RTV Eze (20mg+10mg) Tablet

Rosuvastatin, an HMG-CoA reductase inhibitor (statin), and Ezetimibe, a dietary cholesterol absorption inhibitor, RTV Eze tablet 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.
• The dosage range is 5/10 mg to 40/10 mg orally once a day. The recommended dosage depends on the indication for use, 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 the 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.

The concomitant use of Rosuvastatin & Ezetimibe combination with Cyclosporine or Gemfibrozil is not recommended.
Rosuvastatin & Ezetimibe combination dosage modifications are recommended for patients taking certain antiviral medications, Darolutamide, and Regorafenib. Niacin, fibrates, and Colchicine may also increase the risk of myopathy and rhabdomyolysis.

Contraindicated in patients with:

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

Common side effects are headache, nausea, myalgia, arthralgia, dizziness, asthenia, constipation, abdominal pain, respiratory tract infection, diarrhea, sinusitis, pain in extremity, fatigue, influenza, and back pain.

This preparation is contraindicated in women who are or may become pregnant. Breastfeeding is not recommended.

Myopathy and rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher dosage. Discontinue if markedly elevated creatine kinase (CK) levels occur or myopathy is diagnosed or suspected. Temporarily discontinue in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Hepatic Dysfunction: Increases in serum transaminases have
occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzyme tests before initiating therapy and as clinically indicated thereafter.

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