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Pravachol

Pronunciation

Generic Name: Pravastatin Sodium
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

Introduction

Antilipemic agent; hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitor (i.e., statin).1 2 3 4 5 6

Uses for Pravachol

Prevention of Cardiovascular Events

Adjunct to nondrug therapies (e.g., dietary management) 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 71

Adjunct to nondrug therapies (e.g., dietary management) in patients with clinical evidence of CHD to reduce the risk of total mortality by reducing coronary death, to reduce the risk of MI, to reduce the risk of undergoing myocardial revascularization procedures, and to reduce the risk of stroke or TIA.1 71

Adjunct to nondrug therapies (e.g., dietary management) in patients with clinical evidence of CHD to slow the progression of coronary atherosclerosis.1 13 14 16 71 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

Slideshow: Atrial Fibrillation - Stroke Prevention Guidelines & Treatment Options

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 nondrug therapies (e.g., dietary management) 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 or mixed dyslipidemia (Fredrickson type IIa or IIb).1 2 3 5 17 71

Adjunct to dietary therapy and lifestyle modification in the management of heterozygous familial hypercholesterolemia in children ≥8 years of age who, despite an adequate trial of dietary management, have a serum LDL-cholesterol concentration of ≥190 mg/dL or a serum LDL-cholesterol concentration of ≥160 mg/dL and either a family history of premature cardiovascular disease or ≥2 other cardiovascular risk factors.1 71

Adjunct to nondrug therapies (e.g., dietary management) in the treatment of primary dysbetalipoproteinemia (Fredrickson type III) in patients who do not respond adequately to diet.1 71

Adjunct to nondrug therapies (e.g., dietary management) in the treatment of elevated serum triglyceride concentrations (Fredrickson type IV).1 71

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

Pravachol 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

Monitoring during Antilipemic Therapy

  • Monitor lipoprotein concentrations periodically to ensure that target LDL-cholesterol goals are achieved and maintained at <100 mg/dL (optional goal: <70 mg/dL) for patients with CHD or CHD risk equivalents; <130 mg/dL (optional goal: <100 mg/dL) for patients with ≥2 risk factors and 10-year risk of 10–20%; <130 mg/dL for patients with ≥2 risk factors and 10-year risk <10%; or <160 mg/dL for patients with 0–1 risk factor.

Administration

Oral Administration

Administer orally at any time of day without regard to meals.1

Dosage

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 >20 mg daily have not been evaluated.1

Adolescents 14–18 years of age: 40 mg once daily.1 Dosages >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

Prevention of Cardiovascular Events or Management of Dyslipidemias
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

No specific dosage recommendations at this time.71

Use with caution in patients who consume substantial amounts of alcohol, have a recent (<6 months) history of liver disease, or exhibit manifestations of liver disease (e.g., unexplained increases in aminotransferase concentrations, jaundice).1 71

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 substantial renal impairment.1

Cautions for Pravachol

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

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, immediately discontinue therapy and apprise the patient of the potential hazard to the fetus.1 71

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 dosages of statins; patients with multisystem disease (e.g., renal or hepatic impairment), concurrent serious infections, or uncontrolled hypothyroidism; geriatric patients (>65 years of age); patients with small body frame and frailty; and patients undergoing surgery (i.e., during perioperative periods).71

Certain drug interactions also may increase risk of myopathy and/or rhabdomyolysis.1 71 (See Specific Drugs under Interactions.)

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.

Consider myopathy in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation in CK.71 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

Hepatic Effects

Associated with increases in serum aminotransferase (AST, ALT) concentrations.1

Pancreatitis,71 hepatitis (including chronic active hepatitis),71 cholestatic jaundice,71 fatty change in liver,71 cirrhosis,71 fulminant hepatic necrosis,71 hepatoma,71 and fatal and nonfatal hepatic failure71 have been reported.71

Perform liver function tests before initiation of therapy and as clinically indicated (e.g., presence of manifestations suggestive of liver damage201 ).71 Although manufacturer previously recommended more frequent monitoring, FDA concluded that serious statin-related liver injury is rare and unpredictable, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury.200

If serious liver injury with clinical manifestations and/or hyperbilirubinemia or jaundice occurs, promptly interrupt pravastatin therapy.71 If an alternate etiology is not found, do not restart pravastatin.71

Also see Hepatic Impairment under Cautions.

Hyperglycemic Effects

Increases in HbA1c and fasting serum glucose concentrations reported.200 Possible increased risk of developing diabetes.200 May need to monitor glucose concentrations following initiation of statin therapy.201

FDA states that cardiovascular benefits of statins outweigh these small increased risks.200

Endogenous Steroid Production

Statins interfere with cholesterol synthesis and theoretically may blunt adrenal and/or gonadal steroid production.71

Effects of pravastatin on basal steroid hormone levels not established.71 Effects on pituitary-gonadal axis in premenopausal women unknown.71

If clinical evidence of endocrine dysfunction is present, evaluate patients appropriately.71

Caution advised if a statin or another antilipemic agent is used concomitantly with drugs that may decrease concentrations or activity of endogenous steroid hormones (e.g. ketoconazole, spironolactone, cimetidine).71

Cognitive Impairment

Cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) reported rarely.71

Generally nonserious and reversible, with variable times to symptom onset (1 day to years) and resolution (median of 3 weeks following discontinuance of therapy).71 200 Not associated with fixed or progressive dementia (e.g., Alzheimer’s disease) or clinically important cognitive decline.200 Not associated with any specific statin, patient's age, statin dosage, or concomitant drug therapy.200

FDA states that cardiovascular benefits of statins outweigh the small increased risk of cognitive impairment.200

If manifestations consistent with cognitive impairment occur, National Lipid Association (NLA) statin safety assessment task force recommends evaluating and managing patients appropriately.202

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

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

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 in nursing women; women who require pravastatin therapy should not breast-feed their infants.71

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

Use with caution, since age ≥65 years is a predisposing factor for myopathy.71

Hepatic Impairment

Use with caution in patients who consume substantial amounts of alcohol, have a recent (<6 months) history of liver disease, or exhibit manifestations of liver disease (e.g., unexplained increases in aminotransferase concentrations, jaundice).71

Contraindicated in patients with active liver disease or unexplained, persistent increases in liver function test results.1

Renal Impairment

Monitor closely for adverse musculoskeletal effects, since history of renal impairment may be a risk factor for development of rhabdomyolysis.71

Dosage adjustments necessary in patients with substantial renal impairment.1 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Musculoskeletal pain, nausea or vomiting, upper respiratory infection, diarrhea, headache.71

Interactions for Pravachol

Minimally metabolized by CYP3A4; pharmacokinetic interaction unlikely.1

Specific Drugs

Drug

Interaction

Comments

Antileukotrienes (e.g., zileuton)

Increased risk of myopathy and/or rhabdomyolysis when used with certain statins

Bile acid sequestrants (i.e., cholestyramine, colestipol)

Variable effects on pravastatin concentrations1 71

Administer pravastatin 1 hour before or 4 hours after the resin66

Colchicine

Myopathy, including rhabdomyolysis, reported71

Use concomitantly with caution71

Cyclosporine

Substantially increased pravastatin concentrations; possible increased risk of myopathy or rhabdomyolysis71

If used concomitantly, initiate pravastatin at 10 mg daily; do not exceed pravastatin dosage of 20 mg daily1

Digoxin

Slight increases in plasma digoxin and pravastatin concentrations71

Fibric acid derivatives (e.g., fenofibrate, gemfibrozil)

Increased risk of myopathy or rhabdomyolysis71

Gemfibrozil: Avoid concomitant use71

Other fibric acid derivatives (e.g., fenofibrate): Use concomitantly with caution71

Fluvoxamine

Increased risk of myopathy and/or rhabdomyolysis when used with another statin

HIV protease inhibitors

Ritonavir-boosted darunavir: Increased pravastatin peak plasma concentration and AUC71

Ritonavir-boosted darunavir: Some experts recommend using the lowest necessary dosage of pravastatin and carefully monitoring patients72

Lopinavir/ritonavir: Dosage adjustment not necessary72

Ritonavir-boosted saquinavir: Dosage adjustment not necessary72 73

Itraconazole

Increased pravastatin concentrations1

Macrolides (e.g., clarithromycin, erythromycin)

Clarithromycin: Increased risk of myopathy or rhabdomyolysis71

Erythromycin: Increased risk of myopathy71

Clarithromycin: If used concomitantly, do not exceed pravastatin dosage of 40 mg daily71

Metronidazole

Increased risk of myopathy and/or rhabdomyolysis when used with certain statins

Concomitant use generally should be avoided or undertaken with caution

Niacin (antilipemic dosages [≥1 g daily])

Possible increased risk of myopathy71

Use concomitantly with caution; consider reducing pravastatin dosage71

Troleandomycin

Increased risk of myopathy and/or rhabdomyolysis when used with certain statins

Warfarin

Increased warfarin peak plasma concentration and AUC; increased PT71

Pravachol 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

1.8 hours.71

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

Actions

  • 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

  • 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 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

  • Risk of adverse hepatic effects.71 Importance of promptly reporting any symptoms suggestive of liver injury (e.g., fatigue, anorexia, right upper abdominal discomfort, dark urine, jaundice).71

  • Risk of nonserious, reversible cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion).71 200

  • Risk of increased glucose concentrations and development of type 2 diabetes.200 May need to monitor glucose concentrations following initiation of statin therapy.201

  • Importance of advising women and adolescent girls to avoid pregnancy (i.e., using effective and appropriate contraceptive methods) during therapy and informing pregnant women of risk to fetus.1

  • Importance of avoiding breast-feeding during therapy.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.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Pravastatin Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

10 mg (of pravastatin)*

Pravachol

Bristol-Myers Squibb

Pravastatin Sodium Tablets

20 mg (of pravastatin)*

Pravachol

Bristol-Myers Squibb

Pravastatin Sodium Tablets

40 mg (of pravastatin)*

Pravachol

Bristol-Myers Squibb

Pravastatin Sodium Tablets

80 mg (of pravastatin)*

Pravachol

Bristol-Myers Squibb

Pravastatin Sodium Tablets

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. 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/$139.99 or 90/$399.95

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/$172.98 or 90/$493.98

Pravachol 80MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$191.66 or 90/$529.09

Pravastatin Sodium 10MG Tablets (LUPIN PHARMACEUTICALS): 30/$18.99 or 90/$46.97

Pravastatin Sodium 20MG Tablets (LUPIN PHARMACEUTICALS): 30/$27.99 or 90/$45.97

Pravastatin Sodium 40MG Tablets (DR.REDDY'S LABORATORIES): 30/$25.99 or 90/$49.97

Pravastatin Sodium 80MG Tablets (LUPIN PHARMACEUTICALS): 30/$119.99 or 90/$329.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions January 30, 2013. 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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