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Indinavir is used for:

Treating HIV infection in some patients when used in combination with certain other medicines.

Indinavir is an HIV protease inhibitor. It works by slowing the growth of HIV, the virus that causes AIDS.

Do NOT use Indinavir if:

• you are allergic to any ingredient in Indinavir
• you are taking alfuzosin, amiodarone, astemizole, atazanavir, certain benzodiazepines (eg, alprazolam, midazolam, triazolam), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), cisapride, an ergot derivative (eg, ergonovine, ergotamine), erythromycin, pimozide, a proton pump inhibitor (eg, omeprazole), rifampin, a serotonin 5-HT₁ receptor antagonist (eg, eletriptan, sumatriptan), St. John's wort, or terfenadine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Indinavir :

Some medical conditions may interact with Indinavir . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have cirrhosis, liver or kidney problems, diabetes, high blood sugar, high cholesterol, kidney stones, urinary problems (eg, white blood cells in the urine), or blood problems (eg, hemophilia hemolytic anemia)

Some MEDICINES MAY INTERACT with Indinavir . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amiodarone, astemizole, certain benzodiazepines (eg, alprazolam, midazolam,triazolam), cisapride, ergot alkaloids (eg, ergotamine), erythromycin, pimozide, and terfenadine because serious side effects such as increased or prolonged sedation or breathing problems, seizures, blood vessel problems, or heart problems (eg, irregular heartbeat) may occur
• Atazanavir because it may increase the risk of a buildup of bilirubin in the blood
• Proton pump inhibitors (eg, omeprazole), rifampin, or St. John's wort because they may decrease Indinavir 's effectiveness
• Alfuzosin, certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), conivaptan, ranolazine, serotonin 5-HT1 antagonists (eg, eletriptan, sumatriptan) because the risk of their side effects may be increased by Indinavir
• Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, high cholesterol, heart problems, anxiety, mood or mental problems, depression, sinus problems, erectile dysfunction, seizures, other medicines used for HIV infection), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo) may interact with Indinavir , increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Indinavir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Indinavir :

Use Indinavir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Indinavir . Talk to your pharmacist if you have questions about this information.
• Take Indinavir by mouth on an empty stomach at least 1 hour before or 2 hours after eating. You may also take it with a light meal that is low in calories, fat, and protein. Take this medicine with water. You may also take it with other liquids such as skim milk, juice, coffee, or tea.
• Drinking extra fluids while you are taking Indinavir is recommended. You should drink at least 48 ounces (1.5 L) of water a day unless otherwise directed by your doctor.
• If you take didanosine, ask your doctor or pharmacist how to take it with Indinavir .
• Large amounts of garlic may decrease the effectiveness of Indinavir . Talk with your doctor before including garlic in your diet.
• Eating grapefruit or drinking grapefruit juice while you are taking Indinavir may increase the amount of Indinavir in your blood, which may increase your risk for serious side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
• Take Indinavir on a regular schedule every 8 hours around the clock, unless otherwise directed by your doctor.
• Take Indinavir regularly to receive the most benefit from it. Taking Indinavir at the same time each day will help you remember to take it.
• Continue to take Indinavir even if you feel well. Do not miss any doses.
• If you miss a dose of Indinavir by more than 2 hours, do not take that dose. Take your next dose as scheduled. If you miss the dose by less than 2 hours, take that dose immediately and then return to your regular dosing schedule. It is important not to miss doses of Indinavir . Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Indinavir .

Important safety information:

• Indinavir may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Indinavir with caution. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to it.
• This medicine is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
• Indinavir does not stop the spread of HIV to others through blood or sexual contact. Use barrier forms of contraception (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Indinavir , even for a short period of time. If you do, the virus may grow resistent to the medicine and become harder to treat.
• Indinavir may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice signs or symptoms of an infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Indinavir
• Changes in body fat may occur while you are taking Indinavir (eg, increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss any new questions or concerns with your doctor.
• Indinavir may raise your blood sugar. High blood sugar can make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor immediately.
• Diabetes patients - Indinavir may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Indinavir . To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Lab tests, including liver function tests, cholesterol tests, blood counts, and CD4 counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Indinavir in CHILDREN; they may be more sensitive to its effects, especially kidney stones.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Indinavir to the baby. It is not known if Indinavir is found in breast milk. Do not breast-feed while taking Indinavir .

Possible side effects of Indinavir :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bad taste in the mouth; diarrhea; dizziness; drowsiness; headache; nausea; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back, flank, or side pain; bloody or cloudy urine; change in the amount of urine; changes in appetite; chest pain; chills; confusion; dark urine; fast or irregular heartbeat; fever; flushed face; heartburn; ingrown toenails; joint or muscle aches; mental or mood changes; numbness of the mouth; one-sided numbness or weakness; pain while urinating; pale stools; red, swollen, or blistered skin; severe dizziness or fainting; severe or persistent stomach pain or upset; speech problems; swelling of the feet, hands, lower legs, or stomach; unusual hair loss; unusual paleness; unusual tiredness; unusually dry skin; vision changes; weight changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blood in urine; diarrhea; lower back pain; nausea; vomiting.

Store Indinavir at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in the original bottle. Store away from heat, moisture, and light. Do not store in the bathroom. Leave the desiccant in the bottle. Do not eat the desiccant. Keep Indinavir out of the reach of children and away from pets.

General information:

• If you have any questions about Indinavir , please talk with your doctor, pharmacist, or other health care provider.
• This medicine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Indinavir . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.