PubMed · 1348009
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S Ollier. 1992. Cutaneous responses--a window on inflammatory processes.. https://doi.org/10.1111/j.1365-2222.1992.tb00107.x
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BACKGROUND: H(1)-antihistamines are widely used for symptom relief in allergic disorders in infants and children; however, there are few prospective, randomized, double-blind, controlled studies of these medications in young children, and to date, no such studies have been conducted in infants. OBJECTIVE: This prospective, randomized, parallel-group, double-blind, placebo-controlled study was designed to evaluate the safety of the H(1)-antihistamine cetirizine, particularly with regard to central nervous system and cardiac effects, in infants age 6 to 11 months, inclusive. METHODS: Infants who met the entry criteria for age and had a history of treatment with an H(1)-antihistamine for an allergic or other disorder were randomized to receive 0.25 mg/kg cetirizine orally or matching placebo twice daily orally for 1 week. RESULTS: The mean daily dose in cetirizine-treated infants was 4.5 +/- 0.7 mg (SD). No differences in all-cause or treatment-related adverse events were observed between the cetirizine- and placebo-treated groups. A trend was observed toward fewer adverse events and sleep-related disturbances in the cetirizine group compared with the placebo group. No prolongation in the linear corrected QT interval was observed in cetirizine-treated infants compared with either baseline values or with values in placebo-treated infants. CONCLUSIONS: We have documented the safety of cetirizine in this short-term investigation, the first randomized, double-blind, placebo-controlled study of any H(1)-antihistamine in infants. Additional prospective, randomized, double-blind, placebo-controlled, long-term studies of cetirizine and other H(1)-antihistamines are needed in this population.
Following a single 10-mg oral dose of cetirizine dihydrochloride to 24 healthy volunteers, the analyte was quantified in human plasma. Protein precipitation using acetonitrile (ACN) was followed by reversed-phase liquid chromatography and tandem mass spectrometry. The MS/MS method was optimised using a PE Sciex API 2000 triple quadrupole mass spectrometer in selected reaction monitoring (SRM) mode, using electrospray with positive ionisation. Oxybutynin was used as the internal standard. The assay method represents a robust, high-throughput, highly specific and sensitive quantitative assay procedure, with 0.5 ng/ml being the lowest plasma concentration that could be reliably quantified. The procedure involves minimal sample preparation, and is well suited to clinical studies of the drug involving large numbers of generated samples. Pre-dose as well as post-dose samples up to and including 48 h were quantified, and the data generated were used to determine the pharmacokinetic profile of the drug.
Two simple, rapid and reliable methods for the determination of four antihistamines based on the measurement of the chloride of their hydrochlorides are described. In the titrimetric method, the chloride content of each drug is determined by titrating with mercury(II) nitrate using diphenylcarbazone-bromothymol blue as indicator. In the spectrophotometric method, to a fixed concentration of mercury(II)-diphenylcarbazone complex different amounts of drug are added and the decrease in absorbance of mercury(II)-diphenylcarbazone complex, consequent to the replacement of diphenylcarbazone of the complex by the chloride of the drug, was measured at 540 nm. The stoichiometry of the reaction that forms the basis for titrimetry is assessed. Different variables affecting the color formation in spectrophotometry were studied and optimized. At the wavelength of maximum absorption, Beer's law is obeyed in the 0-100 microg ml(-1) range. The molar absorptivity and Sandell sensitivity are calculated. The proposed methods were applied for the analysis of pharmaceutical formulations containing these drugs. Statistical treatment of the experimental results indicates that the procedures are precise and accurate. Excipients used as additives in pharmaceutical formulations did not interfere in the proposed procedures as shown by the recovery studies.