Santorvastin 40

Atorvastatin

Adjunct to diet for the reduction of elevated total cholesterol (total-C), LDL-C, apo B & triglycerides (TG) in patients w/ primary hypercholesterolemia, combined (mixed) hyperlipidemia, heterozygous & HoFH when response to diet and other non-pharmacological measures are inadequate. Prevention of CV complications in hypertensive patient (≥40 yr) & dyslipidemia w/ at least 3 risk factors for future CV events (eg, LVH, ECG abnormalities, NIDDM, peripheral vascular disease, post history of cerebrovascular events including transient ischemic attack (TIA) ≥3 mth previously, microalbuminuria/proteinuria, smoking (regular smoker w/in the last yr of 20 cigarettes or cigars/wk), TC/HDL-C ratio ≥6, & history of CAD event in 1st degree relative before age 55 (males) or 60 (women). Reduce risk of fatal CHD, non-fatal MI, stroke, revascularization procedures & angina pectoris. 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 an adequate trial of diet therapy, LDL-C remains ≥190 mg/dL or ≥160 mg/dL & if there is +ve family history of premature CVD or ≥2 other CVD risk factors in ped patient.

Usual starting dose: 10 mg once daily. Dosage range: 10-80 mg once daily. Adult Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily w/in therapeutic response of 2 wk up to max response w/in 4 wk. HoFH 80 mg. Childn 10-17 yr Heterozygous familial hypercholesterolemia Recommended starting dose: 10 mg daily. Max dose: 20 mg daily. Adjustments should be made at intervals of ≥4 wk.

May be taken with or without food.

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases >3x ULN. Women of childbearing potential who are not using adequate contraceptive measures. Pregnancy & lactation.

Before instituting therapy, control hypercholesterolemia w/ appropriate diet, exercise, & wt reduction in obese patients, & to treat underlying medical problems. Perform LFTs in patients who develop any signs or symptoms suggestive of liver injury. Monitor patients who develop increased transaminase levels until the abnormalities resolve. Reduce dose or w/draw treatment if an increase in ALT or AST of >3x ULN persists. Patients who consume substantial quantities of alcohol &/or have a history of liver disease. Discontinue use if markedly elevated creatine phosphokinase levels occur. Myalgia. Temporarily w/hold or discontinue therapy in any patient w/ an acute, serious condition suggestive of a myopathy or w/ 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). Promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Adolescent females & women of childbearing potential should use appropriate contraceptive methods.

Nasopharyngitis; pharyngolaryngeal pain, epistaxis; insomnia, nightmare; headache; nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence; myalgia, arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, joint swelling; abnormal LFTs, increased blood creatine phosphokinase. Ped patients (10-17 yr): Infections.

Increased risk of myopathy w/ concurrent administration of cyclosporine, fibric acid derivatives, lipid-modifying doses of niacin, CYP3A4 inhibitors (eg, erythromycin & azole antifungals), colchicine. Increased plasma conc w/ CYP3A4 inhibitors (eg, erythromycin/clarithromycin, PIs), diltiazem & grapefruit juice. Increased bioavailability w/ OATP1B1 inhibitors (eg, cyclosporine). Increased AUC w/ itraconazole. Reduced plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin), oral antacid susp containing Mg & Al hydroxides, colestipol. Increased conc of digoxin. Increased AUC of OCs containing norethindrone & ethinyl estradiol. Increased risk of rhabdomyolysis w/ fusidic acid.

Dyslipidaemic Agents

C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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