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VIDEX
(didanosine, USP)
WARNING
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].
DRUG DESCRIPTION
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:
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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.
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
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