Rosuvastatin, an HMG-CoA reductase inhibitor (statin), and Ezetimibe, a cholesterol absorption inhibitor, combination 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 (HoFH) to reduce LDL-C.

Rosuvastatin: Rosuvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase, thereby reducing hepatic cholesterol synthesis and increasing hepatic LDL receptor expression, which enhances LDL uptake and clearance. It decreases LDL production and LDL particle number.

Ezetimibe: Ezetimibe reduces blood cholesterol by inhibiting intestinal absorption of cholesterol. Its molecular target is the sterol transporter responsible for the uptake of cholesterol and plant sterols in the small intestine.

The dosage range is 5/10 mg to 40/10 mg orally once a day. The recommended dosage depends on the indication for usage, LDL-C, and individual risk for cardiovascular events.

Patients with severe renal impairment (not on hemodialysis): Initiate at 5 mg/10 mg once daily; do not exceed 10 mg/10 mg once daily. Patients should swallow tablet whole. Tablets should not be crushed, dissolved, or chewed. Administer at least 2 hours before or 4 hours after administration of a bile acid sequestrant. Administer at least 2 hours before administration of an aluminium and magnesium hydroxide combination antacid.

Pediatric Use: Safety and effectiveness have not been established in pediatric patients.

Geriatric Use: No dosage adjustment is necessary.

Concomitant use of Rosuvastatin & Ezetimibe combination with Cyclosporine or Gemfibrozil is not recommended. Dose modifications are recommended in patients receiving certain antiviral agents, Darolutamide, or Regorafenib. Niacin, fibrates, and colchicine may increase the risk of myopathy and rhabdomyolysis.

Contraindicated in patients with:

• Active liver disease or decompensated cirrhosis
• Hypersensitivity to any component of the product

Common side effects include headache, nausea, myalgia, arthralgia, dizziness, asthenia, constipation, abdominal pain, respiratory tract infection, diarrhea, sinusitis, pain in extremities, fatigue, influenza-like symptoms, and back pain.

This preparation is contraindicated in pregnancy or in women who may become pregnant. Breastfeeding is not recommended during treatment.

Myopathy and Rhabdomyolysis: Risk factors include age ≥65 years, uncontrolled hypothyroidism, renal impairment, concomitant use of interacting drugs, and higher doses. Discontinue if marked CK elevation or suspected myopathy occurs. Temporarily discontinue in acute conditions with risk of renal failure due to rhabdomyolysis.

Hepatic Dysfunction: Increases in serum transaminases may occur, sometimes persistently. Rare cases of severe hepatic failure have been reported. Liver function tests should be performed before starting therapy and as clinically indicated.

Hepatic Impairment: Contraindicated in acute liver failure or decompensated cirrhosis. Discontinue if serious hepatic injury or jaundice occurs.

Renal Impairment: In severe renal impairment (CrCl <30 mL/min/1.73 m², not on dialysis), starting dose is 5 mg/10 mg once daily; maximum 10 mg/10 mg once daily. No dose adjustment is required in mild to moderate renal impairment.

Other lipid regulating drugs

Store below 30°C. Protect from light and moisture. Keep out of reach of children.