LIPITOR 10MG 28TAB; atorvastatin, cardiovascular agents .
ACTIVE-INGREDIENT OF LIPITOR 10MG 28TAB
Atorvastatin Calcium 10 mg.
INDICATION OF LIPITOR 10MG 28TAB
Therapy with lipid-altering agents should be only one component of multible risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multible risk factors for CHD, LIPITOR can be started simultaneously with diet. 1.1 Prevention of Cardiovascular Disease: In adult patients without clinically evident coronary heart disease, but with multiple risk factors for cornary heart disease such as, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, LIPITOR is indicated to: Reduce the risk of myocardial infarction. Reduce the risk of stroke. Reduce the risk of revascularization procedures and angina. In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multible risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, LIPITOR is indicated to: Reduce the risk of myocardial infarction. Reduce the risk of stroke. In patients with clinically evident coronary heart disease, LIPITOR is indicated to : Reduce the risk of non-fatal myocardial infarction. Reduce the risk of non-fatal stroke. Reduce the risk of revascularization preocedures. Reduce the risk of hospitalization for CHF. Reduce the risk of ANGINA. 1.2 Hyperlipidemia: LIPITOR is indicated: as an adjunct to diet to reduce elevated total-C, LDL-C, apo B and TG levels and to increase GDL-C in patients with hypercholesterolemia ( heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb): As an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Types IV); For the treatment of patients with primary dysbelalipoproteinemia (Fredrickson Types III ) who do not respond adequately to diet; To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments ( e.g., LDL-C apheresis) or if such treatments are unavailable; As an adjunct to diet to reduce total-C and LDL-C and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: a. LDL-C remains ≥190 mg/dL or b. LDL-C remains ≥160 mg/dL and; there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the pediatric patient. 1.3 Limitations of Use: LIPITOR has not been stdied in conditions where the major lipoprotein abnormality is elevation of chlomacrons (Fredrickson Type I and V ).
DOSAGE OF LIPITOR 10MG 28TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
2.1 Hyperlipidemia ( heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb): The recommended starting dose of LIPITOR is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45% ) may be started at 40 mg once daily. The dosage range of LIPITOR is 10 to 80 mg once daily. LIPITOR can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of LIPITOR should be individualized according to patient characteristics such as goal of therapy and response. After initiation and/or upon titration of LIPITOR, lipid levels. should be analyzed within 2 to 4 weeks and dosage adjusted accordingly. 2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years of age): The recommended starting dose of LIPITOR is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy . Adjustments should be made at intervals of 4 weeks or more. 2.3 Homozygous Familial Hypercholesterolemia: The dosage of LIPITOR in patients with Homozygous FH is 10 to 80 mg daily. LIPITOR should be used as an adjunct to other lipid-lowering treatments (e.g, LDL- apheresis) in these patients or if such treatmnets are unavailable. 2.4 Concomitant Lipid-Lowering Therapy: LIPITOR may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution. 2.5 Dosage in patients with renal impairment : Renal disease does not effect the plasma concentrations nor LDL-C reduction of LIPITOR; thus, dosage adjustment in patients with renal dysfunction is not necessary. 2.6 Dosage in patients taking cyclosporine, Clarithromycin, Itraconazole, or Certain Protease inhibitors: In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritronavir) or the hepatitis C protease inhibitor (telaprevir), therapy with LIPITOR should be avoided. In patients with HIV taking topinavir, caution should be used when prescribing LIPITOR and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of sequinavir plus ritonavir, darunavir plus ritonavir. Fosameprenavir, or fosameprenavir plus retonavir, therapy with LIPITOR should be limited to 20 mg , and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of LIPITOR is employed. in patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, Therapy with LIPITOR should be limited to 40 mg , and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of LIPITOR is employed.
OVER-DOSAGE OF LIPITOR 10MG 28TAB
There is no specific treatment of LIPITOR overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituated as required. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance LIPITOR clearance.
CONTRA-INDICATION OF LIPITOR 10MG 28TAB
4.1 Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. 4.2 Hypersensitivity to any component of this medication. 4.3 Pregnancy: Women who are pregnant or may become pregnant. LIPITOR may cause fatal harm when administered to a pregnant women. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol derivatives are essential for fatal development. Atheroscierosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy, should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. There are no adequate and well-controlled studies of LIPITOR use during pregnancy; however in rare reports, congenital anomalies were observed following intrauterine exposure to statins. In rat and rabbit animal reproduction studies, atorvastatin releaved no evidence of teralogenicity, LIPITOR should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards, if the patient becomes pregnant while taking this drug, LIPITOR should be discontinued immediately and the patient apprised of the potential hazard to the fetus. 4.4 Nursing mothers : It is known whether atorvastatin is excreted into human milk; however a small amount of another drug in this class does pass into breast milk. Because statins have the potential for serious adverse reactions in nursing infants. women who require LIPITOR treatment should not breastfeed their infants.
STORAGE OF LIPITOR 10MG 28TAB
Store below 25 °C.
PACK OF LIPITOR 10MG 28TAB
Carton box contains blisters each of 7 tablets.
LIPITOR 10MG 28TAB MANUFACTURED BY
Pfizer Egypt under license of Pfizer AG – Switzerland, a subsidiary of Pfizer Inc. USA.