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PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS
Fatal and nonfatal pancreatitis has occurred during therapy with VIDEX used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. VIDEX should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis [see WARNINGS AND PRECAUTIONS].
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk [see WARNINGS AND PRECAUTIONS].
VIDEX® is a brand name for didanosine, USP, a synthetic purine nucleoside analogue active against HIV-1.
Didanosine is available as VIDEX, a Pediatric Powder for Oral Solution [see HOW SUPPLIED/Storage and Handling] and as VIDEX® EC Delayed-Release Capsules, containing enteric-coated beadlets [consult prescribing information for VIDEX EC (didanosine)].
The chemical name for didanosine is 2',3'-dideoxyinosine. The structural formula is:
Didanosine is a white crystalline powder with the molecular formula C10H12N4O3 and a molecular weight of 236.2. The aqueous solubility of didanosine at 25° C and pH of approximately 6 is 27.3 mg/mL. Didanosine is unstable in acidic solutions. For example, at pH less than 3 and 37° C, 10% of didanosine decomposes to hypoxanthine in less than 2 minutes.
What are the possible side effects of didanosine (Videx, Videx EC)?
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.
Didanosine may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:
- muscle pain or weakness;
- numb or cold feeling in your arms and legs;
- trouble breathing;
- feeling dizzy, light-headed, tired, or very...
Last reviewed on RxList: 12/6/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Videx Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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