Rosetor EZ^®

Rosetor EZ is a combination of Rosuvastatin and Ezetimibe. Rosuvastatin is an inhibitor of HMG CoA-reductase, which converts 3-hydroxy-3-methyIgIutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles. 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.

No Data

Rosetor EZ is indicated in adults-

• As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C).
• Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia to reduce LDL-C.

Route of administration: Rosetor EZ should be taken in oral route with or without food.

The dose range is 5 mg/10 mg to 40 mg/10 mg once daily. The recommended dose depends on a patient's indication for usage, LDL-C and individual risk for cardiovascular events. The starting dose for patients switching to this tablet from co-administration of a statin and ezetimibe is based on an equivalent dose of rosuvastatin and 10 mg of ezetimibe. Assess LDL-C when clinically appropriate, as early as 2 weeks after initiating the medication and adjust the dosage if necessary.
In Asian patients, initiate it at 5 mg/10 mg daily due to increased rosuvastatin plasma concentrations. Consider the risk/benefit when treating patients not adequately controlled at doses up to 20 mg/10 mg once daily.

Renal impairment
In patients with severe renal impairment (CLcr less than 30 mL/min/1.73 m2) not on hemodialysis, the recommended starting dose is 5 mg/10 mg once daily and should not exceed 10 mg/10 mg once daily.

Pregnancy: There are not sufficient well controlled studies of pregnant women exposed to this combination of a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
Lactation: There is no information on the effects of this combination on human milk.

Use in children and adolescents
The safety and efficacy of this combination in children and adolescents have not been established.

It may cause myopathy and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria have occurred as a result of rhabdomyolysis with rosuvastatin. Increases in serum transaminases, HbA1c and fasting serum glucose levels have occurred with rosuvastatin.

The most common side effects are headache, nausea, myalgia, arthralgia and dizziness.

It is contraindicated in patients with history of known hypersensitivity to rosuvastatin, ezetimibe or any other components of this product. It is also contraindicated in patients with acute liver failure or decompensated cirrhosis.

Drug interaction with medication: Avoid concomitant use of cyclosporine or gemfibrozil, sofosbuvir / velpatasvir / voxilaprevir and ledipasvir / sofosbuvir with this combination. The risk of myopathy and rhabdomyolysis is increased with concomitant use of darolutamide, regorafenib, fenofibrates, niacin, colchicine. Dose should not exceed 5mg/10mg in concomitant use with darolutamide and 10mg/10mg in concomitant use with regorafenib. In patients taking antacid, administer 2 hours after the antacid.

Drug interaction with food and others: Not applicable.

In the event of overdose, general supportive measures and proper monitoring should be initiated.

No Data

No Data

Rosetor EZ 5/10 Tablet: Each coated tablet contains Rosuvastatin Calcium BP 5.2 mg equivalent to Rosuvastatin 5 mg & Ezetimibe USP 10 mg.
Rosetor EZ 10/10 Tablet: Each coated tablet contains Rosuvastatin Calcium BP 10.4 mg equivalent to Rosuvastatin 10 mg & Ezetimibe USP 10 mg.
Rosetor EZ 20/10 Tablet: Each coated tablet contains Rosuvastatin Calcium BP 20.8 mg equivalent to Rosuvastatin 20 mg & Ezetimibe USP 10 mg.

Storage
Store below 30°C in a dry place, protected from light. Keep away from the reach of children.

Packing
Rosetor EZ 5/10 Tablet: Carton of 42 tablets in blister pack.
Rosetor EZ 10/10 Tablet: Carton of 28 tablets in blister pack.
Rosetor EZ 20/10 Tablet: Carton of 14 tablets in blister pack.