Product Overview
[Drug Name]
Generic Name: Pitavastatin Calcium Tablets
Trade Name: Bangzhi/Wanbang Pharmaceutical
English Name: Pitavastatin Calcium Tablets
Chinese Pinyin: PiFaTaTingGaiPian (BangZhi)
[Ingredients]
The main active ingredient of this product is pitavastatin calcium. Chemical Name: (3R,5S,6E)-7-[2-cyclopropyl-4(p-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptanoic acid) Molecular Weight: C50H46CaF2N2O8
[Properties]
This product is a film-coated tablet that appears white or off-white after removal of the film coating.
[Indications]
Hypercholesterolemia, familial hypercholesterolemia.
[Dosage and Administration]
Usually, adults take 1-2 mg of pitavastatin calcium orally once daily after meals. The dosage may be adjusted based on age and condition. If the LDL-C level does not decrease significantly, the dosage may be increased, with a maximum daily dose of 4 mg. Note: 1. For patients with liver impairment, the initial dose should be 1 mg/day, with a maximum daily dose of 2 mg. 2. Because rhabdomyolysis may occur with increasing dosage, when increasing the dosage, pay attention to whether CK levels increase, myoglobin levels appear in the urine, and whether muscle pain or fatigue, which are early symptoms of rhabdomyolysis, are present.
[Adverse Reactions]
Among the 886 clinical trial subjects, 197 (22.2%) experienced adverse reactions, with 50 (5.6%) experiencing both subjective and perceived symptoms. Symptoms primarily included abdominal pain, drug rash, fatigue, numbness, and itching. Abnormalities related to clinical examination values were observed in 16 subjects (18.8%), primarily elevated γ-GTP, elevated CK (CPK), elevated serum ALT (GPT), and elevated serum AST (GOT).
[Contraindications]
1. Patients with a history of allergy to the ingredients in this drug 2. Patients with severe liver dysfunction or bile duct obstruction (the blood concentration of this drug will increase when these patients take it, and the chance of adverse reactions will be higher, and it may aggravate liver disease) 3. Patients currently taking cyclosporine (the blood concentration of this drug will increase when these patients take it, and the chance of adverse reactions will be higher. Rhabdomyolysis may also occur) 4. Pregnant or pregnant women or women who are breastfeeding 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, and it can only be used when necessary. [Precautions] 1. Use with caution (the following patients should use this drug with caution as it may cause adverse reactions such as rhabdomyolysis). (1) Patients with liver dysfunction or patients with a history of liver dysfunction Patients with alcohol poisoning (because most of this drug is distributed to the liver). (2) Patients with renal dysfunction or patients with a history of renal dysfunction. (3) Patients currently taking phenoxyacetic acid drugs or niacin. (4) Patients with hypothyroidism, hereditary muscle disorders or those with a history of such diseases. (5) Elderly people. 2. Important precautions (1) For patients with high cholesterol, diet therapy should still be adopted first and exercise therapy should be paid attention to. (2) Liver function tests should be performed at least once a week between the start of medication and then periodically every six months after the start of medication. (3) Blood lipid levels should be checked regularly during medication. If there is no effect within the prescribed course of treatment, the medication should be stopped. Please read the instructions carefully and use according to the doctor's instructions.
[Special population medication]
Children's precautions:
The safety of the drug for children has not been established (no experience of use).
Pregnancy and lactation precautions:
1. Pregnant women or women who are about to become pregnant are prohibited from using this drug. Safety is not yet determined. Perinatal and lactation studies in rats showed that pregnant rats in the dose group of 1 mg/kg or above died before or after delivery. The results of the teratogenic sensitive period study in rabbits showed that pregnant rabbits in the dose group of 0.3 mg/kg or above died. There are reports that when rats are given large amounts of other HMG-CoA reductase inhibitors, fetal rats have skeletal deformities. There have also been reports of congenital malformations in fetuses of pregnant women who took other HMG-CoA reductase inhibitors during the first three months of pregnancy. 2. Do not use during lactation. The drug has been secreted in rat milk.
Precautions for Elderly Patients:
Generally speaking, elderly individuals have decreased physiological function, so if adverse reactions occur, the dosage should be reduced. There have been reports that elderly individuals are more susceptible to rhabdomyolysis.
[Drug Interactions]
Drug interactions may occur if used concurrently with other medications. Please consult your physician or pharmacist for details.
[Pharmacological Actions]
Pitavastatin calcium inhibits hepatic cholesterol synthesis by antagonizing HMG-CoA reductase, the rate-limiting enzyme in the cholesterol biosynthesis pathway. This promotes the expression of low-density lipoprotein (LDL) receptors in the liver and the transport of LDL from the blood into the liver, thereby lowering total cholesterol. Furthermore, it continuously inhibits cholesterol biosynthesis in the liver, reducing the secretion of very low-density lipoprotein (VLDL) into the blood and lowering plasma triglycerides.
[Storage] Sealed. [Specification] 1mg x 7 tablets
[Packaging] Box
[Expiration Date] 24 months
[Approval Number] National Medicine Standard H20110050
[Manufacturer] Jiangsu Wanbang Biopharmaceutical Co., Ltd.
