Dinex EC – Didanosine (Videx EC – Generic)

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Dinex EC – Didanosine (Videx EC – Generic)

WARNING

PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS

FATAL AND NON-FATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WITH DIDANOSINE USED ALONE OR IN COMBINATION REGIMENS IN BOTH TREATMENT-NAIVE AND TREATMENT EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION. DINEX-EC 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: PREGNANCY).

DINEX EC 250
Each capsule contains:
Didanosine (as enteric coated beadlets) 350 mg

DOSAGE FORM
Oral capsule

INDICATIONS
DINEX EC in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection.

DOSAGE AND ADMINISTRATION
DINEX-EC (didanosine) should be administered on an empty stomach. DINEX-EC Delayed-Release Capsules should be swallowed intact.

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, hyperuricaemia and hepatic dysfunction. Didanosine is not dialyzable by peritoneal dialysis, although there is some clearance by hemodialysis.