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:

Advagen Pharma Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxcarbazepine is 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 is 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 oxcarbazepine in pr

Product summary:

Oxcarbazepine tablets, USP 150 mg are yellow to light yellow, biconvex, oval, film coated tablets debossed ‘Λ 136’ on one side and break line on other side. Bottle of 30           NDC 72888-087-30 Bottle of 100         NDC 72888-087-01 Bottle of 500         NDC 72888-087-05 Oxcarbazepine tablets, USP 300 mg are yellow to light yellow, biconvex, oval, film coated tablets debossed ‘Λ 137’ on one side and break line on other side. Bottle of 30           NDC 72888-088-30 Bottle of 100         NDC 72888-088-01 Bottle of 500         NDC 72888-088-05 Oxcarbazepine tablets, USP 600 mg are yellow to light yellow, biconvex, oval, film coated tablets debossed ‘Λ 139’ on one side and break line on other side. Bottle of 30           NDC 72888-089-30 Bottle of 100         NDC 72888-089-01 Bottle of 500         NDC 72888-089-05 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container [see USP].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Advagen Pharma Limited
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MEDICATION GUIDE
Oxcarbazepine (ox-kar-BAY-zeh-peen)
Film coated tablets, 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
• confusion
• tiredness (lack of energy)
• more frequent or more severe seizures
• headache
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
• painful sores in the mouth or around your eyes
• trouble swallowing or breathing
• yellowing of your skin or eyes
• a skin rash
• unusual brusing or bleeding
• hives
• severe fatigue or weakness
• fever, swollen glands, or sore throat that do not go away or come
and go
• severe muscle pain
• frequent infections or infections that do not go away
Many people who are allergic to carbamazepine are also allergic to
oxcarbazepine. Tell your healthcare provider if you are allergic to
carbamazepine.
3. Like other antiepilep

Summary of Product characteristics

OXCARBAZEPINE- OXCARBAZEPINE TABLET, FILM COATED
ADVAGEN PHARMA LIMITED
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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 is 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 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
withdrawn over 3 to 6 w