Tilade (Nedocromil Inhalation Aerosol) Drug Information: Overdosage and Contraindications

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May 27, 2012

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OVERDOSE

There is no experience to date with overdose of Tilade (nedocromil inhalation aerosol) in humans. There were no deaths in rodents at an oral dose of 4,000 mg/kg (approximately 690 times [for mice] and 1,370 times [for rats] the maximum recommended human daily inhalation dose on a mg/m² basis). The subcutaneous or intravenous lethal dose in rats was between 2,000 and 4,000 mg/kg (approximately 690 and 1,370 times, respectively, the maximum recommended human daily inhalation dose on a mg/m² basis). No deaths occurred in mice at a subcutaneous dose of 4,000 mg/kg (approximately 690 times the maximum recommended human daily inhalation dose on a mg/m² basis), and the intravenous lethal dose in mice was between 2,000 and 4,000 mg/kg (approximately 345 and 690 times, respectively, the maximum recommended human daily inhalation dose on a mg/m² basis). An intravenous dose of 240 mg/kg (approximately 110 times the maximum recommended human daily inhalation dose on a mg/m² basis) did not produce any deaths in cats. Head shaking/tremor and salivation were observed in beagle dogs following daily inhalation doses of 5 mg/kg (approximately 6 times the maximum recommended human daily inhalation dose on a mg/m² basis) and transient hypotension was detected following daily subcutaneous doses of 8 mg/kg (approximately 9 times the maximum recommended human daily inhalation dose on a mg/m² basis). In addition, clonic convulsions were observed in dogs following daily inhalation doses of 20 mg/kg plus subcutaneous doses of 20 mg/kg giving peak plasma nedocromil levels of 7.6 µg/mL, some three orders of magnitude greater than peak plasma levels (2.5 ng/mL) of the maximum recommended human daily inhalation dose. Specific tests designed to evaluate CNS activity demonstrated no effects due to nedocromil sodium, and nedocromil sodium does not pass the blood brain barrier. Therefore, overdosage is unlikely to result in clinical manifestations requiring more than observation and discontinuation of the drug where appropriate.

CONTRAINDICATIONS

Tilade (nedocromil inhalation aerosol) Inhaler is contraindicated in patients who have shown hypersensitivity to nedocromil sodium or other ingredients in this preparation.

Last reviewed on RxList: 7/29/2008
This monograph has been modified to include the generic and brand name in many instances.