Altoprev

Altoprev is a prescription medication used to treat high cholesterol levels. It is also used to prevent heart disease or slow the progression of heart disease. Altoprev should be used along with diet and other measures to lower cholesterol. Altoprev belongs to a group of drugs called HMG-CoA reductase inhibitors, also known as statins. It works by decreasing the amount of cholesterol and other fatty substances made in the body and slowing their buildup in arteries.

Altoprev comes as an extended release (long-acting) tablet to take by mouth. It is usually taken once a day at bedtime. Do not crush, chew, or break Altoprev tablets. Swallow the tablets whole.

Common side effects of Altoprev include infection, headache, accidental injury, and back pain.

Altoprev is a prescription medication used to treat high cholesterol levels.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Andrx Laboratories, Inc.

• Shionogi Inc.

Serious side effects have been reported with Altoprev. See "Drug Precautions" section.

Common side effects of Altoprev include:

• constipation
• memory loss or forgetfulness
• confusion
• muscle pain, tenderness, or weakness
• fever
• nausea
• blurred vision
• itching
• rash

This is not a complete list of Altoprev side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• amiodarone (Cordarone, Pacerone)
• cimetidine (Tagamet)
• clarithromycin (Biaxin)
• colchicine (Colcrys)
• danazol (Danocrine)
• cyclosporine (Neoral, Sandimmune)
• spironolactone (Aldactone)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• oral contraceptives (birth control pills)
• spironolactone (Aldactone)
• telithromycin (Ketek)
• verapamil (Calan, Covera, Isoptin)
• warfarin (Coumadin, Jantoven)
• antifungal medications such as itraconazole (Sporanox), posaconazole (Noxafil), and ketoconazole (Nizoral)
• HIV protease inhibitors such as amprenavir (Agenerase), atazanavir (Reyataz), and darunavir (Prezista)
• other cholesterol-lowering medications such as fenofibrate (Tricor), gemfibrozil (Lopid), and niacin (nicotinic acid, Niacor, Niaspan)

This is not a complete list of Altoprev side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Altoprev including:

• Myopathy and rhabdomyolysis (muscle damage and dysfunction): Tell your healthcare provider right away if you have some or all of the following symptoms:
  • muscle pain
  • muscle tenderness
  • muscle weakness. Altoprev therapy should be discontinued immediately if myopathy is diagnosed or suspected.
• Liver problems: Tell your healthcare provider right away if you have some or all of the following symptoms of liver problems:
  • feeling tired or weak
  • loss of appetite
  • upper belly pain
  • dark, amber colored urine
  • yellow tinting of the skin or eyes
• Homozygous Familial Hypercholesterolemia: Use of Altoprev for this rare genetic disorder (increased cholesterol levels) is not sufficient enough for treatment. More aggressive therapies are typically required.

Altoprev can cause dizziness or blurred vision. Do not drive or operate heavy machinery until you know how Altoprev affects you.

Do not take Altoprev if you:

• take medications that stop the function of the CYP3A4 enzyme (e.g. itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, and nefazodone)
• use erythromycin
• are allergic to Altoprev or any ingredient found in this medication
• active liver disease, which may include unexplained high levels of markers of liver function
• are pregnant or are breast feeding

Grapefruit and grapefruit juice may interact with Altoprev and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Altoprev, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have muscle aches or weakness
• have liver problems
• drink alcohol on a daily basis
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Altoprev falls into category X. This drug should not be used during pregnancy as it has the potential to cause miscarriage or severe birth defects.

Altoprev may harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

You should not take Altoprev if you are breastfeeding. It may be excreted in your breast milk and may harm your nursing child.

Take Altoprev exactly as prescribed.

Altoprev comes as an extended-release (long-acting) tablet to take by mouth and is taken once a day at bedtime.

Swallow Altoprev tablets whole, do not crush, chew, or split tablets.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Altoprev at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dosing range of Altoprev is 20 to 60 mg/day in single or two divided doses. The maximum recommended dose is 80 mg/day. 

If you take too much Altoprev, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Altoprev at room temperature.
• Protect from light and store in a well-closed, light-resistant container.
• Keep this and all medicines out of the reach of children.