Liptor-EZ 10: Each film coated tablet contains Atorvastatin Calcium USP equivalent to Atorvastatin 10 mg and Ezetimibe USP 10 mg Tablet.
Liptor-EZ 20: Each film coated tablet contains Atorvastatin Calcium USP equivalent to Atorvastatin 20 mg and Ezetimibe USP 10 mg Tablet.
Atorvastatin:
Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL; atorvastatin also reduces LDL production and the number of LDL particles.
Ezetimibe:
The molecular target of ezetimibe is the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is involved in the intestinal uptake of cholesterol and phytosterols. Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver. This causes a reduction of hepatic cholesterol stores and an increase in clearance of cholesterol from the blood.
Liptor-EZ is indicated in adults:
Route of Administration: Orally.
Swallow Liptor-EZ tablets whole at any time of day, with or without food.
The dosage range is 10 mg/10 mg to 80 mg/10 mg once daily. Recommended starting dose is 10/10 mg/day or 10/20 mg/day. Recommended starting dose is 10/40 mg/day for patients requiring a greater than 55% reduction in LDL-C.
Other lipid-lowering medications: Use with fenofibrates or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with Atorvastatin and Ezetimibe.
Fenofibrates: Combination increases exposure of ezetimibe. If cholelithiasis is suspected in a patient receiving ezetimibe and a fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered.
Cholestyramine: Combination decreases exposure of ezetimibe.
Digoxin: Patients should be monitored appropriately.
Oral contraceptives: Values for norethindrone and ethinyl estradiol may be increased. Rifampin should be simultaneously coadministered with Atorvastatin and Ezetimibe.
Pregnancy: Atorvastatin and Ezetimibe is contraindicated in women who are or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy. Lipid-lowering drugs offer no benefit during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development.
The safety and effectiveness of Atorvastatin and Ezetimibe have not been established in pediatric patients.
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with higher doses and concomitant use of certain CYP3A4 inhibitors, fibric acid derivatives, and cyclosporine. Predisposing factors include advanced age (>65), uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported.
Liver enzyme abnormalities: Persistent elevations in hepatic transaminase can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter.
Store below 30°C temperature & dry place, protected from light. Keep all medicines out of reach of children.