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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.
Somnolence, tachycardia, and headache have been reported with doses of 40 to 180 mg of loratadine; pseudoephedrine. In large doses, sympathomimetics may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma, and respiratory failure.
The oral median lethal dose for the mixture of the two drugs was greater than 525 and 1839 mg/kg in mice and rats, respectively (approximately 10 and 58 times the maximum recommended human daily oral loratadine; pseudoephedrine sulfate 24 hour dose on a mg/m2 basis). The oral median lethal dose for loratadine was greater than 5000 mg/kg in rats and mice (greater than 2000 times the maximum recommended human daily oral loratadine; pseudoephedrine sulfate 24 hourdose 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.
Loratadine; pseudoephedrine sulfate extended release tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients.
This product, due to its pseudoephedrine component, is contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment (see DRUG INTERACTIONS). It is also contraindicated in patients with severe hypertension, severe coronary artery disease, and in those who have shown hypersensitivity or idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. Manifestations of patient idiosyncrasy to adrenergic agents include: insomnia, dizziness, weakness, tremor, or arrhythmias.
This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
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