OXCARBAZEPINE tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Международно Name):

OXCARBAZEPINE

Композиция:

OXCARBAZEPINE 300 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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.

Каталог на резюме:

150 mg Film-Coated Tablets: yellow color, capsule-shaped, biconvex, coated tablets scored and   debossed with ‘183’ on one side and scored on other side. 300 mg Film-Coated Tablets: yellow color, capsule-shaped, biconvex, coated tablets scored and   debossed with ‘184’ on one side and scored on other side. Blistercards of 30:                         NDC 0615-6594-39 600 mg Film-Coated Tablets: yellow color, capsule-shaped, biconvex, coated tablets scored and   debossed with ‘185’ on one side and scored on other side. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).

Статус Оторизация:

Abbreviated New Drug Application

Листовка

OXCARBAZEPINE- OXCARBAZEPINE TABLET, FILM COATED
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
Oxcarbazepine Tablets
(ox kar baz` e peen)
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

Данни за продукта

OXCARBAZEPINE- OXCARBAZEPINE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
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 TABLETS.
OXCARBAZEPINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions (5.4) 06/2014
INDICATIONS AND USAGE
Oxcarbazepine is an antiepileptic drug indicated for:
Adults:
Monotherapy or adjunctive therapy in the treatment of partial seizures
Childre n:
Monotherapy in the treatment of partial seizures in children 4 to 16
years
Adjunctive therapy in the treatment of partial seizures in children 2
to 16 years (1)
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 to 6 weeks, while maximum
dose of oxcarbazepine should be reached in about 2 to 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 to 10 mg/kg/day, given in twice-a-day
regimen. 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 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 achieved over 2 to 4 weeks
and should not to exceed 60mg/kg/day (2.4)
Conversion to Monotherapy for Patients (Aged 4 to 16 Years) Maximum
increment of 10 mg/kg/day at weekly
intervals, concomitant antiepileptic drugs can be comp