Product Overview
[Drug Name]
Generic Name: H Pitavastatin Calcium Tablets
Trade Name: Bangzhi H Pitavastatin Calcium Tablets 2mg x 8 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-heptenoate} calcium Molecular Formula:
C50H46CaF2N2O8 Molecular Weight: 880.98
[Properties]
This product is a film-coated tablet that appears orange after removal of the film 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 using this product. 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*8 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), 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 medication 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 medication in these patients may result in elevated blood concentrations and an increased frequency of adverse reactions. This medication may also worsen liver function.] (See [Pharmacokinetics]). 3) Patients currently taking cyclosporine [This medication may result in elevated blood concentrations and an increased frequency of adverse reactions.] Serious adverse reactions such as rhabdomyolysis may occur (see [Drug Interactions] and [Pharmacokinetics]). 4) Pregnant women, women of childbearing potential, and lactating women. (See [Use in Pregnant and Lactating Women]).
[Precautions]
See package insert for details.
