Monograph Details
|
|
Infections & Infestations
> Viral infections
|
|
VIDEX EC |
| Manufacturer |
|
Bristol-Myers Squibb Virology |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Nucleoside analogue (reverse transcriptase inhibitor). |
| Generic Name |
|
Didanosine 125mg, 200mg, 250mg, 400mg; e-c delayed-release caps. |
| Also |
• VIDEX BUFFERED PWD for ORAL SOLN
• VIDEX PEDIATRIC PWD for ORAL SOLN
|
| Indications |
|
HIV-1 infection. |
| Children |
|
Use other forms. |
| Adults |
|
Take once daily on empty stomach; swallow whole. <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 other forms; ≥60kg: 125mg. |
| Contraindications |
|
Pancreatitis. |
| Precautions |
|
Suspend if signs or symptoms of pancreatitis (discontinue if confirmed), lactic acidosis, or hepatotoxicity (eg, hepatomegaly or steatosis) occurs. History or risk of pancreatitis (eg, obesity, alcohol abuse, hypertriglyceridemia, advanced HIV disease). Women, obesity, or prolonged nucleoside exposure: increased risk of toxicity. Advanced HIV disease, history of neuropathy, or concomitant neurotoxic drugs: consider reducing dose or discontinuing if peripheral neuropathy occurs. Hepatic dysfunction. Hyperuricemia. Do periodic retinal exam. Elderly. Pregnancy (Cat.B); monitor for lactic acidosis if used with stavudine. Nursing mothers: not recommended. |
| Interactions |
|
Extreme caution with pancreatotoxic drugs (eg, alcohol, stavudine, pentamidine): see literature. Caution with hydroxyurea, neurotoxic drugs (eg, stavudine). Potentiated by allopurinol (not recommended), ganciclovir; increased didanosine toxicities with ribavirin, tenofovir (monitor). Antagonized by methadone. Triple therapy (once daily regimen) with lamivudine + tenofovir: high rate of early viral non-response (see literature). Buffered form: separate dosing of delavirdine, indinavir, nelfinavir by 1 hour; give drugs affected by gastric pH (eg, ketoconazole, itraconazole) 2 hours prior. May antagonize quinolones, tetracyclines, others bound by multivalent cations (separate dosing). Give at least 6 hours before or 2 hours after ciprofloxacin. For pediatric pwd: avoid magnesium- or aluminum-containing antacids. |
| Adverse Reactions |
|
GI disturbances, headache, rash; elevated liver enzymes, amylase, and lipase; pancreatitis, lactic acidosis/hepatomegaly with steatosis, retinal changes, optic neuritis, peripheral neuropathy, hyperuricemia, fat redistribution. |
| Extra Text |
|
Note: Register pregnant patients exposed to didanosine by calling (800) 258-4263. |
| How Supplied |
EC caps—30 Pwd (packets)—30 Pediatric pwd (bottles)—1 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|