Ventipulmin Syrup (Canada)

Company: Boehringer Ingelheim Animal Health

Clenbuterol hydrochloride Syrup 0.025 mg/mL

Veterinary Use Only

Bronchodilator

DIN 00705845

Introduction: The treatment of respiratory disease in horses constitutes a problem that has not been satisfactorily solved, even though many efficient therapeutic measures are available today. Pharmacological treatment finds its particular application at the level of either some exogenous stimulus, e.g., infection or some mechanism of bronchial obstruction, e.g., bronchospasm and/or accumulation of mucus. Bronchial obstruction, due to the accumulation of secretions, has been acted upon by mucolytic and expectorant drugs while bronchial obstruction caused by bronchospasm is relieved by sympathomimetic amines, anticholinergics, corticosteroids and xanthine derivatives.

The sympathomimetic amines have attracted special interest, their clinical application having originated in the demonstrated existence of cellular adrenergic receptors, which are called alpha, beta and gamma according to their response to stimuli. The beta receptors were further subdivided into beta-1 and beta-2. Stimulation of beta-2 receptors causes a relaxation of the smooth musculature of the bronchi and uterus, and of the beta-1 receptors of the intestinal tract and an increase in cardiac frequency.

Especially interesting for the treatment of respiratory diseases are the beta-mimetic drugs used as bronchodilators. The phenomenon of bronchial spasm is determined by a defect in metabolism at the cellular level and is seen as an increased sensitivity in the bronchial musculature to some chemical mediators such as histamine, acetylcholine, etc., with the consequent phenomenon of bronchospasm.

Beta-2 stimulant sympathomimetics, resolve bronchial spasm and consequently improve pulmonary ventilation. In many disease states, both subacute and chronic, the pathological state and the clinical phenomena can persist even when the aetiological agent has ceased in its action. The disease still exists due to the continued disturbances of the physiological processes.

Pharmacology

Clenbuterol, the active ingredient in Ventipulmin^®, is a sympathomimetic amine and has been the subject of intensive research in both humans and domestic animals. Due to its chemical structure, a high degree of selectivity for the beta-2 receptor sites in the body has been achieved providing intense bronchodilating properties with minimum effect on the cardiovascular system.

Other properties attributed to Ventipulmin^® include excellent absorption from the gastrointestinal tract following oral administration so that the oral and parenteral dose rates are identical as 0.8 mcg per kg body weight.

The duration of effects is long-lasting and in the range 6-8 hours after a single application. Once a plateau line has been reached after 3-5 days, twice daily administration by the oral route has been found to give a satisfactory level of medication.

Clinical Experience: In clinical trials, the effects of Ventipulmin^® on pulmonary function and clinical response were assessed in horses suffering from a variety of respiratory conditions including chronic obstructive pulmonary disease (COPD).

The horses responded by a marked decrease in intrathoracic pressure, a decrease in respiratory rate, an initial decrease followed by an increase in arterial oxygen partial pressure and clinical improvement. Duration of action of a single application was 6-8 hours.

Other results showed a significant reduction in resistance to airflow and clinical improvement of the animals’ respiratory pattern.

There were no significant side effects due to the treatment in any of the clinical trials. In those conditions where concurrent infection existed, supplementary treatment with chemotherapeutic agents was instituted.

Three separate palatability studies indicated patient acceptance of treated feed. Some animals (55 of 123) exhibited delayed acceptance of treated grain, but none of the horses refused to eat it.

Bronchodilator for the Treatment of Respiratory Disease in Horses:

Description

A colourless, slightly opalescent, viscous syrup with a hardly perceptible odour. Each mL of syrup contains 0.025 mg (25 mcg) of 4-amino-α-[(tert.-butyl-amino) methyl]-3,5, dichlorobenzylalcohol hydrochloride (clenbuterol hydrochloride).

Uses: Treatment of respiratory disease in horses where it is considered that airway obstruction is due to bronchospasm.

Dosage and Administration

Twice daily administration of 0.8 mcg of clenbuterol per kg body weight. This is equivalent to one stroke (4 mL) of the metered dosing pump (provided with each package) for each 125 kg (275 lbs.) b. w. twice daily on the grain portion of the feed.

Route of Administration: Oral.

Duration of Action: Approximately 8 hours after a single dose, 12 hours on repeated twice daily dosing.

Contraindications

Due to a potential risk of increasing the peripheral vasodilating effect of clenbuterol, it is not recommended that corticosteroids be used in conjunction with Ventipulmin^®. Ventipulmin^® antagonises the effects of prostaglandin F_2α and oxytocin. The action of Ventipulmin^® is antagonised by β-adrenergic blocking agents.

Ventipulmin Syrup Caution

If used during pregnancy, Ventipulmin^® must be discontinued at the expected time of delivery, since uterine contractions may be abolished under its influence. The effect on fertility of breeding stallions has not been determined.

Warning

Federal law prohibits the administration of this preparation to animals that produce food or that are intended for consumption as food.

Storage

Do not store above 25°C. Protect from light.

Ventipulmin^® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under licence.

Boehringer Ingelheim Animal Health Canada Inc., 5180 South Service Road, Burlington ON L7L 5H4

159110-002

CPN: 1182195.0