Lovastatin

What is Lovastatin?

• Lovastatin (Altocor; Altoprev; Mevacor) is a cholesterol lowering agent isolated from a strain of Aspergillus terreus.

Lovastatin

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What are the uses of this medicine?

• Lovastatin (Altocor) is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Lovastatin is also used to decrease the amount of cholesterol (a fat-like substance) and other fatty substances in the blood.
• Lovastatin is indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb***), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate.
• Lovastatin is indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age.

In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin is indicated to reduce the risk of:

• Myocardial infarction
• Unstable angina
• Coronary revascularization procedures

How does this medicine work?

• Lovastatin (loe" va stat' in) is an orally available inhibitor of hepatic 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the major rate-limiting enzyme in cholesterol synthesis.
• Like other members of its class (the “statins”), lovastatin lowers total serum cholesterol and low density lipoprotein (LDL) concentrations, thereby reducing the risk of atherosclerosis and its complications – myocardial infarction and stroke.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who are:

• Hypersensitivity to any component of this medication.
• Pregnancy and lactation

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• boceprevir (Victrelis)
• clarithromycin (Biaxin)
• cobicistat-containing medications (Stribild)
• erythromycin (E.E.S.,EryC)
• nefazodone
• certain HIV protease inhibitors including atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), and tipranavir (Aptivus); telaprevir (Incivek)
• telithromycin (Ketek)
• amiodarone (Cordarone, Pacerone)
• anticoagulants ('blood thinners') such as warfarin (Coumadin)
• cimetidine (Tagamet)
• colchicine (Colcrys)
• cyclosporine (Neoral, Sandimmune); danazol (Danocrine)
• diltiazem (Cardizem, Dilacor, Tiazac)
• dronedarone (Multaq)
• other cholesterol-lowering medications such as fenofibrate (Tricor), gemfibrozil (Lopid), and niacin (nicotinic acid, Niacor, Niaspan)
• spironolactone (Aldactone)
• ranolazine (Ranexa)
• verapamil (Calan, Covera, Isoptin, Verelan)

Tell your doctor if you drink more than two alcoholic beverages daily.

Is this medicine FDA approved?

• Lovastatin was approved for use in the United States in 1987, the first of this class of drugs to be commercially available. Lovastatin is a widely prescribed drug with more than 7 million prescriptions filled yearly.

How should this medicine be used?

• The patient should be placed on a standard cholesterol-lowering diet before receiving lovastatin and should continue on this diet during treatment with lovastatin.

Recommended dosage: Adult Patients:

• The usual recommended starting dose is 20 mg once a day given with the evening meal.
• The recommended dosing range is 10-80 mg/day in single or two divided doses; the maximum recommended dose is 80 mg/day.
• Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of lovastatin if cholesterol levels fall significantly below the targeted range.

Dosage in Patients taking Cyclosporine or Danazol:

• Therapy should begin with 10 mg of lovastatin and should not exceed 20 mg/day.

Dosage in Patients taking Amiodarone or Verapamil:

• In patients taking amiodarone or verapamil concomitantly with lovastatin, the dose should not exceed 40 mg/day.

Adolescent Patients (10-17 years of age) with Heterozygous Familial Hypercholesterolemia:

• The recommended dosing range is 10-40 mg/day; the maximum recommended dose is 40 mg/day.

Dosage in Patients with Renal Insufficiency:

• In patients with severe renal insufficiency (creatinine clearance <30 mL/min), dosage increases above 20 mg/day should be carefully considered.

Administration:

• Lovastatin comes as a tablet and an extended-release (long-acting) tablet to take by mouth.
• The regular tablet usually is taken once or twice a day with meals.
• The extended-release tablet usually is taken once a day at bedtime.
• Take lovastatin at around the same time(s) every day.
• Swallow the extended-release tablets whole; do not split, chew, or crush them.
• Your doctor may start you on a low dose of lovastatin and gradually increase your dose, not more than once every 4 weeks.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a tablet and an extended-release (long-acting) tablet

This medicine is available in fallowing brand namesː

• Altocor; Altoprev; Mevacor

What side effects can this medication cause?

The most common side effects of this medicine include:

• Asthenia
• Abdominal pain
• Constipation
• Diarrhea
• Dyspepsia
• Flatulence
• Nausea
• Muscle cramps
• Myalgia
• Dizziness
• Headache
• Rash
• Blurred vision

What special precautions should I follow?

• Lovastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above 10 × the upper limit of normal (ULN). As with other HMG-CoA reductase inhibitors, the risk of myopathy/rhabdomyolysis is dose related.
• The use of lovastatin concomitantly with the potent CYP3A4 inhibitors itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or large quantities of grapefruit juice (>1 quart daily) should be avoided.
• Lovastatin may elevate creatine phosphokinase and transaminase levels.
• Lovastatin is less effective in patients with the rare homozygous familial hypercholesterolemia, possibly because these patients have no functional LDL receptors.
• Patients should be advised about substances they should not take concomitantly with lovastatin and be advised to report promptly unexplained muscle pain, tenderness, or weakness.
• Patients should also be advised to inform other physicians prescribing a new medication that they are taking lovastatin.
• Lovastatin is associated with mild, asymptomatic and self-limited serum aminotransferase elevations during therapy and rarely with clinically apparent acute liver injury. Your doctor will order laboratory tests to see how well your liver is working even if you do not think you have liver disease. Your doctor will probably tell you not to take lovastatin if you have liver disease or if the tests show that you may be developing liver disease.
• Tell your doctor if you drink more than two alcoholic beverages daily, if you are 65 years of age or older, if you have ever had liver disease or if you have or have ever had seizures, muscle aches or weakness, low blood pressure, diabetes, or kidney disease.
• It is not known whether lovastatin is excreted in human milk. Do not breastfeed while you are taking this medication.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking lovastatin. If you are hospitalized due to serious injury or infection, tell the doctor who treats you that you are taking lovastatin.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category X.
• Safety in pregnant women has not been established.

Can this medicine be used in children?

• Safety and effectiveness in patients 10-17 years of age with heFH have been evaluated.
• Doses greater than 40 mg have not been studied in this population.
• Lovastatin has not been studied in pre-pubertal patients or patients younger than 10 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Lovastatin

Inactive ingredients:

• lactose monohydrate
• magnesium stearate
• cellulose, microcrystalline
• poloxamer 188
• Sodium Starch Glycolate Type A Potato
• Starch, Corn
• talc
• butylated hydroxyanisole

Who manufactures and distributes this medicine?

Manufactured by:

• Carlsbad Technology, Inc.
• Carlsbad, CA

Distributed by:

• AvKARE, Inc.
• Pulaski, TN

What should I know about storage and disposal of this medication?

• Store at 20º-25º C (68º-77º F).
• Lovastatin Tablets must be protected from light and stored in a well-closed, light-resistant container.

Lipid lowering medications

• Bile Acid Resins/Sequestrants

• • Cholestyramine
  • Colesevelam
  • Colestipol

• Fibrates
  • Clofibrate
  • Fenofibrate
  • Gemfibrozil

• Monoclonal Antibodies - Anti-PCSK9
  • Alirocumab
  • Evolocumab

• Niacin (Nicotinic Acid)

• • Omega-3 Fatty Acids,
  • Icosapent Ethyl
  • Omega-3 Acid Ethyl Esters
  • Omega-3 Carboxylic Acids

• Statins
  • Atorvastatin
  • Fluvastatin
  • Lovastatin
  • Pitavastatin
  • Pravastatin
  • Rosuvastatin
  • Simvastatin

• Miscellaneous
  • Ezetimibe
  • Lomitapide
  • Mipomersen

• Dailymed label info on Lovastatin
• FDA Lovastatin

Lovastatin Resources
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