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Rostatin

Rostatin

rosuvastatin

Manufacturer:

Maple Pharma

Distributor:

Averroes Pharma
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 atherosclerotic CV disease based on presence of CV disease risk markers. Primary dysbetalipoproteinemia (type III hyperlipoproteinemia); primary hypercholesterolaemia (type IIa including heterozygous familial & severe non-familial hypercholesterolaemia); combined (mixed) dyslipidaemia (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/ heterozygous familial hypercholesterolaemia.
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Dosage/Direction for Use
Adult Initially 5-10 mg once daily, may adjust dose to 20 mg after 4 wk. Severe hypercholesterolaemia (including w/ familial hypercholesterolaemia) Increased to 40 mg once daily. Patient w/ predisposing factors to myopathy, Asian patient Initially 5 mg once daily. Ped 10-17 yr w/ heterozygous familial hypercholesterolemia 5-20 mg daily. Dose adjustment can be made at 4-wk intervals. Max: 20 mg daily.
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Overdosage
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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. Severe renal impairment (CrCl <30 mL/min). Pregnancy & lactation.
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Special Precautions
Discontinue use if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily withheld in 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, uncontrolled seizures. Predisposing factors to myopathy eg, advanced age ≥65 yr, hypothyroidism. Patients w/ specific types of genetic polymorphisms increasing rosuvastatin exposure. Asian patients. Assess renal function during routine follow-up. Perform LFT prior to & 3 mth following initiation. Not recommended in combination w/ gemfibrozil. Concomitant use w/ other lipid-lowering therapies or cyclosporin; fibrates, niacin. Renal impairment. Not to be used during pregnancy & lactation. Childn <10 yr.
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Adverse Reactions
Abdominal, chest, pelvic & neck pain, accidental injury, infection, pain; HTN, angina pectoris, vasodilation, palpitation; constipation, gastroenteritis, vomiting, flatulence, periodontal abscess, gastritis; DM; anaemia, ecchymosis; peripheral edema; arthritis, arthralgia, pathological fracture; dizziness, insomnia, hypertonia, paresthesia, depression, anxiety, vertigo, neuralgia; bronchitis, increased cough, dyspnea, pneumonia, asthma; rash, pruritus.
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Drug Interactions
Increased plasma conc & risk of myopathy w/ OATP1B1 & BCRP inhibitors. Increased INR w/ warfarin. Increased risk of myopathy w/ gemfibrozil. Increased plasma conc w/ PIs. Decreased plasma conc w/ Al- & Mg hydroxide-containing antacid susp. Decreased AUC & Cmax w/ erythromycin. Severe myositis & myoglobinuria w/ fibrates. Not to be used concomitantly w/ ciclosporin.
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Storage
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Description
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Action
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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
Rostatin FC tab 10 mg
Packing/Price
1 × 10's
Form
Rostatin FC tab 20 mg
Packing/Price
1 × 10's
Form
Rostatin FC tab 5 mg
Packing/Price
1 × 10's
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