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Prescribing Information ® at any time of day with or without food. However, it is preferable to administer the dose at bed time. transporter. In patients with SLCO1B1 polymorphism there is a risk of increased exposure of atorvastatin, US FDA Pregnancy category X. Atorvastatin is contraindicated during pregnancy. Safety in pregnant women • In pediatric patients, as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenar- which may lead to an increased risk of rhabdomyolysis. Polymorphism in the gene encoding OATP1B1 Gemfibrozil / fibric acid derivatives has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant chal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia, if after an adequate trial of CONTRAINDICATIONS (SLCO1B1 c.521CC) is associated with a 2.4-fold higher atorvastatin exposure (AUC) than in individuals The use of gemfibrozil and other fibrates such as fenofibrate alone is occasionally associated with muscle women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase diet therapy the following findings are present: • Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. without this genotype variant (c.521TT). A genetically impaired hepatic uptake of atorvastatin is also possible related events, including myopathy/rhabdomyolysis. The risk of these events may be increased with the inhibitors have been received. Animal studies have shown toxicity to reproduction. (Atorvastatin USP) a. LDL-C remains ≥ 190 mg/dL or • Hypersensitivity to Atorvastatin. in these patients. Possible consequences for the efficacy are unknown. concomitant use of atorvastatin. If concomitant administration cannot be avoided, the lowest dose of COMPOSITION b. LDL-C remains ≥ 160 mg/dL and there is a positive family history of premature cardiovascular disease or • During pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate atorvastatin to achieve the therapeutic objective should be used and the patients should be appropriately Serum cholesterol and triglycerides increase during normal pregnancy. Lipid lowering drugs offer no benefit two or more other CVD risk factors are present in the pediatric patient contraceptive measures. Effects on ability to drive and use machines monitored. during pregnancy because cholesterol and cholesterol derivatives are needed for normal fetal development. MYOPRO 10 mg Tablet Atorvastatin has negligible influence on the ability to drive and use machines. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of Each film coated tablet contains: Limitations of Use: WARNINGS AND PRECAUTIONS Niacin cholesterol biosynthesis and hence, may impair normal fetal development. Atherosclerosis is a chronic Atorvastatin USP……. 10 mg (as Calcium trihydrate salt) ADVERSE REACTIONS The risk of skeletal muscle effects may be enhanced when Atorvastatin is used in combination with niacin; a process, and ordinarily discontinuation of lipid-lowering drugs during pregnancy should have little impact on MYOPRO 20 mg Tablet Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of Liver Dysfunction reduction in atorvastatin dosage should be considered in this setting the long-term risk associated with primary hypercholesterolemia. Each film coated tablet contains: chylomicrons (Fredrickson Types I and V) Statins, like some other lipid-lowering drugs, have been associated with biochemical abnormalities of liver Infections and infestations Atorvastatin USP……. 20 mg (as Calcium trihydrate salt) function including persistent elevations (>3 times the upper limit of normal [ULN]) in serum transaminases. Common: nasopharyngitis, Urinary Tract Infection. Ezetimibe For these reasons, Atorvastatin should not be used in women who are pregnant, trying to become pregnant or MYOPRO 40 mg Tablet Prevention of cardiovascular disease in adults Liver function tests should be performed before the initiation of treatment and periodically thereafter. Patients Blood and lymphatic system disorders The use of ezetimibe alone is associated with muscle related events, including myopathy/rhabdomyolysis. suspect they are pregnant. Treatment with Atorvastatin should be suspended for the duration of pregnancy or Each film coated tablet contains: • In adult patients with and without clinically evident coronary heart disease, but with multiple risk factors for who develop any signs or symptoms suggestive of liver injury should have liver function tests performed. Rare: thrombocytopenia. The risk of these events may therefore be increased with concomitant use of ezetimibe and atorvastatin. until it has been determined that the woman is not pregnant. Atorvastatin USP……. 40 mg (as Calcium trihydrate salt) coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary Patients who develop increased transaminase levels should be monitored until the abnormalities resolve. Immune system disorders Appropriate clinical monitoring of these patients is recommended. (USP Specs.) heart disease, MYOPRO is indicated to: Should an increase in transaminases of greater than 3 times the upper limit of normal (ULN) persist, reduction Common: allergic reactions. Nursing mothers • Reduce the risk of myocardial infarction of dose or withdrawal of Atorvastatin is recommended. Upon dose reduction, drug interruption, or discontinu- Very rare: anaphylaxis. Colchicine It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentra- DESCRIPTION • Reduce the risk of stroke ation, transaminase levels return to or near pretreatment levels without sequelae. If serious liver injury with Metabolism and nutrition disorders Cases of myopathy, including rhabdomyolysis, have been reported with atorvastatin co-administered with tions of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious MYOPRO tablets contain Atorvastatin calcium, is a synthetic lipid-lowering agent. Atorvastatin is an • Reduce the risk for revascularization procedures and angina clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly stop Atorvastatin. Common: hyperglycemia colchicine, and caution should be exercised when prescribing atorvastatin with colchicine. adverse reactions, women taking Atorvastatin should not breast-feed their infants. Atorvastatin is contraindi- inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the Uncommon: hypoglycemia, weight gain, anorexia. cated during breastfeeding conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. • In adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or Psychiatric disorders Fusidic acid Atorvastatin calcium is chemically designated as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ- multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, have a history of liver disease. Active liver disease or unexplained persistent transaminase elevations are Uncommon: nightmare, insomnia. As with other statins, muscle related events, including rhabdomyolysis, have been reported in post-marketing Pediatrics dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1Hpyrrole-1-heptanoic acid, calcium salt MYOPRO is indicated to: contraindications to the use of Atorvastatin. Not Known: confusion experience with atorvastatin and fusidic acid given concurrently. The mechanism of this interaction is not Safety and effectiveness in patients 10-17 years of age with heterozygous familial hypercholesterolemia have (2:1) trihydrate. The molecular formula of atorvastatin calcium is (C33H34 FN2O5)2Ca•3H2O. • Reduce the risk of myocardial infarction Nervous system disorders known. Patients should be closely monitored and temporary suspension of atorvastatin treatment may be been demonstrated. There is no significant effect of atorvastatin on growth or sexual maturation in boys or on • Reduce the risk of stroke Patients with Recent stroke or Transient Ischemic Attack (TIA) Common: headache. appropriate. menstrual cycle length in girls. Adolescent females should be counseled on appropriate contraceptive CLINICAL PHARMACOLOGY In a post-hoc analysis of stroke subtypes in patients without coronary heart disease (CHD) who had a recent Uncommon: dizziness, paraesthesia, hypoesthesia, dysgeusia, amnesia. methods while on therapy. Atorvastatin has not been studied in controlled clinical trials involving pre-pubertal • In adult patients with clinically evident coronary heart disease, Myopro is indicated to: stroke or transient ischemic attack (TIA) there was a higher incidence of hemorrhagic stroke in patients Rare: peripheral neuropathy. Grapefruit Juice patients or patients younger than 10 years of age. Pediatric use should only be carried out by physicians Mechanism of Action • Reduce the risk of non-fatal myocardial infarction initiated on atorvastatin 80 mg compared to placebo. The increased risk was particularly noted in patients with Eye disorders Grapefruit contains one or more components that inhibit CYP 3A4 and can increase plasma concentrations of experienced in the treatment
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