In the U.S.—

In Canada—

• Antiviral, systemic

Indinavir ( in-DIN-a-veer) is used, alone or in combination with other medicines, in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Indinavir will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Indinavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Capsules (U.S. and Canada)

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 indinavir, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to indinavir. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Indinavir has not been studied in pregnant women. However, it has caused increased levels of a substance called bilirubin in the mother, which can cause jaundice. It is not known if it causes this effect in the baby. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether indinavir passes into the breast milk in humans. However, it does pass into the milk in animals. Because it can cause serious unwanted effects, breast-feeding is usually not recommended while you are taking indinavir.

Children—Studies on this medicine have been done only in adult patients, and there is limited recommendations comparing the use of indinavir in children with use in other age groups.

Older adults—Indinavir has not been studied specifically in older people. Therefore, it is not known whether it causes different side effects or problems in the elderly than it does in younger adults.

Other medicines—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 indinavir, it is especially important that your health care professional know if you are taking any of the following:

• P450 CYP3A4 substrates such as:
• Cisapride (e.g., Propulsid) or
• Ergot derivatives (e.g., Ergotrate) or
• Midazolam (e.g., Versed) or
• Pimozide (e.g., Orap)
• Triazolam (e.g., Halcion)—There is a possibility that indinavir may interfere with the removal of these medicines from the body, which could lead to serious side effects

• Delavirdine (e.g., Rescriptor) — Use of this medicine with indinavir may increase the amount of indinavir in the body

• Didanosine (e.g., Videx)—It is recommended that this medicine and indinavir be taken at least 1 hour apart so that both will be absorbed properly from the stomach

• Efavirenz (e.g., Sustiva) — Use of this medicine with indinavir may decrease the amount of indinavir in the body

• HMG-CoA inhibitors such as
• Lovastatin (e.g., Mevacor ) or
• Simvastatin (e.g., Zocor) — Use of this medicine may cause an increased risk of certain side effects

• Itraconazole (e.g., Sporanox) — Use of this medicine with indinavir may increase the amount of indinavir in the body

• Ketoconazole (e.g., Nizoral)—Use of this medicine with indinavir may increase the amount of indinavir in the body

• Rifabutin (e.g., Mycobutin)—Use of this medicine with indinavir may increase the amount of rifabutin and decrease the amount of indinavir in the body

• Rifampin (e.g., Rifadin)—Use of this medicine with indinavir may decrease the amount of indinavir in the body

• St. John's Wort (Hypericum perforatum) — Use of this medicine with indinavir may cause indinavir not to work properly

• Sildenafil (e.g., Viagra) — Use of this medicine with indinavir may increase the amount of serious side effects

• Hemophilia— Increased effects of hemophilia may occur when using indinavir

• Hepatitis— Increased effects of hepatitis and hepatic failure may happen when using indinavir

• Hyperbilirubinemia— may make these effects greater in newborn babies

• Liver disease—Effects of indinavir may be increased because of slower removal from the body

This medicine should be taken with water on an empty stomach (1 hour before or 2 hours after a meal) or with a light meal Indinavir may also be taken with other liquids (skim milk, juice, coffee, or tea) or with a light meal (dry toast with jelly, juice, coffee with skim milk and sugar, or corn flakes with skim milk and sugar).

While you are taking indinavir, it is important that you drink extra fluids so that you will pass more urine. This will help prevent possible kidney stones. Follow your doctor's instructions carefully about how much fluid to drink. Usually you will need to drink at least 48 ounces (1.5 liters) of fluids every day during your treatment.

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

Keep taking indinavir for the full time of treatment, even if you begin to feel better.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take three doses a day, the doses should be spaced about 8 hours apart. If you need help in planning the best times to take your medicine, check with your health care professional.

Only take medicine that your doctor has prescribed specially for you. Do not share your medicine with others.

Dosing—

The dose of indinavir may 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 indinavir. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine.

• For oral dosage form (capsules):
  • For treatment of HIV infection:
    • Adults—800 mg every eight hours.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as you remember. 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—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Indinavir capsules are very sensitive to moisture. Keep them in their original container and leave the drying packet in the container.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Do not take any other medicines without checking with your doctor first. To do so may increase the chance of side effects from indinavir.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

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:

• More common
  • Blood in urine;  sharp back pain just below ribs 
  
  

Also, check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Abdominal or stomach pain;  chills;  clay-colored stools;  dark urine;  dizziness;  fever;  headache;  itching;  loss of appetite;  nausea;  rash ;  unpleasant breath odor;  unusual tiredness or weakness;  vomiting of blood ;  yellow eyes or skin 
  
  

• Rare
  • Confusion;  dehydration;  dry or itchy skin;  fatigue;  fruity mouth odor;  increased hunger ;  increased thirst;  increased urination;  pale skin;  troubled breathing with exertion;  unusual bleeding or bruising ;  unusual tiredness or weakness;  vomiting;  weight loss 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Change in sense of taste;  diarrhea;  difficulty in sleeping;  generalized weakness 
  
  

• Less common
  • Acid regurgitation;  acid or sour stomach ;  appetite increase;  belching ;  cough;  general feeling of discomfort or illness ;  heartburn;  indigestion;  sleepiness 
  
  

Other side effects not listed above have occurred since indinavir was released on the market and these side effects may also occur in some patients. How often these side effects occur is unknown. If you notice any other effects, check with your doctor.