Atorvastatin Sandoz

Atorvastatin Sandoz

atorvastatin

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma

Marketer:

Novartis
Concise Prescribing Info
Contents
Atorvastatin Ca
Indications/Uses
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.
Administration
May be taken with or without food.
Contraindications
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.
Presentation/Packing
Form
Atorvastatin Sandoz FC tab 10 mg
Packing/Price
30's
Form
Atorvastatin Sandoz FC tab 20 mg
Packing/Price
100's;30's
Form
Atorvastatin Sandoz FC tab 40 mg
Packing/Price
100's;30's
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