Atorvastatin Sandoz

Atorvastatin Sandoz





Zuellig Pharma


Concise Prescribing Info
Atorvastatin Ca
Adjunct to diet for reduction of elevated total cholesterol (total-C), LDL cholesterol (LDL-C), apolipoprotein B, & triglycerides in adults, adolescents & childn ≥10 yr w/ primary hypocholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined hyperlipidaemia (corresponding to types IIa & IIb of the Fredrickson classification) when response to diet & other nonpharmacological measures is inadequate. Reduction of total-C & LDL-C in adults w/ homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable. Prevention of CV events in patients w/o clinical evidence of CV disease who have multiple risk factors for a 1st CV event, as an adjunct to correction of other risk factors. Reduction of the risk for CV disease in patients w/ diabetes w/ moderately decreased estimated eGFR. Reduction of the risk of major CV events including stroke in patients w/ clinically evident CHD & CKD not requiring dialysis. Reduction rate of GFR decline & progression of CKD in patients w/ clinically evident CHD &/or diabetes w/ microalbuminuria. Adjunct to diet to reduce total cholesterol, LDL-C & apo B levels in boys & post-menarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia.
Dosage/Direction for Use
Individualized dose. Usual dose: Initially 10 mg once daily. Dose adjustments should be in ≥4 wk intervals. Max: 80 mg/day. Primary hypercholesterolemia or mixed hyperlipidemia 10 mg/day. Heterozygous familial hypercholesterolemia Initially 10 mg/day. Dose should be individualized & adjusted every 4 wk to 40 mg daily. Thereafter, either dose may be increased to a max of 80 mg daily or bile acid sequestrant may be combined w/ 40 mg once daily. Homozygous familial hypercholesterolemia 10-80 mg/day. Childn ≥10 yr 10 mg/day w/ titration up to 20 mg/day.
May be taken with or without food.
Hypersensitivity. Active liver disease, unexplained & persistent elevation of serum transaminases >3 times the upper limit of normal. Women of childbearing potential not using OC. Pregnancy & lactation.
Special Precautions
Perform liver function test before initiation of treatment & periodically thereafter. Reduce dose or w/draw if increase in transaminases is >3x ULN persist. Patients who consume substantial quantities of alcohol &/or have history of liver disease. Prior hemorrhagic stroke or lacunar infarct. Pre-disposing factors for rhabdomyolysis. Measure creatine kinase (CK) level before starting statin treatment in: Renal impairment, hypothyroidism, personal or familial history of hereditary muscular disorders, previous history of muscular toxicity w/ a statin or fibrate, previous history of liver disease &/or where substantial quantities of alcohol are consumed, elderly >70 yr, situations where an increase in plasma levels may occur. Remeasure CK levels within 5-7 days if significantly elevated at baseline (>5x ULN). Discontinue use if clinically significant elevation of CK levels (>10x ULN) occur, or rhabdomyolysis is diagnosed or suspected. Concomitant use w/ drugs that may increase plasma conc eg, potent inhibitors of CYP3A4 or transport proteins (eg, ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole & HIV PIs including ritonavir, lopinavir, atazanavir, indinavir, darunavir; gemfibrozil & other fibric acid derivatives, boceprevir, erythromycin, niacin, ezetimibe, telaprevir or tipranavir/ritonavir; fusidic acid. Interstitial lung disease. DM. Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
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; abdominal pain. Childn: Increased alanine aminotransferase & blood creatine phosphokinase.
Drug Interactions
Increased plasma conc & risk of myopathy w/ drugs that are CYP3A4 inhibitors or transport proteins; moderate CYP3A4 eg, erythromycin, diltiazem, verapamil & fluconazole. Increased conc w/ potent CYP3A4 eg, ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole & HIV PIs including ritonavir, lopinavir, atazanavir, indinavir, darunavir. Reduced plasma conc w/ CYP450 3A inducers eg, efavirenz, rifampin, St. John’s wort. Increased systemic exposure w/ transport proteins inhibitors eg, ciclosporin. Increased risk of muscle-related events including rhabdomyolysis w/ fibric acid derivatives, ezetimibe & fusidic acid. Decreased plasma conc w/ colestipol. Myopathy may occur w/ colchicine. May slightly increase conc of digoxin. Increase plasma conc of norethindrone & ethinyl oestradiol. May cause a small decrease in prothrombin time w/ warfarin.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Atorvastatin Sandoz FC tab 10 mg
Atorvastatin Sandoz FC tab 20 mg
Atorvastatin Sandoz FC tab 40 mg
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in