Atazanavir Sulfate Oral capsule

What is this medicine?

ATAZANAVIR (at a za NA 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 requiring dialysis treatment

• liver disease

• irregular heartbeat

• an unusual or allergic reaction to atazanavir, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. 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, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

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

• alfuzosin

• belinostat

• cisapride

• etravirine

• indinavir

• irinotecan

• lomitapide

• lovastatin

• medicines for headaches like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• midazolam

• nevirapine

• pimozide

• red yeast rice

• rifampin

• rifapentine

• sildenafil (when given as Revatio for treatment of pulmonary arterial hypertension)

• simvastatin

• St. John's wort

• triazolam

• zalcitabine

This medicine may also interact with the following medications:

• antacids or buffered medications

• birth control pills or patch

• buprenorphine

• certain medicines for blood pressure, heart disease, irregular heart beat

• certain medicines for cholesterol like atorvastatin or rosuvastatin

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for erectile dysfunction

• certain medicines for fungal infections like ketoconazole, itraconazole, posaconazole, and voriconazole

• certain medicines for seizures like carbamazepine, lamotrigine, phenobarbital, phenytoin

• certain medicines for stomach problems like cimetidine, famotidine, omeprazole, lansoprazole

• clarithromycin

• cyclosporine

• fluticasone

• other medicines for HIV

• rifabutin

• salmeterol

• sirolimus

• tacrolimus

• warfarin

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.

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

• dizziness

• feeling faint or lightheaded, falls

• increased hunger or thirst

• increased urination

• irregular heart rate

• nausea, vomiting, abdominal pain

• pain in the lower back or side

• pain when urinating

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• 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):

• depressed mood

• diarrhea

• headache

• muscle pain

• tingling or burning in your hands, feet or around the mouth

• trouble sleeping

• 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. Dispose of unused medicines through community take-back disposal programs when available or place this medicine in an unrecognizable, closed container in the household trash.