DIDANOSINE capsule, delayed release pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

DIDANOSINE

Composition:

DIDANOSINE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Didanosine Delayed-Release Capsules are available as: 250 mg: Two-piece hard gelatin capsule with blue opaque cap and white opaque body filled with white pellets. Imprinted in black ink barr over 250 mg on one piece and 589 on the other piece. Available in bottles of 30 capsules NDC 54868-5464-0. 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIDANOSINE - DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS
Physicians Total Care, Inc.
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MEDICATION GUIDE
DidanosineDelayed-Release Capsules (enteric-coated pellets)
Read this Medication Guide before you start taking didanosine
delayed-release capsules and each time
you get a refill. There may be new information. This information does
not take the place of talking with
your healthcare provider about your medical condition or your
treatment. You and your healthcare
provider should talk about your treatment with didanosine
delayed-release capsules before you start
taking it and at regular check-ups. You should stay under your
healthcare provider’s care when taking
didanosine delayed-release capsules.
What is the most important information I should know about Didanosine
Delayed-Release Capsules?
Didanosine Delayed-Release Capsules may cause serious side effects,
including:
1.
Swelling of your pancreas (pancreatitis) that may cause death.
Pancreatitis can happen at any time
during your treatment with Didanosine Delayed-Release Capsules. Before
you start taking
didanosine delayed-release capsules, tell your healthcare provider if
you:
•
have had pancreatitis
•
have advanced HIV (human immunodeficiency virus) infection
•
have kidney problems
•
drink alcoholic beverages
•
take a medicine called ZERIT® (stavudine)
It is important to call your healthcare provider right away if you
have:
•
stomach pain
•
swelling of your stomach
•
nausea and vomiting
•
fever
1.
Build-up of acid in your blood (lactic acidosis). Lactic acidosis must
be treated in the hospital as it
may cause death. Before you start taking didanosine delayed-release
capsules, tell your healthcare
provider if you:
•
have liver problems
•
are pregnant. There have been deaths reported in pregnant women who
get lactic acidosis after
taking didanosine delayed-release capsules and ZERIT (stavudine).
•
are overweight
•
have been treated for a long time with other medicines to treat HIV
It is important to call your healthcare provi

Summary of Product characteristics

DIDANOSINE - DIDANOSINE CAPSULE, DELAYED RELEASE PELLETS
PHYSICIANS TOTAL CARE, INC.
----------
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.
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. 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)_
RECENT MAJOR CHANGES
Warnings and Precautions,
Immune Reconstitution Syndrome (5.7) 11/2011
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 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)
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
Renal impairment: Dose reduction is recommended. (2.2)
Coadministration with tenofovir: Dose reduction is recommended.
Patients should be monitored closely for didanosine-
associated adverse reactions. (2.3, 7.1)
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
Pan