Tegral 200 Carbamazepine Tablets
Composition :
A scored tablet contains 200 mg Carbamazepine, related chemically to the tricyclic antidepressants, and is a derivative of iminostilbene with a carbamyl group, essential for potent antiepileptic activity.
Properties :
anticonvulsant properties : tagral scored tablets has marked anticonvulsant properties. At therapeutic concentrations, it can inhibit maximal electroshock seizures, abolish focal brain discharges induced by locally applied penicillin. In acdiuon.lt is more effective than phenytoin in raising the threshold for minimal electroshock seizures in response
to pentylenetetrazol. the electrophysiological and biochemical actions responsible for the anticonvulsant effects are still unknown it is particularly effective in grand mal epilepsy tonicclonic seizures) with temporal fobe features, partial seizures temporal lobe epilepsy I
psychomotor and jacksonian epilepsy.
Psychotropic properties :
It alleviates the personality changes associated with epilepsy, and patients become more familiar and integrate themselves into society
Antineuralgic properties :
Tagral alleviate pain of trigeminal neuralgia and of glossopharyngal neuralgia.
Metabolism :
T agral is absorbed rapidly after oral administration, the presence of food may slightly increase absorption .
Peak concentrations in plasma are reached in 4 to 6 hours following oral ingestion , and therapeutic concentrations are in the range of 3-6 mcg / ml Half-life in plasma is 21 to 53 hours and is reduced to 8-27 hours in children. Tegral enter the cerebrospinal fluid crosses the placenta and is secreted in milk, in blood it is taken up by red blood cells.Tegral and its epoxide metabolite binds to plasma protein at the extent of 70 to 80 % and about 50% respectively, less than 1% of a dose is excreted unchanged in the urine, and aboot 25% Is excreted in the urine as 10;11-dihydroxymetabolite.
Indications & Dosage :
Tegral CID is useful in :
– Epilepsy characterized by motor and psychopathological manifestations like psychomotor temporal lobe epilepsy , Jacksonian epilepsy, grand mal and mixed forms of epilepsy.
– Epilepsy characterized solely by psychic symptoms such as general mental sluggishness or mood disorders, as well as other psychic disturbances, associated with non specific EEG changes.
– In all cases treatment should be initiated with small dose, and gradually increase the dose according to the patient’s need, and in conjunction with the other anttconvulsant drugs.
When starting treating a patient with TEGRAL instead of another medicament, the dose of the later should be reduced gradually, before being replaced by tegral
Dosage :
Adult dosage:
100-200 mg, 1-2 times daily to minimize side effects, then increase the dose gradually to be 600 to 1200 mg daily in divided doses, according to the patient’s need .
Children dosage: 10-20 mg per kg. body weight per day in divided doses, since short ha~-life often necessitates dosage intervals of 6-8 hours to minimize fluctuations in plasma concentrations.
Up to one year 100-200 mg/day.
1-5 years 200-400 mg/day.
5-10 years 400-600 mg/day.
10-15 years. 0.6- 1 g/day.
Dosage should be taken with fluid during or after meal .
– Trigeminal neuralgia ( idiopathic) and glossopharyngeal neuralgia:
The dose is generally started by a dose of 200 mg daily and may be Increased tolerate that amount .
– Pain syndrome associated with neurological disorders as tabes dorsalis and multiple sclerosis.
– Prophylaxis of manic depression unresponsive to lithium.
Contra-Indications :
Tegral should not be given to patients showing previous sensitivity to carbamazepine , and patients on monoamine oxidase inhibitors ( MAOI ) or within a couple of week of MAOI therapy.
Tegral also should not be given during the first three months of pregnancy, unless indicated by a physician. In cases of nursing mothers, is given with great caution.
Side Effects :
At a concentration of 8.5 to 10 mcg I ml side effects referable to eNS are frequently reported .Loss of appetite, dryness of the mouth, dizziness, drowsiness visual and gastro-intestinal disturbances and rashes may occur but these side effects usually disappear within 7-14 days or following a temporary reduction in the dosage. Leucopenia, agranulocytosis, thrombocytopenia, aplastic anemia and jaundice have
Drug Interactions :
Tegral has apparently few interactions with other drugs, phenobarbital is said to inaease the metabolism of the medicament, and it may enhance the biotransfonnation of phenytoin. TEGRAL shows no incompatibility with other antiepileptic drugs. Women using oral contraceptives should be advised to use an alternative non
hormonal method of contraception.
Warning during drugs Intake :
Tegral should be given under medical supervision taking these medical considerations into account:
– Blood counting and liver function tests:These tests should be performed before starting theTreafment and monthly. If allergic skin reactions occur, or if there is a decrease in leucocyte andior platelet count, or finally if the tests reveal a deterioration in the liver functions the drug should be withdrawn – ingestion of alcohol should be avoided when on tegral treatment, also the patient should be heedful while driving a vehicle.
– In case of pregnancy, consult the physician.
– If skin rashes, fever or sore throat appear consult the physician immediately.
Packing :
Boxes 0150 tablets of 200 mg carbamazepine .
Storage :
Store below 30·C and R.H below 70 %, away of reach of children.
• Keep medicament out d chiIdr9n reach
Produced by :
Chemical Industrle. Development (CID) • Giza • A.R.E
