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Pulmicort Flexhaler

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Pulmicort Flexhaler

Overdosage
Contraindications

OVERDOSE

The potential for acute toxic effects following overdose of PULMICORT FLEXHALER (budesonide inhalation powder) is low. If used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism may occur [see WARNINGS AND PRECAUTIONS, Hypercorticism and Adrenal Suppression]. Another budesonide-containing dry powder inhaler at 3200 mcg daily administered for 6 weeks caused a significant reduction (27%) in the plasma cortisol response to a 6-hour infusion of ACTH compared with placebo (+1%). The corresponding effect of 10 mg prednisone daily was a 35% reduction in the plasma cortisol response to ACTH.

The minimal inhalation lethal dose in mice was 100 mg/kg (approximately 280 times the maximum recommended daily inhalation dose in adults and approximately 330 times the maximum recommended daily inhalation dose in children 6 to 17 years of age on a mcg/m² basis). There were no deaths following the administration of an inhalation dose of 68 mg/kg in rats (approximately 380 times the maximum recommended daily inhalation dose in adults and approximately 450 times the maximum recommended daily inhalation dose in children 6 to 17 years of age on a mcg/m² basis). The minimal oral lethal dose was 200 mg/kg in mice (approximately 560 times the maximum recommended daily inhalation dose in adults and approximately 670 times the maximum recommended daily inhalation dose in children 6 to 17 years of age on a mcg/m² basis) and less than 100 mg/kg in rats (approximately 560 times the maximum recommended daily inhalation dose in adults and approximately 670 times the maximum recommended daily inhalation dose in children 6 to 17 years of age based on a mcg/m² basis).

Post-marketing experience showed that acute overdose of inhaled budesonide commonly remained asymptomatic. The use of excessive doses (up to 6400 mcg daily) for prolonged periods showed systemic corticosteroid effects such as hypercorticism.

CONTRAINDICATIONS

The use of PULMICORT FLEXHALER (budesonide inhalation powder) is contraindicated in the following conditions:

  • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
  • Severe hypersensitivity to milk proteins or any ingredients of PULMICORT FLEXHALER [see WARNINGS AND PRECAUTIONS, DESCRIPTION].

Last reviewed on RxList: 7/29/2010
This monograph has been modified to include the generic and brand name in many instances.

Overdosage
Contraindications
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Pulmicort Flexhaler - User Reviews

Pulmicort Flexhaler User Reviews

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