| Composition |
Carbatec 100 Chewable tablets: each tablet contains 100 mg carbamazepine.
Carbatec 200 tablets: each tablet contains 200 mg carbamazepine.
Carbatec 400 SR tablets: each SR. Tablet contains 400 mg carbamazepine.
Carbatec Suspension: each 5 ml suspension contains 100 mg carbamazepine. |
| Properties |
Carbatec, carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal
neuralgia. |
| Pharmacodynamics properties |
Carbatec has demonstrated anticonvulsant properties in electrically and chemically induced seizures. It appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation. It depresses thalamic potential and bulbar and polysynaptic reflexes.
The principal metabolite of Carbatec, carbamazepine-10-11-epoxide, has anticonvulsant activity. |
| Therapeutic indications |
1. Epilepsy
• Partial seizures (psychomotor, temporal lobe).
• Generalized tonic-clonic seizures (grand mal).
• Mixed seizure patterns
2. Trigeminal Neuralgia: Carbatec is indicated in the treatment of the pain associated with true trigeminal neuralgia.
3. Beneficial results have also been reported in glossopharyngeal neuralgia.
4. Carbamazepine, an anticonvulsant has been shown to be effective in the treatment of neuropathic pain associated with diabetes. |
| Side effect |
| In few cases it may be happened: aplastic anemia, bone marrow depression, pruritic and erythematous rashes urticaria, Lyell’s syndrome, Stevens-Johnson syndrome, photosensitivity, edema, dizziness, drowsiness, headache, fatigue, nausea, vomiting, diarrhea, constipation, Aching joints and muscles. |
| Warnings and precautions |
WARNINGS:
• Patients with a history of adverse hematologic reaction to any drug may be particularly
at risk.
• Severe dermatologic reactions, including toxic epidermal necrolysis (Lyell’s syndrome) and Stevens-Johnson syndrome, have been reported with Carbatec.
These reactions have been extremely rare. However, a few fatalities have been reported.
• Carbatec has shown mild anticholinergic activity; therefore, patients with increased intraocular pressure should be closely observed during therapy.
PRECAUTIONS:
Before initiating therapy, a detailed history and physical examination should be made. |
| Contraindication |
| Carbatec should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic. |
| Pregnancy and lactation |
Usage in Pregnancy: Pregnancy Category D. Carbamazepine can cause fetal harm when administered to a pregnant woman.
Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from carbamazepine, a decision should be made whether to discontinue nursing or to discontinue the drug.
|
| Drug interactions |
Increased carbamazepine level with concurrent use of cimetidine, macrolide, diltiazem, fluxetine, isoniazid, ketoconazole, loratadin, valproate, verapamil, propoxyphene.
Whereas the activity and level of carbamazepine is decreased with concurrent use with: cisplatin, phenobarbital, rifampicin, primidone, theophylline.
Carbamazepine may increase the level of clomipramin and may decrease the level of warfarin, oral contraceptives, doxycycline, theophyllin, clonazepam. |
| DOSAGE & ADMINISTRATION |
As doctor prescribe and the following cases:
1. Epilepsy:
A. Adult and children over 12 years of age:
Either 200 mg twice a day for tablet or 5 ml four times a day for suspension
(400 mg/day) to be increased gradually at weekly intervals by adding up to
200mg/day using two dosages of sustained release form or 3–4 regimen of the other
formulations until the optimal response is obtained.
Dosage generally should not exceed 1000 mg daily in children 12–15 years of age,
and 1200 mg daily in patients above 15 years of age.
B. Children 6–12 years of age:
Either 100 mg twice a day for tablets or 5 ml twice a day for suspension, to be increased
at weekly intervals by adding up to 100 mg/day.
C. Children under 6 years of age:
10–20 mg /kg 2–3 times a day.
2. Trigeminal neuralgia:
On the first day either 100 mg twice a day for tablets or 5 ml twice a day for suspension, the
daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12
hours for tablets or sustained release tablet form or 50 mg 4 times/day for suspension form.
3. Therapies of Diabetic Neuropathy: starts 200 mg 2–4 times/day and titrates up to
600 mg 2 times/day. |
| Package |
Carbatec 100 Chewable tablets: Carton box of 20 tablets blister packed.
Carbatec 200 tablets : Carton box of 20 tablets blister packed.
Carbatec 400 SR tablets : Carton box of 20 tablets blister packed.
Carbatec Suspension : Carton box of 125 ml glass bottle. |
| Storage |
| Store at room temperature (15–30)°C, protect from light and moisture. |
