Mevacor


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Related to Mevacor: lovastatin

lovastatin

Altoprev, Apo-Lovastatin (CA), Co Lovastatin (CA), Dom-Lovastatin (CA), Gen-Lovastatin (CA), Mevacor, Novo-Lovastatin (CA), Nu-Lovastatin (CA), PHL-Lovastatin (CA), PMS-Lovastatin (CA), Ran-Lovastatin (CA), Ratio-Lovastatin (CA), Sandoz Lovastatin (CA)

Pharmacologic class: HMG-CoA reductase inhibitor

Therapeutic class: Antihyperlipidemic

Pregnancy risk category X

Action

Inhibits HMG-CoA reductase, an enzyme crucial to cholesterol synthesis. Decreases total cholesterol and low-density lipoprotein (LDL) levels and increases high-density lipoprotein level.

Availability

Tablets: 10 mg, 20 mg, 40 mg

Tablets (extended-release): 10 mg, 20 mg, 40 mg, 60 mg

Indications and dosages

To reduce LDL, total cholesterol, triglyceride, and apolipoprotein B levels

Adults: Initially, 20 mg P.O. daily. May be increased, as needed, at 4-week intervals to a maximum of 80 mg/day as a single dose or in divided doses. Or 20 mg P.O. (extended-release) daily. May be increased, as needed, at 4-week intervals to a maximum daily dosage of 60 mg.

Heterozygous familial hypercholesterolemia in boys and postmenarchal girls ages 10 and older who have high LDL and cholesterol levels despite adequate trial of diet therapy

Adolescents ages 10 to 17: 10 to 40 mg P.O. daily, with adjustments made at 4-week intervals

Dosage adjustment

• Severe renal insufficiency

Off-label uses

• High-risk patients with diabetic dyslipidemia, familial dysbetalipoproteinemia, familial combined hyperlipidemia, or nephrotic hyperlipidemia

Contraindications

• Hypersensitivity to drug, its components, or angiotensin-converting enzyme inhibitors

• Active hepatic disease or unexplained persistent hepatic enzyme elevation

• Concurrent gemfibrozil or azole antifungal therapy

• Pregnancy or breastfeeding

Precautions

Use cautiously in:

• cerebral arteriosclerosis, heart disease, renal impairment, severe acute infection, severe hypotension or hypertension, uncontrolled seizures, myopathy, visual disturbances, major surgery, trauma, alcoholism

• severe metabolic, endocrine, or electrolyte problems

• women of childbearing age

• children.

Administration

• Give daily dose with evening meal.

• Increase dosage at intervals of 4 weeks or longer, as ordered.

• Don't give with grapefruit juice (may increase drug blood level).

Discontinue if alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level exceeds three times the upper limit of normal.

Adverse reactions

CNS: headache, dizziness, asthenia

EENT: blurred vision, eye irritation

GI: nausea, vomiting, constipation, diarrhea, abdominal pain or cramps, dyspepsia, flatulence

Hepatic: hepatotoxicity

Musculoskeletal: myalgia, cramps, rhabdomyolysis

Skin: pruritus, rash, photosensitivity

Other: hypersensitivity reaction

Interactions

Drug-drug. Azole antifungals, cyclosporine, erythromycin, folic acid derivatives, gemfibrozil, niacin: increased risk of myopathy and rhabdomyolysis

Bile acid sequestrants: decreased lovastatin blood level

Isradipine: increased lovastatin clearance

Warfarin: increased prothrombin time, bleeding

Drug-diagnostic tests. ALT, AST: increased levels

Drug-food. Grapefruit juice: increased lovastatin blood level

Drug-herbs. Red yeast rice: increased risk of adverse reactions

Chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, St. John's wort: increased risk of hepatotoxicity

Patient monitoring

• Obtain liver function tests before starting therapy, 6 and 12 weeks after therapy begins or dosage is increased, and periodically thereafter.

Patient teaching

• Tell patient to take immediate-release tablets with evening meal or extended-release tablets at bedtime.

• Instruct patient not to break, crush, or chew extended-release tablets.

• Emphasize importance of cholesterol-lowering diet and other therapies, such as exercise and weight control.

Instruct patient to report unexplained muscle pain, tenderness, or weakness, as well as signs or symptoms of hepatotoxicity (fever, malaise, abdominal pain, yellowing of skin or eyes, clay-colored stools, or tea-colored urine).

Advise patient to contact prescriber immediately if she is breastfeeding or suspects pregnancy.

• Tell patient not to use herbs without consulting prescriber.

• Inform patient that drug may cause photosensitivity. Caution him to avoid excessive sun or heat lamp light.

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

lovastatin

(loe-va-sta-tin) ,

Altoprev

(trade name),

Mevacor

(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, unstable angina, and coronary revascularization) in asymptomatic patients with increased total and low-density lipoprotein (LDL) cholesterol and decreased high-density lipoprotein (HDL) cholesterol.Slows the progression of coronary atherosclerosis in patients with coronary artery 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 after oral administration.
Distribution: Crosses the blood-brain barrier and placenta.
Metabolism and Excretion: Extensively metabolized by the liver, most during first pass; excreted in bile and feces. 10% excreted unchanged by the kidneys.
Half-life: 3 hr.

Time/action profile (cholesterol-lowering effect)

ROUTEONSETPEAKDURATION
PO, PO-ER2 wk4–6 wk6 wk†
†After discontinuation

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Active liver disease or unexplained persistant elevations in AST and ALT; Concurrent use with strong CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone) Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: History of liver disease; Alcoholism; Renal impairment; Concurrent use of gemfibrozil, niacin, cyclosporine, amiodarone, danazol, diltiazem, verapamil, colchicine, or ranolazine (higher risk of myopathy/rhabdomyolysis); Pediatric: Children <10 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

  • blurred vision

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

Endocrinologic

  • hyperglycemia

Genitourinary

  • erectile dysfunction

Dermatologic

  • rashes (most frequent)
  • pruritus

Musculoskeletal

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

Miscellaneous

  • hypersensitivity reactions

Interactions

Drug-Drug interaction

Strong CYP3A4 inhibitors, including ketoconazole, itraconazole, posaonazole, protease inhibitors, boceprevir, telaprevir, clarithromycin, erythromycin, telithromycin, and nefazodone ↑ risk of myopathy; concurrent use contraindicatedCholesterol-lowering effect may be ↑ with cholestyramine andcolestipol, but bioavailability may be ↓.Risk of myopathy is ↑ by concurrent amiodaronecyclosporine,gemfibrozil, diltiazem, verapamil, danazol, and large doses of niacin (concurrent use with gemfibrozil or cyclosporine should be avoided; use ↓ doses with danazol, amiodarone, diltiazem, or verapamil).May ↑ effects of warfarin.St. John's wort may ↓ levels and effectiveness.Grapefruit juice ↑ blood levels and the risk of rhabdomyolysis.Food enhances blood levels of lovastatin.

Route/Dosage

Oral (Adults) 20 mg once daily with evening meal. May be ↑ at 4-wk intervals to a maximum of 80 mg/day (immediate-release) or 60 mg/day (extended-release); Concurrent danazol, verapamil, or diltiazem therapy—Initiate at 10 mg/day; do not exceed 20 mg/day; Concurrent amiodarone therapy—Dose should not exceed 40 mg/day;.

Renal Impairment

Oral (Adults) CCr <30 mL/min—dosage should not exceed 20 mg/day unless carefully titrated.
Oral (Children /Adolescents 10-17 yr) Familial heterozygous hypercholesterolemia—10-40 mg/day; adjusted at 4 wk intervals.

Availability (generic available)

Tablets: 10 mg, 20 mg, 40 mg
Extended-release tablets: 20 mg, 40 mg, 60 mg
In combination with: Niacin (Advicor). See combination drugs.

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 occur, discontinue simvastatin and do not restart. May also cause ↑ alkaline phosphatase and bilirubin levels.
    • If patient develops muscle tenderness during therapy, monitor CPK levels. If CPK levels are >10 times the upper limit of normal or myopathy occurs, therapy should be discontinued.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)
Noncompliance (Patient/Family Teaching)

Implementation

  • Do not confuse Mevacor with Benicar (olmesartan).
  • Oral: Administer with food. Administration on an empty stomach decreases absorption by approximately 30%. Initial once-daily dose is administered with the evening meal. Swallow extended-release tablets whole; do not crush, break or chew.
    • Avoid grapefruit and grapefruit juice during therapy; may increase risk of toxicity.

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 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 wear sunscreen and protective clothing to prevent photosensitivity reactions (rare).
  • Advise patient to notify health care professional of medication regimen before treatment or surgery.,.
  • Instruct female patients to notify health care professional promptly if pregnancy is planned or suspected or if breastfeeding.
  • 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.

Mevacor

(mĕv′ə-kôr′)
A trademark for the drug lovastatin.

Mevacor®

Lovastatin, see there.
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?
The leading statin drugs are Lipitor (generic name atorvastatin), Crestor (rosuvastatin), Mevacor (lovastatin), Pravacol (pravastatin), Zocor (simvastatin) and Lescol (fluvastatin).
(2.) Draft summary of reproductive toxicology studies on Mevacor NDA 21-213: Joint Meeting of the Nonprescription Drugs Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee of the Federal Drug Administration, Merck & Co, (July 13, 2000).
One of these drugs, lovastatin (brand name Mevacor), was tested in the five-year Air Force/Texas Coronary Atherosclerosis Prevention Study, a study of 6,600 people middle-aged and older with slightly elevated LDLs and below normal HDLs, good cholesterol.
Six months ago, a cholesterol-lowering drug called Mevacor was set to be reclassified as an over-the-counter medicine, a move that would have made the drug physically and financially available to people like Alston.
The six HMG-CoA reductase inhibitors (statins) are atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor, Altocor), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor).
The survey of retail executives in all trade classes takes on special significance, an IRI spokesman says, because of the recent withdrawal of Merck & Co.'s Vioxx, the Food and Drug Administration's denial of O-T-C status for Merck's cholesterol-lowering drug Mevacor and proposed laws across the country seeking to move products formulated with pseudoephedrine behind the pharmacy counter.
Merck hit pay dirt with lovastatin (Mevacor), another fungal metabolite.
Women who have a family history of heart attack or stroke, or who suffer from chronic high levels of cholesterol (hypercholesterolemia) may decide to see a cardiologist who may prescribe a statin--Zocor (simvastatin), Mevacor (luvastatin), Pravachol (pravastatin), etc.--to lower cholesterol levels.
And just around that time, a flurry of breakthrough drugs came to market, like Mevacor for elevated cholesterol and Prozac for depression, and new drugs are always pricier than older ones with generic competition.
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.