Myungmoon Rosuvastatin

Myungmoon Rosuvastatin





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Concise Prescribing Info
Primary hyperlipidemia & mixed dyslipidemia in adult patients, as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C & triglyceride levels & increase HDL-C. Heterozygous familial hypercholesterolemia in ped patients 10-17 yr to reduce elevated total-C, LDL-C & ApoB after failing an adequate trial of diet therapy. Hypertriglyceridemia & primary dysbetalipoproteinemia (type III hyperlipoproteinemia) in adults as an adjunct to diet. Homozygous familial hypercholesterolemia in adults to reduce LDL-C, total-C & ApoB. Slows the progression of atherosclerosis as part of a treatment strategy to lower total-C & LDL-C as an adjunct to diet. Risk reduction of MI, stroke & arterial revascularization procedures in patients w/o clinically evident CHD, but w/ multiple risk factors.
Dosage/Direction for Use
Adult Usual starting dose: 10-20 mg once daily. Max: 40 mg (only for patients who have not achieved LDL-C goal w/ 20-mg dose). Homozygous familial hypercholesterolemia Initially 20 mg once daily. Ped patient 10-17 yr Heterozygous familial hypercholesterolemia Usual starting dose: 5-20 mg once daily. Patient w/ severe renal impairment (CrCl <30 mL/min/1.73 m2) not on hemodialysis Max: 10 mg once daily.
May be taken with or without food.
Hypersensitivity. Patients w/ active liver disease including unexplained, persistent elevation of serum transaminases & any serum transaminase elevation exceeding 3x the upper limit of normal; severe renal impairment; myopathy. Patients receiving concomitant ciclosporin. Women of childbearing potential not using appropriate contraceptive measure. Pregnancy & lactation. 40 mg: Patients w/ predisposing factors for myopathy/rhabdomyolysis including: Moderate 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 when an increase in plasma levels may occur; Asian patients; concomitant use of fibrates. Concomitant use w/ PIs is not recommended.
Special Precautions
Patients w/ repeated or unexplained muscle aches or pains; personal or family history of muscle problems, or previous history of muscle problems w/ other cholesterol-lowering medicines; impairment of thyroid gland function; severe resp failure; patients feeling unwell, w/ fever or w/ constant muscle weakness; patients who consume excessive quantities of alcohol; Asian patients. Perform liver function tests prior to treatment & thereafter when clinically indicated. Rare reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) associated w/ statin use. Reports of increases in HbA1c & fasting serum glucose levels w/ HMG-CoA reductase inhibitor. Medication w/ fusidic acid (orally or by inj) in the last 7 days. Concomitant use w/ medicines for HIV eg, ritonavir w/ lopinavir &/or atazanavir; fibrates. Intolerance to some sugars. Patients w/ renal or hepatic impairment. Elderly >70 yr.
Adverse Reactions
Headache, stomach pain, constipation, feeling sick, muscle pain, feeling weak, dizziness; DM; proteinuria (for 40 mg dose); allergic reactions.
Drug Interactions
Potential interactions w/ ciclosporin; warfarin or clopidogrel; fibrate or any other medicine used to lower cholesterol; indigestion remedies; erythromycin; OCs; regorafenib; hormone replacement therapy; anti-viral medications eg, ritonavir or lopinavir &/or atazanavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. Risk of muscle weakness, tenderness or pain w/ fusidic acid.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Myungmoon Rosuvastatin tab 10 mg
10 × 10's
Myungmoon Rosuvastatin tab 20 mg
10 × 10's
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