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See Use in effects Specific Populations (8.5). It is side a effects relatively polar hydrophilic compound with crestor a from partition coefficient (octanol/water).59 at a crestor pH.0. Effects of from lipid lowering by pravastatin on progression and crestor regression of crestor coronary artery disease in symptomatic man with normal to crestor moderately elevated serum cholesterol levels. Overall, clinical trial experience showed that liver function test abnormalities observed during pravastatin therapy were usually asymptomatic, not associated with cholestasis, and did not appear to crestor be related to side treatment crestor duration. Limit pravastatin to 20 mg once effects daily for concomitant use with cyclosporine see Dosage and Administration effects (2.6), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3). Marked abnormalities of crestor ALT or AST occurred with similar low frequency (1.2) in both treatment groups. Pravachol Description Pravachol (pravastatin sodium) is one of a class of lipid-lowering compounds, the crestor statins, which reduce cholesterol biosynthesis. The primary safety endpoint was from crestor the proportion of subjects crestor with at least one ALT 2 times the ULN for those with normal ALT ( ULN) at baseline or a doubling of the baseline ALT for those with elevated ALT ( ULN) at baseline. 1 aluminum hydroxide povidones Product Characteristics Color green Score no score Shape rectangle Size 14mm Flavor Imprint Code P;Pravachol;40 Contains Packaging # Item Code Package Description 1 NDC: tablet in 1 bottle Marketing Information Marketing Category Application Number or Monograph. Table 6: care - Primary and Secondary Endpoints Number of Subjects Event Pravastatin 40 effects mg (N2081) Placebo (N2078) Risk Reduction p-value a The risk reduction due to treatment with Pravachol was consistent in both sexes. 10 FD C Blue. Homozygous Familial Hypercholesterolemia Pravastatin has not been evaluated in patients crestor with rare homozygous familial hypercholesterolemia. The Long-term Intervention with Pravastatin in Ischemic Disease Group (lipid). Pravastatin should crestor BE administered TO women OF childbearing AGE only when such patients from ARE highly unlikely TO conceive AND have effects been informed OF THE potential hazards. See Clinical Pharmacology (12.3). Based on urinary recovery of total crestor radiolabeled drug, the average oral absorption of pravastatin is 34 and absolute bioavailability. Concomitant Lipid-Altering Therapy Pravachol may crestor be used with bile acid resins. Uncomplicated myalgia has also been reported in pravastatin-treated patients see Adverse Reactions (6). Pravachol - Clinical Pharmacology Mechanism of Action Pravastatin is a reversible inhibitor of A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate limiting step in the biosynthetic pathway for cholesterol. The reports from are side generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks). Salonen R, Nyyssonen K, Porkkala E,. Jukema JW, Bruschke AVG, van Boven AJ, et al, for the Regression Growth Evaluation Statin Study Group (regress). There have been rare reports of immune-mediated necrotizing side myopathy associated with statin use see Warnings and Precautions (5.1). In 89 of the prospectively followed pregnancies, drug treatment was initiated prior effects to pregnancy and was discontinued at some point in the first crestor side effects trimester when pregnancy was identified. Animal Toxicology and/or Pharmacology CNS Toxicity CNS vascular lesions, characterized by perivascular hemorrhage and edema and mononuclear cell infiltration of perivascular spaces, were seen in dogs treated side with pravastatin at a dose of 25 mg/kg/day. For dosing information see Dosage and Administration (2.4). Niacin The risk of skeletal muscle effects side may effects be enhanced when pravastatin is used in combination with niacin; a reduction in Pravachol dosage should from be considered in this setting see Warnings and Precautions (5.1). Tell your doctor all medications you are taking. Pravastatin, side lipids, and atherosclerosis from in the carotid arteries: Design features of a clinical trial with carotid atherosclerosis outcome (plac II). Reduce the risk. Endocrine Function Statins interfere with cholesterol synthesis and lower effects circulating cholesterol levels from and, as crestor coupon such, might theoretically blunt adrenal or gonadal steroid hormone production. Transient, asymptomatic eosinophilia has been reported. Analysis of pooled events from plac I, plac II,8 regress, and kaps9 studies (combined N1891) showed that treatment with pravastatin was associated with a statistically significant reduction in the composite event rate of fatal and nonfatal MI (46. Livalo may interact with cyclosporine, erythromycin, rifampin, gemfibrozil, other fibrates, niacin, or warfarin. There have been rare reports of immune-mediated necrotizing myopathy (imnm an autoimmune myopathy, associated with statin use. The dose range for Livalo is 1 to 4 mg orally once daily. Patients were exposed to pravastatin for a mean.0.1 years in WOS, care, and lipid and.9.9 years in plac I, plac II, kaps, and regress. LDL-C levels in this patient population ranged from 101 to 180 mg/dL (mean 139 mg/dL). LDL-C remains 160 mg/dL and: there is a positive family history of premature cardiovascular canada crestor generic disease (CVD) or two or more other CVD risk factors are present in the patient. Pravastatin sodium is designated chemically as 1-Naphthalene-heptanoic acid, monosodium salt, 1S-1(S S 2,6,8(R. Similarly, the peak pravastatin values varied side effects of crestor 47-fold for cirrhotic patients compared to 6-fold for healthy subjects. The benefit of further alterations in lipid levels by the combined use of Pravachol with fibrates should be carefully weighed against the potential risks of this combination. Also call your doctor at once if you have: confusion, memory problems; kidney problems -vomiting, pain in your side or lower back, little or no urinating, swelling, rapid weight gain; or liver problems -loss of appetite, stomach pain (upper right side. Patients with Renal Impairment In patients with severe renal impairment, a starting dose of 10 mg pravastatin daily is recommended. This response is maintained during extended periods of therapy. See Use in Specific Populations (8.4). Livalo Side Effects Center, find Lowest Prices on, last reviewed on RxList 8/17/2017. Lactation Pravastatin is present in human milk. Other macrolides (e.g., erythromycin and azithromycin) have the potential to increase statin exposures while used in combination. In a 2-year study in mice fed pravastatin at doses of 250 and 500 mg/kg/day, there was an increased incidence of hepatocellular carcinomas in males and females at both 250 and 500 mg/kg/day (p.0001). Adverse Clinical Events Short-Term Controlled Trials In the Pravachol placebo-controlled clinical trials database of 1313 patients (age range 20-76 years,.4 women,.5 Caucasians, 5 Blacks,.9 Hispanics,.4 Asians,.2 Others) with a median treatment duration. Serum pravastatin levels at 15 mg/kg/day are approximately 1 times (AUC) the maximum pediatric dose of. The safety and tolerability profile in the pravastatin group was comparable to that of the placebo group. Secondary Prevention of Cardiovascular Events In the lipid4 study, the effect of Pravachol, 40 mg daily, was assessed in 9014 patients (7498 men; 1516 women; 3514 elderly patients age 65 years; 782 diabetic patients) who had experienced either. This is not a complete list of side effects and others may occur. View All, indications and Usage for Pravachol, therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Postmarketing Experience In addition side to the events reported above, as with other drugs in this class, the following events have been reported during postmarketing experience with Pravachol, regardless of causality crestor assessment: Musculoskeletal: myopathy, rhabdomyolysis, tendon disorder, side polymyositis. In pregnant rats given oral gavage doses of 4, 20, 100, 500, and 1000 mg/kg/day from gestation days 7 through 17 (organogenesis) increased mortality of offspring and increased cervical rib skeletal anomalies were observed at 100 mg/kg/day systemic. As an adjunct to diet and lifestyle modification for treatment of heterozygous familial hypercholesterolemia (HeFH) in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present:. However, neither myopathy nor significant increases in CPK levels have been observed in 3 reports involving a total of 100 post-transplant patients (24 renal and 76 cardiac) treated for up to 2 years concurrently with pravastatin 10 to 40 mg and cyclosporine. Juvenile male rats given 90 times (AUC) the 40 mg dose had decreased fertility (20) with sperm abnormalities compared to controls. Hepatic crestor Impairment: In a study comparing the kinetics of pravastatin in patients with biopsy confirmed cirrhosis (N7) and normal subjects (N7 the mean AUC varied 18-fold in cirrhotic patients and 5-fold in healthy subjects. Generic Name: pravastatin sodium, dosage Form: tablet, medically reviewed on Jun 1, 2017, show On This Page. Geriatric: In a single oral dose study using pravastatin 20 mg, the mean AUC for pravastatin was approximately 27 greater and the mean cumulative urinary excretion (CUE) approximately 19 lower in elderly men (65-75 years old) compared with younger men (19-31 years old). In pregnant rats given oral gavage doses of 10, 100, and 1000 mg/kg/day from gestation day 17 through lactation day 21 (weaning increased mortality of offspring and developmental delays were observed at 100 mg/kg/day systemic exposure, corresponding. USE IN specific populations Pregnancy Risk Summary Pravachol is contraindicated for use in pregnant woman because of the potential for fetal harm. Breastfeeding is not recommended while taking this medication. Colchicine The risk of myopathy/rhabdomyolysis is increased with concomitant administration of colchicine see Warnings and Precautions (5.1). Renal: urinary abnormality (including dysuria, frequency, nocturia). All adverse clinical events (regardless of causality) reported in 2 of pravastatin-treated patients in placebo-controlled trials of up to 8 months duration are identified in Table 1: Table 1: Adverse Events in 2 of Patients Treated with. The beneficial effect of pravastatin in elderly subjects in reducing cardiovascular events and in modifying lipid profiles was similar to that seen in younger subjects. J Am Coll Cardiol. Despite this decrease in systemic bioavailability, the efficacy of pravastatin administered once daily in the evening, although not statistically significant, was marginally more effective than that after a morning dose. Doses greater than 40 mg have not been studied in this patient population. Structural formula: Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. Data Human Data Limited published data on pravastatin have not shown an increased risk of major congenital malformations or miscarriage. Pediatric Patients In a 2-year, double-blind, placebo-controlled study involving 100 boys and 114 girls with HeFH (n214; age range 8-18.5 years, from 53 female, 95 Caucasians, 1 Blacks, 3 Asians, 1 Other the safety and tolerability profile of pravastatin was generally similar to that of placebo. Animal Data Embryofetal and neonatal mortality was observed in rats given pravastatin during the period of organogenesis or during organogenesis continuing through weaning. A single daily dose is as effective as the same total daily dose given twice a day. There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Excretion: Approximately 20 of a radiolabeled oral dose is excreted in urine and 70 in the feces. This finding was not evident in rats examined at the completion of the dosing period and was not associated with any inflammatory or degenerative changes in the brain. Although the Pravachol 10 mg tablets are no longer available, pravastatin 10 mg tablets are available. However, the percentage of patients showing a 50 rise in plasma testosterone after human chorionic effects gonadotropin stimulation did not change significantly after therapy in these patients. Pitt B, Mancini GBJ, Ellis SG, crestor et al, for the PLAnvestigators. Table 7: Primary Hypercholesterolemia Studies: from Dose Response of Pravachol Once Daily Administration a A multicenter, double-blind, placebo-controlled study. Exposures were 10 times (rabbit) or 120 times (rat) the human exposure at 80 mg/day mrhd based on body surface area (mg/m2). Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK. At these doses, lung adenomas in females were increased (p0.013). If an alternate etiology is not found do not restart Pravachol. LDL-C.04b.07b.07b.52 crestor (26.74,.86).75b.08b.72b.65 (20.40,.83) HDL-C.04.71.97.13 (1.71,.43).188.8.131.52 (13.95,.01) from ApoB (N).16b (61).08b (39).11b (100).97 (106) (24.29. Pravastatin significantly decreased plasma levels of LDL-C, Total-C, and ApoB in both children and adolescents (see Table 10 ). When administered to juvenile rats (postnatal days PND 4 through 80 at 5-45 mg/kg/day no drug related changes were observed at 5 mg/kg/day. At baseline, 84 of patients were receiving side aspirin and 82 from were taking antihypertensive medications. All patients treated with Pravachol should be advised to promptly report any symptoms that may indicate liver injury, including crestor fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice see Warnings and Precautions (5.2). Although the difference between pravastatin and placebo for the primary endpoint (per-patient change in mean coronary artery diameter) and 1 of 2 secondary endpoints (change in percent lumen diameter stenosis) did not reach statistical significance, for the secondary endpoint of change.
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