OXCARBAZEPINE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

REMEDYREPACK INC.

SNN (starptautisko nepatentēto nosaukumu):

OXCARBAZEPINE

Kompozīcija:

OXCARBAZEPINE 300 mg

Receptes veids:

PRESCRIPTION DRUG

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

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, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXCARBAZEPINE
TABLETS, USP.
OXCARBAZEPINE TABLETS, USP
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.4) 06/2014
INDICATIONS AND USAGE
Oxcarbazepine tablets, USP are 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 4-16
years
- Adjunctive therapy in the treatment of partial seizures in children
2-16 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withdrawn over 3-6 weeks, while maximum
dose of oxcarbazepine tablets, USP should be reached in about 2-4
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 8-10 mg/kg/day, given in twice-a-day
regimen. For patients aged 2 - <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 4-16 years,
target maintenance dose should be achieved over
2 weeks ( 2.4). For patients aged 2 - <4 years, maximum maintenance
dose should be achieved over 2-4 weeks and
should not to exceed 60mg/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 o