OXCARBAZEPINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

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-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. Oxcarbazepinetablets 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, during pregnancy. Encourage women who are taking oxcarbazepine 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 developmental risks associated with the use of o

Product summary:

Tablets 150 mg Film-Coated Tablets: yellow, film coated oval, biconvex tablets with deep break line on both sides and "G" engraved on one side of the deep break line on one side of the tablet and "13" and "7" engraved on either side of the deep break line on the other side of the tablet. Bottle of 30.........NDC 71205-411-30 Bottle of 60.........NDC 71205-411-60 Bottle of 90…….NDC 71205-411-90 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]. Dispense in tight container (USP).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OXCARBAZEPINE- OXCARBAZEPINE TABLET, FILM COATED
Proficient Rx LP
----------
MEDICATION GUIDE
Oxcarbazepine Tablets
(ox kar baz' e peen),
for oral use
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
•
•
painful sores in the mouth or around your
eyes
•
yellowing of your skin or eyes
a skin rash
•
hives
•
fever, swollen glands, or sore throat that do not
go away or come and go
•
unusual bruising or bleeding
•
severe fatigue or weakness
•
severe muscle pain
•
frequent infections or infections that do not
go away
Many people who are allergic to carbamazepine are also allergic to
oxcarbazepine tablets. Tell your
healthcare provider if you are allergic to

Summary of Product characteristics

OXCARBAZEPINE- OXCARBAZEPINE TABLET, FILM COATED
PROFICIENT RX LP
----------
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 TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Oxcarbazepine tablets are indicated for:
•
•
DOSAGE AND ADMINISTRATION
Adults: initiate with a dose of 600 mg/day, given twice-a-day
•
•
•
•
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.
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Known hypersensitivity to oxcarbazepine or to any of its components,
or to eslicarbazepine acetate (4,
5.2)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
Adults: Monotherapy or adjunctive therapy in the treatment of
partial-onset seizures
Pediatrics:
o
o
Monotherapy in the treatment of partial-onset seizures in children 4
to 16 years
Adjunctive therapy in the treatment of partial-onset seizures in
children 2 to 16 years (1)
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)
Adjunctive Patients (Aged 2 to 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 ac