What is Altoprev?

Lovastatin is used together with a proper diet to lower cholesterol and triglyceride (fat) levels in the blood. This medicine may also help prevent medical problems (eg, chest pain, heart attack, stroke) caused by fat clogging the blood vessels. It may also be used to prevent certain types of heart and blood vessel problems in patients with risk factors for heart problems.

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

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

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.

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.

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.

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lovastatin tablets in children 10 to 17 years of age. However, safety and efficacy in children younger than 10 years of age have not been established.

Teenage girls taking lovastatin tablets should be counseled on appropriate birth control methods to prevent pregnancy.

Appropriate studies have not been performed on the relationship of age to the effects of lovastatin extended-release tablets in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lovastatin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving lovastatin.

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

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

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Bezafibrate
• Ceritinib
• Ciprofibrate
• Clofibrate
• Colchicine
• Conivaptan
• Cyclosporine
• Dabigatran Etexilate
• Dalfopristin
• Danazol
• Daptomycin
• Delavirdine
• Diltiazem
• Dronedarone
• Duvelisib
• Fenofibrate
• Fenofibric Acid
• Fluconazole
• Fosnetupitant
• Gemfibrozil
• Glecaprevir
• Ivosidenib
• Letermovir
• Lomitapide
• Lumacaftor
• Netupitant
• Niacin
• Pibrentasvir
• Quinupristin
• Ranolazine
• Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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 how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

The presence of other medical problems may affect the use of this medicine. Make sure you 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 cause side effects to become worse.

• 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 problems.

• 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.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride levels and to decide if you should continue to take it. Blood tests may be needed 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 keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

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

Check with your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM).

Check with 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 symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

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

Make sure any doctor or dentist who treats you knows that 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 problems.

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