Pitavastatin Calcium Tablets

Pitavastatin calcium blocks cholesterol synthesis in the liver by antagonizing HMG-CoA reductase, the rate-limiting enzyme in the cholesterol synthesis pathway. It promotes the expression of low-density lipoprotein (LDL) receptors in the liver and the entry of LDL from the blood into the liver, thereby reducing total cholesterol. In addition, it continuously inhibits the biosynthesis of cholesterol in the liver, reduces the secretion of very low-density lipoprotein (VLDL) into the blood, and reduces triglycerides in plasma.

The main active ingredient of this product is pitavastatin calcium. Chemical name: (3R, 5S, 6E)-7-[2-cyclopropyl-4 (p-fluorophenyl)-3-quinolyl]-3, 5-dihydroxy-6-heptanoic acid) Molecular weight: C50H46CaF2N2O8

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

Hypercholesterolemia, familial hypercholesterolemia.

Usually, adults take 1-2 mg of pitavastatin calcium once a day, orally after meals. The dosage can be increased or decreased according to age and condition. When the low-density lipoprotein value does not decrease significantly, you can consider increasing the dosage. The maximum daily dosage is 4 mg. Note: 1. The first dose for patients with liver disorders starts with 1 mg/day, and the maximum daily dosage is 2 mg. 2. Since rhabdomyolysis may occur with increasing dosage, when increasing the dosage, pay attention to whether the CK value increases, whether myoglobin appears in the urine, muscle pain or fatigue and other early symptoms of rhabdomyolysis.

Among the 886 subjects in the clinical trial, 197 (22.2%) experienced adverse reactions, and 50 (5.6%) experienced subjective and subjective symptoms, including abdominal pain, drug rash, fatigue, numbness, itching, etc. Abnormalities related to clinical examination values occurred in 16 subjects (18.8%), mainly increased γ-GTP, increased CK (CPK), increased serum ALT (GPT), and increased serum AST (GOT).

1. Patients with a history of allergy to the ingredients contained in this drug; 2. Patients with severe liver dysfunction or bile duct occlusion (when these patients take this drug, the blood concentration of the drug will increase, the chance of adverse reactions will be relatively high, and the liver disease may be aggravated) 3. Patients taking cyclosporine (when these patients take this drug, the blood concentration of the drug will increase, the chance of adverse reactions will be relatively high. And there may be rhabdomyolysis) 4. Pregnant or preparing to become pregnant or breastfeeding women 5. The following patients are prohibited from using this drug in principle, but it can be used with caution when necessary: Patients with abnormal renal function in clinical examinations taking this drug and phenoxyacetic acid drugs at the same time can only be used when necessary.

Precautions for children: The safety of the drug for children has not been established (no experience of use). Precautions for pregnancy and lactation: 1. Pregnant women or women who are preparing to become pregnant are prohibited from using it. Safety is not yet determined. Perinatal and lactation tests in rats showed that pregnant rats in the dose group of 1 mg/kg or more died before or after delivery. The results of the teratogenic sensitive period test in rabbits showed that pregnant rabbits in the dose group of 0.3 mg/kg or more died. There are reports showing that when rats are given a large amount of other HMG-CoA reductase inhibitors, fetal rats have skeletal deformities. There are also reports showing that pregnant women who take other HMG-CoA reductase inhibitors in the first 3 months of pregnancy have congenital malformations in their fetuses. 2. Women who are breastfeeding are prohibited from using it. The drug is secreted in rat milk. Precautions for the elderly: Generally speaking, the physiological functions of the elderly decline, so when adverse reactions occur, you should pay attention to reducing the dosage. There are reports that the elderly are prone to rhabdomyolysis.

Drug interactions may occur if used with other drugs. Please consult your doctor or pharmacist for details.

seal.

1mg

24 months

Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.

• Founded in:

  1998-12-30

• Address:

  South side of Dongshan, Jinshanqiao Development Zone, Xuzhou City, Jiangsu Province

• Tax NO.:

  91320300714139872F

• Registered Funds:

  480.4554 million yuan

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