Atasin EZ^®

Atasin EZ is a combination of Atorvastatin and Ezetimibe. 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 reduces LDL production and the number of LDL particles. Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. The molecular target of Ezetimibe has been shown to be the sterol transporter, which is involved in the intestinal uptake of cholesterol and phytosterols.

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Atasin EZ is indicated for -
• The reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C) and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.
• The reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable

Atasin EZ should be taken in oral route with or without food at any time of the day. Tablets should not be crushed, dissolved or chewed.

The dosage range of Atasin® EZ is 10/10 mg to 80/10 mg daily. The recommended starting dose is 10/10 mg or 20/10 mg daily. The recommended starting dose for patients who require a larger reduction in LDL-C (greater than 55%) is 40/10 mg daily. After initiation and/or upon titration of this medicine, lipid levels should be analyzed within 2 or more weeks and dosage adjusted accordingly. The dosage in patients with homozygous familial hypercholesterolemia is 40/10 mg or 80/10 mg daily.

Pregnancy: It may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy.

Lactation: There are no data on the presence of this combination in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from this combination, advise women not to breastfeed during treatment.

Use in children and adolescents
Safety and effectiveness have not been established in pediatric patients.

Special warning: Embryo-Fetal Toxicity

The combination may cause fetal harm when administered to a pregnant woman. The drug should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, it should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus. Risks of skeletal muscle effects (e.g., myopathy and rhabdomyolysis) 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. A history of renal impairment may be a risk factor for statin-associated myopathy. These patients need closer monitoring for skeletal muscle effects and therapy should be temporarily withheld or discontinued if necessary. Regular monitoring of serum transaminase level, HbA1c and fasting serum glucose is necessary as the combination may elevate their levels.

Most common side effects are increased ALT, increased AST and musculoskeletal pain.

It is contraindicated in patients with history of known hypersensitivity to atorvastatin or ezetimibe or any other components of this product. It is also contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminase levels.

Drug interaction with medication: The risk of myopathy during treatment with statins is increased with concomitant administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine or strong CYP3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole). The co-administration with cyclosporine should be avoided. Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are co-administered with gemfibrozil, concomitant administration with gemfibrozil should be avoided. The risk of skeletal muscle effects may be enhanced when used in combination with niacin. Patients taking digoxin should be monitored appropriately. The increase in AUC values for norethindrone and ethinyl estradiol should be considered when selecting an oral contraceptive for a woman. Caution should be exercised when prescribing with colchicine. If added to warfarin, the INR should be appropriately monitored.

Drug interaction with food and others: Not applicable.

In case of overdose, treatment should be symptomatic and supportive measures instituted as required.

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Atasin EZ 10/10 tablet: Each coated tablet contains Atorvastatin 10 mg as Atorvastatin Calcium Trihydrate USP and Ezetimibe USP 10 mg.
Atasin EZ 20/10 tablet: Each coated tablet contains Atorvastatin 20 mg as Atorvastatin Calcium Trihydrate USP and Ezetimibe USP 10 mg.

Storage
Store below 25⁰C in a dry place, protected from light. Keep away from the reach of children.

Packing
Atasin EZ 10/10 tablet: Carton of 30 tablets in blister pack.
Atasin EZ 20/10 tablet: Carton of 30 tablets in blister pack.