Torus-10/Torus-20

Torus-10/Torus-20

rosuvastatin

Manufacturer:

Torrent

Distributor:

Torrent
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/ homozygous familial hypercholesterolemia; 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.
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.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease including unexplained persistent elevations of serum transaminases & exceeding 3x the upper limit of normal. Patients w/ myopathy. Concomitant use w/ ciclosporin. Severe renal impairment. Pregnancy & lactation.
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;  w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ PIs. Discontinue if creatine kinase levels are markedly elevated (>5xULN), muscular symptoms are severe & cause daily discomfort, level of serum transaminases is >3xULN; interstitial lung disease. Increase exposure in Asians. Severe renal impairment. Childn <10 yr. Elderly.
Adverse Reactions
DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.
Drug Interactions
Increased plasma conc & risk of myopathy w/ transporter protein inhibitors. Increased AUC values w/ ciclosporin, ezetimibe. Increased AUC & Cmax w/ PIs, gemfibrozil & other lipid-lowering products. Increased AUC w/ ezetimibe. Increased AUC of ethinyl estradiol & norgestrel in OCs/hormonal replacement therapy. Decreased plasma conc w/ antacid susp containing Al & Mg hydroxide; AUC & Cmax w/ erythromycin. Increased INR w/ vit K antagonist (eg, warfarin or another coumarin anticoagulant). Muscle related events including rhabdomyolysis 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.
Presentation/Packing
Form
Torus-10 FC tab 10 mg
Packing/Price
30's (P897/pack)
Form
Torus-20 FC tab 20 mg
Packing/Price
30's (P1,122/box)
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