Mevacor (Oral)

Lovastatin is used along with a proper diet to lower cholesterol and triglyceride (fat) levels in the blood. This medicine may also help prevent medical problems (like chest pain, heart attack, and stroke) that can happen when fat clogs the blood vessels. It may also be used to prevent certain heart and blood vessel problems in patients who have risk factors for heart issues.

Lovastatin belongs to a group of medicines called HMG-CoA reductase inhibitors, or statins. It works by reducing the amount of cholesterol in the blood by blocking an enzyme that the body needs to make cholesterol.

This medicine is available only with a doctor's prescription.

It is very important for your doctor to check your progress during regular visits. This allows your doctor to see if the medicine is effectively lowering your cholesterol and triglyceride levels and to decide if you should continue taking it. You may need blood tests to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you might be pregnant while using the medicine, tell your doctor immediately.

Do not use lovastatin if you are also taking boceprevir (Victrelis®), cobicistat-containing products (Stribild®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), gemfibrozil (Lopid®), nefazodone (Serzone®), telaprevir (Incivek®), certain antibiotics (e.g., clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole, Nizoral®), or medicines to treat HIV/AIDS (e.g., atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Kaletra®, Lexiva®, Norvir®, Prezista®, Reyataz®). Using these medicines with lovastatin may increase your risk of muscle injury and could lead to kidney problems.

Contact your doctor immediately if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These may be signs of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM).

Contact your doctor right away if you have dark urine, diarrhea, fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be signs of a serious muscle issue called rhabdomyolysis, which can cause kidney problems.

Call your doctor immediately if you have a headache, stomach pain, vomiting, dark urine, loss of appetite, weight loss, a general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellowing of the eyes or skin. These could be signs of liver damage.

Make sure that any doctor or dentist treating you knows you are using this medicine. You may need to stop using this medicine if you have major surgery, a major injury, or if you develop other serious health issues.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it compared to its benefits. Here are some important points to think about:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any specific problems that would limit the use of lovastatin tablets in children aged 10 to 17 years. However, safety and effectiveness in children younger than 10 years have not been proven.

Teenage girls taking lovastatin tablets should be advised on suitable birth control methods to avoid pregnancy.

No appropriate studies have been performed on how age affects the use of lovastatin extended-release tablets in children. Safety and effectiveness have not been established.

Geriatric

Studies done so far have not shown any specific problems that would limit the use of lovastatin in older adults. However, older patients are more likely to have age-related kidney issues, which might require a dose adjustment for those taking lovastatin.

Breast Feeding

Research in breastfeeding women has shown harmful effects on infants. You should either be prescribed a different medication or stop breastfeeding while taking this medicine.

Interactions with Medicines

Some medicines should never be used together, while others may be used together with caution. In cases where there might be an interaction, your doctor may change the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The following interactions are based on their potential significance and are not a complete list.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you are taking.

• Amprenavir
• Atazanavir
• Boceprevir
• Clarithromycin
• Cobicistat
• Darunavir
• Erythromycin
• Fosamprenavir
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Lopinavir
• Mibefradil
• Mifepristone
• Nefazodone
• Nelfinavir
• Nirmatrelvir
• Posaconazole
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

Using this medicine with any of the following is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Adagrasib
• Amiodarone
• Belzutifan
• Bezafibrate
• Ceritinib
• Ciprofibrate
• Clofibrate
• Colchicine
• Conivaptan
• Cyclosporine
• Dabigatran Etexilate
• Dabrafenib
• Dalfopristin
• Danazol
• Daptomycin
• Delavirdine
• Diltiazem
• Dronedarone
• Duvelisib
• Fedratinib
• Fenofibrate
• Fenofibric Acid
• Fexinidazole
• Fluconazole
• Fosnetupitant
• Gemfibrozil
• Glecaprevir
• Ivosidenib
• Larotrectinib
• Lefamulin
• Lenacapavir
• Letermovir
• Lomitapide
• Lorlatinib
• Lumacaftor
• Mavacamten
• Netupitant
• Niacin
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Phenobarbital
• Pibrentasvir
• Pirtobrutinib
• Primidone
• Quinupristin
• Ranolazine
• Ritlecitinib
• Tocilizumab
• Trofinetide
• Verapamil

Using this medicine with any of the following may increase the risk of certain side effects, but using both may be the best treatment for you. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Azithromycin
• Bosentan
• Clopidogrel
• Oat Bran
• Pectin
• St John's Wort

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtimes or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are chosen for their potential significance and are not a complete list.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of this medicine or provide special instructions regarding food, alcohol, or tobacco use.

• Grapefruit Juice

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or
• Diabetes, poorly controlled or
• Hypothyroidism (an underactive thyroid) or
• Liver disease, history of—Use with caution. May worsen side effects.

• Electrolyte disorder, severe or
• Endocrine disorder, severe or
• Epilepsy (seizures), uncontrolled or
• Hypotension (low blood pressure) or
• Kidney disease, severe or
• Metabolic disorder, severe or
• Sepsis (severe infection)—Patients with these conditions may be at risk for muscle or kidney issues.

• Hypercholesterolemia (high cholesterol in the blood), familial homozygous—Less effective in patients with this condition.

• Liver disease, active or
• Liver enzymes, elevated—Should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Bladder pain
• bloody or cloudy urine
• chest tightness
• cough
• dark urine
• difficult, burning, or painful urination
• difficulty with moving
• fever
• frequent urge to urinate
• headache
• joint pain or swelling
• lower back or side pain
• muscle ache, cramp, spasm, stiffness, pain, tenderness, or weakness
• pain or tenderness around the eyes and cheekbones
• stuffy or runny nose
• swollen joints
• trouble breathing
• unusual tiredness or weakness

Incidence not known

• Bloating
• chills
• constipation
• diarrhea
• difficulty swallowing
• dizziness
• fast heartbeat
• general tiredness and weakness
• hives, itching, skin rash
• indigestion
• light-colored stools
• loss of appetite
• nausea
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• upper right abdominal or stomach pain
• vomiting
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Belching
• bloated or full feeling
• blurred vision
• difficulty having a bowel movement
• dizziness
• excess air or gas in the stomach or bowels
• heartburn
• lack or loss of strength
• passing gas
• stomach discomfort, upset, or pain

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• changes to the hair or nails
• confusion
• decreased interest in sexual intercourse
• depression
• discoloration or dryness of the skin or mucous membrane
• false sense of well-being
• fear or nervousness
• feeling of constant movement of self or surroundings
• forgetfulness
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• loss of libido
• memory loss
• mood swings
• partial or slight paralysis of the face
• personality changes
• sensation of spinning
• swelling of the breasts or breast soreness in both females and males
• tremor
• trouble sleeping
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet
• white area over the eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Altoprev
• Mevacor

Available Dosage Forms:

• Tablet, Extended Release
• Tablet

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: HMG-COA Reductase Inhibitor

Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take more or less often than your doctor ordered.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.

Take the tablet with food. Take the extended-release tablet without food.

Swallow the extended-release tablet whole. Do not crush, break, or chew it.

If you are taking danazol (Danocrine®), diltiazem (Cardizem®), dronedarone (Multaq®), or verapamil (Calan®, Isoptin®, Verelan®) together with lovastatin, your lovastatin dose should not be higher than 20 milligrams (mg) per day, unless otherwise directed by your doctor. Do not use more than 40 mg per day of lovastatin together with amiodarone (Cordarone®). When used together with higher doses of lovastatin, these medicines may increase your risk of muscle injury and could result in kidney problems.

Tell your doctor if you drink grapefruit juice. Drinking large amounts of grapefruit juice (more than 1 quart each day) while taking this medicine may increase your risk of muscle injury and could result in kidney problems.

Do not drink large amounts of alcohol with lovastatin. This could cause unwanted effects on the liver.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For high cholesterol: For oral dosage form (extended-release tablets): Adults—At first, 20 to 60 milligrams (mg) once a day, in the evening at bedtime. Your doctor may increase your dose as needed. Children—Use and dose must be determined by your doctor. For oral dosage form (tablets): Adults—At first, 20 milligrams (mg) once a day given with the evening meal. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg per day. Children 10 to 17 years of age—At first, 10 mg once a day given with the evening meal. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day. Children younger than 10 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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