Class: HMG-CoA Reductase Inhibitors
VA Class: CV350
Chemical Name: [1S - [1α(βS*,δS*),2α,6α,8β(R*),8aα]] - 1,2,6,7,8,8a - Hexahydro - β,δ,6 - trihydroxy - 2 - methyl - 8 - (2 - methyl - 1 - oxobutoxy) - 1 - naphthalene - heptanoic acid monosodium salt
CAS Number: 81131-70-6
Brands: Pravachol
Special Alerts:
[Posted 09/30/2008] An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as “Lou Gehrig's Disease.” The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.
The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.
Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins. For more information visit the FDA website at: and .
Introduction
Antilipemic agent; hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitor (i.e., statin).1 2 3 4 5 6
Uses for Pravastatin Sodium
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Prevention of Cardiovascular Events
Adjunct to dietary therapy in patients with hypercholesterolemia without clinical evidence of CHD to reduce the risk of MI, to reduce the risk of undergoing myocardial revascularization procedures, and to reduce the risk of cardiovascular mortality (with no increase in death from noncardiovascular causes).1 12
Adjunct to dietary therapy in patients with clinical evidence of CHD to reduce the risk of total mortality by reducing coronary death, to reduce the risk of recurrent MI, to reduce the risk of undergoing myocardial revascularization procedures, and to reduce the risk of stroke or TIA.1
Adjunct to dietary therapy in patients with clinical evidence of CHD to slow the progression of atherosclerosis.1 13 14 16 Has been shown to slow the progression and/or induce regression of atherosclerosis in a few patients without clinical evidence of CHD† who had mild to moderate elevations of LDL-cholesterol concentrations.61
Intensive antilipemic therapy (atorvastatin 80 mg daily) shown to be more effective than moderate antilipemic therapy (pravastatin 40 mg daily) in reducing the risk of cardiovascular events in patients hospitalized for acute coronary syndrome (16% reduction in composite risk of death or major cardiovascular events for atorvastatin compared with pravastatin regimen).69 Intensive antilipemic therapy also more effective in slowing progression of coronary atherosclerosis in patients with CHD.70
Dyslipidemias
Adjunct to dietary therapy in adults to decrease elevated serum total and LDL-cholesterol, apolipoprotein B (apo B), and triglyceride concentrations and to increase HDL-cholesterol concentrations in the management of primary hypercholesterolemia and mixed dyslipidemia, including heterozygous familial hypercholesterolemia and other causes of hypercholesterolemia (e.g., polygenic hypercholesterolemia).1 2 3 5 17
Adjunct to dietary therapy and lifestyle modification in the management of heterozygous familial hypercholesterolemia in children 8 years of age and older who have a serum LDL-cholesterol concentration of 190 mg/dL or greater and in those who have a serum LDL-cholesterol concentration of 160 mg/dL or greater and either a family history of premature cardiovascular disease or multiple cardiovascular risk factors despite an adequate trial of dietary management.1
Adjunct to dietary therapy in the treatment of patients with primary dysbetalipoproteinemia who do not respond adequately to diet.1
Adjunct to dietary therapy in the treatment of patients with elevated serum triglyceride concentrations.1
Reduction of total and LDL-cholesterol concentrations in patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus† (diabetic dyslipidemia),51 62 cardiac† or liver† transplantation,19 63 or nephrotic syndrome† (nephrotic hyperlipidemia).20
Pravastatin Sodium Dosage and Administration
General
Patients should be placed on a standard lipid-lowering diet before initiation of pravastatin therapy and should remain on this diet during treatment with the drug.1
Administration
Oral Administration
Administer orally at any time of day without regard to meals.1
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Available as pravastatin sodium; dosage expressed in terms of pravastatin.1
Pediatric Patients
Dyslipidemias
Oral
Children 8–13 years of age: 20 mg once daily.1 Dosages exceeding 20 mg daily have not been evaluated.1
Adolescents 14–18 years of age: 40 mg once daily.1 Dosages exceeding 40 mg daily have not been evaluated.1
Re-evaluate in adulthood and modify therapy appropriately to achieve adult target LDL-cholesterol goals.1
Adults
Dyslipidemias and Prevention of Cardiovascular Events
Oral
Initially, 40 mg once daily.1 If antilipemic response is inadequate, increase dosage to 80 mg daily.1 Adjust dosage at intervals of ≥4 weeks until the desired effect on lipoprotein concentrations is observed.1
Special Populations
Hepatic Impairment
Initially, 10 mg once daily in patients with a history of substantial hepatic impairment.1
Use with caution in patients who consume substantial amounts of alcohol, in patients who have a history of liver disease, or in those with manifestations of liver disease (e.g., jaundice);1 monitor such patients closely.1 Contraindicated in patients with active liver disease or unexplained, persistent increases in serum aminotransferase concentrations.1
Renal Impairment
Initially, 10 mg once daily in patients with a history of substantial renal impairment.1
Cautions for Pravastatin Sodium
Contraindications
Active liver disease or unexplained, persistent elevations of serum aminotransferases.1
Pregnancy or lactation.1 Administer to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards.1
Known hypersensitivity to pravastatin or any ingredient in the formulation.1
Warnings/Precautions
Warnings
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Fetal/Neonatal Morbidity and Mortality
Suppression of cholesterol biosynthesis could cause fetal harm.1 Congenital anomalies following intrauterine exposure to statins reported rarely.1
Administer to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards.1 If the patient becomes pregnant while taking the drug, discontinue therapy and apprise the patient of the potential hazard to the fetus.1
Hepatic Effects
Associated with increases in serum aminotransferase (AST, ALT) concentrations.1
Pancreatitis,1 hepatitis (including chronic active hepatitis),1 cholestatic jaundice,1 fatty change in liver,1 abnormal liver function tests,1 and, rarely, cirrhosis,1 fulminant hepatic necrosis,1 and hepatoma1 have been reported.1
Perform liver function tests before initiation of therapy or increase in dosage and thereafter as clinically indicated.1
Patients who develop increased serum AST/ALT concentrations or manifestations of liver disease should have a second liver function evaluation to confirm the finding and should receive frequent liver function tests thereafter until the abnormalities return to normal.1 If increases in AST or ALT concentrations of 3 times the upper limit of normal (ULN) or higher persist, discontinue therapy.1
Musculoskeletal Effects
Myopathy (manifested as muscle pain, tenderness, or weakness and serum creatine kinase [CK, creatine phosphokinase, CPK] concentration increases >10 times the ULN) reported occasionally.1
Rhabdomyolysis (characterized by muscle pain or weakness with marked increases [>10 times the ULN] in serum CK concentrations and increases in Scr [usually accompanied by brown urine and urinary myoglobinuria]) with acute renal failure secondary to myoglobinuria has been reported.1
Risk of myopathy increased in patients receiving higher doses of statins; in patients with multisystem disease (e.g., renal or hepatic impairment); in patients with concurrent serious infections or hypothyroidism; in patients (particularly women) of advanced age (especially >80 years of age); in patients with small body frame and frailty; and in patients undergoing surgery (i.e., during perioperative periods). Risk is increased by concomitant administration of certain statins with cyclosporine, erythromycin, niacin, or fibric acid derivatives (e.g., gemfibrozil).1 (See Interactions.) Myopathy or substantial increases in serum CK concentrations were not observed in >100 transplant recipients receiving pravastatin (10–40 mg daily) and cyclosporine concomitantly for up to 2 years.1 Myopathy was not reported in a limited number of patients receiving pravastatin concomitantly with niacin.1 Myopathy also was not reported in patients receiving pravastatin (40 mg daily) concomitantly with gemfibrozil (1200 mg daily); however, marked serum CK elevations and discontinuance of therapy due to adverse musculoskeletal effects occurred more frequently in patients receiving combination therapy with gemfibrozil than in those receiving pravastatin alone.1
Measure baseline serum CK concentrations prior to initiation of therapy, particularly in black men or in patients receiving concomitant therapy with fibric acid derivatives.
Obtain serum CK concentrations and compare with baseline concentrations in patients presenting with musculoskeletal symptoms suggestive of myopathy; because hypothyroidism may be a predisposing factor, thyrotropin (thyroid-stimulating hormone, TSH) concentrations also should be obtained in such patients.
Discontinue if serum CK concentrations increase markedly or if myopathy is diagnosed or suspected.1
Monitor patients weekly if myalgia (muscle pain, tenderness) is present with either no CK elevation or a moderate elevation (3–10 times the ULN) until manifestations improve; discontinue if manifestations worsen.
Dosage reduction or temporary discontinuance may be prudent in patients with muscle discomfort and/or weakness in the presence of progressive elevation of CK concentrations on serial measurements.
Temporarily withhold therapy in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; uncontrolled seizures).1
Sensitivity Reactions
Hypersensitivity Reactions
Anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, hemolytic anemia, positive antinuclear antibody (ANA), increased erythrocyte sedimentation rate (ESR), arthritis, arthralgia, asthenia, photosensitivity, chills, malaise, toxic epidermal necrolysis, and erythema multiforme (including Stevens-Johnson syndrome) reported during postmarketing surveillance.1
General Precautions
Role as Adjunct Therapy
Prior to institution of antilipemic therapy, vigorously attempt to control serum cholesterol by appropriate dietary regimens, weight reduction, exercise, and treatment of any underlying disorder that might be the cause of lipid abnormality.1
CNS Effects
CNS vascular lesions (e.g., perivascular hemorrhage and edema, mononuclear cell infiltration of perivascular spaces) observed in animals.1
Ocular Effects
Optic nerve degeneration observed in animals treated with certain statins.1
Specific Populations
Pregnancy
Category X.1 (See Contraindications and also see Fetal/Neonatal Morbidity and Mortality under Cautions.)
Lactation
Small amounts distributed into milk.1 Use contraindicated.1
Pediatric Use
Safety and efficacy not established in children <8 years of age.1 Advise adolescent girls to use effective and appropriate contraceptive methods during therapy to reduce the likelihood of unintended pregnancy.1
Geriatric Use
No substantial differences in safety or efficacy relative to younger adults.1
Caution in patients (particularly women) of advanced age (especially >80 years of age) and in those with small body frame and frailty.
Hepatic Impairment
Use with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease; monitor such patients closely.1
Contraindicated in patients with active liver disease or unexplained, persistent increases in liver function test results.1
Renal Impairment
Small increase in plasma concentrations of inactive metabolite; closely monitor patients with renal impairment.1
Common Adverse Effects
GI disturbances (e.g., nausea, vomiting, flatulence, constipation, diarrhea, abdominal pain, heartburn), headache, fatigue, localized pain, rash, dizziness, urinary abnormality, chest pain, rhinitis, cough.1
Interactions for Pravastatin Sodium
Minimally metabolized by CYP3A4; pharmacokinetic interaction unlikely.1
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Anticoagulants, oral (e.g., warfarin) | Pharmacologic interaction (e.g., increased PT) unlikely1 | |
Antileukotrienes (e.g., zileuton) | Increased risk of myopathy and/or rhabdomyolysis when used with certain statins | |
Bile acid sequestrants (i.e., cholestyramine, colestipol) | Possible decreased plasma pravastatin concentrations1 | Administer pravastatin ≥ 1 hour before or at least 2–4 hours after the resin1 |
Cyclosporine | Possible increased pravastatin concentrations.1 (See Musculoskeletal Effects under Cautions.) | If pravastatin is used concomitantly, initiate pravastatin at 10 mg daily; pravastatin dosage should not exceed 20 mg daily.1 |
Digoxin | Increased plasma digoxin concentrations when used with certain statins | |
Erythromycin | Increased risk of myopathy and/or rhabdomyolysis when used with certain statins1 | |
Fibric acid derivatives (e.g., gemfibrozil) | Possible decreased urinary excretion and protein binding of pravastatin1 (See Musculoskeletal Effects under Cautions.) | Concomitant use generally should be avoided unless benefits of combined therapy outweigh risks.1 |
Fluvoxamine | Increased risk of myopathy and/or rhabdomyolysis when used with another statins | |
Itraconazole | Increased pravastatin concentrations1 | |
Metronidazole | Increased risk of myopathy and/or rhabdomyolysis when used with certain statins | Concomitant use generally should be avoided or undertaken with caution |
Niacin | Increased risk of myopathy and/or rhabdomyolysis when used with certain statins1 (See Musculoskeletal Effects under Cautions.) | |
Troleandomycin | Increased risk of myopathy and/or rhabdomyolysis when used with certain statins |
Pravastatin Sodium Pharmacokinetics
Absorption
Bioavailability
Rapidly absorbed following oral administration; undergoes extensive first-pass metabolism in the liver.1 Mean peak plasma concentrations occur at 1–1.5 hours.1
Absolute bioavailability is 17%.1
Evening administration of the drug is associated with a decrease in the extent of absorption;1 however, the antilipemic activity remains unchanged and may be superior to the activity achieved with morning administration.1
Onset
A therapeutic response to pravastatin is usually apparent within 1 week after initiating therapy, with a maximal response occurring within 4 weeks.1
Food
Food appears to reduce the systemic bioavailability of pravastatin;1 however, antilipemic effects are similar whether pravastatin is administered with or 1 hour prior to meals.1
Distribution
Extent
Distributed mainly to the liver.1
Distributed into milk in small amounts.1
Plasma Protein Binding
Approximately 50%.1
Elimination
Metabolism
Undergoes enzymatic and nonenzymatic biotransformation independent of the CYP enzyme system. The principal metabolites are pharmacologically inactive.
Elimination Route
Excreted in urine (20%) and feces (70%).1
Half-life
0.5–3 hours.
Special Populations
Renal impairment may reduce clearance of pravastatin and/or active metabolites.1
Hepatic impairment may reduce clearance of pravastatin and/or active metabolites.1
Stability
Storage
Oral
Tablets
Tight containers at 25°C (may be exposed to 15–30°C); protect from light and moisture.1
ActionsActions
Inhibits HMG-CoA reductase, causing subsequent reduction in hepatic cholesterol synthesis.1 Reduces serum concentrations of total cholesterol, LDL-cholesterol, apolipoprotein B (apo B), and triglycerides.1
Statins may slow progression of and/or induce regression of atherosclerosis in coronary and/or carotid arteries, modulate blood pressure in hypercholesterolemic patients with hypertension, and possess anti-inflammatory activity.
Advice to Patients
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Importance of informing patients about risks, especially rhabdomyolysis, associated with statins alone or combined with other drugs.1 Importance of patients promptly reporting muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.1
Importance of adhering to nondrug therapies and measures (i.e., therapeutic lifestyle changes, including dietary management, weight control, physical activity, and management of potentially contributory disease [e.g., diabetes mellitus]).
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 Necessity for clinicians to advise women and adolescent girls to avoid pregnancy (i.e., using effective and appropriate contraceptive methods) during therapy and to advise pregnant women of risk to fetus.1
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 10 mg (of pravastatin) | Pravachol (with povidone) | Bristol-Myers Squibb |
20 mg (of pravastatin) | Pravachol (with povidone) | Bristol-Myers Squibb | ||
40 mg (of pravastatin) | Pravachol (with povidone) | Bristol-Myers Squibb | ||
80 mg (of pravastatin) | Pravachol (with povidone) | Bristol-Myers Squibb |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Pravachol 10MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$119.99 or 90/$335.98
Pravachol 20MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$121.99 or 90/$349.98
Pravachol 40MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$169.98 or 90/$484.99
Pravachol 80MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$191.66 or 90/$529.09
Pravastatin Sodium 10MG Tablets (TEVA PHARMACEUTICALS USA): 30/$18.99 or 90/$46.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
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Compare Pravastatin Sodium with other medications
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- Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
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