VIDEX- didanosine powder, for solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

didanosine (UNII: K3GDH6OH08) (didanosine - UNII:K3GDH6OH08)

Boleh didapati daripada:

Bristol-Myers Squibb Company

INN (Nama Antarabangsa):

didanosine

Komposisi:

didanosine 10 mg in 1 mL

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

VIDEX® (didanosine, USP), 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) ]. VIDEX is contraindicated when coadministered with the following medications: - Stavudine- potential for serious and/or life-threatening events notably pancreatitis, lactic acidosis, hepatotoxicity, and peripheral neuropathy [see Warnings and Precautions (5.1, 5.2, 5.3, 5.5)]. - Allopurinol- systemic exposures of didanosine are increased, which may increase didanosine-associated toxicity [see Clinical Pharmacology (12.3) ]. - Ribavirin- 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. There is a pregnancy exposure registry that monitors pregnancy outcomes in individ

Ringkasan produk:

VIDEX (didanosine, USP) Pediatric Powder for Oral Solution is supplied as shown in Table 15: 0087-6632-41 One, 4-ounce glass, bottle per carton 2 g/bottle Storage The bottles of powder should be stored at 59 °F to 86 °F (15 °C to 30 °C). The VIDEX admixture may be stored up to 30 days in a refrigerator, 36 °F to 46 °F (2 °C to 8 °C). Discard any unused portion after 30 days.

Status kebenaran:

New Drug Application

Risalah maklumat

VIDEX- DIDANOSINE POWDER, FOR SOLUTION
Bristol-Myers Squibb Company
----------
MEDICATION GUIDE
VIDEX (VY-DEX)
(DIDANOSINE, USP) PEDIATRIC POWDER
FOR ORAL SOLUTION
What is the most important information I should know about VIDEX?
VIDEX can cause serious side effects, including:
•
Inflammation of your pancreas (pancreatitis) can happen in people who
take VIDEX and can lead to
death. People who take VIDEX in combination with the medicine
stavudine may be at an increased
risk for pancreatitis. Do not take VIDEX with stavudine.
Call your healthcare provider right away if you have any of the
following symptoms of pancreatitis:
•
severe stomach (abdomen) pain
•
nausea and vomiting
•
swelling of your stomach
•
fever
•
Build-up of an acid in your blood (lactic acidosis). Lactic acidosis
can happen in some people who
take VIDEX or similar medicines (nucleoside analogues). Lactic
acidosis is a serious medical
emergency that can lead to death. There have been deaths reported in
pregnant women who get lactic
acidosis after taking VIDEX and stavudine. Do not take VIDEX with
stavudine.
•
Call your healthcare provider right away if you have any of the
following symptoms which could be
signs of lactic acidosis:
•
feel very weak or tired
•
feel cold, especially in your arms and legs
•
have unusual (not normal) muscle pain
•
feel dizzy or light-headed
•
have trouble breathing
•
have a fast or irregular heartbeat
•
have stomach pain with nausea and vomiting
•
weight loss
•
Severe liver problems, including liver failure, can happen in people
who take VIDEX. Your liver may
become large (hepatomegaly), you may develop fat in your liver
(steatosis), or you may have high
blood pressure in the large vein of your liver (portal hypertension).
Severe liver problems can lead to
liver transplantation or death in some people taking VIDEX. Taking
VIDEX with medicines that
contain hydroxyurea or stavudine may increase your risk for liver
problems.
You may be more likely to get lactic acidosis or severe liver probl

Ciri produk

VIDEX- DIDANOSINE POWDER, FOR SOLUTION
BRISTOL-MYERS SQUIBB COMPANY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIDEX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VIDEX.
VIDEX (DIDANOSINE, USP) PEDIATRIC POWDER FOR ORAL SOLUTION
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. VIDEX 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. SUSPEND TREATMENT IF
CLINICAL OR LABORATORY FINDINGS SUGGESTIVE OF LACTIC ACIDOSIS OR
PRONOUNCED HEPATOTOXICITY OCCUR. FATAL
LACTIC ACIDOSIS HAS BEEN REPORTED IN PREGNANT INDIVIDUALS WHO RECEIVED
THE COMBINATION OF VIDEX AND
STAVUDINE. (5.2) COADMINISTRATION OF VIDEX WITH STAVUDINE IS
CONTRAINDICATED. (4)
INDICATIONS AND USAGE
VIDEX (didanosine, USP) is 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 at least 30 minutes
before or 2 hours after eating. Dosing is based
on body weight. (2.1)
AT LEAST 60 KG
LESS THAN 60 KG
Preferred dosing
200 mg twice daily
125 mg twice daily
Dosing for patients whose management
requires once-daily frequency
400 mg once daily
250 mg once daily
Pediatric patients (2 weeks old to 18 years old): Administered on an
empty stomach at least 30 minutes before or 2
hours after eating.
- Between 2 weeks and 8 months old, dosing is 100 mg per m twice
daily.
- For those greater than 8 months old, dosing is 120 mg per m twice
daily but not to exceed the adult dosing
recommendation. (2.1)
Renal impairment: Dose reduction is recommended. (2.2)
Coadministration with tenofovir: Dose reduction is