Comparative drug monitoring of carbamazepin suspension (TroyaPharm) and Tegretol syrup (Ciba Geigy) in epileptic children.
BACKGROUND
Administration of antiepileptic therapy requires use of proper drugs. The introduction and implementation of home carbamazepine preparations has substantial economic and social effects for Bulgaria.


METHODS
Fifty nine epileptic children were enrolled in the trial. The serum concentrations of Carbamazepin suspension (TroyaPharm, Bulgaria) and Tegretol syrup (Ciba Geigy, Switzerland) were evaluated by gas-chromatographic analysis.


RESULTS
Steady-state serum antiepileptic drug concentrations (4-12 micrograms/ml) were maintained during the 3-month period of administration of both preparations. At the end of the first month of trial serum drug concentrations below the therapeutic range were observed in 15.2% of the patients on carbamazepin therapy and in 33.3% of the patients treated with Tegretol. At the end of the third month these indices changed to 21.2% and 13.3%, respectively. At the end of the first month serum level above the therapeutic range was found in 3.0% of the carbamazepin-treated patients and in none of those receiving Tegretol, while at the end of the third month in none of the blood samples did serum concentration of both drugs exceed the therapeutic range. Both preparations showed quick and substantial absorption in the first two hours after administration. It was determined by the indirect pharmacokinetic variable delta, representing the difference CSS2I- CssminI and expressed as a percentage of CssminI. This variable was 45.43% for Carbamazepin suspension and 41.00% for Tegretol syrup.


CONCLUSIONS
No statistically significant differences in the examined pharmacokinetic parameters were found between both preparations.
Peytchev
L
L
Department of Pharmacology and Toxicology, Higher Medical Institute, Plovdiv, Bulgaria.
Chakova
L
L
D000284:Administration, Oral; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000097:blood; D002220:Carbamazepine / Q000008:administration & dosage* / Q000097:blood; D016022:Case-Control Studies; D002648:Child; D002675:Child, Preschool; D016903:Drug Monitoring; D004827:Epilepsy / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male
D000927:Anticonvulsants; D002220:Carbamazepine