RiteMed Rosuvastatin

RiteMed Rosuvastatin

rosuvastatin

Manufacturer:

Lek Pharma

Distributor:

RiteMED
Concise Prescribing Info
Contents
Rosuvastatin
Indications/Uses
Primary hyperlipidemia (type IIa including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) as an adjunct to diet & reduce elevated total-cholesterol, LDL-cholesterol, Apo B, non HDL-cholesterol & triglycerides levels & to increase HDL-cholesterol. HoFH. Reduce the risk of atherosclerosis by lowering total cholesterol levels & LDL cholesterol levels; risk of CV disease. Primary dysbetalipoproteinemia (type III).
Dosage/Direction for Use
Individualized dosage. May be given at any time of the day. Adult Primary hyperlipidemia (including heterozygous familial hypercholesterolaemia), mixed dyslipidaemia, dysbetalipoproteinaemia, & HoFH Initially 5 mg once daily. Maintenance dose: 20 mg once daily. Max: 40 mg once daily. Heterozygous familial hypercholesterolaemia Elderly >70 yr 10 mg once daily. Childn 10-17 yr 5 mg once daily. Max: 20 mg once daily. Mild & moderate renal impairment 10-20 mg once daily. Asian patients Initially 5 mg. Patients known to have myopathy 5 mg once daily.
Administration
May be taken with or without food.
Contraindications
Active liver disease including unexplained, persistent elevations of hepatic transaminase levels. Women of child bearing potential. Pregnancy & lactation.
Special Precautions
Hypersensitivity. Patients w/ liver disease; severe kidney problems; has repeated or unexplained muscle aches or pains. Do not administer high dose in patients w/ moderate kidney problems; problems in thyroid gland; have repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines. Patients who have problems in thyroid gland. Concomitant use w/ fibrates & medicines for HIV infection. Excessive alcohol consumption. Asian patients. Pregnancy & lactation. Not recommended for childn <10 yr.
Adverse Reactions
Headache, stomach pain, constipation, feeling sick, muscle pain, feeling weak, dizziness, increased amount of protein in the urine, diabetes.
Drug Interactions
Increased risk of myopathy w/ gemfibrozil, cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir, organic anion transporting polyprotein 1B1 inhibitors, or BCRP inhibitors. May affect INR w/ coumarin anticoagulant. Increased risk of skeletal muscle effects w/ >1 g/day of niacin. Decreased levels or activity of endogenous steroid hormones (eg, ketoconazole, spironolactone, cimetidine), fenofibrates, or PIs in combination w/ ritonavir. Increased levels w/ cyclosporine. Myopathy, including rhabdomyolysis may occur w/ colchicine.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
RiteMed Rosuvastatin FC tab 10 mg
Packing/Price
30's (P840/box, P28/film-coated tab)
Form
RiteMed Rosuvastatin FC tab 20 mg
Packing/Price
30's (P34/film-coated tab, P1,020/box)
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