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U.S. Department of Health and Human Services

Animal & Veterinary

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New Dosage Form Drug Approved For Horses

FDA Veterinarian Newsletter January/February 2002 Volume XVII, No 1

FDA recently announced the first metered-dose inhaler approved for use in horses. The active ingredient, albuterol, is a new chemical entity never before approved for veterinary use.

Albuterol sulfate is administered to horses intranasally via a metered-dose inhaler for the immediate relief of bronchospasm and bronchoconstriction associated with reversible airway obstruction [also known as chronic obstructive pulmonary disease (COPD)] in horses. Marketed under the trade name, Torpex, and sponsored by Boehringer Ingelheim VetMedica, Inc., the drug is supplied in a pressurized aluminum canister contained within an actuator system equipped with a detachable nasal delivery bulb. The nasal bulb is inserted into the horse's nostril and when the horse inhales, the device is actuated providing a puff of aerosolized albuterol which is delivered to the horse's lungs. This aerosol dosage provides an alternative to the approved drug, clenbuterol, an oral syrup. Aerosol albuterol provides relief to affected horses within minutes allowing the horse to breath easier. Typical adverse reactions are transient sweating, muscle tremors, or excitement.