Didanosine (3 brand names, 4 dosage forms, 1 route)
Available dosage forms: CAPSULE, DELAYED REL PELLETS, FOR SOLUTION, TABLET, CHEWABLE, TABLET, FOR SUSPENSION.
Routes of administration: ORAL.
Brand Names
- DIDANOSINE
- VIDEX
- VIDEX EC
Boxed Warning
Fatal and nonfatal pancreatitis has occurred during therapy with didanosine used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Didanosine delayed-release capsules should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis [see Warnings and Precautions (5.1)]. 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 (5.2)].
Indications and Usage
Didanosine delayed-release capsules, also known as ddI, in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [see Clinical Studies (14)].
Dosage and Administration
Didanosine delayed-release capsules should be administered on an empty stomach. Didanosine delayed-release capsules should be swallowed intact.
Contraindications
These recommendations are based on either drug interaction studies or observed clinical toxicities.
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections: Pancreatitis [see Boxed Warning, Warnings and Precautions (5.1)] Lactic acidosis/severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions (5.2)] Hepatic toxicity [see Warnings and Precautions (5.3)] Non-cirrhotic portal hypertension [see Warnings and Precautions (5.4)] Peripheral neuropathy [see Warnings and Precautions (5.5)] Retinal changes and optic neuritis [see Warnings and Precautions (5.6)]
Mechanism of Action
Didanosine is an antiviral agent [see Clinical Pharmacology (12.4)].
Overdosage
There is no known antidote for didanosine overdosage. In phase 1 studies, in which buffered formulations of didanosine were initially administered at doses ten times the currently recommended dose, toxicities included: pancreatitis, peripheral neuropathy, diarrhea, hyperuricemia, and hepatic dysfunction. Didanosine is not dialyzable by peritoneal dialysis, although there is some clearance by hemodialysis [see Clinical Pharmacology (12.3)].