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Tegretol (Carbamazepine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Epilepsy

Tegretol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Tegretol 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 Tegretol (see PRECAUTIONS, General).

Trigeminal Neuralgia

Tegretol is 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)

Tegretol suspension in combination with liquid chlorpromazine or thioridazine results in precipitate formation, and, in the case of chlorpromazine, there has been a report of a patient passing an orange rubbery precipitate in the stool following coadministration of the two drugs (see PRECAUTIONS, Drug Interactions). Because the extent to which this occurs with other liquid medications is not known, Tegretol suspension should not be administered simultaneously with other liquid medications or diluents.

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. Medication should be taken with meals.

Since a given dose of Tegretol suspension will produce higher peak levels than the same dose given as the tablet, it is recommended to start with low doses (children 6-12years: 1/2teaspoon q.i.d.) and to increase slowly to avoid unwanted side effects.

Conversion of patients from oral Tegretol tablets to Tegretol 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).

Tegretol-XR is an extended-release formulation for twice-a-day administration. When converting patients from Tegretol conventional tablets to Tegretol-XR, the same total daily mg dose of Tegretol-XR should be administered. Tegretol -XR tablets must be swallowed whole and never crushed or chewed. Tegretol-XR tablets should be inspected for chips or cracks. Damaged tablets, or tablets without a release portal, should not be consumed. Tegretol-XR tablet coating is not absorbed and is excreted in the feces; these coatings may be noticeable in the stool.

Epilepsy (SEE INDICATIONS AND USAGE)

Adults and children over 12years of age - Initial: Either 200mg b.i.d. for tablets and XR tablets, or 1teaspoon q.i.d. for suspension (400mg/day). Increase at weekly intervals by adding up to 200mg/day using a b.i.d. regimen of Tegretol-XR or a t.i.d. or q.i.d. regimen of the other formulations until the optimal response is obtained. Dosage generally should not exceed 1000mg daily in children 12-15years of age, and 1200mg daily in patients above 15years of age. Doses up to 1600mg daily have been used in adults in rare instances. Maintenance: Adjust dosage to the minimum effective level, usually 800-1200mg daily.

Children 6 -12years of age - Initial: Either 100mg b.i.d. for tablets or XR tablets, or 1/2teaspoon q.i.d. for suspension (200mg/day). Increase at weekly intervals by adding up to 100mg/day using a b.i.d. regimen of Tegretol-XR or a t.i.d. or q.i.d. regimen of the other formulations until the optimal response is obtained. Dosage generally should not exceed 1000mg daily. Maintenance: Adjust dosage to the minimum effective level, usually 400-800mg daily.

Children under 6years of age - Initial: 10-20mg/kg/day b.i.d. or t.i.d. as tablets, or q.i.d. as suspension. 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 35mg/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 35mg/kg/24hours can be made.

Combination Therapy: Tegretol 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 CategoryD).

Trigeminal Neuralgia (SEE INDICATIONS AND USAGE)

Initial: On the first day, either 100mg b.i.d. for tablets or XR tablets, or 1/2teaspoon q.i.d. for suspension, for a total daily dose of 200mg. This daily dose may be increased by up to 200mg/day using increments of 100mg every 12hours for tablets or XR tablets, or 50mg (1/2teaspoon) q.i.d. for suspension, only as needed to achieve freedom from pain. Do not exceed 1200mg daily. Maintenance: Control of pain can be maintained in most patients with 400-800mg daily. However, some patients may be maintained on as little as 200mg daily, while others may require as much as 1200mg daily. At least once every 3months 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 Dose Subsequent Dose Maximum Daily Dose
Indication Tablet* XR Suspension Tablet* XR Suspension Tablet* XR Suspension
Epilepsy
Under 6yr

10-20mg/kg/day
b.i.d. or t.i.d.

10-20mg/kg/day
q.i.d.

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

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

35mg/kg/24hr (see Dosage and Administration section above)

35mg/kg/24hr (see Dosage and Administration section above)
6-12yr 100mg b.i.d.
(200 mg/day)
100mg b.i.d.
(200mg/day)
tsp q.i.d.
(200mg/day)
Add up to 100mg/day at weekly intervals, t.i.d. or q.i.d. Add 100mg/day at weekly intervals, b.i.d. Add up to 1tsp (100mg)/day at weekly intervals, t.i.d. or q.i.d. 1000mg/24hr
Over 12yr 200mg b.i.d.
(400mg/day)
200mg b.i.d.
(400mg/day)
1 tsp q.i.d.
(400mg/day)
Add up to 200mg/day at weekly intervals, t.i.d. or q.i.d. Add up to 200mg/day at weekly intervals, b.i.d. Add up to 2tsp (200mg)/day at weekly intervals, t.i.d. or q.i.d. 1000 mg/24 hr (12-15 yr)
1200 mg/24 hr (>15 yr)
1600 mg/24 hr (adults, in rare instances)
Trigeminal Neuralgia 100mg b.i.d.
(200mg/day)
100mg b.i.d.
(200mg/day)
tsp q.i.d.
(200mg/day)
Add up to 200mg/day in increments of 100 mg every 12hr Add up to 200mg/day in increments of 100 mg every 12hr Add up to 2tsp (200mg)/day
in increments of 50mg
( tsp) q.i.d.
1200mg/24hr

*Tablet = Chewable or conventional tablets

XR = Tegretol®-XR extended-release tablets

HOW SUPPLIED

Chewable Tablets 100mg - round, red-speckled, pink, single-scored (imprinted Tegretol on one side and 52 twice on the scored side)

Bottles of 100 NDC0078-0492-05

Unit Dose (blister pack)

Box of 100 (strips of 10) NDC0078-0492-35

Do not store above 30C (86F). Protect from light and moisture.

Dispense in tight, light -resistant container (USP).

Meets USP Dissolution Test1.

Tablets 200mg - capsule-shaped, pink, single-scored (imprinted Tegretol on one side and 27twice on the partially scored side)

Bottles of 100 NDC0078-0509-05

Do not store above 30C (86F). Protect from moisture.

Dispense in tight container (USP).

Meets USP Dissolution Test2.

XR Tablets 100mg - round, yellow, coated (imprinted T on one side and 100mg on the other), release portal on one side

Bottles of 100 NDC0078-0510-05

XR Tablets 200mg - round, pink, coated (imprinted T on one side and 200mg on the other), release portal on one side

Bottles of 100 NDC0078-0511-05

XR Tablets 400mg - round, brown, coated (imprinted T on one side and 400mg on the other), release portal on one side

Bottles of 100 NDC0078-0512-05

Store at controlled room temperature 15C-30C (59F-86F). Protect from moisture.

Dispense in tight container (USP).

Suspension 100mg/5mL (teaspoon) yellow-orange, citrus-vanilla flavored

Bottles of 450mL NDC0078-0508-83

Shake well before using.

Do not store above 30C (86F). Dispense in tight, light -resistant container (USP).

*Thorazine® is a registered trademark of GlaxoSmithKline.

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

REV: FEBRUARY 2009 T2008-29

Novartis

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