same time. 6. Women who are pregnant, breastfeeding, or who may become pregnant but do not take appropriate contraceptive measures.

Precautions for children: The safety and effectiveness of this product in children have not been established. The experience of pediatric use is limited to a small number of children (age ≥ years) with homozygous familial hypercholesterolemia. Therefore, this product is not recommended for pediatric use. Precautions for pregnancy and lactation: This product is contraindicated for pregnant and lactating women. Precautions for the elderly: Not yet clear.

Rosuvastatin is a selective competitive HMG-CoA reductase inhibitor. HMG-CoA reductase is the rate-limiting enzyme in the conversion of -hydroxy-methylglutaryl coenzyme A to mevalonate. Mevalonate is a precursor of cholesterol. Animal and cell culture test results show that rosuvastatin is highly taken up by the liver and is selective. The liver is the target organ for lowering cholesterol. In vivo and in vitro test results show that rosuvastatin can increase the number of liver LDL receptors on the cell surface, thereby enhancing the uptake and catabolism of LDL and inhibiting liver VLDL synthesis, thereby reducing the total number of VLDL and LDL particles. For homozygous and heterozygous familial hypercholesterolemia patients, non-familial hypercholesterolemia patients, and patients with mixed dyslipidemia, rosuvastatin can lower total cholesterol LDL-

Store tightly closed in a cool, dry place.

20mg (calculated as rosuvastatin)

36 months

Lunan BETTER Pharmaceutical Co., Ltd.

• Founded in:

  2003-12-16

• Address:

  No. 209, Hongqi Road, Linyi City

• Tax NO.:

  91371300756399007K

• Registered Funds:

  115 million yuan

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