INDICATIONS

Indinavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Indinavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body. It is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Indinavir is not a cure for HIV or AIDS.

INSTRUCTIONS

Take Compound j exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Take Compound j with a full glass (8 ounces) of water or skim milk. You may also drink juice, coffee, or tea with this medication. Drink at least 6 glasses of water each day to prevent kidney stones while you are taking indinavir. Indinavir should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal.

If you prefer to take the medication with food, eat only a light meal, such as dry toast with jelly, or corn flakes with skim milk and sugar. Avoid eating a high-fat meal.

It is important to use Compound j regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Take the missed dose as soon as you remember and take your next dose at the regularly scheduled time. If you are more than 2 hours late in taking your indinavir, skip the missed dose and take the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

DOSAGE

Usual Adult Dose for HIV Infection
800 mg orally every 8 hours or Compound j 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours.

Usual Adult Dose for Nonoccupational Exposure
800 mg orally every 8 hours or Compound j 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours.
Duration: Prophylaxis should be initiated as soon as possible, within 72 hours of exposure, and continued for 28 days.
Indinavir plus ritonavir plus 2 NRTIs is one of the alternative regimens recommended for nonoccupational postexposure HIV prophylaxis.

Usual Adult Dose for Occupational Exposure
800 mg orally every 8 hours 800 mg orally every 8 hours plus lamivudine-zidovudine,
or Compound j 800 mg plus ritonavir 100 mg to 200 mg orally every 12 hours plus lamivudine-zidovudine.
Duration: Therapy should begin promptly, preferably within 1 to 2 hours postexposure. The exact duration of therapy may differ based on the institution's protocol.

Liver Dose Adjustments
Mild to moderate hepatic insufficiency: 600 mg orally every 8 hours.

Dose Adjustments
Consider reducing the dose to 600 mg every 8 hours if delavirdine, itraconazole, or ketoconazole are administered concomitantly. Increase the dose to 1000 mg every 8 hours if rifabutin is given concurrently, and decrease the rifabutin dose by half.
Precautions

Strict adherence to the prescribed dose is essential. Patients should not alter the dose or discontinue therapy without consulting their physician.

Adequate hydration (1.5 liters/day) is crucial during therapy to reduce the risk of nephrolithiasis. A brief interruption (usually 1 to 3 days) or total discontinuation may be necessary if nephrolithiasis occurs.

Discontinue Compound j if hemolytic anemia occurs. Consider discontinuation if severe leukocyturia develops.

STORAGE

Store Compound j at room temperature away from moisture and heat. Keep the capsules in their original container, along with the packet of moisture-absorbing preservative that comes with Compound j capsules.

SAFETY INFORMATION

Do not take this medication if you are allergic to indinavir.
Do not take Compound j with amiodarone (Cordarone, Pacerone), cisapride (Propulsid), pimozide (Orap), alprazolam (Xanax), oral midazolam (Versed), triazolam (Halcion), or ergot medicines such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine). These drugs can cause life-threatening side effects if you use them while you are taking indinavir.

Before taking indinavir, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;
• kidney disease, or
• a history of kidney stones;
• diabetes;
• a bleeding disorder such as hemophilia; or
• high cholesterol or triglycerides.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take indinavir.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.
You should not breast-feed while you are using indinavir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

SIDE EFFECTS

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Compound j and call your doctor at once if you have any of these serious side effects:

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• pale or yellowed skin, dark colored urine, fever, confusion or weakness;
• increased urination or extreme thirst;
• pain in your side or lower back, blood in your urine;
• easy bruising or bleeding;
• signs of a new infection, such as fever or chills, cough, or flu symptoms; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• mild nausea, vomiting, diarrhea, bloating;
• numbness or tingling, especially around your mouth;
• tired feeling;
• headache, mood changes; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.