OXCARBAZEPINE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

West-Ward Pharmaceticals Corp.

INN（国際名）:

OXCARBAZEPINE

構図:

OXCARBAZEPINE 150 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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. 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 oxcarbaze

製品概要:

Oxcarbazepine Tablets, USP 150 mg tablets are supplied as a round, peach, speckled, biconvex tablet, debossed with product identification “54 331” on one side and a bisect on the other side. NDC 0054-0097-25: Bottle of 100 Tablets NDC 0054-0097-20: 2x5x10 Unit-Dose 300 mg tablets are supplied as a round, peach, speckled, biconvex tablet, debossed with product identification “54 515” on one side and a bisect on the other side. NDC 0054-0098-25: Bottle of 100 Tablets NDC 0054-0098-20: 2x5x10 Unit-Dose 600 mg tablets are supplied as a modified oval, peach, speckled, biconvex tablet, debossed with product identification “54 171” on one side and a bisect on the other side. NDC 0054-0099-25: Bottle of 100 Tablets NDC 0054-0099-20: 2x5x10 Unit-Dose Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, child-resistant container as defined in the USP/NF.

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

West-Ward Pharmaceticals Corp.
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MEDICATION GUIDE
Oxcarbazepine Tablets
(ox” kar baz’ e peen)
Rx Only
What is the most important information I should know about
oxcarbazepine?
Do not stop taking oxcarbazepine without first talking to your
healthcare provider. Stopping oxcarbazepine
suddenly can cause serious problems.
Oxcarbazepine can cause serious side effects, including:
1. Oxcarbazepine 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. 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.
2. Oxcarbazepine 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 allergic to
oxcarbazepine. Tell your healthcare
provider if you are allergic to carbamazepine.
3. Like other antiepileptic drugs, oxcarbazepine may cause suicidal
thoughts or actions in a

製品の特徴

OXCARBAZEPINE- OXCARBAZEPINE TABLET
WEST-WARD PHARMACETICALS CORP.
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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 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
Pe diatrics:
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 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 a