X-Tin

X-Tin

atorvastatin

Manufacturer:

Millimed

Distributor:

Prosp Pharma

Marketer:

Prosp Pharma
Concise Prescribing Info
Contents
Atorvastatin
Indications/Uses
Reduce risk of revascularization procedures, angina, non-fatal MI, fatal & non-fatal stroke, hospitalization for CHF in patients w/ CHD. Adjunctive treatment to diet in patients w/ hyperlipidemia; primary hypercholesterolemia, mixed dyslipidemia & dysbetalipoproteinemia; elevated serum triglyceride levels; homozygous familial hypercholesterolemia.
Dosage/Direction for Use
Hypercholesterolemia (heterozygous familial & non-familial) & mixed dyslipidemia Initially 10 mg or 20 mg once daily. Patients who required large reduction in LDL-C Initially 40 mg once daily. Dose range: 10-80 mg once daily. Heterozygous familial hypercholesterolemia Childn 10-17 yr Initially 10 mg daily. Max recommended dose: 20 mg daily. Homozygous familial hypercholesterolemia 10-80 mg daily.
Administration
May be taken with or without food: Avoid grapefruit juice. Take at least 2 hr after bile acid-binding resins.
Contraindications
Hypersensitivity. Discontinue if renal failure secondary to rhabdomyolysis develops. Unexplained persistent elevations of serum transaminases >3x ULN. Not to be used in active & chronic alcoholic liver disease. Severe electrolyte, endocrine & metabolic disorders, hypotension, severe acute infection, uncontrolled seizure, major surgery & trauma.
Special Precautions
Discontinue if calf, back or whole body myalgia occurs; transaminase level >3x ULN; markedly elevated in conjunction w/ increased creatine phosphokinase values >10x ULN levels; myopathy/rhabdomyolysis is diagnosed or suspected. Perform LFTs before treatment & after 6 & 12 wk, then followed-up every 6 mth. Increased risk of rhabdomyolysis at high dose; in elderly; patients w/ hepatic/renal insufficiency & hypothyroidism, alcoholism. Temporarily withhold or discontinue in patient having surgery. Unexplained muscle pain, tenderness or weakness accompanied by malaise or fever. Concomitant use w/ digoxin, warfarin; azole antifungals (eg, ketoconazole, itraconazole), macrolides (eg, erythromycin, clarithromycin), HIV PIs (eg, indinavir, ritonavir, nelfinavir, saquinavir), verapamil, gemfibrozil, nicotinic acid, cyclosporine, amiodarone. Not to be used in active & chronic alcoholic liver disease. Renal impairment. Not to be used in pregnancy & lactation. Ped. Elderly.
Adverse Reactions
Insomnia, headache, nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence, myalgia, asthenia. Hypoglycemia, hyperglycemia, anorexia, peripheral neuropathy, paresthesia, pancreatitis, vomiting, hepatitis, cholestatic jaundice, alopecia, pruritus, rash, myopathy, myositis, muscle/leg cramps, impotence. Rhabdomyolysis.
Drug Interactions
Elevated plasma levels w/ CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides, verapamil, diltiazem, grapefruit juice, niacin. Reduced level w/ CYP3A4 inducer eg, rifampin. Elevated plasma conc of digoxin. Decreased plasma conc w/ bile acid-binding resins. Decreased metabolism w/ cyclosporine. Concomitant use w/ gemfibrozil. Increased AUC of OCs eg, ethinyl estradiol & norethindrone.
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
X-Tin FC tab 40 mg
Packing/Price
3 × 10's
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