Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-C, Apo B, total-C: HDL-C ratio & triglycerides & for increasing HDL-C in hyper- & dyslipidemic conditions. Reduce total mortality & risk of major CV events in adults w/ increased risk of ASCVD based on presence of CV disease risk markers. Primary dysbetalipoproteinemia (type III hyperlipoproteinemia); primary hypercholesterolaemia [type IIa including heterozygous familial hypercholesterolaemia (HeFH) & severe non-familial hypercholesterolaemia]; combined (mixed) dyslipidemia (type IIb); HoFH. Adjunctive therapy to diet to slow progression of atherosclerosis in adults as part of treatment strategy to lower total-C & LDL-C to target levels. Adjunct to diet to reduce total-C, LDL-C & Apo B levels in adolescents at least 1 yr post-menarche, 10-17 yr w/ HeFH.
Dosage/Direction for Use
Initially 10 mg once daily. Patient requiring less aggressive LDL-C reductions, w/ predisposing factors to myopathy, Asian patient Initially 5 mg once daily. Severe hypercholesterolemia at high CV risk including w/ familial hypercholesterolaemia Increased to 40 mg once daily. Ped patient 10-17 yr w/ HeFH 5-20 mg daily. Dose adjustments should be made at ≥4-wk interval. Max: 20 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases >3 times ULN; myopathy. Concomitant use w/ cyclosporine. Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.
Special Precautions
Discontinue use if markedly elevated creatine kinase (>5 x ULN) occurs or ILD is suspected. Not to be used in patients w/ acute, serious condition suggestive of myopathy or predisposing to development of renal failure secondary to rhabdomyolysis eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders or uncontrolled seizures. Predisposing factors for myopathy/rhabdomyolysis eg, hypothyroidism, history of hereditary muscular disorders or toxicity w/ another HMG-CoA reductase inhibitor or fibrate, situations where increased plasma levels occur. Risk factors for DM eg, fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m2, raised triglycerides, HTN. Assess renal function during routine follow-up. Perform LFTs prior to & 3 mth following initiation. Patients w/ specific types of genetic polymorphisms increasing rosuvastatin exposure. Asian patients. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in combination w/ gemfibrozil. Concomitant use w/ ciclosporin, nicotinic acid, azole antifungals, PIs, macrolides. History of hepatic disease, excessive alcohol consumption. Severe renal impairment. Women of childbearing potential should use effective contraception. Childn <10 yr. Elderly >70 yr.
Adverse Reactions
DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.
Drug Interactions
Increased plasma conc w/ OATP1B1 & BCRP inhibitors. Increased risk of myopathy w/ ciclosporin, gemfibrozil, fenofibrate, other fibrates, niacin ≥1 g daily. Increased AUC w/ ezetimibe. Decreased plasma conc w/ Al- & Mg hydroxide-containing antacid susp. Muscle-related events w/ fusidic acid. Decreased AUC & Cmax w/ erythromycin. Severe myositis & myoglobinuria w/ fibrates. Increased INR w/ vit K antagonists. Increased AUC of ethinyl estradiol, norgestrel.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Roxatin FC tab 10 mg
Packing/Price
3 × 10's
Form
Roxatin FC tab 20 mg
Packing/Price
3 × 10's
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