Elimination: Approximately 80% of the total loratadine dose administered can be found equally distributed between urine and feces in the form of metabolic products within 10 days. In nearly all patients, exposure (AUC) to the metabo-lite is greater than to the parent loratadine. The mean elimination half-lives in normal adult subjects (n = 54) were 8.4 hours (range = 3 to 20 hours) for loratadine and 28 hours (range = 8.8 to 92 hours) for descarboethoxyloratadine. Loratadine and descarboethoxyloratadine reached steady-state in most patients by approximately the fifth dosing day. There was considerable variability in the pharmacokinetic data in all studies of CLARITIN Tablets and Syrup, probably due to the extensive first-pass metabolism.

Special Populations: Pediatric: The pharmacokinetic profile of loratadine in children in the 6- to 12-year age group is similar to that of adults. In a single-dose pharmacokinetic study of 13 pediatric volunteers (aged 8 to 12 years) given 10 mL of CLARITIN Syrup containing 10 mg loratadine, the ranges of individual subject values of pharmacokinetic para-meters (AUC and Cmax) were comparable to those following administration of a 10 mg tablet or syrup to adult volunteers.

The pharmacokinetic profile of loratadine in children in the 2 to 5-year age group (n = 18) is similar to that of adults. In a single-dose pharmacokinetic study of pediatric subjects (age 2 to 5 years) given 5 mL of CLARITIN Syrup containing 5 mg loratadine, the range of individual subject values of pharmacokinetic parameters (AUC and Cmax) were comparable to those following administration of a 10 mg tablet or syrup to adult volunteers or children eight years of age and older.

Geriatric: In a study involving 12 healthy geriatric subjects (66 to 78 years old), the AUC and peak plasma levels (Cmax) of both loratadine and descarboethoxyloratadine were approximately 50% greater than those observed in studies of younger subjects. The mean elimination half-lives for the geriatric subjects were 18.2 hours (range = 6.7 to 37 hours) for loratadine and 17.5 hours (range = 11 to 38 hours) for descarboethoxyloratadine.

Renal Impairment: In a study involving 12 subjects with chronic renal impairment (creatinine clearance ≤ 30 mL/min)both AUC and Cmax increased by approximately 73% for loratadine and by 120% for descarboethoxyloratadine, as compared to six subjects with normal renal function (creatinine clearance ≥ 80 mL/min). The mean elimination half-lives of loratadine (7.6 hours) and descarboethoxyloratadine (23.9 hours) were not substantially different from that observed in normal subjects. Hemodialysis does not have an effect on the pharmacokinetics of loratadine or descarboethoxyloratadine in subjects with chronic renal impairment.

Hepatic Impairment: In seven patients with chronic alcoholic liver disease, the AUC and Cmax of loratadine were dou-ble while the pharmacokinetic profile of descarboethoxyloratadine was not substantially different from that observed in other trials enrolling normal subjects. The elimination half-lives for loratadine and descarboethoxyloratadine were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.

Clinical Trials: Clinical trials of CLARITIN Tablets involved over 10,700 patients, 12 years of age and older, who received either CLARITIN Tablets or another antihistamine and/or placebo< in double-blind randomized controlled studies. In placebo-controlled trials, 10 mg once daily of CLARITIN Tablets was superior to placebo and similar to clemastine (1 mg BID) or terfenadine (60 mg BID) in effects on nasal and non-nasal symptoms of allergic rhinitis. In these studies, somnolence occurred less frequently with CLARITIN Tablets than with clemastine and at about the same frequency as terfenadine or placebo. In studies with CLARITIN Tablets at doses two to four times higher than the recommended dose of 10 mg, a dose-related increase in the incidence of somnolence was observed. Therefore, some patients, particularly those with hepatic or renal impairment and the elderly, or those on medications that impair clearance of loratadine and its metabolites, may experience somnolence. In addition, three placebo-controlled, double-blind, 2-week trials in 188 pediatric patients with seasonal allergic rhinitis aged 6 to 12 years, were conducted at doses of CLARITIN Syrup up to 10 mg once daily. In a double-blind, placebo-controlled study, the safety of 5 mg loratadine, administered in 5 mL of CLARITIN Syrup, was evaluated in 60 pediatric patients between 2 and 5 years of age. No unexpected adverse events were observed.

Clinical trials of CLARITIN REDITABS (loratadine rapidly-disintegrating tablets) involved over 1300 patients who received either CLARITINREDITABS (loratadine rapidly-disintegrating tablets), CLARITINTablets, or placebo. In placebo-controlled trials, one CLARITIN REDITABS (loratadine rapidly-disintegrating tablets) once daily was superior to placebo and similar to CLARITIN Tablets in effects on nasal and non-nasal symptoms of seasonal allergic rhinitis.

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