Duopharma Manufacturing (Bangi)


Duopharma Marketing
Concise Prescribing Info
Atorvastatin Ca
Adjunct to diet for patients w/ elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B (apo B) & triglycerides (TG) & to increase HDL-cholesterol (HDL-C) in patients w/ primary hypercholesterolemia (heterozygous familial & non-familial), combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum TG levels (Fredrickson type IV) & patients w/ dysbetalipoproteinemia (Fredrickson type III) who do not respond adequately to diet. Reduction of total-C & LDL-C in patients w/ homozygous familial hypercholesterolemia. Prevention of CV disease w/o clinically evident CHD but w/ multiple risk factors eg, age, smoking, HTN, low HDL-C or family history of early CHD to reduce risk of MI, stroke, revascularization procedures & angina. Type 2 diabetes w/o clinically evident CHD but w/ multiple risk factors eg, retinopathy, albuminuria, smoking or HTN to reduce risk of MI & stroke. Patients w/ clinically evident CHD to reduce risk of non-fatal MI, fatal & non-fatal stroke, revascularization procedures, CHF hospitalization & angina. Reduction of total-C & apo B levels in boys & postmenarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia if after adequate diet therapy LDL-C remains ≥190 mg/dL or ≥160 mg/dL & there is positive family history of premature CV disease, or ≥2 other CV disease risk factors.
Dosage/Direction for Use
Dose range: 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia 80 mg once daily. Heterozygous familial hypercholesterolemia in ped patient 10-17 yr Initially 10 mg once daily, dose adjustments made at ≥4 wk intervals. Max: 20 mg once daily. Severe dyslipidemia in ped patient ≥10 yr Initially 10 mg once daily, may be increased to 80 mg daily. Dose adjustments made at ≥4 wk intervals. Childn Homozygous familial hypercholesterolemia Up to 80 mg daily.
May be taken with or without food: May be taken w/o regard to time of day w/ or w/o food. Avoid excessive consumption (1.2 L daily) of grapefruit juice.
Hypersensitivity. Concomitant use w/ hepatitis C antivirals eg, glecaprevir/pibrentasvir. Active liver disease or unexplained persistent elevations of serum transaminases >3 times upper limit of normal. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
Discontinue use if interstitial lung disease develops; elevated CK levels occur; rhabdomyolysis is diagnosed or suspected. Increased risk in patients w/ prior haemorrhagic stroke or lacunar infarct. Immune-mediated necrotizing myopathy; predisposing factors for rhabdomyolysis; DM. Substantial alcohol consumption &/or history of liver disease. Perform liver function tests prior to initiation & periodically thereafter. Reduce dose or w/draw use if increased transaminases of >3 times upper limit of normal persist. Not to be co-administered w/ systemic fusidic acid or w/in 7 days of discontinuation. Avoid use w/ cyclosporine, clarithromycin, itraconazole, HIV PIs, hepatitis C PIs. Concomitant use w/ fibrates, erythromycin, immunosuppressives, azole antifungals, niacin ≥1 g daily; other potent CYP3A4 or transport protein inhibitors. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Women of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation.
Adverse Reactions
Nasopharyngitis; allergic reactions; hyperglycaemia; headache; pharyngolaryngeal pain, epistaxis; constipation, flatulence, dyspepsia, nausea, diarrhoea; myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain; abnormal liver function test, increased blood creatine kinase.
Drug Interactions
Increased conc w/ potent (eg, ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, HCV antivirals, HIV PIs) & moderate (eg, erythromycin, diltiazem, verapamil, fluconazole) CYP3A4 inhibitors. Increased risk of myopathy w/ erythromycin, fusidic acid. Increased exposure w/ amiodarone, verapamil. Reduced plasma conc by CYP450 3A inducers eg, efavirenz, rifampin, St. John's wort. Increased systemic exposure w/ ciclosporin. Severe myositis & myoglobinuria w/ fibrates. Increased risk of muscle-related events including rhabdomyolysis w/ ezetimibe. Lowered plasma conc w/ colestipol. Cases of myopathy w/ colchicine. Increased steady-state digoxin conc. Increased plasma conc of norethindrone & ethinyl oestradiol.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Crystorvas FC tab 20 mg
3 × 10's
Crystorvas FC tab 40 mg
3 × 10's
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