Brand Name(s):

• Videx®EC
• Videx®Pediatric

Other Name(s):

• ddI
• dideoxyinosine

IMPORTANT WARNING

Didanosine may cause serious or life-threatening pancreatitis (swelling of the pancreas). Tell your doctor if you drink or have ever drunk large amounts of alcoholic beverages and if you have or have ever had pancreatitis or kidney disease. Also tell your doctor if you are taking pentamidine (Nebupent, Pentam), stavudine (Zerit), or sulfamethoxazole and trimethoprim (Bactrim, Septra). If you experience any of the following symptoms, call your doctor immediately: stomach pain or swelling, nausea, vomiting, or fever.

Didanosine may also cause serious or life-threatening lactic acidosis (build-up of acid in the blood) that will probably need to be treated in the hospital. The risk that you will develop lactic acidosis is higher if you are a woman, if you are overweight, and if you have been treated with medications for human immunodeficiency virus (HIV) for a long time. The risk may also be higher if you are pregnant and you are taking didanosine along with stavudine (Zerit). If you experience any of the following symptoms, call your doctor immediately: weakness, tiredness, muscle pain, stomach pain, nausea, vomiting, feeling cold, especially in the arms and legs, dizziness, lightheadedness, trouble breathing, and fast or irregular heartbeat.

Didanosine may cause serious liver problems. These problems may need to be treated with a liver transplant or may cause death. Tell you doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately: yellowing of the skin or eyes, dark urine, stomach pain or swelling, easy bruising or bleeding, vomiting a substance that is bloody or looks like coffee grounds, or dark stools.

Ask your doctor about the safe use of alcohol while you are taking didanosine. Drinking alcohol can increase the risk that you will develop serious side effects of didanosine.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to didanosine.

Talk to your doctor about the risks of taking didanosine.

WHY is this medicine prescribed?

Didanosine is used along with other medications to treat human immunodeficiency virus (HIV) infection. Didanosine is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV in the blood. Although didanosine 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 life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

HOW should this medicine be used?

Didanosine comes as extended-release (long-acting) capsules and a solution (liquid) to be taken by mouth on an empty stomach, 30 minutes before or 2 hours after eating. The extended-release capsules are usually taken once a day. The liquid is usually taken once or twice a day. Try to take didanosine around the same time(s) 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 didanosine exactly as directed. Do not take more or less of it, or take it more often than prescribed by your doctor.

If you are using the extended-release capsules, swallow them whole; do not split, chew, crush, break, or dissolve them. Tell your doctor if you are unable to swallow the extended-release capsules whole.

If you are using the solution, you should shake it well before each use to mix the medication evenly. Use a dose-measuring spoon or cup to measure the correct amount of liquid for each dose, not a regular household spoon.

Didanosine controls HIV infection but does not cure it. Continue to take didanosine even if you feel well. Do not stop taking didanosine without talking to your doctor. If you miss doses or stop taking didanosine, your condition may become more difficult to treat.

Are there OTHER USES for this medicine?

Didanosine is also sometimes used with other medications to help prevent infection in healthcare workers or other people who were accidentally exposed to HIV. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking didanosine,

• tell your doctor and pharmacist if you are allergic to didanosine, any other medications, or any of the ingredients in didanosine capsules or solution. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor if you are taking allopurinol (Aloprim, Lopurin, Zyloprim) or ribavirin (Rebetol, Virazole). Your doctor will probably tell you not to take didanosine if you are taking one or both of these medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the medications listed in the IMPORTANT WARNING section and the following: antacids: cimetidine (Tagamet), dapsone (Aczone), ganciclovir (Cytovene), hydroxyurea (Droxia, Hydrea), methadone (Dolophine, Methadose), ranitidine (Zantac), tenofovir (Viread), or valganciclovir (Valcyte). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• you should know that some medications must be taken several hours before or after you take didanosine. If you are taking any of the following medications, ask your doctor exactly when you should take them: antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); atazanvir (Reyataz); delavirdine (Rescriptor); indinavir (Crixivan); nelfinavir (Viracept); quinolone antibiotics such as ciprofloxacin (Cipro), gatifloxacin (Tequin), moxifloxacin (Avelox), and ofloxacin (Floxin); ritonavir (Norvir); tetracycline antibiotics such as tetracycline (Sumycin) and tipranavir (Aptivus).
• tell your doctor if you have or have ever had peripheral neuropathy (numbness, tingling, burning, or pain sensation in your hands or feet, or decreased ability to feel temperature or touch in your hands or feet).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking didanosine, call your doctor. You should not breast-feed if you are infected with HIV or are taking didanosine.
• you should know that didanosine may cause side effects that must be treated right away before they become serious. Children who are taking didanosine may not be able to tell you about the side effects they are feeling. If you are giving didanosine to a child, ask the child's doctor how you can tell if the child is having these serious side effects.
• you should be aware that your body fat may increase or move to different areas of your body, such as your upper back, neck (''buffalo hump''), breasts, and around your stomach. You may notice a loss of body fat from your face, legs, and arms.
• 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 after starting treatment with didanosine, be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, 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?

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

Keep didanosine capsules in the container they came in, tightly closed, and out of reach of children. Store them at room temperature and away from excess heat and moisture (not in the bathroom). Keep didanosine liquid in the refrigerator, closed tightly, and throw away any unused medication after 30 days. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• diarrhea
• numbness, tingling, burning, or pain in hands or feet
• nausea
• vomiting
• loss of appetite
• stomach pain
• swelling of the stomach
• muscle or joint pain
• extreme tiredness
• weakness
• dizziness
• lightheadedness
• fast, slow or irregular heartbeat
• deep or rapid breathing
• shortness of breath
• dark yellow or brown urine
• unusual bleeding or bruising
• vomiting a substance that is bloody or looks like coffee grounds
• dark stools
• yellowing of the skin or eyes
• feeling cold
• fever
• flu-like symptoms

What OTHER INFORMATION should I know?

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.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2012.