Atswift

Atswift

atorvastatin

Manufacturer:

Ind-Swift

Distributor:

Goldplus
Concise Prescribing Info
Contents
Atorvastatin
Indications/Uses
Adjust 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 hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types IIa & IIb of the Fredrickson classification) when responses to diet & other non-pharmacological measures is inadequate. Reduce 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. Reduce the risk of MI in adult hypertensive patients w/o clinically evident CHD but w/ at least 3 additional risk factors for CHD eg, age ≥55 yr, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on ECG, microalbuminia or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol ≥6 or premature family history of CHD. Adults w/ type 2 diabetes & w/o clinically evident CHD but w/ multiple risk factors for CHD eg, retinopathy, albuminuria, smoking or HTN. Reduce risk of MI, stroke. Reduce the risk of nonfatal MI, fatal & nonfatal stroke, revascularization procedures, hospitalization for CHF & angina in adults w/ clinically evident CHD.
Dosage/Direction for Use
Individualised dosage. Initially 10 mg once daily. Dose may be adjusted at intervals of  ≥4 wk. Max: 80 mg once daily. Primary hypercholesterolaemia & combined (mixed) hyperlipidaemia 10 mg once daily. Homozygous familial hypercholesterolaemia 80 mg. Prevention of CV disease Primary: 10 mg once daily. Secondary: 10-80 mg once daily. Patient ≥10 yr Initially 10 mg/day w/ titration up to 20 mg/day.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases >3x the upper limit of normal. Pregnancy & Lactation.
Special Precautions
Perform liver function tests before initiating treatment & periodically thereafter. Patient who consume substantial quantities of alcohol &/or have history of liver disease. Consider potential risk of hemorrhagic stroke before initiating treatment in patients w/ recent stroke or transient ischemic attack. Discontinue use if markedly elevated creatinine phosphokinase levels occur or myopathy is diagnosed or suspected. Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, erythromycin, niacin, azole antifungals, colchicine, telaprevir, boceprevir or the combination of tipranavir/ritonavir. Temporarily w/held or discontinued in any patient w/ acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders & uncontrolled seizures). Measure CK level before starting statin 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; liver disease &/or where substantial quantities of alcohol are consumed, elderly (>70 yr). Discontinue if clinically significant elevation of CK levels (>10 x ULN) occur or if rhabdomyolysis is diagnosed or suspected. Concomitant treatment w/ ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole & HIV protease inhibitors eg, ritonavir, lopinavir, atazanavir, indinavir, darunavir. Increased risk of myopathy w/ gemfibrozil & other fibric acid derivates, erythromycin, niacin & ezetimibe.
Adverse Reactions
Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; insomnia; headache; nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; asthenia; abnormal liver function test, increased blood creatine phosphokinase.
Drug Interactions
Increased risk of myopathy w/ gemfibrozil/fibric acid derivatives & ezetimibe. Increased plasma conc w/ potent CYP3A4 inhibitors (eg, ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole & HIV PI (eg, ritonavir, lopinavir, atazanavir, indinavir, darunavir); moderate CYP3A4 inhibitors (eg, erythromycin, diltiazem, verapamil & fluconazole); grapefruit juice. Increased exposure w/ amiodarone, verapamil, amlodipine. Reduced plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin, St. John's wort). Increased bioavailability w/ OATP1B1 inhibitors (eg, cyclosporine). Decreased plasma conc w/ Mg & Al hydroxide oral antacid susp; colestipol. Increase AUC w/ itraconazole. Increased digoxin conc. Increased AUC values of norethindrone & ethinyl estradiol. Monitor patients receiving warfarin.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Atswift FC tab 20 mg
Packing/Price
3 × 10's
Form
Atswift FC tab 10 mg
Packing/Price
3 × 10's
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