Pravachol


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Related to Pravachol: Lipitor, Ezetrol, Crestor

pravastatin sodium

Apo-Pravastatin (CA), CO Pravastatin (CA), Dom-Pravastatin (CA), Gen-Pravastatin (CA), Lipostat (UK), Novo-Pravastatin (CA), Nu-Pravastatin (CA), PHL-Pravastatin, (CA), PMS-Pravastatin (CA), Pravachol, Ran-Pravastatin (CA), Ratio-Pravastatin (CA), Riva-Pravastatin (CA), Sandoz Pravastatin (CA)

Pharmacologic class: HMG-CoA reductase inhibitor

Therapeutic class: Antilipemic

Pregnancy risk category X

Action

Inhibits HMG-CoA reductase, an enzyme that catalyzes cholesterol synthesis pathway. This action decreases cholesterol, triglyceride, apolipoprotein B, and low-density lipoprotein (LDL) levels and increases high-density lipoprotein levels.

Availability

Tablets: 10 mg, 20 mg, 40 mg, 80 mg

Indications and dosages

Adjunct to diet to reduce risk of total mortality by reducing coronary death, myocardial infarction, revascularization, stroke or transient ischemic attack, and progression of coronary atherosclerosis in patients with clinically evident coronary heart disease; to reduce elevated total cholesterol, LDL cholesterol (LDL-C), apolipoprotein B, and triglyceride (TG) levels and increase high-density lipoprotein levels in patients with primary hypercholesterolemia and mixed dyslipidemia; to reduce elevated serum TG levels in patients with hypertriglyceridemia; to treat patients with primary dysbetalipoproteinemia who aren't responding to diet

Adults: 40 mg P.O. once daily. Use 80-mg dose only for patients not reaching LDL-C goal with 40 mg. Adjust dosage at 4 weeks according to patient's response and established treatment guidelines.

Heterozygous familial hypercholesterolemia after failure of adequate trial of diet therapy

Adolescents ages 14 to 18: 40 mg P.O. daily

Children ages 8 to 13: 20 mg P.O. daily

Dosage adjustment

• Significant renal impairment

• Concurrent use of niacin

Contraindications

• Hypersensitivity to drug or other HMG-CoA reductase inhibitors

• Active hepatic disease or unexplained, persistent transaminase elevations

• Pregnancy, breastfeeding, females of childbearing age

Precautions

Use cautiously in:

• renal impairment; severe hypotension or hypertension; severe acute infection; severe metabolic, endocrine, or electrolyte disorders; uncontrolled seizures; visual disturbances; myopa-thy; major surgery; trauma; alcoholism

• history of hepatic disease

• concurrent use of gemfibrozil (avoid use)

• concurrent use of colchicine, fibrates, or lipid-modifying doses of niacin (1 g/day or greater)

• children younger than age 8 (safety not established).

Administration

• If patient's also receiving bile-acid resin, give pravastatin at bedtime, at least 4 hours after resin.

Adverse reactions

CNS: headache, malaise, fatigue, dizziness, insomnia, anxiety, depression, tremor, vertigo, memory loss, peripheral nerve palsy, paresthesia, peripheral neuropathy, asthenia

EENT: impaired extraocular eye movements, cataract progression, ophthalmoplegia, dry eyes

GI: nausea, vomiting, diarrhea, constipation, abdominal or biliary pain, flatulence, dyspepsia, heartburn, anorexia, pancreatitis

GU: decreased libido, erectile dysfunction, gynecomastia

Hematologic: anemia, thrombocytopenia, leukopenia

Hepatic: jaundice, cholestatic jaundice, fatty liver changes, hepatoma, hepatic necrosis, hepatitis

Musculoskeletal: joint pain, myalgia, myositis, rhabdomyolysis

Respiratory: dyspnea, upper respiratory tract infection

Skin: nodules, skin discoloration, alopecia, dry skin, pruritus, rash, urticaria, nail changes, photosensitivity

Other: altered taste, localized pain, rare hypersensitivity reactions (including polymyalgia rheumatica, arthritis, dermatomyositis, vasculitis, purpura, positive antinuclear antibody, eosinophilia, fever, chills, flushing, hemolytic anemia, epidermal necrol-ysis, erythema multiforme, Stevens-Johnson syndrome, angioedema, lupus erythematosus-like reaction, and anaphylaxis)

Interactions

Drug-drug. Clarithromycin, colchicine, cyclosporine, erythromycin, fibrates, gemfibrozil, lipid-modifying doses of niacin, other HMG-CoA reductase inhibitors: increased risk of myopathy

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, creatine kinase, creatinine phosphokinase: increased levels

Patient monitoring

• Watch for signs and symptoms of allergic reaction.

• Monitor vital signs and cardiovascular status.

Evaluate liver function tests before starting therapy, 6 to 12 weeks later, and at least semiannually thereafter. Also monitor lipid levels, and watch for evidence of hepatic disorders (rare).

Assess creatine kinase level if patient has muscle pain or is receiving other drugs associated with myopathy. Discontinue drug if myopathy is diagnosed or suspected. Continue to monitor for signs and symptoms of rhabdomyolysis (rare).

Patient teaching

• Caution patient not to take with antacids.

Teach patient to recognize and immediately report signs and symptoms of allergic response and other adverse reactions, especially myositis.

• Tell patient drug may cause headache and musculoskeletal pain. Encourage him to discuss activity recommendations and pain management with prescriber.

Advise patient to promptly report unusual fatigue, yellowing of skin or eyes, and unexplained muscle pain, tenderness, or weakness.

• Advise female of childbearing age to notify prescriber of suspected pregnancy. Caution her not to breastfeed during therapy.

• Tell male patient that drug may cause erectile dysfunction and abnormal ejaculation. Suggest that he discuss these issues with prescriber.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, alertness, and vision.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

pravastatin

(pra-va-sta-tin) ,

Pravachol

(trade name)

Classification

Therapeutic: lipid lowering agents
Pharmacologic: hmg coa reductase inhibitors
Pregnancy Category: X

Indications

Adjunctive management of primary hypercholesterolemia and mixed dyslipidemias.Primary prevention of coronary heart disease (myocardial infarction, coronary revascularization, cardiovascular mortality) in asymptomatic patients with increased total and low-density lipiprotein (LDL) cholesterol and decreased high-density lipoprotein (HDL) cholesterol.Secondary prevention of myocardial infarction, coronary revascularization, stroke, and overall mortality in patients with clinically evident coronary heart disease.

Action

Inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme which is responsible for catalyzing an early step in the synthesis of cholesterol.

Therapeutic effects

Lowering of total and LDL cholesterol and triglycerides. Slightly increases HDL cholesterol.
Slows the progression of coronary atherosclerosis with resultant decrease in coronary heart disease-related events.

Pharmacokinetics

Absorption: Poorly and variably absorbed following oral administration.
Distribution: Unknown.
Metabolism and Excretion: Extensively metabolized by the liver, most during first pass; excreted in bile and feces. 20% excreted unchanged by the kidneys.
Half-life: 1.3–2.7 hr.

Time/action profile (cholesterol-lowering effect)

ROUTEONSETPEAKDURATION
POdays2–4 wkunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Active liver disease or unexplained persistent ↑ in AST and ALT; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: History of liver disease; Alcoholism; Renal impairment; Pediatric: Children <8 yr (safety not established); Women of childbearing age.

Adverse Reactions/Side Effects

Central nervous system

  • amnesia
  • confusion
  • dizziness
  • headache
  • insomnia
  • memory loss
  • weakness

Ear, Eye, Nose, Throat

  • rhinitis

Respiratory

  • bronchitis

Cardiovascular

  • chest pain
  • peripheral edema

Gastrointestinal

  • abdominal cramps (most frequent)
  • constipation (most frequent)
  • diarrhea (most frequent)
  • flatus (most frequent)
  • heartburn (most frequent)
  • altered taste
  • drug-induced hepatitis
  • dyspepsia
  • ↑ liver enzymes
  • nausea
  • pancreatitis

Genitourinary

  • erectile dysfunction

Dermatologic

  • rash (most frequent)
  • pruritus

Endocrinologic

  • hyperglycemia

Musculoskeletal

  • rhabdomyolysis (life-threatening)
  • arthralgia
  • arthritis
  • immune-mediated necrotizing myopathy
  • myalgia
  • myositis

Miscellaneous

  • hypersensitivity reactions

Interactions

Drug-Drug interaction

Cholesterol-lowering effect may be ↑ with bile acid sequestrants (cholestyramine, colestipol ).Bioavailability may be ↓ by bile acid sequestrants ; administer pravastatin ≥1 hr before or 4 hr after bile acid sequestrants.Risk of myopathy is ↑ by concurrentcyclosporine, fibrates, colchicine, erythromycin, clarithromycin, or large doses of niacin ; concurrent use with gemfibrozil should be avoided; consider lower dose of pravastatin with niacin.May ↑ effects of warfarin.Levels may be significantly ↑ by azoleantifungals (temporarily discontinue HMG-CoA reductase inhibitor, effect is less than with other statins).Saquinavir and ritonavir may ↓ levels and effectiveness.

Route/Dosage

Oral (Adults) 10–20 mg once daily at bedtime, may be adjusted at 4-wk intervals as needed (usual range 10–40 mg/day); Concurrent cyclosporine therapy—Dose should not exceed 20 mg/day; Concurrent clarithromycin therapy—Dose should not exceed 40 mg/day.
Oral (Children 14-18 yrs) 40 mg once daily.
Oral (Children 8-13 yrs) 20 mg once daily.
Oral (Geriatric Patients) 10–20 mg once daily at bedtime, may be adjusted at 4-wk intervals as needed (usual range 10–20 mg/day).

Hepatic Impairment

Renal Impairment

Oral (Adults) 10–20 mg once daily at bedtime, may be adjusted at 4-wk intervals as needed (usual range 10–20 mg/day).

Availability (generic available)

Tablets: 10 mg, 20 mg, 40 mg, 80 mg

Nursing implications

Nursing assessment

  • Obtain a diet history, especially with regard to fat consumption.
  • Lab Test Considerations: Evaluate serum cholesterol and triglyceride levels before initiating, after 4–6 wk of therapy, and periodically thereafter.
    • Monitor liver function tests prior to initiation of therapy and as clinically indicated. If symptoms of serious liver injury, hyperbilirubinemia, or jaundice occurs should be discontinue pravastatin and do not restart. May also cause ↑ alkaline phosphatase and bilirubin levels.
    • If patient develops muscle tenderness during therapy, CPK levels should be monitored. If CPK levels are markedly ↑ or myopathy occurs, therapy should be discontinued.

Potential Nursing Diagnoses

Noncompliance (Patient/Family Teaching)

Implementation

  • Oral: Administer once daily in the evening. May be administered without regard to food.
    • Avoid grapefruit and grapefruit juice during therapy; may increase risk of toxicity.
    • If administered in conjunction with bile acid sequestrants (cholestyramine, colestipol), administer 1 hr before or 4 hr after bile acid sequestrant.

Patient/Family Teaching

  • Instruct patient to take medication as directed, not to skip doses or double up on missed doses. Advise patient to avoid drinking more that 200 mL/day of grapefruit juice during therapy. Medication helps control but does not cure elevated serum cholesterol levels.
  • Advise patient that this medication should be used in conjunction with diet restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, and cessation of smoking.
  • Instruct patient to notify health care professional if unexplained muscle pain, tenderness, or weakness occurs, especially if accompanied by fever or malaise.
  • Advise patient to wear sunscreen and protective clothing to prevent photosensitivity reactions (rare).
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
  • Instruct female patients to notify health care professional promptly if pregnancy is planned or suspected.
  • Emphasize the importance of follow-up exams to determine effectiveness and to monitor for side effects.

Evaluation/Desired Outcomes

  • Decrease in LDL and total cholesterol levels.
    • Increase in HDL cholesterol levels.
    • Decrease in triglyceride levels.
  • Slowing of the progression of coronary artery disease.

Pravachol

(prăv′ə-kōl′)
A trademark for the drug pravastatin.
References in periodicals archive ?
First FDA Half-life in Brand name Generic name approval the body Mevacor Lovastatin 1987 Less than 2 hours Zocor Simvastatin * 1991 Less than 2 hours Pravachol Pravastatin 1991 2 hours Lescol Fluvastatin 1993 Less than 3 hours Lipitor Atorvastatin 1996 14 hours Crestor Rosuvastatin 2003 19 hours Lipophilic or Manufacturer and Brand name lipophobic derivation Mevacor Lipophilic Merck, natural compounds Zocor Lipophilic Merck, natural compounds Pravachol Lipophobic Bristol-Myers Squibb, natural compounds Lescol Lipophilic Novartis, synthetic Lipitor Lipophilic Pfizer, synthetic Crestor Lipophobic Pharmaceuticals, synthetic * Low-dose pill approved for over-the-counter sales in U.K.
Atorvastatin (Lipitor) Yes Yes Yes Lovastatin (Mevacor) Limited No Yes Pravastatin (Pravachol) No No Yes Rosuvastatin (Crestor) Limited No Yes Simvastatin (Zocor) Yes No Yes Tips for Drug lifestyle interactions References Generic (brand) modifications?
In an article published last May in Circulation, the journal of the American Heart Association, researchers from Tufts-New England Medical Center's Molecular Cardiology Research Center reported their finding that Crestor isn't as safe as three other statins--Lipitor, Pravachol, and Zocor.
The six HMG-CoA reductase inhibitors (statins) are atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor, Altocor), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor).
For all other statins (including Lipitor, Zocor, Lescol, Pravachol and Mevacor), there have been 27 cases of acute renal failure or renal insufficiency reported from January 1, 2001, through September 30, 2004, out of 316 million prescriptions filled-a rate of .085 cases reported per million prescriptions filled.
In fact, statin medications, which include lovastatin (Mevacor), simvastatin (Zocor), pravastatin (Pravachol), rosuvastatin (Crestor), fluvastatin (Lescol) and atorvastatin (Lipitor), best known for their cholesterol-lowering benefits, work so well at preventing heart disease in people with diabetes, regardless of cholesterol level, that in June 2003 experts began recommending that all people with diabetes, even those with normal cholesterol levels, take a statin.
Patients over age 13 years received 40 mg/day pravastatin (Pravachol) or placebo.
For example, Pravachol was the preferred statin on Michigan's list until the Medicaid program switched to Lipitor, Dr.
In the CRP case, two of the researchers had coauthored an article in 2001 that had been funded by the manufacturer of the statin drug Pravachol, Bristol-Myers Squibb.
There is also evidence for the cholesterol-lowering drugs called statins (Lipitor, Lescol, Mevacor, Pravachol and Zocor) that, when started in middle to later middle-age years, they reduce the risk of dementia, type 2 diabetes and osteoporosis.
Moody's said sales of Sankyo's cholesterol reducer, Mevalotin, sold as Pravachol in the United States, are likely to decline due to price-cutting and stronger competition from new drugs.