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Carbamazepine (Carbamazepine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Epilepsy: Carbamazepine tablets are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types:

1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types.

2. Generalized tonic-clonic seizures (grand mal).

3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).

Trigeminal Neuralgia: Carbamazepine tablets are indicated in the treatment of the pain associated with true trigeminal neuralgia.

Beneficial results have also been reported in glossopharyngeal neuralgia.

This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.

DOSAGE AND ADMINISTRATION

(See table below)

Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS: Laboratory Tests). Dosage should be adjusted to the needs of the individual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Tablets should be taken with meals.

Conversion of patients from oral carbamazepine tablets to carbamazepine suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e., b.i.d. tablets to t.i.d. suspension).

Epilepsy (see INDICATIONS AND USAGE):

Adults And Children Over 12 Years Of Age — Initial: 200 mg b.i.d. Increase at weekly intervals by adding up to 200 mg/day using a t.i.d. or q.i.d. regimen until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances. Maintenance: Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily.

Children 6 to 12 years of age — Initial: 100 mg b.i.d. Increase at weekly intervals by adding up to 100 mg/day using a t.i.d. or q.i.d. regimen until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily.  Maintenance: Adjust dosage to the minimum effective level, usually 400 to 800 mg daily.

Children Under 6 Years Of Age — Initial: 10 to 20 mg/kg/day b.i.d. or t.i.d. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d.  Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of carbamazepine for use at doses above 35 mg/kg/24 hours can be made.

Combination Therapy:Carbamazepine may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased (see PRECAUTIONS: Drug Interactions,and Pregnancy Category D).

Trigeminal Neuralgia (see INDICATIONS AND USAGE):

Initial:On the first day, 100 mg b.i.d., for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets, only as needed to achieve freedom from pain. Do not exceed 1200 mg daily. Maintenance:Control of pain can be maintained in most patients with 400 to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug.

Dosage Information
Initial DoseSubsequent DoseMaximum Daily Dose
Indication
Epilepsy

Under 6 yr


10 to 20 mg/kg/dayb.i.d. or t.i.d.


Increase weekly to achieve optimal clinical response, t.i.d. or q.i.d.


35 mg/kg/24 hr (see DOSAGE AND ADMINISTRATION section above)
6 to 12 yr100 mg b.i.d.(200 mg/day)Add up to 100 mg/dayat weekly intervals,t.i.d. or q.i.d.1000 mg/24 hr
Over 12 yr200 mg b.i.d.(400 mg/day)Add up to200 mg/day at weekly intervals, t.i.d. or q.i.d.1000 mg/24 hr (12 to 15 yr)1200 mg/24 hr (>15 yr)1600 mg/24 hr (adults, in rare instances)
Trigeminal Neuralgia

100 mg b.i.d. (200 mg/day)


Add up to 200 mg/day in increments of 100 mg every 12 hr


1200 mg/24 hr

HOW SUPPLIED

Carbamazepine Tablets, USP are available as follows:

200 mg — Each white, round, flat faced beveled edge tablet, imprinted with

on one side and 143 and bisect on the other side, contains 200 mg of Carbamazepine USP. Tablets are supplied in bottles of 100 (NDC 0228-2143-10), 500 (NDC 0228-2143-50), and 1000 (NDC 0228-2143-96).

Dispense in a tight container, preferably of glass, as defined in the USP, labeled: “Store in a dry place. Protect from moisture.”

Store at controlled room temperature 15°-30°C (59°-86°F) (see USP).

Store in a dry place. Protect from moisture.

Rx only

Manufactured by:

Actavis Elizabeth LLC

200 Elmora Avenue

Elizabeth, NJ 07207 USA

40-9022

Revised — August 2007

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