Anzitor® EZ 10/10: Each Film coated tablet contains Atorvastatin 10 mg (as Atorvastatin Calcium Trihydrate Ph. Eur.) and Ezetimibe USP 10 mg.
Anzitor® EZ 20/10: Each Film coated tablet contains Atorvastatin 20 mg (as Atorvastatin Calcium Trihydrate Ph. Eur.) and Ezetimibe USP 10 mg.
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 reduces LDL production and the number of LDL particles.
Ezetimibe: 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.
Primary Hyperlipidemia: Anzitor® 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.
Homozygous Familial Hypercholesterolemia: Anzitor® EZ is indicated for 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.
The dosage range of Anzitor® EZ is 10/10 mg/day to 80/10 mg/day. The recommended starting dose of Anzitor® EZ is 10/10 mg/day or 20/10 mg/day. Anzitor® EZ can be administered as a single dose at any time of the day, with or without food. The recommended starting dose for patients who require a larger reduction in LDL-C (greater than 55%) is 40/10 mg/day. After initiation and/or upon titration of Anzitor® EZ, lipid levels should be analyzed within 2 or more weeks and dosage adjusted accordingly. Patients should swallow Anzitor® EZ tablet whole. Tablets should not be crushed, dissolved, or chewed. The dosage of Anzitor® EZ in patients with homozygous familial hypercholesterolemia is 10/40 mg/day or 10/80 mg/day. Anzitor® EZ should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
The risk of myopathy during treatment with statins is increased with concurrent 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/rhab.
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.