OXCARBAZEPINE- 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:

REMEDYREPACK INC.

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 seizures in adults and as monotherapy in the treatment of partial seizures in pediatric patients aged 4 years and above with epilepsy, and as adjunctive therapy in pediatric patients aged 2 years and above with partial seizures. Oxcarbazepine Tablets 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)]. Clinical Considerations Oxcarbazepine levels may decrease during pregnancy [see Warnings and Precautions ( 5.10)]. Pregnancy Category C Fetal Risk Summary 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. Data on a limited number of pregnancies from pregnancy registries suggest congenital malformations associated w

製品概要:

Oxcarbazepine Tablets 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: 10x10 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: 10x10 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: 10x10 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

REMEDYREPACK INC.
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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 very small
n

製品の特徴

OXCARBAZEPINE- OXCARBAZEPINE TABLET
REMEDYREPACK INC.
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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 ADMINISTRATION
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
1. Dosage and Administration ( 2.1, 2.4) 11/2017
2. Contraindications ( 4) 09/2017
3. Warnings and Precautions ( 5.1, 5.3, 5.6, 5.7, 5.8, 5.11) 09/2017
INDICATIONS AND USAGE
Oxcarbazepine tablets are indicated for:
Adults: Monotherapy or adjunctive therapy in the treatment of partial
seizures
Pe diatrics:
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: 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
should be reached in about 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 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 exceed 60mg/kg/day. ( 2.4)
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