Didanosine Delayed-Release Capsules

Enteric-Coated Pellets 

What is didanosine? 

Didanosine is a prescription medicine used in combination with other drugs to treat children and adults who are infected with HIV (the human immunodeficiency virus, the virus that causes AIDS). Didanosine belongs to a class of drugs called nucleoside analogues. By reducing the growth of HIV, didanosine helps your body maintain its supply of CD4 cells, which are important for fighting HIV and other infections. 

Didanosine will not cure your HIV infection. At present there is no cure for HIV infection. Even while taking didanosine, you may continue to have HIV-related illnesses, including infections with other disease-producing organisms. Continue to see your doctor regularly and report any medical problems that occur. 

Didanosine does not prevent a patient infected with HIV from passing the virus to other people. To protect others, you must continue to practice safe sex and take precautions to prevent others from coming in contact with your blood and other body fluids. 

There is limited information on the antiviral response of long-term use of didanosine. 

In didanosine, an enteric coating is used to protect the medicine while it is in your stomach since stomach acids can break it down. The enteric coating dissolves when the medicine reaches your small intestine. 

Who should not take didanosine? 

Do not take didanosine if you are allergic to any of its ingredients, including its active ingredient, didanosine, and the inactive ingredients. (See Inactive Ingredients at the end of this leaflet.) Tell your doctor if you think you have had an allergic reaction to any of these ingredients. 

How should I take didanosine? How should I store it? 

Didanosine should only be taken once daily. Your doctor will determine your dose based on your body weight, kidney and liver function, other medicines you are taking, and any side effects that you may have had with didanosine or other medicines. Take didanosine on an empty stomach. Do not take didanosine with food. Swallow the capsule whole; do not open it. Try not to miss a dose, but if you do, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. 

Store capsules in a tightly closed container at room temperature away from heat and out of the reach of children and pets. 

If you have kidney disease: If your kidneys are not working properly, your doctor will need to do regular tests to check how they are working while you take didanosine. Your doctor may also lower your dosage of didanosine. 

What should I do if someone takes an overdose of didanosine? 

If someone may have taken an overdose of didanosine, get medical help right away. Contact their doctor or a poison control center. 

What should I avoid while taking didanosine? 

Alcohol. Do not drink alcohol while taking didanosine since alcohol may increase your risk of pancreatitis (pain and inflammation of the pancreas) or liver damage.

Allopurinol, also known as ZYLOPRIM®, ALOPRIM®, or others. Do not take allopurinol while taking didanosine because the risk of side-effects of didanosine are increased. 

Ribavirin, also known as COPEGUS®, REBETOL®, or others. Do not take ribavirin while taking didanosine because pancreatitis, peripheral neuropathy, lactic acidosis and fatal liver damage have been reported. (See "What are the possible side effects of didanosine?") 

Other medicines. Other medicines, including those you can buy without a prescription, may interfere with the actions of didanosine or may increase the possibility or severity of side effects. Do not take any medicine, vitamin supplement, or other health preparation without first checking with your doctor. 

Pregnancy. It is not known if didanosine can harm a human fetus. Also, pregnant women have experienced serious side effects when taking didanosine in combination with ZERIT (stavudine), also known as d4T, and other HIV medicines. Didanosine should be used during pregnancy only after discussion with your doctor. Tell your doctor if you become pregnant or plan to become pregnant while taking didanosine. 

Nursing. Studies have shown didanosine is in the breast milk of animals getting the drug. It may also be in human breast milk. The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breast-feed. This should reduce the risk of passing HIV infection to their babies and the potential for serious adverse reactions in nursing infants. Therefore, do not nurse a baby while taking didanosine.

What are the possible side effects of didanosine? 

Pancreatitis. Pancreatitis is a dangerous inflammation of the pancreas that may cause death. Tell your doctor right away if you or a child taking didanosine develop stomach pain, nausea, or vomiting. These can be signs of pancreatitis. Before starting didanosine therapy, let your doctor know if you or a child for whom it has been prescribed have ever had pancreatitis. This condition is more likely to happen in people who have had it before. It is also more likely in people with advanced HIV disease. However, it can occur at any stage of HIV disease. It may be more common in patients with kidney problems, those who drink alcohol, and those who are also treated with stavudine. If you get pancreatitis, your doctor will tell you to stop taking didanosine. 

Lactic acidosis, severe liver enlargement, and liver failure, including deaths, have been reported among patients taking didanosine (including pregnant women). Symptoms that may indicate a liver problem are: 

• feeling very weak, tired, or uncomfortable 

• unusual or unexpected stomach discomfort 

• feeling cold 

• feeling dizzy or lightheaded 

• suddenly developing a slow or irregular heartbeat 

Lactic acidosis is a medical emergency that must be treated in a hospital. 

If you notice any of these symptoms or if your medical condition changes, stop taking didanosine and call your doctor right away. Women, overweight patients, and those who have been treated for a long time with other medicines used to treat HIV infection are more likely to develop lactic acidosis. Your doctor should check your liver function periodically while you are taking didanosine. You should be especially careful if you have a history of heavy alcohol use or a liver problem. 

Vision changes. Didanosine may affect the nerves in your eyes. Because of this, you should have regular eye examinations. You should also report any changes in vision to your doctor right away. This includes, for example, seeing colors abnormally or blurred vision. 

Peripheral neuropathy. This is a problem with the nerves in your hands or feet. The nerve problem may be serious. Tell your doctor right away if you or a child taking didanosine have continuing numbness, tingling, or pain in the feet or hands. A child may not recognize these symptoms or know to tell you that his or her feet or hands are numb, burning, tingling, or painful. Ask your child’s doctor how to find out if your child is developing peripheral neuropathy.

Before starting didanosine therapy, let your doctor know if you or a child for whom it has been prescribed have ever had peripheral neuropathy. This condition is more likely to happen in people who have had it before. It is also more likely in patients taking medicines that affect the nerves and in people with advanced HIV disease. However, it can occur at any stage of HIV disease. If you get peripheral neuropathy, your doctor will tell you to stop taking didanosine. After stopping didanosine, the symptoms may get worse for a short time and then get better. Once symptoms of peripheral neuropathy go away completely, you and your doctor should decide if starting didanosine again is right for you. 

Special note about other medicines. If you take didanosine along with other medicines with similar side effects, you may increase the chance of having these side effects. For example, using didanosine in combination with other medicines that may cause pancreatitis, peripheral neuropathy, or liver problems (including stavudine) may increase your chance of having these side effects. 

Other side effects: The most common side effects in adults taking didanosine in combination with other HIV drugs included diarrhea, nausea, headache, vomiting, and rash. Children may have similar side effects as adults.

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long term health effects of these conditions are not known at this time. 

Inactive Ingredients: 

Croscarmellose sodium, hydroxypropyl cellulose, hypromellose, methacrylic acid copolymer dispersion, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, sodium hydroxide, talc, titanium dioxide, triacetin and triethyl citrate. The capsule shell contains FD&C blue no. 1, gelatin, and titanium dioxide. The 200 mg capsule shell also contains D&C red no. 33, and FD&C yellow no. 6. The 250 mg capsule shell also contains D&C red no. 28. The 400 mg capsule shell also contains D&C red no. 33, and FD&C yellow no. 6. The edible imprinting ink contains D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, iron oxide, propylene glycol and shellac glaze.

This medicine was prescribed for your particular condition. Do not use didanosine for another condition or give it to others. Keep all medicines out of the reach of children and pets at all times. Do not keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place didanosine in an unrecognizable closed container in the household trash. 

This summary does not include everything there is to know about didanosine. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. If you have questions or concerns, or want more information about didanosine, your physician and pharmacist have the complete prescribing information upon which this leaflet is based. You may want to read it and discuss it with your doctor or other healthcare professional. Remember, no written summary can replace careful discussion with your doctor. 

This Patient Information Leaflet has been approved by the U.S. Food and Drug Administration. 

Zerit® is a registered trademark of Bristol-Myers Squibb Company.

TEVA PHARMACEUTICALS USA  
Sellersville, PA 18960

This Product was Repackaged By:

State of Florida DOH Central Pharmacy   
104-2 Hamilton Park Drive  
Tallahassee, FL 32304  
United States