Atostin

Atostin

atorvastatin

Manufacturer:

Y.S.P. Industries

Distributor:

Y.S.P. Industries
Concise Prescribing Info
Contents
Atorvastatin Ca
Indications/Uses
Adjunct to diet for patients w/ elevated total cholesterol (total-C), LDL-C, Apo B & triglycerides (TG) & to increase 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) & for patients w/ dysbetalipoproteinemia (Fredrickson type III) who inadequately respond to diet. Reduction of total-C & LDL-C in patients w/ HoFH. 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, revascularisation 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, revascularisation procedures, hospitalisation for chronic heart failure & angina. Adjunct to diet to reduce total-C, LDL-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 +ve 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. HoFH Most patient responded to 80 mg once daily. Heterozygous familial hypercholesterolemia in ped patient 10-17 yr Initially 10 mg daily, dose adjustments made at ≥4 wk intervals. Max: 20 mg daily. Severe dyslipidemia in ped patient ≥10 yr Initially 10 mg daily, may be increased to 80 mg daily. Dose adjustments made at ≥4 wk intervals. Childn HoFH Up to 80 mg daily.
Administration
May be taken with or without food: May be given at any time of day. Avoid excessive consumption (>1.2 L daily) of grapefruit juice.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevated serum transaminases >3 x ULN. Women of childbearing potential not using adequate contraceptive measures. Pregnancy & lactation.
Special Precautions
Discontinue use if markedly elevated creatine phosphokinase levels occur; myopathy is diagnosed or suspected. Temporarily withheld or discontinue in acute, serious condition suggestive of myopathy or risk factor predisposing to renal failure secondary to rhabdomyolysis development eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, uncontrolled seizures. Increased risk for recurrent hemorrhagic stroke; increased HbA1c & fasting serum glucose levels; immune-mediated necrotizing myopathy. Substantial alcohol consumption &/or history of liver disease. Perform LFTs prior to & periodically thereafter. Not recommended w/ concurrent use of fusidic acid. Avoid use w/ cyclosporine, clarithromycin, itraconazole, certain PIs. Concurrent use w/ fibric acid derivatives, erythromycin, niacin, azole antifungals, colchicines, telaprevir, boceprevir, tipranavir/ritonavir; immunosuppressives. Women of childbearing potential should use effective contraception.
Adverse Reactions
Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; diarrhoea, dyspepsia, nausea, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; abnormal LFT, increased blood creatine kinase.
Drug Interactions
Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, niacin, erythromycin, azole antifungals. Increased plasma conc by CYP3A4 inhibitors, erythromycin/clarithromycin, PIs, diltiazem, grapefruit juice. Increased bioavailability w/ OATP1B1 inhibitors. Increased AUC w/ itraconazole. Reduced plasma conc by CYP3A4 inducers, Mg- & Al hydroxide-containing antacids, colestipol. Increased digoxin conc. Increased AUC values for norethindrone & ethinyl estradiol. Cases of myopathy w/ colchicine. Increased risk of rhabdomyolysis w/ fusidic acid. Severe myositis & myoglobinuria w/ fibrates.
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
Atostin FC tab 20 mg
Packing/Price
10 × 10's;3 × 10's
Form
Atostin FC tab 40 mg
Packing/Price
10 × 10's;3 × 10's
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