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VIDEX EC
Viral infections
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Drug Name:

VIDEX EC Rx

Generic Name and Formulations:
Didanosine 125mg, 200mg, 250mg, 400mg; e-c del-rel caps.

Company:
Bristol-Myers Squibb

Therapeutic Use:

Indications for VIDEX EC:

HIV-1 infection, in combination with other antiretroviral agents.

Adults and Children:

Swallow whole. Take once daily on an empty stomach. <20kg: use oral soln. 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.

Contraindications:

Concomitant stavudine, allopurinol, ribavirin.

Boxed Warning:

Pancreatitis. Lactic acidosis and hepatomegaly with steatosis.

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 (Cat.B). Nursing mothers: not recommended.

See Also:

VIDEX PEDIATRIC PWD for ORAL SOLN

Pharmacological Class:

Nucleoside analogue (reverse transcriptase inhibitor).

Interactions:

See Contraindications. Avoid with hydroxyurea. Potentiated by ganciclovir, tenofovir DF (see Adult). Antagonized by methadone. Caution with neurotoxic drugs or those that may cause pancreatic toxicity. For pediatric pwd: caution with magnesium- or aluminum-containing antacids. 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.

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.

Note:

Register pregnant patients exposed to didanosine by calling (800) 258-4263.

How Supplied:

Caps—30; pwd—4oz (2g), 8oz (4g)

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