OXCARBAZEPINE tablet, film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

OXCARBAZEPINE (UNII: VZI5B1W380) (OXCARBAZEPINE - UNII:VZI5B1W380)

MAH:

American Health Packaging

INN:

OXCARBAZEPINE

composition:

OXCARBAZEPINE 150 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. Oxcarbazepine tablets are contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [see Warnings and Precautions ( 5.2, 5.3)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as oxcarbazepine tablets, during pregnancy. Encourage women who are taking oxcarbazepine tablets during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the development

leaflet_short:

Oxcarbazepine Tablets, USP are provided as: 150 mg Film-Coated Tablets: beige, film-coated, modified oval shaped tablet, scored on both sides, debossed "B2 | 92" on one side and plain on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-845-01 300 mg Film-Coated Tablets: beige, film-coated, modified oval shaped tablet, scored on both sides, debossed "B | 293" on one side and plain on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-853-01 600 mg Film-Coated Tablets: beige, film-coated, modified oval shaped tablet, scored on both sides, debossed "B | 294" on one side and plain on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-867-01 Store at 20°-25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

authorization_status:

Abbreviated New Drug Application

PIL

OXCARBAZEPINE- OXCARBAZEPINE TABLET, FILM COATED
American Health Packaging
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MEDICATION GUIDE
8284501/1219
Oxcarbazepine Tablets, USP
(ox kar baz' e peen)
film-coated tablets, for oral use
Oxcarbazepine Tablets, USP contains FD&C yellow no. 5 (tartrazine)
which may cause allergic-type
reactions (including bronchial asthma) in certain susceptible
individuals. Although the overall incidence
of FD&C yellow no. 5 (tartrazine) sensitivity in the general
population is low, it is frequently seen in
patients who also have aspirin hypersensitivity.
What is the most important information I should know about
oxcarbazepine tablets?
Do not stop taking oxcarbazepine tablets without first talking to your
healthcare provider. Stopping
oxcarbazepine tablets suddenly can cause serious problems.
Oxcarbazepine tablets can cause serious side effects, including:
1. Oxcarbazepine tablets may cause the level of sodium in your blood
to be low. Symptoms of low blood
sodium include:
•
nausea
•
tiredness (lack of energy)
•
headache
•
confusion
•
more frequent or more severe seizures
Similar symptoms that are not related to low sodium may occur from
taking oxcarbazepine tablets. You
should tell your healthcare provider if you have any of these side
effects and if they bother you or they do
not go away.
Some other medicines can also cause low sodium in your blood. Be sure
to tell your healthcare provider
about all the other medicines that you are taking.
Your healthcare provider may do blood tests to check your sodium
levels during your treatment with
oxcarbazepine tablets.
2. Oxcarbazepine tablets may also cause allergic reactions or serious
problems which may affect organs
and other parts of your body like the liver or blood cells. You may or
may not have a rash with these
types of reactions.
Call your healthcare provider right away if you have any of the
following:
•
swelling of your face, eyes, lips, or tongue
•
trouble swallowing or breathing
•
a skin rash
•
hives
•
fever, swollen glands, or sore throat that

SPC

OXCARBAZEPINE- OXCARBAZEPINE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXCARBAZEPINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OXCARBAZEPINE TABLETS.
OXCARBAZEPINE FILM-COATED TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Oxcarbazepine tablets are indicated for:
Adults: Monotherapy or adjunctive therapy in the treatment of
partial-onset seizures
Pediatrics:
Monotherapy in the treatment of partial-onset seizures in children
4-16 years
Adjunctive therapy in the treatment of partial-onset seizures in
children 2-16 years ( 1)
DOSAGE AND ADMINISTRATION
Adults: initiate with a dose of 600 mg/day, given twice-a-day
Adjunctive Therapy: Maximum increment of 600 mg/day at approximately
weekly intervals. The
recommended daily dose is 1200 mg/day ( 2.1)
Conversion to Monotherapy: withdrawal concomitant over 3 to 6 weeks,
reach maximum dose of
oxcarbazepine tablets in 2 to 4 weeks with increments of 600 mg/day at
weekly intervals to a
recommended daily dose of 2400 mg/day ( 2.2)
Initiation of Monotherapy: Increments of 300 mg/day every third day to
a dose of 1200 mg/day ( 2.3)
Initiate at one-half the usual starting dose and increase slowly in
patients with a creatinine clearance
<30 mL/min ( 2.7)
Pediatrics: initiation with 8 to 10 mg/kg/day, given twice-a-day. For
patients aged 2 to <4 years and under
20 kg, a starting dose of 16 to 20 mg/kg/day may be considered.
Recommended daily dose is dependent
upon patient weight
Adjunctive Patients (Aged 2-16 Years): For patients aged 4 to 16
years, target maintenance dose
should be achieved over 2 weeks ( 2.4). For patients aged 2 to <4
years, maximum maintenance dose
should be achieved over 2 to 4 weeks and should not to exceed 60
mg/kg/day ( 2.4)
Conversion to Monotherapy for Patients (Aged 4-16 Years): Maximum
increment of 10 mg/kg/day at
weekly intervals, concomitant antiepileptic drugs can be completely
withd