Crixivan

DRUG DESCRIPTION

CRIXIVAN* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease. CRIXIVAN (indinavir sulfate) Capsules are formulated as a sulfate salt and are available for oral administration in strengths of 100, 200, and 400 mg of indinavir (corresponding to 125, 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, titanium dioxide, silicon dioxide, and sodium lauryl sulfate.

The chemical name for indinavir sulfate is [1(1S,2R),5(S)]-2,3,5-trideoxy-N-(2,3-dihydro-2-hydroxy-1Hinden-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:

CRIXIVAN®
(indinavir sulfate) Structural Formula Illustration

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.

What are the possible side effects of indinavir (Crixivan)?

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 indinavir 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...

Read All Potential Side Effects and See Pictures of Crixivan »

What are the precautions when taking indinavir sulfate (Crixivan)?

Before taking indinavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood fat levels (cholesterol/triglycerides), diabetes, hemophilia, kidney problems (including kidney stones), heart problems (coronary artery disease, heart attack), liver problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug,...

Read All Potential Precautions of Crixivan »


Crixivan Consumer (continued)

SIDE EFFECTS: Stomach pain, nausea, vomiting, heartburn, loss of appetite, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: yellowing eyes/skin.

Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), easy bruising/bleeding, persistent nausea/vomiting, stomach/abdominal pain, dark urine, decrease in the amount of urine.

Indinavir may cause kidney stones. Tell your doctor immediately if you have symptoms such as side or mid-back pain, pink/bloody urine, or pain with urination.

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst and urination. If you already have diabetes, check your blood sugar levels regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Changes in body fat may occur while you are taking this medication (such as 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 the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking indinavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood fat levels (cholesterol/triglycerides), diabetes, hemophilia, kidney problems (including kidney stones), heart problems (coronary artery disease, heart attack), liver problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially effects on the kidney (such as kidney stones).

During pregnancy, this medication should be used only when clearly needed. However, it is now normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. Indinavir may be part of that treatment. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Crixivan Patient Information Including Side Effects

Brand Names: Crixivan

Generic Name: indinavir (Pronunciation: in DIN a veer)

  • What is indinavir (Crixivan)?
  • What are the possible side effects of indinavir (Crixivan)?
  • What is the most important information I should know about indinavir (Crixivan)?
  • What should I discuss with my healthcare provider before taking indinavir (Crixivan)?
  • How should I take indinavir (Crixivan)?
  • What happens if I miss a dose (Crixivan)?
  • What happens if I overdose (Crixivan)?
  • What should I avoid while taking indinavir (Crixivan)?
  • What other drugs will affect indinavir (Crixivan)?
  • Where can I get more information?

What is indinavir (Crixivan)?

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.

Indinavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Indinavir is not a cure for HIV or AIDS.

Indinavir may also be used for other purposes not listed in this medication guide.

What are the possible side effects of indinavir (Crixivan)?

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 indinavir 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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about indinavir (Crixivan)?

Do not take indinavir with amiodarone (Cordarone, Pacerone), cisapride (Propulsid), pimozide (Orap), alprazolam (Xanax), oral midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, Methergine.

These drugs can cause life-threatening side effects if you use them while you are taking indinavir.

There are many other medicines that can interact with indinavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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. 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.

Taking indinavir will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

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