DIDANOSINE capsule, delayed release pellets

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

State of Florida DOH Central Pharmacy

INN (Nama Internasional):

DIDANOSINE

Komposisi:

DIDANOSINE 250 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Didanosine delayed-release capsules, also known as ddI, in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [see Clinical Studies (14) ]. These recommendations are based on either drug interaction studies or observed clinical toxicities. Coadministration of didanosine and allopurinol is contraindicated because systemic exposures of didanosine are increased, which may increase didanosine-associated toxicity [see Clinical Pharmacology (12.3) ]. Coadministration of didanosine and ribavirin is contraindicated because exposures of the active metabolite of didanosine (dideoxyadenosine 5’-triphosphate) are increased. Fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving both didanosine and ribavirin. Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses up to 12 and 14.2 times the estimated human exp

Ringkasan produk:

Didanosine Delayed-Release Capsules are available as: 200 mg: Two-piece hard gelatin capsule with green opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 588 over 200 mg. 250 mg: Two-piece hard gelatin capsule with blue opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 589 over 250 mg. 400 mg: Two-piece hard gelatin capsule with red opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 590 over 400 mg. They are supplied by State of Florida DOH Central Pharmacy as follows: Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DIDANOSINE - DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS
STATE OF FLORIDA DOH CENTRAL PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIDANOSINE DELAYED-RELEASE CAPSULES
ENTERIC-COATED PELLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR DIDANOSINE DELAYED-RELEASE
CAPSULES ENTERIC-COATED PELLETS.
INITIAL U.S. APPROVAL: 1991
WARNING: PANCREATITIS, LACTIC ACIDOSIS AND HEPATOMEGALY WITH STEATOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
FATAL AND NONFATAL PANCREATITIS HAS OCCURRED DURING THERAPY WITH
DIDANOSINE USED ALONE OR IN
COMBINATION REGIMENS IN BOTH TREATMENT-NAIVE AND TREATMENT-EXPERIENCED
PATIENTS, REGARDLESS OF DEGREE
OF IMMUNOSUPPRESSION. DIDANOSINE DELAYED-RELEASE CAPSULES SHOULD BE
SUSPENDED IN PATIENTS WITH
SUSPECTED PANCREATITIS AND DISCONTINUED IN PATIENTS WITH CONFIRMED
PANCREATITIS [_SEE WARNINGS AND_
_PRECAUTIONS (5.1 )_]_._
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 (5.2)_]_._
RECENT MAJOR CHANGES
Dosage and Administration (2) 09/2008
Contraindications
Allopurinol (4.1 ) 06/2009
Ribavirin (4.2 ) 06/2009
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
Adult patients: Administered on an empty stomach. Dosing is based on
body weight. (2.1)
Pediatric patients: Ages 6 to