Atorsan

Atorsan

atorvastatin

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
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 adult, adolescents & childn ≥10 yr w/ primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia. Reduction of total-C & LDL-C in adult w/ homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis). Prevent 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. Reduce risk of CV disease in patients w/ DM w/ moderately decreased estimated glomerular filtration rate (eGFR). Reduce risk of major CV events including stroke in patients w/ clinically evident CHD & chronic kidney disease not requiring dialysis. Reduce rate of GFR decline & progression of chronic kidney disease in patients w/ clinically evident CHD &/or diabetes w/ microalbuminuria. Adjunct to diet to reduce total-C, LDL-C & apo B levels in boys & post-menarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following are present: LDL-C remains ≥190 mg/dL, or LDL-C remains ≥160 mg/dL & positive family history of premature CV disease or ≥2 CV disease risk factors are present.
Dosage/Direction for Use
Adult Individualised dosage according to baseline LDL-C levels. Usual starting dose: 10 mg once daily. Dose adjustment should be made at intervals of ≥4 wk. Max dose: 80 mg once daily. Primary hypercholesterolaemia & combined (mixed) hyperlipidaemia 10 mg once daily. Heterozygous familial hypercholesterolemia Initially 10 mg daily. May be adjusted every 4 wk to 40 mg daily. Thereafter, either the dose may be increased to a max of 80 mg daily or a bile acid sequestrant may be combined w/ 40 mg atorvastatin once daily. Homozygous familial hypercholesterolaemia 10-80 mg daily. Prevention of CVD 10 mg daily. Ped patients ≥10 yr Hypercholesterolaemia 10 mg daily w/ titrations up to 20 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevation of serum transaminases >3 x ULN. Concomitant use w/ hepatitis C antivirals eg, glecaprevir/pibrentasvir. Pregnancy & lactation.
Special Precautions
Perform liver function tests prior to the initiation of treatment & periodically thereafter; & in patients who develop liver injury. Monitor patients who develop increased transaminase levels until abnormalities resolved. Patients who consume substantial quantities of alcohol &/or have a history of liver disease; w/ prior hemorrhagic stroke or lacunar infarct. Patients w/ pre-disposing factors for rhabdomyolysis. Measure creatine kinase level before treatment in patients w/ renal impairment, hypothyroidism, personal or familial history of hereditary muscular disorders, previous history of muscular toxicity w/ a statin or fibrate, or of liver disease &/or where substantial quantities of alcohol are consumed, elderly >70 yr, situations where an increase in plasma levels may occur. Do not start if creatine kinase levels elevated to >5 x ULN. Discontinue if clinically significant elevation of creatine kinase levels (>10 x ULN) or rhabdomyolysis; interstitial lung disease occurs. Concomitant use w/ potent CYP3A4 inhibitors or transport proteins [eg, ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole & HIV PIs (eg, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir)]; gemfibrozil & other fibric acid derivatives, antivirals for hepatitis C (boceprevir, telaprevir, elbasvir/grazoprevir), erythromycin, niacin or ezetimibe. Do not co-administer w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid treatment. Monitor patients at risk of DM (fasting blood glucose 5.6-6.9 mmol/L, BMI >30 kg/m2, raised triglycerides, HTN). Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption. Women of childbearing potential should use appropriate contraceptive measures during treatment.
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 tests, increased blood creatine kinase.
Drug Interactions
Increased risk of myopathy & plasma conc w/ CYP3A4 inhibitors [eg, ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, some antivirals for hepatitis C virus (eg, elbasvir/grazoprevir) & HIV PIs including ritonavir, lopinavir, atazanavir, indinavir, darunavir)] or transport proteins. Increased plasma conc w/ moderate CYP3A4 inhibitors (eg, erythromycin, diltiazem, verapamil & fluconazole). Reduced plasma conc w/ CYP450 3A inducers eg, efavirenz, rifampin, St. John's wort. Increased systemic exposure w/ transport protein inhibitors eg, ciclosporin. Increase risk of myopathy including rhabdomyolysis w/ gemfibrozil/fibric acid derivatives, ezetimibe, fusidic acid. Decreased plasma conc w/ colestipol. Colchicine. May increase conc of digoxin, OCs. 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
Atorsan FC tab 40 mg
Packing/Price
10 × 10's
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