Indinavir

WHY is this medicine prescribed?

Indinavir is used along with other medications to treat human immunodeficiency virus (HIV) infection. Indinavir is in a class of medications called protease inhibitors. It works by decreasing the amount of HIV in the blood. Although indinavir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting the HIV virus to other people.

Are there OTHER USES for this medicine?

Indinavir is also used sometimes in combination with other medications to treat healthcare workers and other individuals exposed to HIV infection after accidental contact with HIV-contaminated blood, tissues, or other body fluids. Talk to your doctor about the possible risks of using this drug for your condition.

HOW should this medicine be used?

Indinavir comes as a capsule to take by mouth. It is usually taken every 8 hours (three times a day). Take indinavir at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take indinavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Take indinavir on an empty stomach, 1 hour before meals or 2 hours after meals, with water, skim or nonfat milk, juice, coffee, or tea. However, if indinavir upsets your stomach, it may be taken with a light meal, such as dry toast or cornflakes with skim or nonfat milk. Talk to your doctor or pharmacist about what foods may be taken with indinavir.

Do not crush or chew the capsule, but it may be opened and mixed with fruit puree (such as banana).

Continue to take indinavir even if you feel well. Do not stop taking indinavir without talking to your doctor.

Your doctor may need to interrupt your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with indinavir.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking indinavir,

• tell your doctor and pharmacist if you are allergic to indinavir, any other medications, or any of the ingredients in indinavir capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you are taking any of the following medications: alfuzosin (Uroxatral); alprazolam (Xanax); amiodarone (Nexterone, Pacerone); cisapride (Propulsid) (not available in the U.S.); ergot-type medications such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Ergomar, in Cafergot, in Migergot), and methylergonovine (Methergine); lovastatin (Altoprev, Mevacor); lurasidone (Latuda); midazolam (Versed) by mouth; pimozide (Orap); sildenafil (only Revatio brand used for lung disease); simvastatin (Zocor, in Vytorin); or triazolam (Halcion). Your doctor will probably tell you not to take indinavir.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: bosentan (Tracleer); calcium-channel blockers such as amlodipine (Norvasc, in Amturnide, in Tekamlo), felodipine, nicardipine, and nifedipine (Adalat, Afeditab, Procardia); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, others); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet) and rosuvastatin (Crestor); clarithromycin (Biaxin, in PrevPac); colchicine (Colcrys, Mitigare, in Col-Probenecid); dexamethasone; fluconazole (Diflucan); fluticasone (Flonase, Flovent, in Advair, in Dymista); itraconazole (Onmel, Sporanox); ketoconazole (Extina, Nizoral, Xolegel); other medications for HIV including atazanavir (Reyataz, in Evotaz), delavirdine (Rescriptor), efavirenz (Sustiva, in Atripla), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra, in Viekira Pak), and saquinavir (Invirase); medications for irregular heartbeat such as lidocaine (Glydo, Xylocaine) and quinidine (in Nuedexta); medications that suppress the immune system such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf XL, Envarsus XR, Prograf); midazolam (Versed) by injection; certain phosphodiesterase inhibitors (PDE-5 inhibitors) used for erectile dysfunction such as sildenafil (Viagra), tadalafil (Adcirca, Cialis), and vardenafil (Levitra, in Staxyn); phenobarbital; phenytoin (Dilantin, Phenytek); quetiapine (Seroquel); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); salmeterol (Serevent, in Advair); trazodone; and venlafaxine (Effexor). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with indinavir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• if you are taking didanosine (Videx), take it at least one hour before or after indinavir.

• tell your doctor if you have or have ever had hemophilia (bleeding disorder in which the blood does not clot properly), diabetes, or kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking indinavir, call your doctor. You should not breastfeed if you are infected with HIV or if you are taking indinavir.

• you should know that your body fat may increase or move to different areas of your body such as your breasts, upper back, neck, chest, and stomach area. Loss of fat from the legs, arms, and face can also happen.

• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. Tell your doctor immediately if you have any of the following symptoms while you are taking indinavir: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms at any time during your treatment with indinavir, be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

Drink at least 48 ounces (1.5 liters), which is approximately six 8-ounce (240-milliliter) glasses, of water or other liquids every 24 hours.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

If you miss a dose by less than 2 hours, take the missed dose as soon as you remember it. However, if you miss a dose by more than 2 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Indinavir may cause side effects. Tell your doctor if this symptom is severe or does not go away:

• change in sense of taste

Indinavir may cause side effects. Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment:

• rash
• hives
• itching
• peeling or blistering skin
• back pain
• pain in the side of your body
• middle to lower stomach pain
• blood in urine
• muscle pain or weakness
• nausea
• excessive tiredness
• unusual bleeding or bruising
• loss of appetite
• pain in the upper right part of your stomach
• flu-like symptoms
• dark yellow or brown urine
• yellowing of the skin or eyes
• shortness of breath
• fast heartbeat
• confusion
• dizziness
• headache
• paleness

Indinavir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. A desiccant (drying agent) is included with your capsules; keep this in your medicine bottle at all times. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• pain in the side of your body
• blood in urine
• nausea
• vomiting
• diarrhea

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to indinavir.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.