Zyrovazet 10 mg/5 mg 30 tablets

Zyrovazet 10 mg/5 mg 30 tablets

Composition:
Each tablet contains:
Rosuvastatin calcium 10.4 mg (equivalent to 10 mg Rosuvastatin)
Ezetimibe 5 mg.
Description:
Zyrovazet is a fixed-dose combination of Rosuvastatin and Ezetimibe. Rosuvastatin is an HMG-CoA reductase inhibitor, reducing cholesterol synthesis in the liver. Ezetimibe inhibits cholesterol absorption in the intestine. The medication is used to control cholesterol levels in adults already stabilized on the individual components.
Indications for Use:
Primary hypercholesterolemia in adults (as an adjunct to diet).
Substitution therapy in adults adequately controlled with separate components at equivalent doses.
Dosage and Method of Administration:
Adults: 1 tablet daily, with or without food
Elderly (>70 years): start with 5 mg Rosuvastatin; combination not suitable for initial therapy
Hepatic impairment: not recommended in moderate or severe impairment or active liver disease
Renal impairment: no adjustment for mild or moderate; severe impairment (<30 ml/min) – contraindicated
Children (<18 years): safety and efficacy not established
Tablets should be swallowed whole; if co-administered with bile acid sequestrants, take ≥2 hours before or ≥4 hours after.
Contraindications:
- Hypersensitivity to Rosuvastatin, Ezetimibe, or excipients
- Active liver disease, unexplained persistent transaminase elevation >3x ULN
- Pregnancy and breastfeeding
- Severe renal impairment (<30 ml/min)
- Myopathy, including previous reactions to statins or fibrates
- Concomitant ciclosporin
- Predisposing factors for myopathy: hypothyroidism, hereditary muscle disorders, alcohol abuse
- Concomitant use of fibrates in some cases.
Precautions:
- Monitor liver enzymes and CK levels
- Caution in patients with genetic polymorphisms increasing Rosuvastatin exposure
- Initiate therapy with monocomponents before switching to combination.
Side Effects:
Common: headache, myalgia, dyspepsia, elevated liver enzymes
Rare: rhabdomyolysis, myopathy, serious liver injury, interstitial lung disease, sexual dysfunction
Dose-related: CK elevation, myopathy, transaminase elevation
Renal: mild, reversible proteinuria.
Pregnancy and Breastfeeding:
Contraindicated during pregnancy and lactation
Rosuvastatin: potential fetal risk due to inhibition of cholesterol synthesis
Ezetimibe: no data, unknown excretion in breast milk.
Storage Conditions:
Store in a dry place below 30°C, out of reach of children.
Packaging:
Carton box containing 3 blisters of 10 tablets each and leaflet insert.