"The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain"...
Carbatrol (carbamazepine extended-release) is 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:
- Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements than those with other types.
- Generalized tonic-clonic seizures (grand mal).
- 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).
Carbatrol (carbamazepine extended-release) 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
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 patients. A low initial daily dosage with gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. The Carbatrol (carbamazepine extended-release) capsules may be opened and the beads sprinkled over food, such as a teaspoon of applesauce or other similar food products if this method of administration is preferred. Carbatrol (carbamazepine extended-release) capsules or their contents should not be crushed or chewed. Carbatrol (carbamazepine extended-release) can be taken with or without meals.
Carbatrol (carbamazepine extended-release) is an extended-release formulation for twice a day administration. When converting patients from immediate release carbamazepine to Carbatrol extended-release capsules, the same total daily mg dose of carbamazepine should be administered.
(see INDICATIONS AND USAGE)
Adults and children over 12 years of age
Initial: 200 mg twice daily. Increase at weekly intervals by adding up to 200 mg/day until the optimal response is obtained. Dosage generally should not exceed 1000 mg per day in children 12-15 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.
Maintenance: Adjust dosage to the minimum effective level, usually 800-1200 mg daily.
Children under 12 years of age
Children taking total daily dosages of immediate-release carbamazepine of 400 mg or greater may be converted to the same total daily dosage of Carbatrol (carbamazepine extended-release) extended-release capsules, using a twice daily regimen. 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 Carbatrol (carbamazepine extended-release) for use at doses above 35 mg/kg/24 hours can be made.
Combination Therapy: Carbatrol (carbamazepine extended-release) 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).
(see INDICATIONS AND USAGE)
Initial: On the first day, start with one 200 mg capsule. This daily dose may be increased by up to 200 mg/day every 12 hours 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 400-800 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.
Carbatrol (carbamazepine) extended-release capsules is supplied in three dosage strengths.
100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.
Supplied in bottles of 120........................... NDC 54092-171-12
200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.
Supplied in bottles of 120 ............................NDC 54092-172-12
300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.
Supplied in bottles of 120 ............................NDC 54092-173-12
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.
Manufactured for: Shire US Inc. 725 Chesterbrook Blvd, Wayne PA 19087, 1-800-828-2088. (Rev 09/2010)This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/18/2011
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