DESCRIPTION:
A synthetic lipid-lowering agent for oral administration.
INDICATIONS:
- Hyperlipidemia and Mixed Dyslipidemia
- Hypertriglyceridemia
- Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
- Homozygous Familial Hypercholesterolemia
- Slowing of the Progression of Atherosclerosis
DOSAGE AND ADMINISTRATION:
- The dose range for this product is 5 to 40 mg orally once daily.
- Can be administered as a single dose at any time of day, with or without food.
DOSAGE FORMS AND STRENGTHS:
- 5 mg: Yellow, round, biconvex, coated tablets.
- 10 mg: Pink, round, biconvex, coated tablets.
SIDE EFFECTS:
Following are serious adverse reactions:
- Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis).
- Liver enzyme abnormalities
The most common adverse reactions that led to treatment discontinuation were:
- myalgia
- abdominal pain
- nausea
- headache
- asthenia
STORAGE:
Store at controlled room temperature, 20-25ºC.
