OXCARBAZEPINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Oxcarbazepine (UNII: VZI5B1W380) (Oxcarbazepine - UNII:VZI5B1W380)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Oxcarbazepine

Composition:

Oxcarbazepine 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 2 years and above with partial seizures. Oxcarbazepine tablets should not be used in patients with a known hypersensitivity to oxcarbazepine or to any of its components. Oxcarbazepine levels may decrease during pregnancy [see Warnings and Precautions (5.10)]. Pregnancy Category C There are no adequate and well-controlled clinical studies of oxcarbazepine in pregnant women; however, oxcarbazepine is closely related structurally to carbamazepine, which is considered to be teratogenic in humans. Given this fact, and the results of the animal studies described, it is likely that oxcarbazepine is a human teratogen. Oxcarbazepine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Increased

Product summary:

Oxcarbazepine Tablets, 150 mg: Pale peach, ovaloid, slightly biconvex, scored on both sides. Imprinted with R/O on one side and O/C on the other side. Oxcarbazepine Tablets, 300 mg: Pale peach, ovaloid, slightly biconvex, scored on both sides. Imprinted with OX/C3 on one side and TA/RO on the other side. Oxcarbazepine Tablets, 600 mg: Pale peach, ovaloid, slightly biconvex, scored on both sides. Imprinted with OX/C6 on one side and TA/RO on the other side. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OXCARBAZEPINE- OXCARBAZEPINE TABLET
Taro Pharmaceuticals U.S.A., Inc.
----------
MEDICATION GUIDE
Oxcarbazepine
(ox" kar baz' e peen)
Tablets
Read this Medication Guide before you start taking oxcarbazepine
tablets and each time you get a refill.
There may be new information. This information does not take the place
of talking to your healthcare
provider about your medical condition or treatment.
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.
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 do not go away or come and
go
•
painful sores in the mouth or around your eyes
•
yellowing of your skin or eyes
•
unusual bruising or bleeding
•
severe fatigue or weakness
•
severe muscle pain
•
frequent infections or infections that do not go away
Many people who

Summary of Product characteristics

OXCARBAZEPINE- OXCARBAZEPINE TABLET
TARO PHARMACEUTICALS U.S.A., INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXCARBAZEPINE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR OXCARBAZEPINE.
OXCARBAZEPINE TABLETS FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions (5.4)
06/2014
Warnings and Precautions (5.8)
07/2014
INDICATIONS AND USAGE
Oxcarbazepine tablet is an antiepileptic drug indicated for:
Adults:
-
Childre n:
-
-
DOSAGE AND ADMINISTRATION
ADULTS: initiated with a dose of 600 mg/day, given in twice-a-day
regimen
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: Concomitant AEDs should be completely
withdrawn over 3-6 weeks, while maximum
dose of oxcarbazepine should be reached in about 2-4 weeks. Maximum
increment of 600 mg/day at approximately
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)
CHILDREN: initiation with 8-10 mg/kg/day, given in twice-a-day
regimen.
Adjunctive Patients (Aged 2-16 Years): For patients aged 4-16 years,
target maintenance dose should be achieved over
2 weeks (2.4). For patients aged 2 - <4 years, maximum maintenance
dose should be achieved over 2-4 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 withdrawn over 3-6
weeks (2.5)
Initiation of Monotherapy for Patients (Aged 4-16 Years) Increments of
5 mg/kg/day every third day (2.6)
DOSAGE FORMS AND STRENGTHS
Tablets: 150 mg, 300 mg and 600 mg (3)
CONTRAINDICATIONS
Oxcarbazepine should not be used in patients with a known
hypersensitivity to oxcarbazepine or to any of its
components (4)
WARNINGS AND PRECAUTIONS
Hyponat