Notice
[Posted 3/1/2012] ISSUE: FDA notified healthcare professionals of updates to the prescribing information concerning interactions between protease inhibitors and certain statin drugs. Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk for muscle injury (myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.
BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (''bad cholesterol''). HIV protease inhibitors are a class of prescription anti-viral drugs used to treat HIV. HCV protease inhibitors are a class of prescription anti-viral drugs used to treat hepatitis C infection.
RECOMMENDATION: Healthcare professionals should follow the recommendations in the prescribing information (drug labels) when prescribing HIV or HCV protease inhibitors with statins. See the FDA Drug Safety Communication for additional information, including a data summary. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
Indinavir is used to treat human immunodeficiency virus infection (HIV) in adults. It belongs to a class of drugs called protease inhibitors, which slow the spread of HIV infection in the body. It is usually taken with other antiviral medications. Indinavir is not a cure and may not decrease the number of HIV-related illnesses. Indinavir does not prevent the spread of HIV to other people.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Indinavir comes as a capsule to take by mouth. It is usually taken every 8 hours (three times a day). Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take indinavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Continue to take indinavir even if you feel well. Do not stop taking indinavir without talking to your doctor.
Other uses for this medicine
Indinavir is also used sometimes in combination with zidovudine (Retrovir, AZT) and lamivudine (Epivir) to treat health-care workers and other individuals exposed to HIV infection after accidental contact with HIV-contaminated blood, tissues, or other body fluids. Talk to your doctor about the possible risks of using this drug for your condition.
What special precautions should I follow?
Before taking indinavir,
tell your doctor and pharmacist if you are allergic to indinavir or any other drugs.
tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially astemizole (Hismanal), atorvastatin (Lipitor), cerivastatin (Baycol), cisapride (Propulsid), clarithromycin (Biaxin), delavirdine (Rescriptor), dexamethasone (Decadron), efavirenz (Sustiva), fluconazole (Diflucan), isoniazid (INH), itraconazole (Sporanox), ketoconazole (Nizoral), lovastatin (Mevacor), medications for seizures, midazolam (Versed), oral contraceptives, quinidine, rifabutin (Mycobutin), rifampin (Rifadin), sildenafil (Viagra), simvastatin (Zocor), terfenadine (Seldane), and triazolam (Halcion).
tell your doctor what vitamins and herbal products you are taking, especially St. John's wort.
if you are taking didanosine, take it at least one hour before or after indinavir.
tell your doctor if you have or have ever had hemophilia or kidney or liver disease or a history of alcohol abuse.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking indinavir, call your doctor.
tell your doctor if you drink alcohol.
What special dietary instructions should I follow?
Take indinavir on an empty stomach, 1 hour before meals or 2 hours after meals, with plenty of fluids (an 8-ounce [240-milliliter] glass of water). However, if indinavir upsets your stomach, it may be taken with a light meal, such as dry toast or cornflakes with skim milk. Do not take with grapefruit juice. If you are also taking didanosine (DDI), take 1 hour apart on an empty stomach.
Drink at least 48 ounces (1.5 liters), which is approximately six 8-ounce (240-milliliter) glasses, of water or other liquids every 24 hours.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Indinavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
If you experience any of the following symptoms, call your doctor immediately:
rash
back pain
pain in the side of your body
blood in urine
muscle pain
upset stomach
excessive tiredness
unusual bleeding or bruising
loss of appetite
pain in the upper right part of your stomach
flu-like symptoms
dark yellow or brown urine
yellowing of the skin or eyes
paleness
Indinavir may increase the sugar level in your blood. If you experience any of the following symptoms, call your doctor immediately:
frequent urination
increased thirst
weakness
dizziness
headache
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. A desiccant (drying agent) is included with your capsules; keep this in your medicine bottle at all times. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
