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Claritin (Loratadine) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Loratadine (10 mg once daily) has been coadministered with therapeutic doses of erythromycin, cimetidine, and ketoconazole in controlled clinical pharmacology studies in adult volunteers. Although increased plasma concentrations (AUC 0-24 hrs) of loratadine and/or descarboethoxyloratadine were observed following coadministration of loratadine with each of these drugs in normal volunteers (n = 24 in each study), there were no clinically relevant changes in the safety profile of loratadine, as assessed by electrocardiographic parameters, clinical laboratory tests, vital signs, and adverse events. There were no significant effects on QTc intervals, and no reports of sedation or syncope. No effects on plasma concentrations of cimetidine or ketoconazole were observed. Plasma concentrations (AUC 0-24 hrs) of erythromycin decreased 15% with coadministration of loratadine relative to that observed with erythromycin alone. The clinical relevance of this difference is unknown. These above findings are summarized in TABLE 1.

Effects on Plasma Concentrations (AUC 0-24 hrs) of Loratadine and Descarboethoxyloratadine After 10 Days of Coadministration (Loratadine 10 mg) in Normal Volunteers
Loratadine Descarboethoxyloratadine
Erythromycin (500 mg q8h) +40% +46%
Cimetidine (300 mg qid) +103% +6%
Ketoconazole (200 mg q12h) +307% +73%

There does not appear to be an increase in adverse events in subjects who received oral contraceptives and loratadine.

OVERDOSE

In adults, somnolence, tachycardia, and headache have been reported with overdoses greater than 10 mg with the tablet formulation (40 to 180 mg). Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg of loratadine syrup. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary.
Treatment of overdosage would reasonably consist of emesis (ipecac syrup), except in patients with impaired consciousness, followed by the administration of activated charcoal to absorb any remaining drug. If vomiting is unsuccessful, or contraindicated, gastric lavage should be performed with normal saline. Saline cathartics may also be of value for rapid dilution of bowel contents. Loratadine is not eliminated by hemodialysis. It is not known if loratadine is eliminated by peritoneal dialysis.
No deaths occurred at oral doses up to 5000 mg/kg in rats and mice (greater than 2400 and 1200 times, respectively, the maximum recommended human daily oral dose on a mg/m2 basis). Single oral doses of loratadine showed no effects in rats, mice, and monkeys at doses as high as 10 times the maximum recommended human daily oral dose on a mg/m2 basis.

CONTRAINDICATIONS

CLARITIN (Loratadine) is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients.

DRUG ABUSE AND DEPENDENCE

There is no information to indicate that abuse or dependency occurs with CLARITIN.

Schering Corporation
Kenilworth, NJ 07033 USA

CLARITIN REDITABS (loratadine rapidly-disintegrating tablets) are manufactured for Schering Corporation by Scherer DDS, England.

U.S. Patent Nos. 4,282,233 and 4,371,516. Copyright © 1997, 1998, 1999, 2000, Schering Corporation. All rights reserved.

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