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.