Rauto

Rauto® 5 mg Tablet: Each tablet contains Rosuvastatin Calcium USP 5.21 mg equivalent to Rosuvastatin 5 mg.

Rauto® 10 mg Tablet: Each tablet contains Rosuvastatin Calcium USP 10.42 mg equivalent to Rosuvastatin 10 mg.

Rosuvastatin calcium is a synthetic lipid-lowering agent. Rosuvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

• Patients with primary hyperlipidemia & mixed dyslipidemia as an adjunct to diet to reduce elevated total-C, LDL-c, ApoB, non-HDL-c & TG levels & to increase HDL-c, • Patients with hypertriglyceridemia as an adjunct to diet, • Patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet, • Patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-c, total-c and ApoB, • Slowing the progression of atherosclerosis as part of a treatment strategy to lower total-c & LDl-c as an adjunct to diet, • Pediatric patients 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total-c, LDL-c & ApoB after failing an adequate trial of diet therapy, • Risk reduction of MI, stroke & arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors.

5-40 mg once daily with or without food at any time of the day. 40 mg only for patients not reaching LDL-c goal with 20 mg. In pediatric patients 10-17 yrs of age with HeFH, the usual dose range is 5-20 mg/day; doses greater than 20 mg have not been studied in this patient population.

Rosuvastatin is generally well tolerated. Adverse reactions have usually been mild and transient. 3.7% patients discontinued the therapy due to adverse experiences attributed to Rosuvastatin. The most frequent adverse events thought to be related to Rosuvastatin were myalgia, constipation, asthenia, abdominal pain and nausea.

Before instituting therapy with Rosuvastatin, an attempt should be made to control hypercholesterolemia with appropriate diet, exercise, and weight reduction in obese patients and treatment of underlying medical problems. Administration of Rosuvastatin 20 mg to patients with severe renal impairment (CLcr<30 ml/min/1.73 m2) resulted in a 3-fold increase in plasma concentrations compared with healthy subjects.

Rosuvastatin clearance is not dependent on metabolism by cytochrome P450 3A4 to a clinically significant extent. This is confirmed in studies with known cytochrome P450 3A4 inhibitors (Ketoconazole, Erythromycin, Itraconazole).

Ketoconazole: Coadministration of ketoconazole with Rosuvastatin (80 mg) resulted in no change in plasma concentration of Rosuvastatin.

Erythromycin: Coadministration of erythromycin with Rosuvastatin (80 mg) decreased AUC and Cmax of Rosuvastatin by 20% and 31% respectively. These reductions are not considered clinically significant.

Itraconazole: Itraconazole resulted in a 39% and 28% increase in AUC of Rosuvastatin after 10 mg and 80 mg dosing respectively. These increases are not clinically significant.

Fluconazole: Coadministration of fluconazole with Rosuvastatin (80 mg) resulted in 14% increase in AUC of Rosuvastatin. This increase is not considered clinically significant.

Cyclosporine: Coadministration of cyclosporine with Rosuvastatin resulted in no significant change in cyclosporine plasma concentrations.

Warfarin: Coadministration of warfarin (20 mg) with Rosuvastatin (40 mg) did not change warfarin plasma concentrations.

Digoxin: Coadministration of digoxin (0.5 mg) with Rosuvastatin (40 mg) resulted in no change to digoxin plasma concentrations.

Fenofibrate: Coadministration of fenofibrate with Rosuvastatin (10 mg) resulted in no significant change in plasma concentrations of Rosuvastatin or fenofibrate.

Antacid: Coadministration of an antacid (aluminium and magnesium hydroxide combination) with Rosuvastatin (40 mg) resulted in a decrease in plasma concentrations of Rosuvastatin by 54%. However, when antacid is given 2 hours after Rosuvastatin, there is no clinically significant change in plasma concentrations of Rosuvastatin.

Oral Contraceptives: Coadministration of oral contraceptives (ethinyl estradiol and norgestrel) with Rosuvastatin resulted in an increase in plasma concentrations of ethinyl estradiol and norgestrel by 26% and 34% respectively.

There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis does not significantly enhance clearance of Rosuvastatin.

Store at temperature not exceeding 30º C in a dry place. Protect from light and moisture.

Rauto® 5 mg Tablet: Each box contains 3x10’s tablets in Alu-Alu blister stips.

Rauto® 10 mg Tablet: Each box contains 3x10’s tablets in Alu-Alu blister stips.