Indications Rosuvastatin, an HMG-CoA reductase inhibitor (statin), and Ezetimibe, a dietary 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.

Pharmacology Rosuvastatin: It lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver, and by increasing hepatic LDL receptors to enhance LDL uptake and breakdown. Ezetimibe: It reduces blood cholesterol by inhibiting intestinal absorption of cholesterol. Its molecular target is the sterol transporter responsible for cholesterol and phytosterol uptake in the intestine.

Dosage & Administration The dosage range is 5/10 mg to 40/10 mg orally once daily. The recommended dose depends on indication, LDL-C level, and cardiovascular risk. • Patients with severe renal impairment (not on hemodialysis): Start at 5 mg/10 mg once daily; do not exceed 10 mg/10 mg daily. • Tablets should be swallowed whole, not crushed or chewed. • Administer at least 2 hours before or 4 hours after bile acid sequestrants. • Administer at least 2 hours before aluminum and magnesium hydroxide antacids. Pediatric Use: Safety and efficacy not established. Geriatric Use: No dosage adjustment required.

Interaction Concomitant use with Cyclosporine or Gemfibrozil is not recommended. Dose modifications are advised for patients taking certain antivirals, Darolutamide, or Regorafenib. Niacin, Fibrates, and Colchicine may increase risk of myopathy and rhabdomyolysis.

Contraindications • Active liver disease or decompensated cirrhosis. • Hypersensitivity to any component.

Side Effects Common side effects include headache, nausea, muscle pain, joint pain, dizziness, weakness, constipation, abdominal pain, respiratory infection, diarrhea, sinusitis, limb pain, fatigue, influenza, and back pain.

Pregnancy & Lactation Contraindicated in women who are or may become pregnant. Breastfeeding is not recommended.

Precautions & Warnings Myopathy and Rhabdomyolysis: Risk factors include age ≥65 years, hypothyroidism, renal impairment, concomitant drug use, and high doses. Discontinue if markedly elevated CK or myopathy occurs. Hepatic Dysfunction: Persistent increases in transaminases and rare cases of hepatic failure have been reported. Test liver enzymes before starting therapy and as clinically indicated.

Use in Special Populations Hepatic Impairment: Contraindicated in acute liver failure or decompensated cirrhosis. Discontinue if hepatic injury or jaundice occurs. Renal Impairment: For severe renal impairment (CrCl <30 mL/min/1.73 m²) not on hemodialysis, start at 5 mg/10 mg daily; do not exceed 10 mg/10 mg daily. No adjustment needed for mild or moderate impairment.