Torus-10/Torus-20 Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Rosuvastatin Ca

Indications/Uses

Adjunctive therapy, to diet to reduce elevated total-C, LDL-C, Apo B, non HDL-C & triglycerides & to increase HDL-C in adults w/ primary hyperlipidemia or mixed dyslipidemia; to reduce total-C, LDL-C & Apo B in adolescent boys & girls, who are at least 1 yr post-menarche, 10-17 yr w/ heterozygous familial hypercholesterolemia & +ve family history of premature CV disease or ≥2 other CV disease risk factors; patients w/ hypertriglyceridemia; primary dysbetalipoproteinemia (type III hyperlipoproteinemia); other lipid-lowering treatments (eg, LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, total-C & Apo B in adult patients w/ HoFH; to slow the progression of atherosclerosis in adults, as part of a treatment strategy to lower total-C & LDL-C. Reduce risk of stroke, MI & arterial revascularization procedures.

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Dosage/Direction for Use

Hypercholesterolemia Initially 5 or 10 mg once daily, may be adjusted after 4 wk if necessary. Patients w/ severe hypercholesterolemia at high CV risk Final titration to a max of 40 mg. Prevention of CV events 20 mg daily. Childn & adolescent 10-17 yr (boys Tanner stage ≥2 & girls at least 1 yr post-menarche) Heterozygous familial hypercholesterolemia 5 mg daily. Usual dose range: 5-20 mg once daily. Elderly >70 yr, patient w/ renal insufficiency & predisposing factors to myopathy, Asian patient Initially 5 mg.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Patients w/ active liver disease including unexplained persistent elevations of serum transaminases & any serum transaminase elevation exceeding 3 times ULN; myopathy; receiving concomitant ciclosporin; severe renal impairment (CrCl <30 mL/min). Pregnancy & lactation; women of childbearing potential not using appropriate contraceptive measure. 40 mg dose in patients w/ predisposing factors for myopathy/rhabdomyolysis eg, moderate renal impairment (CrCl <60 mL/min); 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 increase in plasma levels may occur; Asian patients; concomitant use of fibrates.

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Special Precautions

Assess liver function prior to & 3 mth following initiation of treatment. Patients w/ predisposing factors for myopathy/rhabdomyolysis. Monitor patients at risk of developing DM. Patients who consume excessive quantities of alcohol &/or have history of liver disease. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ PIs. Discontinue if creatine kinase levels are markedly elevated (>5 times ULN), muscular symptoms are severe & cause daily discomfort, level of serum transaminases is >3 times ULN; ILD. Increased exposure in Asians. Mild to moderate renal impairment. Women of childbearing potential should use appropriate contraceptive measures. Not recommended in childn <10 yr. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.

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Drug Interactions

Increased plasma conc & risk of myopathy w/ transporter protein inhibitors. Increased AUC values w/ ciclosporin, ezetimibe. Increased AUC & C_max w/ PIs, gemfibrozil & other lipid-lowering products. Increased AUC of ethinyl estradiol & norgestrel in OCs/hormonal replacement therapy. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide. Decreased AUC & C_max w/ erythromycin. Increased INR w/ vit K antagonist (eg, warfarin or another coumarin anticoagulant). Muscle related events including rhabdomyolysis w/ fusidic acid.

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Storage

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Description

View Torus-10/Torus-20 description for details of the chemical structure and excipients (inactive components).

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.

Regulatory Classification

Presentation/Packing

Form

Torus-10 FC tab 10 mg

Packing/Price

30's (P945/pack)

Form

Torus-20 FC tab 20 mg

Packing/Price

30's (P1,140/box)

Torus-10/Torus-20

rosuvastatin

Manufacturer:

Torrent

Distributor:

Torrent