DIDANOSINE capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

INN (International Name):

DIDANOSINE

Composition:

DIDANOSINE 125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Didanosine delayed-release capsules, also known as ddI, in combination with other antiretroviral agents are indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [see Clinical Studies (14) ] . Didanosine delayed-release capsules are 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. Pregnancy Exposure Registry There is a preg

Product summary:

Didanosine Delayed-Release Capsules USP, 125 mg are white / white size ‘3’ hard gelatin capsules imprinted with ‘D’ on white cap and ‘70’ on white body with black edible ink filled with white to off-white beadlets.            Bottle of 30                                NDC 65862-310-30          Bottle of 500                              NDC 65862-310-05          10 x 14 Unit-dose Capsules        NDC 65862-310-14   Didanosine Delayed-Release Capsules USP, 200 mg are white / white size ‘1’ hard gelatin capsules imprinted with ‘D’ on white cap and ‘69’ on white body with black edible ink filled with white to off-white beadlets.            Bottle of 30                                NDC 65862-311-30          Bottle of 500                              NDC 65862-311-05          10 x 10 Unit-dose Capsules        NDC 65862-311-10   Didanosine Delayed-Release Capsules USP, 250 mg are white / white size ‘0’ hard gelatin capsules imprinted with ‘D’ on white cap and ‘10’ on white body with black edible ink filled with white to off-white beadlets.          Bottle of 30                                NDC 65862-312-30          Bottle of 500                              NDC 65862-312-05          10 x 10 Unit-dose Capsules        NDC 65862-312-10   Didanosine Delayed-Release Capsules USP, 400 mg are white / white size ‘00’ hard gelatin capsules imprinted with ‘D’ on white cap and ‘09’ on white body with black edible ink filled with white to off-white beadlets.            Bottle of 30                                NDC 65862-313-30          Bottle of 500                              NDC 65862-313-05          10 x 5 Unit-dose Capsules          NDC 65862-313-50   Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].   Store in tightly closed containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIDANOSINE - DIDANOSINE CAPSULE, DELAYED RELEASE
Aurobindo Pharma Limited
----------
MEDICATION GUIDE
Didanosine Delayed-Release Capsules USP
(dye dan' oh seen)
Enteric-Coated Beadlets
What is the most important information I should know about didanosine
delayed-release capsules?
Didanosine delayed-release capsules can cause serious side effects,
including:
•
Inflammation of your pancreas (pancreatitis) can happen in people who
take didanosine delayed-
release capsules and can lead to death. People who take didanosine
delayed-release capsules in
combination with the medicine stavudine may be at an increased risk
for pancreatitis. Do not take
didanosine delayed-release capsules with stavudine.
Call your healthcare provider right away if you have any of the
following symptoms of pancreatitis:
•
severe stomach (abdomen) pain
•
swelling of your stomach
•
nausea and vomiting
•
fever
•
Build-up of an acid in your blood (lactic acidosis). Lactic acidosis
can happen in some people who
take didanosine delayed-release capsules 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 didanosine delayed-release
capsules and stavudine. Do not
take didanosine delayed-release capsules 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
•
have unusual (not normal) muscle pain
•
have trouble breathing
•
have stomach pain with nausea and vomiting
•
feel cold, especially in your arms and legs
•
feel dizzy or light-headed
•
have a fast or irregular heartbeat
•
weight loss
•
Severe liver problems , including liver failure, can happen in people
who take didanosine delayed-
release capsules. 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 h

Summary of Product characteristics

DIDANOSINE - DIDANOSINE CAPSULE, DELAYED RELEASE
AUROBINDO PHARMA LIMITED
----------
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, FOR ORAL USE
(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. 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. 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 DIDANOSINE DELAYED-RELEASE CAPSULES WITH
STAVUDINE IS CONTRAINDICATED. (4)
RECENT MAJOR CHANGES
Boxed Warning 01/2018
Contraindications (4) 01/2018
Warnings and Precautions (5.1, 5.2, 5.3, 5.5) 01/2018
Warnings and Precautions, Lipoatrophy (5.8) 01/2018
Warnings and Precautions, Fat Redistribution (5.8) Removed 01/2018
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
DOSE
20 kg to less than 25 kg 200 mg once daily
25 kg to less than 60 kg 250 mg once daily
at