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Oxcarbazine 

                                                  

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23O026 Oxcarbazine (Trileptal ® ) 6%,100ml Oral Suspension

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Product name
Trileptal ®
Dosage form
6%,100ml Oral Suspension
Indications
Partial seizure
Administration & Dosage

PO ,

Adult

Partial seizure, Monotherapy:

1) initiation of monotherapy,

300 mg twice a day, then increase by 300 mg/day every third

day to 1200 mg/day OR 2400mg/day in patients converted

from other antiepileptic drug therapy to oxcarbazepine

monotherapy.

2) conversion to monotherapy,

initial, 300 mg twice a day; may increase by up to 600

mg/day at weekly intervals to 2400 mg/day reached in about

2-4 weeks while simultaneously reduce the dose of

concomitant antiepileptic drugs over 3-6 weeks.

Partial seizure; Adjunct:

initial, 300 mg twice a day; may increase by up to 600 mg/day

 at weekly intervals to 1200mg/day.

 

Pediatric

With adjunctive therapy:

1) 2 to less than 4 years old

up to twice the oxcarbazepine dose per body weight

compared to adults.

2) 4 to less than or equal to 12 years old

 a 50% higher oxcarbazepine dose per body weight

compared to adults.

Partial seizure, Monotherapy:

1) 4 to 16 year old

initiation of monotherapy, 8-10 mg/kg/day in 2 divided doses; may increase dose by 5 mg/kg/day every 3 days to the recommended maintenance dose.

conversion to monotherapy, initial, 8-10 mg/kg/day in 2

divided doses; may increase doses by up to 10 mg/kg/day at

weekly intervals to the recommended maintenance dose;

simultaneously reduce the dose of concomitant antiepileptic

drugs over 3-6 weeks.

maintenance, 600 to 900 mg/day for 20 kg children; 900 to

1200 mg/day for 25 to 30 kg ; 900 to 1500 mg/day for 35 to

40 kg children; 1200 to 1500 mg/day for 45 kg children;

1200 to 1800 mg/day for 50 to 55 kg children; 1200 to 2100

mg/day for 60 to 70 kg children.

Partial seizure; Adjunct:

1) 4 to 16 year old

 initial, 8-10 mg/kg/day in 2 divided doses; Max. 600 mg/day.

maintenance, target maintenance dose of oxcarbazepine

should be achieved over 2 weeks, and is dependent upon

patient weight: (20 to 29 kg , 900 mg/day); (29.1 to 39 kg ,

1200 mg/day); and (greater than 39 kg , 1800 mg/day).

2) 2 to less than 4 years old

initial, 8-10 mg/kg/day in 2 divided doses; Max. 600 mg/day;

patients under 20 kg , consider initial dose of 16-20 mg/kg/day

 in 2 divided doses.

maintenance, should be titrated over 2 to 4 weeks; Max. 60

mg/kg/day in 2 divided doses.

 
Contraindication
 hypersensitivity to oxcarbazepine, or to any product component.
Precaution
 
Adverse reaction

Abdominal pain, nausea, vomiting; abnormal gait, ataxia,

dizziness, headache, nystagmus, somnolence, tremor, vertigo,

metabolic encephalopathy, seizure; increased liver function test;

abnormal vision, diplopia, oculogyric crises; rhinitis, upper

respiratory infection; skin rash, urticaria, erythema multiforme, allergic skin reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis; hyponatremia, thyroid hormone change, body temperature change, hyperlipidemia, acute intermittent porphyria, weight gain, reproductive hormone level change;

anaphylaxis, immune hypersensitivity reaction; angioedema; suicidal thoughts.

 
Drug Interaction
 
Pregnancy Category
C
Notes

1) Shake well before use. Take with or without food.

2) Stored between 15 -30 .After the first opening, oral suspension may be stored for 7 weeks.

 
最近更新日期 2015年9月25日