VIDEX EC- didanosine capsule, delayed release

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Bristol-Myers Squibb Company

INN (Jina la Kimataifa):

didanosine

Tungo:

didanosine 125 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

VIDEX® EC (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 EC 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 indivi

Bidhaa muhtasari:

VIDEX EC (didanosine, USP) Delayed-Release Capsules are white, opaque capsules that are packaged in bottles with child-resistant closures as described in Table 14. 125 mg capsule imprinted with “BMS 125 mg 6671” in Tan NDC No. 0087-6671-17 30 capsules/bottle 200 mg capsule imprinted with “BMS 200 mg 6672” in Green NDC No. 0087-6672-17 30 capsules/bottle 250 mg capsule imprinted with “BMS 250 mg 6673” in Blue NDC No. 0087-6673-17 30 capsules/bottle 400 mg capsule imprinted with “BMS 400 mg 6674” in Red NDC No. 0087-6674-17 30 capsules/bottle Storage The capsules should be stored in tightly closed containers at 25° C (77° F). Excursions between 15° C and 30° C (59° F and 86° F) are permitted (see USP Controlled Room Temperature).

Idhini hali ya:

New Drug Application

Taarifa za kipeperushi

VIDEX EC- DIDANOSINE CAPSULE, DELAYED RELEASE
Bristol-Myers Squibb Company
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Medication Guide
VIDEX EC (VY-dex Ee-see)
(didanosine, USP)
Delayed-Release Capsules
Enteric-Coated Beadlets
What is the most important information I should know about VIDEX EC?
VIDEX EC can cause serious side effects, including:
•
Inflammation of your pancreas (pancreatitis) can happen in people who
take VIDEX EC and can
lead to death. People who take VIDEX EC in combination with the
medicine stavudine may be at
an increased risk for pancreatitis. Do not take VIDEX EC 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 EC 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 EC and stavudine. Do not take VIDEX
EC with stavudine.
Call your healthcare provider right away if you have any of the
following symptoms which could be signs
of lactic acidosis:
•
feel 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 EC. Your
liver may become large (hepatomegaly), you may develop fat in the
liver (steatosis), or you may
have high blood pressure in the large vein of the liver (portal
hypertension). Severe liver problems
can lead to liver transplantation or death in some people taking VIDEX
EC. Taking VIDEX EC
with medicines that contain hydroxyurea or stavudine may increase your
risk for liver problems.
You may be mor

Tabia za bidhaa

VIDEX EC- DIDANOSINE CAPSULE, DELAYED RELEASE
BRISTOL-MYERS SQUIBB COMPANY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIDEX EC SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VIDEX EC. VIDEX EC (DIDANOSINE, USP)
DELAYED-RELEASE CAPSULES
ENTERIC-COATED BEADLETS
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 EC 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
didanosine and stavudine.
(5.2) Coadministration of VIDEX EC with stavudine is contraindicated.
(4)
INDICATIONS AND USAGE
VIDEX EC (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
•
•
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
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 125 mg, 200 mg, 250 mg, 400 mg (3)
CONTRAINDICATIONS
Coadministration with stavudine, allopurinol or ribavirin is
contraindicated. (4)
WARNINGS AND PRECAUTIONS
Pancreatitis: Suspension or discontinuation of didanosine may be
necessary. (5.1) Coadministration of VIDEX EC with
stavudine is contraindicated. (4)
Lactic acidosis and severe hepatomegaly with steatosis: Suspend
didanosine in patients who develop clinical symptoms
or signs with or without laboratory findings. (5.2)
Hepatic toxicity: Interruption or discontinuation of didano