Product Overview
[Drug Name]
Generic Name: Pitavastatin Calcium Tablets
Trade Name: Pitavastatin Calcium Tablets (2mg x 24 tablets)
[Main Ingredients]
The main ingredient of this product is pitavastatin calcium. Chemical name: Bis{(3R,5S,6E)-7-{[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxy-6-heptenoic acid} monocalcium salt pentahydrate Molecular formula:
C50H46CaF2N2O8·5H2O Molecular weight: 971.06
[Properties]
This product is a 1mg white film-coated tablet. The 2mg and 4mg tablets are white film-coated tablets with a single-sided notch. After removing the film coating, the tablets appear white or off-white.
[Indications/Main Functions]
Hypercholesterolemia and 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*24 tablets
[Dosage and Administration]
Usually, for adults, take 1-2 mg orally once daily. The dose may 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 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 [Cautionary Dosage] [Pharmacokinetics]). 2. Because increasing the dose (blood concentration) 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. [Dosing exceeding 8 mg in international clinical trials was discontinued due to rhabdomyolysis and related adverse events.] 3. For patients with moderate and severe renal impairment (glomerular filtration rate 30-59 ml/min/1.73 m² and 15-29 ml/min/1.73 m², respectively, not receiving hemodialysis) and end-stage renal disease receiving 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.
