الوصف الطبي
Antilipidemic agent, HMG-CoA reductase inhibitor used in the treatment of hypercholesterolemia and in the prevention of atherosclerotic cardiovascular diseases.
الدلالة و الاستخدام
-Heterozygous familial hypercholesterolemia: High-intensity therapy: Oral: Initial: 20 or 40 mg once daily; if 20 mg once daily is initiated and tolerated, increase to 40 mg once daily.
-Homozygous familial hypercholesterolemia: High-intensity therapy: Oral: 40 mg once daily.
-Prevention of atherosclerotic cardiovascular disease:
Primary prevention:
1-Patients without diabetes, 40 to 75 years of age, and with LDL-C 70 to 189 mg/dL:
a-In case of patients with ASCVD 10-year risk = 5% to <7.5%: Moderate-intensity therapy: Oral: 5 to 10 mg once daily to reduce LDL-C by 30% to 49%.
b-In case of patients with ASCVD 10-year risk ≥7.5% to <20%: Moderate-intensity therapy: Oral: 5 to 10 mg once daily to reduce LDL-C by 30% to 49%.
c-In case of patients with ASCVD 10-year risk ≥20%: High-intensity therapy: Oral: 20 to 40 mg once daily to reduce LDL-C by ≥50%.
2-Patients with diabetes:
a-In case of patients 40 to 75 years of age without additional ASCVD risk factors: Moderate-intensity therapy: Oral: 5 to 10 mg once daily to reduce LDL-C by 30% to 49%.
b-In case of patients with ASCVD risk ≥20% or multiple ASCVD risk factors: High-intensity therapy: Oral: 20 to 40 mg once daily to reduce LDL-C by ≥50%.
3-Patients with LDL-C ≥190 mg/dL and 20 to 75 years of age: High-intensity therapy is indicated regardless of ASCVD risk calculation or coexisting diabetes mellitus: High-intensity therapy: Oral: 20 to 40 mg once daily to reduce LDL-C by ≥50%.
Secondary prevention in patients with established ASCVD (eg, coronary heart disease, cerebrovascular disease, peripheral arterial disease): High-intensity therapy: Oral: 20 to 40 mg once daily to reduce LDL-C by ≥50%.
-Pediatric dosing: see dosage and administration.
المكونات النشطة
Rosuvastatin
الجرعة و طريقة الاستعمال
-Capsule: Oral: Administer with or without food. May be taken at any time of the day.
-Tablet: Administer with or without food. May be taken at any time of the day.
-Pediatric dosing:
1-Heterozygous familial hypercholesterolemia: Children 8 to <10 years: Oral: 5 to 10 mg once daily; maximum daily dose: 10 mg/day. While in case of children ≥10 years and adolescents: Oral: 5 to 20 mg once daily; maximum daily dose: 20 mg/day.
2-Homozygous familial hypercholesterolemia: Children ≥7 years and adolescents: Oral: Initial dose: 20 mg once daily.
الاّثار الجانبية
-Increased serum transaminases and hepatotoxicity, myalgia, myopathy and rhabdomyolysis.
-Diabetes mellitus, constipation, nausea, cystitis, increased serum alanine aminotransferase, increased serum transaminases, dizziness, headache, arthralgia, asthenia and increased creatine phosphokinase in blood specimen.
نصائح احترازية
-Should not be given to patients suffering from hypersensitivity to rosuvastatin.
-Rosuvastatin may cause small increases in HbA1c (mean: ~0.1%) and fasting blood glucose.
-Adults receiving rosuvastatin 40 mg daily may experience hematuria (microscopic) and proteinuria, which is transient and not associated with a decrease in renal function.
-Use with caution in patients who consume large amounts of ethanol and/or have a history of liver disease.
-May rarely worsen or precipitate myasthenia gravis.
-Dosage adjustment may be required in patients with renal impairment.
-Use with caution in patients with advanced age; these patients are more predisposed to myopathy.
-In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.
التخزين
Store at room temperature.
تفاعلات الأدوية
-Antacids: May decrease the serum concentration of Rosuvastatin.
-Carbamazepine: May decrease the serum concentration of Rosuvastatin.
-Clopidogrel: May increase the serum concentration of Rosuvastatin.
-Colchicine: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins).
-Fenofibrate and Derivatives: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins).
-Itraconazole: May increase the serum concentration of Rosuvastatin.
-Niacinamide: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins).
-Red Yeast Rice: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins).
-Rifampin: May decrease the serum concentration of Rosuvastatin.
-Ticagrelor: May enhance the adverse/toxic effect of Rosuvastatin.
-Vitamin K Antagonists (eg, warfarin): HMG-CoA Reductase Inhibitors (Statins) may enhance the anticoagulant effect of Vitamin K Antagonists.
الحمل والرضاعة
-Rosuvastatin is contraindicated in females who may become pregnant.
-Rosuvastatin is present in breast milk (limited data). Due to the potential for serious adverse reactions in a breastfed infant, use while breastfeeding is contraindicated.
-Ask your physician before taking any medication during pregnancy or lactation.