Posology : מינונים

4.2   Posology and method of administration

Dosage
Epilepsy
When possible, Tegretol should be prescribed as monotherapy.

Treatment should be initiated with a low daily dosage, to be slowly increased until an optimal effect is obtained.

The dose of carbamazepine should be adjusted to the needs of the individual patient to achieve adequate control of seizures. Determination of plasma levels may help in establishing the optimum dosage. In the treatment of epilepsy, the dose of carbamazepine usually requires total plasma-carbamazepine concentrations of about 4 to 12 micrograms/mL (17 to 50 micromoles/litre) (see Warnings and precautions, & Pharmacokinetics: absorption).

When Tegretol is added to existing antiepileptic therapy, this should be done gradually while maintaining or, if necessary, adapting the dosage of the other antiepileptic(s) (see Interactions).

General target population / Adults

Dosage in Epilepsy
Oral forms:
Initially, 100 to 200 mg once or twice daily; the dosage should be slowly raised until – generally at 400 mg 2 to 3 times daily – an optimum response is obtained. In some patients 1600 mg or even 2000 mg daily may be appropriate


Dosage in Acute mania and maintenance treatment of bipolar affective disorders Dosage range: about 400 to 1600 mg daily, the usual dosage being 400 to 600 mg daily given in 2 to 3 divided doses. In acute mania, the dosage should be increased rather quickly, whereas small dosage increments are recommended for maintenance therapy of bipolar disorders in order to ensure optimal tolerability.

Dosage in Trigeminal neuralgia
The initial dosage of 200 to 400 mg should be slowly raised daily until freedom from pain is achieved (normally at 200 mg 3 to 4 times daily). The dosage should then be gradually reduced to the lowest possible maintenance level. Maximum recommended dose is 1200 
mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs.


Diabetes insipidus centralis
Average dosage for adults: 200 mg 2 to 3 times daily.
Special populations
Renal impairment/ Hepatic impairment
No data are available on the pharmacokinetics of carbamazepine in patients with impaired hepatic or renal function.


Pediatrics, children, and adolescents
Dosage in Epilepsy

Oral forms
For children aged 4 years or less, a starting dose of 20 to 60 mg/day, increasing by 20 to 60 mg every second day, is recommended. For children over the age of 4 years, therapy may begin with 100 mg/day, increasing at weekly intervals by 100 mg.

Maintenance dosage: 10 to 20 mg/kg body weight daily in divided doses, e.g.
•     Up to 1 year of age:     100 to 200 mg daily (= 5 to 10mL = 1-2 measures of syrup)
•     1 to 5 years of age:     200 to 400 mg daily (= 10 to 20 mL = 2× 1-2 measures of syrup)
•     6 to 10 years of age:    400 to 600 mg daily (= 20 to 30 mL = 2-3× 2 measures of syrup)
•     11 to 15 years of age: 600 to 1000 mg daily (= 30 to 50 mL = 3× 2-3 measures of syrup (plus an extra measure of 5 mL in case of administration of 1000 mg))
•     >15 years of age:        800 to 1200 mg daily (same as adult dose 
Note: one 5 mL measure of syrup is equivalent to 100 mg carbamazepine.

Maximum recommended dose
Up to 6 years of age: 35 mg/kg/day
6-15 years of age:     1000 mg/day
>15 years of age:      1200 mg/day
Diabetes insipidus centralis
In children the dosage should be reduced proportionally to the child's age and body weight.


Geriatric patients (65 years or above)
Dosage in Trigeminal neuralgia
Due to drug interactions and different antiepileptic drug pharmacokinetics, the dosage of Tegretol should be selected with caution in elderly patients.
In elderly patients, an initial dose of 100 mg twice daily is recommended. The initial dosage of 100 mg twice daily should be slowly raised daily until freedom from pain is achieved (normally at 200 mg 3 to 4 times daily). The dosage should then be gradually reduced to the lowest possible maintenance level. Maximum recommended dose is 1200 mg/day. When pain relief has been obtained, attempts should be made to gradually discontinue therapy, until another attack occurs.

Method of Administration
The tablets and the syrup (to be shaken before use) may be taken during, after, or between meals. Tablets should be taken with a little liquid.

The CR tablets (either whole or, if so prescribed, only half a tablet) should be swallowed unchewed with a little liquid. The syrup (one measure = 5 mL = 100 mg; half a measure = 2.5 mL = 50 mg) is particularly suitable for patients who have difficulty in swallowing tablets or need initial careful adjustment of the dosage.
As a result of slow, controlled release of the active substance from the CR tablets, these are designed to be taken in a twice-daily dosage regimen.

Since a given dose of Tegretol Syrup will produce higher peak levels than the same dose in tablet form, it is advisable to start with low doses and increase slowly so as to avoid adverse reactions.

Switching patients from Tegretol tablets to syrup
This should be done by giving the same number of mg per day in smaller, more frequent doses (e.g. Syrup three times a day (t.i.d.) instead of tablets twice a day (b.i.d)).

Switching patients from conventional tablets to CR tablets
Clinical experience shows that in some patients the dosage in the form of CR tablets may need to be increased.