Indications

As an adjunct to diet in adults with primary non‑familial hyperlipidemia to reduce LDL‑C.
Alone or with other LDL‑C lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL‑C.

Pharmacology Rosuvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG‑CoA reductase and cholesterol synthesis in the liver, while increasing hepatic LDL receptors to enhance LDL uptake and catabolism. Ezetimibe reduces blood cholesterol by inhibiting intestinal absorption of cholesterol via the sterol transporter.

Dosage & Administration

Range: 5/10 mg to 40/10 mg orally once daily.
Severe renal impairment (not on dialysis): Start at 5/10 mg daily; maximum 10/10 mg daily.
Tablets must be swallowed whole.
Administer at least 2 hours before or 4 hours after bile acid sequestrants.
Pediatric use: Not established.
Geriatric use: No dosage adjustment required.

Interactions

Avoid with cyclosporine or gemfibrozil.
Dosage modifications required with certain antivirals, darolutamide, regorafenib.
Niacin, fibrates, colchicine increase risk of myopathy and rhabdomyolysis.

Contraindications

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

Side Effects Common: Headache, nausea, myalgia, arthralgia, dizziness, constipation, abdominal pain, diarrhea, sinusitis, fatigue, influenza, back pain.

Pregnancy & Lactation Contraindicated in pregnancy. Not recommended during breastfeeding.

Precautions & Warnings Risk of myopathy and rhabdomyolysis increases with age ≥65, hypothyroidism, renal impairment, drug interactions, and high dosage. Monitor CK levels. Hepatic dysfunction may occur; monitor liver enzymes.

Use in Special Populations

Hepatic impairment: Contraindicated in acute liver failure or decompensated cirrhosis.
Renal impairment: Severe impairment (CrCl <30 mL/min/1.73 m², not on dialysis): Start at 5/10 mg daily; max 10/10 mg daily. No adjustment for mild/moderate impairment.