Indinavir

What is indinavir used for?

Indinavir is a prescription medicine that is used to treat HIV infection.

Description

CRIXIVAN® (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease. CRIXIVAN Capsules are formulated as a sulfate salt and are available for oral administration in strengths of 200 and 400 mg of indinavir (corresponding to 250 and 500 mg indinavir sulfate, respectively). Each capsule also contains the inactive ingredients anhydrous lactose and magnesium stearate. The capsule shell has the following inactive ingredients and dyes: gelatin and titanium dioxide.

The chemical name for indinavir sulfate is [1(1S,2R),5(S)]-2,3,5-trideoxy-N-(2,3-dihydro-2-hydroxy-1H-inden-1-yl)-5-[2-[[(1,1-dimethylethyl)amino]carbonyl]-4-(3-pyridinylmethyl)-1-piperazinyl]-2-(phenylmethyl)-D-erythro-pentonamide sulfate (1:1) salt. Indinavir sulfate has the following structural formula:

Indinavir sulfate is a white to off-white, hygroscopic, crystalline powder with the molecular formula C36H47N5O4 • H2SO4 and a molecular weight of 711.88. It is very soluble in water and in methanol.

Before taking indinavir, tell your doctor:

• If you are allergic to indinavir; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with indinavir, like certain drugs that are used for high cholesterol, migraines, or mood problems. There are many drugs that must not be taken with indinavir.
• If you are taking St. John’s wort. Do not take St. John’s wort with indinavir. This medicine may not work as well.
• If you are breast-feeding. Do not breast-feed while you take indinavir.

This is not a list of all drugs or health problems that interact with indinavir.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take indinavir with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take indinavir?

• Tell all of your health care providers that you take indinavir. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine interacts with many other drugs. The chance of indinavir’s side effects may be raised or how well indinavir works may be lowered. The chance of the other drugs’ side effects may also be raised. This may include very bad, life-threatening, or deadly side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take indinavir with all of your other drugs (prescription or OTC, natural products, vitamins).
• High blood sugar has happened with indinavir. This includes diabetes that is new or worse.
• Check your blood sugar as you have been told by your doctor.
• Some people with hemophilia have had times of more bleeding when taking drugs like this one. If you have hemophilia, talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may raise the chance of kidney stones. Be sure to drink lots of fluids while taking indinavir. Children are more likely to get kidney stones than adults.
• Very bad and sometimes deadly liver problems have happened with indinavir. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• A very bad and sometimes deadly type of anemia called hemolytic anemia has happened with indinavir. Call your doctor right away if you have pale skin, dizziness, fever or chills, very bad back or belly pain, dark urine, yellow skin or eyes, or you feel very tired or weak.
• This medicine is not a cure for HIV. Stay under the care of your doctor.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using indinavir while you are pregnant.

How is indinavir best taken?

Use indinavir as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with water, juice, skim milk, coffee, tea, or a light snack. Take 1 hour before or 2 hours after meals.
• If taking indinavir with ritonavir, you may take it with food.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Do not take didanosine within 1 hour of indinavir.
• Keep taking indinavir as you have been told by your doctor or other health care provider, even if you feel well.
• It is important that you do not miss or skip a dose of indinavir during treatment.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it has been 2 hours or more since the missed dose, skip the missed dose and go back to the normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are the side effects of indinavir that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Pain in side.
• Cloudy or pink-red urine.
• Bladder pain or pain when passing urine or change in how much urine is passed.
• Back pain, belly pain, or blood in the urine. May be signs of a kidney stone.
• Change in body fat.
• Changes in your immune system can happen when you start taking drugs to treat HIV. If you have an infection that you did not know you had, it may show up when you take indinavir. Tell your doctor right away if you have any new signs after you start indinavir, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.

What are some other side effects of indinavir?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Belly pain.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out indinavir?

• Store at room temperature.
• Store in the original container. Do not take out the antimoisture cube or packet.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 200 MG CAPSULE BOTTLE LABEL

• NDC 0006-0571-43
• Crixivan®
  (Indinavir Sulfate) Capsules
• 200 mg
• ALERT
  Find out about medicines that should
  NOT be taken with CRIXIVAN.
• Note to Pharmacist:
  Do not cover ALERT box with Pharmacy label.
• USUAL DOSAGE: See Package Insert.
• Rx only
• 360 Capsules

PRINCIPAL DISPLAY PANEL – 400 MG CAPSULE BOTTLE LABEL

• NDC 0006-0573-62
• Crixivan®
  (Indinavir Sulfate) Capsules
• 400 mg
• ALERT
  Find out about medicines that should NOT
  be taken with CRIXIVAN.
• Note to Pharmacist:
  Do not cover ALERT box with Pharmacy label.
• USUAL DOSAGE: See Package Insert.
• Rx only
• 180 Capsules

SRC: NLM .