Surotin

Surotin

rosuvastatin

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Prevention of CV events as adjunct to non-drug therapies in patients w/o clinical CHD who have an increase risk of CV disease. Reduce the risk of stroke or MI & reduce the risk of undergoing arterial revascularization procedures; progression of coronary atherosclerosis as adjunct to dietary therapy. Adjunct to diet for the management of primary hyperlipidemia or mixed dyslipidemia, hypertriglyceridemia, primary dysbetalipoproteinemia & homozygous familial hypercholesterolemia. Adjunct to diet to reduce total cholesterol, LDL-C & apolipoprotein B level in patients w/ heterozygous familial hypercholesterolemia age 10-17 yr.
Dosage/Direction for Use
Prevention of CV disease Initially 5-40 mg once daily. Patients w/ LDL-C ≥190 mg/dL, 40-75 yr w/ type 1 or 2 DM & an estimated 10-yr atherosclerotic CV disease risk ≥7.5% 20-40 mg once daily. Patients 40-75 yr w/ type 1 or 2 DM 5-10 mg once daily. Patients 40-75 yr & an estimated 10-yr atherosclerotic CV disease risk ≥7.5% 5-40 mg once daily. Patients w/ atherosclerotic CV disease ≥75 yr 5-10 mg once daily, ≤75 yr 20-40 mg once daily. Dyslipidemia Initially 10-20 mg once daily. May be adjusted after 2-4 wk, if necessary. Dosing range: 5-40 mg/day. Max: 40 mg once daily. Adult w/ homozygous familial hypercholesterolemia Initially 20 mg once daily. Ped patients w/ heterozygous familial hypercholesterolemia 10-17 yr 5-20 mg once daily. Dose adjustment at 4 wk or longer. Max: 20 mg daily. Patients w/ renal impairment CrCl <30 mL/min/1.73 m2 Initially 5 mg once daily. Max: 10 mg once daily. Asian patients Recommended dose: 5 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease including unexplained, persistent elevation of hepatic aminotransferase conc. Pregnancy & lactation.
Special Precautions
Discontinue therapy if signs of myalgia, back pain, CK conc elevation or myopathy occur; if level of serum transaminase is >3x ULN. Increase in serum aminotransferase conc for transient & resolved or improved w/ continued or interrupted therapy. Perform liver function tests before & at 6, 12 wk after initiation of therapy, & every 6 mth in patients w/ long term use. Concomitant use w/ cyclosporin, fenofibrate, gemfibrozil, nicotinic acid, azole antifungal, macrolide antibacterial, HIV PIs, verapamil, diltiazem, amiodarone; colchicine especially in geriatric patients or w/ renal dysfunction. Increase risk of rhabdomyolysis in geriatric patients, hepatic or renal dysfunction, chronic alcoholism & hypothyroidism patients. Increased risk of myopathy in patients ≥65 yr, renal impairment, inadequately treated hypothyroidism. Risk of hyperglycemia is increased. Excessive alcohol consumption & history of liver disease. Interrupt therapy promptly if serious liver injury w/ hyperbilirubinemia or jaundice occurs. Obtain baseline CK conc prior to therapy, & measure CK conc in adults experiencing muscle symptoms during therapy. Temporarily withhold therapy in acute, serious condition suggestive of myopathy or predisposing development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine or electrolyte disorders, uncontrolled seizures).
Adverse Reactions
Dizziness, headache; abdominal pain, constipation, nausea; arthralgia, myalgia, weakness.
Drug Interactions
Decreased peak plasma conc w/ antacids, erythromycin, ketoconazole. Increased peak plasma conc w/ cyclosporin, HIV PIs (eg, atazanavir, fosamprenavir, lopinavir), fenofibrate, gemfibrozil, azole antifungal (eg, fluconazole, itraconazole). Increased peak plasma conc of ethinyl estradiol & norgestrel w/ OCs. Increased INR w/ warfarin. Increased plasma conc of digoxin. Increased risk of myopathy w/ cyclosporin, fenofibrate, gemfibrozil, niacin.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Surotin FC tab 20 mg
Packing/Price
3 × 10's
Form
Surotin FC tab 10 mg
Packing/Price
3 × 10's
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