Indinavir

Indinavir is a prescription medicine used for the treatment of HIV (Human Immunodeficiency Virus), the virus that causes AIDS. Indinavir is in a group of medications called protease inhibitors. It works by blocking protease enzymes that are required for the virus to make DNA and replicate. 

Indinavir is a prescription medication used for the treatment of HIV (Human Immunodeficiency Virus). HIV is the virus that causes AIDS (acquired immune deficiency syndrome). Indinavir is usually prescribed with other anti-HIV drugs such as ZDV (also called AZT), 3TC, ddI, ddC, or d4T.

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

Indinavir may be found in some form under the following brand names:

• Crixivan

Some patients treated with indinavir developed kidney stones. In some of these patients this led to more severe kidney problems, including kidney failure or inflammation of the kidneys or kidney infection which sometimes spread to the blood. Drinking at least six 8-ounce glasses of liquids (preferably water) each day should help reduce the chances of forming a kidney stone. Call your doctor or other health care provider if you develop kidney pains (middle to lower stomach or back pain) or blood in the urine.

Some patients treated with indinavir have had rapid breakdown of red blood cells (hemolytic anemia) which in some cases was severe or resulted in death.

Some patients treated with indinavir have had liver problems including liver failure and death. Some patients had other illnesses or were taking other drugs. It is uncertain if indinavir caused these liver problems.

Diabetes and high blood sugar (hyperglycemia) have occurred in patients taking protease inhibitors. In some of these patients, this led to ketoacidosis, a serious condition caused by poorly controlled blood sugar. Some patients had diabetes before starting protease inhibitors, others did not. Some patients required adjustments to their diabetes medication. Others needed new diabetes medication.

In some patients with hemophilia, increased bleeding has been reported.

Severe muscle pain and weakness have occurred in patients taking protease inhibitors, including indinavir, together with some of the cholesterol-lowering medicines called "statins". Call your doctor if you develop severe muscle pain or weakness.

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long term health effects of these conditions are not known at this time.

In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from opportunistic infections may occur when combination antiretroviral treatment is started.

Increases in bilirubin (one laboratory test of liver function) have been reported in approximately 14% of patients. Usually, this finding has not been associated with liver problems. However, on rare occasions, a person may develop yellowing of the skin and/or eyes.

Side effects occurring in 2% or more of patients included: abdominal pain, fatigue or weakness, low red blood cell count, flank pain, painful urination, feeling unwell, nausea, upset stomach, diarrhea, vomiting, acid regurgitation, increased or decreased appetite, back pain, headache, dizziness, taste changes, rash, itchy skin, yellowing of the skin and/or eyes, upper respiratory infection, dry skin, and sore throat.

Swollen kidneys due to blocked urine flow occurred rarely.

Other side effects reported since indinavir has been marketed include: allergic reactions; severe skin reactions; yellowing of the skin and/or eyes; heart problems including heart attack; stroke; abdominal swelling; indigestion; inflammation of the kidneys; decreased kidney function; inflammation of the pancreas; joint pain; depression; itching; hives; change in skin color; hair loss; ingrown toenails with or without infection; crystals in the urine; painful urination; numbness of the mouth and increased cholesterol.

Tell your doctor promptly about these or any other unusual symptoms. If the condition persists or worsens, seek medical attention.

Tell your doctor about any medicines you are taking or plan to take, including non-prescription medicines, herbal products including St. John's wort (Hypericum perforatum), or dietary supplements.

Especially tell your doctor if you take:

• Versed (midazolam)
• Orap (pimozide)
• Cordarone (amiodarone)
• Halcion (triazolam)
• Xanax (alprazolam)
• Revatio (sildenafil)
• Uroxatral (alfuzosin)
• Ergot medications
• Rifampin
• Statins such as Zocor (simvastatin), Mevacor (lovastatin), Lipitor (atorvastatin), and Crestor (rosuvastatin)
• calcium channel blockers such as amlodipine, felodipine
• antiarrhythmics such as quinidine
• anticonvulsants such as phenobarbital, phenytoin, or carbamazepine
• steroids such as dexamethasone

Taking indinavir with Reyataz (atazanavir) is not recommended because they can both sometimes cause increased levels of bilirubin in the blood.

Taking indinavir with St. John's wort (Hypericum perforatum), an herbal product sold as a dietary supplement, or products containing St. John's wort is not recommended. Taking St. John's wort has been shown to decrease indinavir levels and may lead to increased viral load and possible resistance to indinavir or cross resistance to other antiretroviral drugs.

Indinavir does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using indinavir.

Avoid doing things that can spread HIV-1 infection.

• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Do not take indinavir if you have had a serious allergic reaction to any of its components.

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

Talk to your doctor if:

• you are pregnant or breastfeeding

Also talk to your doctor if you have:

• problems with your liver, especially if you have mild or moderate liver disease caused by cirrhosis
• problems with your kidneys
• diabetes
• hemophilia
• high cholesterol and you are taking cholesterol-lowering medicines called "statins"

Tell your doctor about any medicines you are taking or plan to take, including non-prescription medicines, herbal products including St. John's wort (Hypericum perforatum), or dietary supplements.

Tell your doctor if you are pregnant or if you become pregnant while you are taking indinavir. It is not known how indinavir affects pregnant women or their developing babies.

Tell your doctor if you are breastfeeding. Do not breastfeed. It is not known if indinavir can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

There are six important things you must do to help you benefit from indinavir:

1. Take indinavir capsules every day as prescribed by your doctor. Continue taking indinavir unless your doctor tells you to stop. Take the exact amount of indinavir that your doctor tells you to take, right from the very start. To help make sure you will benefit from indinavir, you must not skip doses or take "drug holidays". If you don't take indinavir as prescribed, the activity of indinavir may be reduced (due to resistance).
    
2. Take indinavir capsules every 8 hours around the clock, every day. It may be easier to remember to take indinavir if you take it at the same time every day. If you have questions about when to take indinavir, your doctor or health care provider can help you decide what schedule works for you.
    
3. If you miss a dose by more than 2 hours, wait and then take the next dose at the regularly scheduled time. However, if you miss a dose by less than 2 hours, take your missed dose immediately. Then take your next dose at the regularly scheduled time. Do not take more or less than your prescribed dose of indinavir at any one time.
    
4. Take indinavir with water. You can also take indinavir with other beverages such as skim or non-fat milk, juice, coffee, or tea.
    
5. Ideally, take each dose of indinavir without food but with water at least one hour before or two hours after a meal. Or you can take indinavir with a light meal. Examples of light meals include dry toast with jelly, juice, and coffee (with skim or non-fat milk and sugar if you want) and cornflakes with skim or non-fat milk and sugar.
   Do not take indinavir at the same time as any meals that are high in calories, fat, and protein (for example — a bacon and egg breakfast). When taken at the same time as indinavir, these foods can interfere with indinavir being absorbed into your bloodstream and may lessen its effect.
    
6. It is critical to drink plenty of fluids while taking indinavir. Adults should drink at least six 8-ounce glasses of liquids (preferably water) throughout the day, every day. Your health care provider will give you further instructions on the amount of fluid that you should drink. Indinavir can cause kidney stones. Having enough fluids in your body should help reduce the chances of forming a kidney stone. Call your doctor or other health care provider if you develop kidney pains (middle to lower stomach or back pain) or blood in the urine.

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:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your liver function

The recommended dose of indinavir is 800 mg (usually two 400-mg capsules) orally every 8 hours.

If you take too much indinavir, call your doctor or local Poison Control Center, or seek emergency medical attention.

• Keep indinavir capsules in the bottle they came in and at room temperature (59°-86°F).
• Keep indinavir capsules dry by leaving the small desiccant in the bottle. Keep the bottle closed.