HMG-CoA reductase inhibitors (statins)

Hypertriglyceridemia Indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) Indicated as an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (Type lll Hyperlipoproteinemia). Homozygous Familial Hypercholesterolemia Indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.

Each film coated tablet contains Rosuvastatin calcium USP equivalent to Rosuvastatin 5 mg

3 x 10's per box

General Dosing - 5 to 40 mg once daily or as directed by Phycisians

Hypersensitivity to rosuvastatin or any component (may cause rash, pruritus, urticaria, angioedema). Active liver disease or unexplained, persistent elevation of hepatic transaminases. Pregnancy – may cause fetal harm; no clinical benefit during pregnancy. Discontinue if pregnancy occurs. Breastfeeding – potential for serious adverse effects in infants; advise against nursing while on therapy.

Serious adverse reactions Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis). Most common adverse reactions Myalgia Abdominal pain Nausea Headache Nausea

Transporter Proteins Substrate for OATP1B1 (hepatic uptake) and BCRP (efflux) transporters. Inhibitors may increase plasma levels and risk of myopathy. Ciclosporin - contraindicated with concomitant use. No effect on ciclosporin levels. Protease Inhibitors - may markedly increase rosuvastatin exposure; mechanism unknown – use lowest possible dose. Gemfibrozil & Other Lipid-Lowering Agents Gemfibrozil: increase myopathy risk. Other fibrates/niacin ≥1 g/day: increase myopathy risk. 40 mg dose contraindicated with fibrates; start at 5 mg if needed. Ezetimibe Pharmacodynamic interaction risk (myopathy) cannot be excluded. Antacids Aluminium/magnesium hydroxide suspension decrease rosuvastatin plasma levels by ~50%; separate dosing by ≥2 hours. Erythromycin -Increase gut motility. Cytochrome P450 Minimal metabolism via CYP enzymes; not an inhibitor or inducer. No clinically relevant interaction with fluconazole or ketoconazole

Inventia Healthcare Limited.,India