DRUG INTERACTION
Erythromycin: Co-administration of Erythromycin with Rosuvastatin decreased AUC and Cmax of Rosuvastatin by 20% and 31%, respectively. Itraconazole: Itraconazole resulted in a 39% and 28% increase in AUC of Rosuvastatin after 10 mg and 80 mg dosing, respectively. Fluconazole: Co-administration of Fluconazole with Rosuvastatin resulted in a 14% increase in AUC of Rosuvastatin. Warfarin: Co-administration of Warfarin (25 mg) with Rosuvastatin (40mg) did not change Warfarin plasma concentrations but increased the international Normalized Ration (INR). Gemfibrozil: Co-administration of Gemfibrozil (600 mg twice daily for 7 days) with Rosuvastatin (80 mg) resulted in a 90% and 120% increase for AUC and Cmax of Rosuvastatin, respectively. Antacid: Co-administration of an antacid (aluminum and magnesium hydroxide combination) with Rosuvastatin (40 mg) resulted in a decrease in plasma concentrations of Rosuvastatin by 54%. Oral contraceptives: Co-administration 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.
USE IN PREGNANCY AND LACTATION
Rosuvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, therapy should be discontinued immediately. It is not known whether Rosuvastatin is excreted in human milk.
USE IN PEDIATRIC PATIENTS
The safety and effectiveness in pediatric patients have not been established.
STORAGE CONDITION
Store ina cool and dry place below 250C temperature, protected from light and moisture. Keep all medicines out of the reach of children.
Ambar 5 Tablet: Each box contains 3×10 / 5×10 tablets in blister pack.
Ambar 10 Tablet: Each box contains 2×10 / 3×10 tablets in blister pack.
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