Didanosine Generic Name & Formulations
Legal Class
Rx
General Description
Didanosine 125mg, 200mg, 250mg, 400mg; e-c del-rel caps.
Pharmacological Class
Nucleoside analogue (reverse transcriptase inhibitor).
How Supplied
Contact supplier
Manufacturer
Didanosine Indications
Indications
HIV-1 infection, in combination with other antiretroviral agents.
Didanosine Dosage and Administration
Adults and Children
Swallow whole. Take once daily on an empty stomach. 20–<25kg: 200mg. 25–<60kg: 250mg. ≥60kg: 400mg. Renal impairment (CrCl 30–59mL/min): <60kg: 125mg. ≥60kg: 200mg. CrCl 10–29mL/min: 125mg. CrCl <10mL/min or dialysis: <60kg: use oral soln; ≥60kg: 125mg. Concomitant tenofovir DF (CrCl ≥60mL/min): <60kg: 200mg; ≥60kg: 250mg.
Didanosine Contraindications
Contraindications
Concomitant stavudine, allopurinol, ribavirin.
Didanosine Boxed Warnings
Boxed Warning
Pancreatitis. Lactic acidosis and hepatomegaly with steatosis.
Didanosine Warnings/Precautions
Warnings/Precautions
Suspend if signs or symptoms of pancreatitis (discontinue if confirmed), lactic acidosis, or hepatotoxicity (eg, hepatomegaly with steatosis) occurs. Increased risk of pancreatitis (eg, alcohol abuse, advanced HIV disease, elderly, renal impairment); monitor. Women, obesity, or prolonged nucleoside exposure: increased risk of toxicity. Advanced HIV disease, history of neuropathy, or concomitant neurotoxic drugs: consider discontinuing if peripheral neuropathy occurs. Monitor for non-cirrhotic portal hypertension; discontinue if occurs. Monitor for lipoatrophy; use alternative if suspected. Hepatic dysfunction. Do periodic retinal exam. Elderly. Pregnancy. Nursing mothers: not recommended.
Didanosine Pharmacokinetics
See Literature
Didanosine Interactions
Interactions
See Contraindications. Avoid with hydroxyurea. Potentiated by ganciclovir, tenofovir DF (see Adults). Antagonized by methadone. Caution with neurotoxic drugs or those that may cause pancreatic toxicity. Separate dosing of delavirdine, indinavir, nelfinavir by 1hr; give ketoconazole, itraconazole ≥2hrs prior. May antagonize quinolones, tetracyclines. Give at least 6hrs before or 2hrs after ciprofloxacin.
Didanosine Adverse Reactions
Adverse Reactions
Diarrhea, peripheral neuropathy, nausea, headache, rash, vomiting; pancreatitis, lactic acidosis, hepatomegaly with steatosis, retinal changes, optic neuritis, immune reconstitution syndrome, non-cirrhotic portal hypertension.
Didanosine Clinical Trials
See Literature
Didanosine Note
Notes
Formerly known under the brand name Videx EC. Register pregnant patients exposed to didanosine by calling (800) 258-4263.
Didanosine Patient Counseling
See Literature