DIDANOSINE capsule delayed release pellets

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

DIDANOSINE (UNII: K3GDH6OH08) (DIDANOSINE - UNII:K3GDH6OH08)

Disponible des:

Teva Pharmaceuticals USA, Inc.

Designació comuna internacional (DCI):

DIDANOSINE

Composición:

DIDANOSINE 200 mg

tipo de receta:

PRESCRIPTION DRUG

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

DIDANOSINE- DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIDANOSINE DELAYED-RELEASE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DIDANOSINE DELAYED-RELEASE
CAPSULES.
DIDANOSINE DELAYED-RELEASE CAPSULES (ENTERIC-COATED PELLETS),
FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
WARNING: PANCREATITIS, LACTIC ACIDOSIS AND HEPATOMEGALY WITH STEATOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
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INDICATIONS AND USAGE
Didanosine delayed-release capsules are a nucleoside reverse
transcriptase inhibitor for use in combination with other
antiretroviral agents for the treatment of human immunodeficiency
virus (HIV)-1 infection. (1)
DOSAGE AND ADMINISTRATION
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BODY WEIGHT
DO SE
20 kg to less than 25 kg
200 mg once daily
25 kg to less than 60 kg
250 mg once daily
at least 60 kg
400 mg once daily
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DOSAGE FORMS AND STRENGTHS
Capsules: 200 mg, 250 mg, 400 mg (3)
CONTRAINDICATIONS
Coadministration with allopurinol or ribavirin is contraindicated.
(4.1 and 4.2)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
FATAL AND NONFATAL PANCREATITIS. DIDANOSINE DELAYED-RELEASE CAPSULES
SHOULD BE SUSPENDED IN
PATIENTS WITH SUSPECTED PANCREATITIS AND DISCONTINUED IN PATIENTS WITH
CONFIRMED PANCREATITIS. (5.1)
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES. FATAL LACTIC ACIDOSIS
HAS BEEN REPORTED IN PREGNANT WOMEN WHO RECEIVED THE COMBINATION OF
DIDANOSINE AND STAVUDINE.
(5.2)
Adult patients: Administered on an empty stomach. Dosing is based on
body weight. (2.1)
Pediatric patients: Ages 6 to 18 years, can safely swallow capsules
and body weight at least 20 kg. Administered on an
empty stomach, dosing is based on body weight. (2.1)
Renal impairment: Dose reduction is recommended. (2.2)
Coadministration with tenofovir: Dose reduction is recommended.
Patients should be monitored closely for
didanosine-a