What is the most important information I should know about lovastatin?

You should not take lovastatin if you are allergic to it, if you are pregnant or breast-feeding, or if you have liver disease.

Stop taking this medication and tell your doctor right away if you become pregnant.

Before taking lovastatin, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, or if you drink more than 2 alcoholic beverages daily.

In rare cases, lovastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Avoid eating foods that are high in fat or cholesterol. Lovastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

There are many other drugs that can increase your risk of serious medical problems if you take them together with lovastatin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Lovastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

What is lovastatin?

Lovastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Lovastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Lovastatin is used to lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors

Lovastatin is used in adults and children who are at least 10 years old.

Lovastatin may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking lovastatin?

You should not take lovastatin if you are allergic to it, if you are pregnant or breast-feeding, or if you have liver disease.

If you have any of these other conditions, you may need a dose adjustment or special tests:

• history of liver disease;
• history of kidney disease;
• diabetes;
• a thyroid disorder; or
• if you drink more than 2 alcoholic beverages daily.

In rare cases, lovastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Tell your doctor about all other medications you use. Certain other drugs can increase your risk of serious muscle problems, and it is very important that your doctor knows if you are using any of them:

• amiodarone (Cordarone, Pacerone);
• danazol (Danocrine);
• nefazodone (an antidepressant);
• verapamil (Calan, Covera, Isoptin, Verelan);
• gemfibrozil (Lopid), fenofibric acid (Fibricor, Trilipix), or fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, Tricor, Triglide);
• antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
• antifungal medications such as itraconazole (Sporanox) or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);
• HIV medications such as atazanavir (Reyataz), ritonavir (Norvir), lopinavir/ritonavir (Kaletra), saquinavir (Invirase), and others;
• medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others); or
• drugs that weaken your immune system, such as steroids, cancer medicine, or medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not take lovastatin if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking lovastatin.

Lovastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking lovastatin.

How should I take lovastatin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Lovastatin is usually taken at bedtime or with an evening meal. If you take lovastatin several times daily, take it with meals. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may need to stop using lovastatin for a short time if you have surgery or a medical emergency.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

Lovastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

You may need to take lovastatin on a long-term basis for the treatment of high cholesterol.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking lovastatin?

Avoid eating foods that are high in fat or cholesterol. Lovastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Grapefruit and grapefruit juice may interact with lovastatin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

What are the possible side effects of lovastatin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking lovastatin and call your doctor at once if you have any of these serious side effects:

• unexplained muscle pain, tenderness, or weakness;
• fever, unusual tiredness, and dark colored urine;
• chest pain;
• swelling, weight gain, urinating less than usual or not at all; or
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• headache;
• mild muscle pain;
• joint pain;
• back pain;
• mild nausea;
• stomach pain or indigestion;
• constipation; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect lovastatin?

Tell your doctor about all other medications you use, especially:

• cimetidine (Tagamet);
• a blood thinner such as warfarin (Coumadin);
• spironolactone (Aldactone, Aldactazide); or
• any other "statin" medication such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin and niacin (Advicor), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Simcor, Vytorin).

This list is not complete and other drugs may interact with lovastatin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about lovastatin.