TRILEPTAL- oxcarbazepine tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

DIRECT RX

DCI (Dénomination commune internationale):

OXCARBAZEPINE

Composition:

OXCARBAZEPINE 300 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Oxcarbazepine tablets USP 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. 8.1 Pregnancy 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

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

TRILEPTAL- OXCARBAZEPINE TABLET
DIRECT RX
----------
Oxcarbazepine Tablets USP
(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 away
Many people who are allergic to carbamazepine are also all

Résumé des caractéristiques du produit

TRILEPTAL- OXCARBAZEPINE TABLET
DIRECT RX
----------
OXCARBAZEPINE
Oxcarbazepine tablets USP 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.
All dosing should be given in a twice-a-day regimen.
Oxcarbazepine tablets should be kept out of the reach and sight of
children.
Oxcarbazepine tablets can be taken with or without food [see Clinical
Pharmacology (12.3)].
2.1 Adjunctive Therapy for Adults
Treatment with oxcarbazepine tablets should be initiated with a dose
of 600 mg/day, given in a twice-a-
day regimen. If clinically indicated, the dose may be increased by a
maximum of 600 mg/day at
approximately weekly intervals; the recommended daily dose is 1200
mg/day. Daily doses above 1200
mg/day show somewhat greater effectiveness in controlled trials, but
most patients were not able to
tolerate the 2400 mg/day dose, primarily because of CNS effects. It is
recommended that the patient be
observed closely and plasma levels of the concomitant AEDs be
monitored during the period of
oxcarbazepine tablets titration, as these plasma levels may be
altered, especially at oxcarbazepine
tablets doses greater than 1200 mg/day [see Drug Interactions (7.1)].
2.2 Conversion to Monotherapy for Adults
Patients receiving concomitant AEDs may be converted to monotherapy by
initiating treatment with
oxcarbazepine tablets at 600 mg/day (given in a twice-a-day regimen)
while simultaneously initiating the
reduction of the dose of the concomitant AEDs. The concomitant AEDs
should be completely
withdrawn over 3-6 weeks, while the maximum dose of oxcarbazepine
tablets should be reached in
about 2-4 weeks. Oxcarbazepine tablets may be increased as clinically
indicated by a maximum
increment of 600 mg/day at approximately weekly intervals to achieve
the recommended daily dose of
2400 mg/day. A daily d