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What is the most important information I should know about didanosine?

Didanosine can cause life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Do not take didanosine without telling your doctor if you are pregnant. Didanosine may be harmful to an unborn baby, and may also be more likely to cause pancreatitis in a pregnant woman.

Didanosine may also cause a build up of lactic acid in the body. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Contact your doctor at once if you have any of these symptoms, even if they are only mild.

There are many other medicines that can interact with didanosine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Warning

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.

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What is didanosine?

Didanosine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Didanosine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Didanosine is not a cure for HIV or AIDS.

Didanosine may also be used for other purposes not listed in this medication guide.

Precautions

Didanosine can cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking didanosine: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Didanosine may also cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Contact your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal.

Do not use this medication if you are allergic to didanosine.

Before taking didanosine, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;
  • kidney disease (or if you are on dialysis);
  • a history of pancreatitis; or
  • a history of peripheral neuropathy (numbness or tingling in your hands or feet).

Do not take didanosine without telling your doctor if you are pregnant. Didanosine may be harmful to an unborn baby, and may also be more likely to cause pancreatitis in a pregnant woman.

HIV can be passed to a baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using didanosine. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether didanosine had any effect on the baby.

You should not breast-feed while you are using didanosine. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Avoid using antacids without your doctor’s advice while taking didanosine. Use only the specific type of antacid your doctor recommends.

Avoid drinking alcohol while taking didanosine. Alcohol may increase the risk of damage to the pancreas and/or liver.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include numbness or tingling, joint pain, severe pain in your upper stomach spreading to your back, nausea and vomiting, diarrhea, fast heart rate, low fever, loss of appetite, dark urine, clay-colored stools, and yellowing of the skin or eyes.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using didanosine and call your doctor at once if you have any of these serious side effects:

  • liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, and fast or uneven heart rate;
  • pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • peripheral neuropathy - numbness, tingling, or pain in your hands or feet;
  • problems with vision, increased sensitivity to light;
  • fever, chills, body aches, flu symptoms; or
  • any other signs of new infection.

Less serious side effects may include:

  • mild stomach pain, diarrhea;
  • headache;
  • weak feeling; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Before taking didanosine, tell your doctor if you are using any of the following drugs:

  • allopurinol (Zyloprim);
  • ganciclovir (Cytovene);
  • hydroxyurea (Droxie, Hydrea);
  • methadone (Dolophine, Methadose);
  • ribavirin (Rebetol, Ribasphere, Copegus Virazole);
  • stavudine (Zerit);
  • tenofovir (Viread);
  • antibiotics such as tetracycline (Brodspec, Panmycin, Sumycin), doxycycline (Doryx, Vibramycin), or minocycline (Minocin); or
  • antibiotics such as enoxacin (Penetrex), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), ofloxacin (Floxin), trovafloxacin (Trovan), or norfloxacin (Noroxin).

This list is not complete and there may be other drugs that can interact with didanosine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04