Product Overview
[Drug Name]
Generic Name: H Pitavastatin Calcium Tablets
Trade Name: Xinliming H Pitavastatin Calcium Tablets, 2mg x 7 tablets
[Main Ingredients]
The active ingredient of this product is pitavastatin calcium. Chemical name: (+)-Bis(3R,5S,6E)-7-{2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoic acid) calcium salt (2:1), pentahydrate. Molecular formula: C50H46CaF2N2O8•5H20. Molecular weight: 971.06
[Properties]
This product is a pink film-coated tablet that turns yellow after removal of the coating.
[Indications/Main Functions]
Hypercholesterolemia, familial hypercholesterolemia. Precautions: 1. Before use, a thorough examination must be performed to confirm that the patient has hypercholesterolemia or familial hypercholesterolemia before considering this preparation. 2. Since there is no experience with homozygous forms of familial hypercholesterolemia, this preparation should only be considered as an adjunct to non-drug therapies such as partial LDL-cholesterol depletion when absolutely necessary.
[Specifications]
2mg*7 tablets
[Dosage and Administration]
Usually, adults take 1-2 mg of pitavastatin calcium orally once daily. The dose can be increased or decreased as appropriate based on age and response to treatment. If LDL-cholesterol reduction is insufficient, the maximum daily dose may be increased, to a maximum of 4 mg. Precautions: 1. For patients with liver disease, the initial dose is 1 mg daily, with a maximum daily dose of 2 mg. (See [Precautionary Dosage] [Pharmacokinetics]). 2. Because increasing the dose (blood concentration) of this preparation may increase the risk of rhabdomyolysis-related adverse events, pay close attention to pre-rhabdomyolysis symptoms such as elevated CK (CPK) levels, myoglobinuria, muscle pain, and weakness when increasing the dose to 4 mg. [Dosages exceeding 8 mg in international clinical trials were discontinued due to rhabdomyolysis and related adverse events.] 3. For patients with moderate and severe renal impairment (glomerular filtration rates of 30-59 ml/min/1.73 m² and 15-29 ml/min/1.73 m², respectively, not undergoing hemodialysis) and end-stage renal disease undergoing hemodialysis, the initial dose is 1 mg once daily, with a maximum dose of 2 mg once daily.
[Adverse Reactions]
See package insert for details.
[Contraindications]
1. This drug is contraindicated in the following patients: 1) Patients with a history of hypersensitivity to any of the ingredients in this preparation. 2) Patients with severe liver disease or biliary obstruction [Administration of this drug in these patients may result in elevated blood concentrations and an increased frequency of adverse reactions. This may also worsen liver function.] (See [Pharmacokinetics]). 3) Patients currently taking cyclophosphamide [This drug may result in elevated blood concentrations and an increased frequency of adverse reactions.] Serious adverse reactions such as rhabdomyolysis may occur (see [Drug Interactions], [Pharmacokinetics]). 4) Pregnant women, women of childbearing potential, and breastfeeding women. (See [Use in Pregnant and Lactating Women]). 2. In principle, this drug is contraindicated in the following patients; however, it may be used with caution if necessary: Patients with abnormal clinical test values related to renal function, limited to situations where coadministration of this drug with a fibrate is clinically necessary. [Risk of rhabdomyolysis.] (See [Drug Interactions]).
[Precautions]
1. Use with caution in the following patients: 1) Patients with or with a history of liver disease, and those with alcoholism (This drug primarily distributes and acts on the liver, potentially worsening liver function. In addition, there have been reports of rhabdomyolysis in alcoholics.) 2) Patients with or with a history of kidney disease. (Reported cases of rhabdomyolysis have mostly occurred in patients with renal impairment, and rapid deterioration of renal function has been observed with rhabdomyolysis.) 3) Patients currently taking fibrates (e.g., bezafibrate) or niacin [are at increased risk of rhabdomyolysis (see [Drug Interactions]]). 4) Patients with hypothyroidism, hereditary muscle disorders (e.g., muscular dystrophy), or a family history of these disorders, or those with a history of drug-induced muscle disorders [have been reported to be at increased risk of rhabdomyolysis]. 5) Elderly patients (see [Use in Elderly Patients]) 2. Important Precautions When using this medication, pay close attention to the following points. 1) Before using this medication, first implement dietary therapy, a basic treatment for hypercholesterolemia, and reduce risk factors for ischemic heart disease, such as hypertension and smoking, and further exercise therapy. 2) Liver function tests should be performed at least once within 12 weeks of starting medication, and then regularly thereafter (e.g., every six months). 3) Blood lipid levels should be checked regularly during medication, and if unresponsive, medication should be discontinued. 4) HMG-CoA reductase inhibitors (statins) have been reported to increase glycated hemoglobin and fasting blood glucose levels. 3. Precautions for Use: When administering this product to patients, instruct them to remove the PTP packaged medication from the PTP plate before taking the product. (There have been reports of accidental ingestion of PTP plates, where hard corners have pierced the esophageal mucosa, causing perforation and serious complications such as mediastinitis.) 4. Other Precautions: 1) There have been reports of immune necrotizing myopathy characterized by proximal muscle weakness, elevated CK (CPK), and non-inflammatory myofiber necrosis, which persists even after discontinuation of HMG-CoA reductase inhibitors. These symptoms resolve with immunosuppressant administration. 2) Oral administration studies in dogs (3 mg/kg/day for 3 months or more, 1 mg/kg/day for 12 months or more) have demonstrated the development of cataracts. However, no similar findings have been observed in other animal species (rats or monkeys).
