Indinavir Sulfate Oral capsule

What is this medicine?

INDINAVIR (in DIN a veer) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes
• hemophilia
• kidney disease
• liver disease
• an unusual or allergic reaction to indinavir, other medicines, foods, dyes, or preservatives
• breast-feeding
• pregnancy or recent attempts to get pregnant

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. You may take it with a light meal, like dry toast with jelly, juice, and coffee with skim milk and sugar; or corn flakes, skim milk, and sugar. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose by more than 2 hours, wait and take the next dose at the regular time. But, if you miss a dose by less than 2 hours, take your missed dose right away. Then take your next dose at the regular time. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• alprazolam
• astemizole
• atazanavir
• amiodarone
• cisapride
• conivaptan
• dofetilide
• medicines for headaches like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• medicines for high cholesterol like cerivastatin, lovastatin, simvastatin
• midazolam
• pimozide
• ranolazine
• rifampin
• rifapentine
• red yeast rice
• St. John's wort
• triazolam

This medicine may also interact with the following medications:

• atorvastatin
• carbamazepine
• clarithromycin
• cyclosporine
• dexamethasone
• fluticasone
• lidocaine
• medicines for depression, anxiety, or psychotic disturbances
• medicines for erectile dysfunction
• medicines for fungal infections like ketoconazole and itraconazole
• medicines for blood pressure like amlodipine, felodipine, nifedipine
• other medicines for HIV
• phenytoin
• phenobarbital
• quinidine
• rifabutin
• sirolimus
• tacrolimus

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom or diaphragm.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

This medicine may cause kidney stones. To help avoid kidney stones, drink plenty of fluids while taking this medicine. Adults should drink at least six 8-ounce glasses of liquids (preferably water) throughout the day, every day. Call your doctor if you notice pain or difficulty passing urine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• blood in the urine
• breathing problems
• dark urine
• dizziness
• general ill feeling or flu-like symptoms
• light-colored stools
• loss of appetite, nausea
• pain in the lower back or side
• pain when urinating
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• right upper belly pain
• unusually weak or tired
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• increased hunger or thirst
• increased urination
• nausea, vomiting
• stomach pain
• weight gain around waist, back, or thinning of face, arms, legs

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store tightly closed at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.