Rozuor

Rozuor

Manufacturer:

Servier

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per 10 mg/10 mg cap Rosuvastatin 10 mg, ezetimibe 10 mg. Per 20 mg/10 mg cap Rosuvastatin 20 mg, ezetimibe 10 mg
Indications/Uses
Adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adults adequately controlled w/ separately administered monocomponent prep of the same doses as the recommended combination.
Dosage/Direction for Use
Adult 1 cap daily at the same time of the day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation >3x ULN; myopathy. Concomitant use w/ sofosbuvir, velpatasvir, voxilaprevir; cyclosporine. Severe renal impairment (CrCl <30 mL/min). Pregnancy & lactation. Women of childbearing potential not using appropriate contraceptive measure.
Special Precautions
Severe cutaneous adverse reactions including SJS & DRESS. Discontinue immediately if myopathy is suspected. Treatment should not be started if repeat test confirms baseline creatine kinase >5x ULN. Patients w/ pre-disposing factors for myopathy/rhabdomyolysis including renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in plasma levels may occur, concomitant use of fibrates. Immune-mediated necrotizing myopathy (rarely). Concomitant use w/ gemfibrozil or PIs is not recommended. Concomitant use w/ fibrates or niacin; anticoagulants (eg, warfarin, another coumarin anticoagulant, or fluindione. Do not use in patient w/ an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, or uncontrolled seizures). Must not be co-administered w/ systemic formulations of fusidic acid or w/in 7 days of stopping treatment. LFT should be carried out prior to, & 3 mth following the initiation of rosuvastatin treatment. Patients w/ secondary hypercholesterolemia caused by hypothyroidism or nephrotic syndrome. ILD (long-term therapy). DM. Patients who consume excessive quantities of alcohol &/or have a history of liver disease. Dizziness may occur which may affect ability to drive & use machines. Not recommended in patients w/ moderate or severe hepatic insufficiency. Asians. Childn. Elderly >70 yr.
Adverse Reactions
DM; headache, dizziness; constipation, nausea, abdominal pain, diarrhea, flatulence; myalgia; asthenia, fatigue; increased ALT &/or AST.
Drug Interactions
Increased plasma conc & risk of myopathy w/ ATP1B1 & BRCP inhibitors. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & lipid lowering doses (≥1 g/day) of niacin; fusidic acid. Rosuvastatin: Increased AUC values w/ ciclosporin. Increased exposure w/ PIs. Decreased plasma conc w/ Al & Mg hydroxide. Decreased AUC0-τ & Cmax w/ erythromycin. Increased INR w/ vit K antagonists (eg, warfarin or another coumarin anticoagulant). Increase AUC of ethinyl estradiol & norgestrel. Ezetimibe: Decreased AUC w/ cholestyramine.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10BA06 - rosuvastatin and ezetimibe ; Belongs to the class of HMG CoA reductase inhibitors in combination with other lipid modifying agents. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Rozuor 10 mg/10 mg cap
Packing/Price
30's (P1,205.45/box)
Form
Rozuor 20 mg/10 mg cap
Packing/Price
30's (P1,311.92/box)
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