Aeropulmin Syrup

Company: Henry Schein^® Animal Health

(clenbuterol HCl)

NADA 140-973, Approved by FDA

For oral use in horses only.

Aeropulmin Syrup Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Aeropulmin Syrup Caution

Federal law prohibits the extra-label use of this drug in food animals.

EACH mL CONTAINS: Clenbuterol HCl 72.5 mcg

Description

Clenbuterol (4-amino-alpha-[(tert-butylamino) methyl]-3, 5-dichlorobenzyl alcohol hydrochloride) is a beta-2-adrenergic agonist which provides bronchodilating properties as well as other effects, with minimum effect on the cardiovascular system. It is provided as a colorless, palatable syrup. Aeropulmin Syrup (clenbuterol hydrochloride) is antagonized by beta-adrenergic blocking agents.

Aeropulmin Syrup Indications

Aeropulmin Syrup (clenbuterol hydrochloride) is indicated for the management of horses affected with airway obstruction, such as occurs in chronic obstructive pulmonary disease (COPD).

Contraindications

Aeropulmin Syrup antagonizes the effects of prostaglandin F₂alpha and oxytocin. Aeropulmin Syrup should not be used in pregnant mares near term. Because tachycardia may occur, Aeropulmin Syrup should not be used in horses suspected of having cardiovascular impairment.

Warning

The effect on reproduction in breeding stallions and brood mares has not been determined. Treatment starting with dosages higher than the initial dose is not recommended.

HUMAN WARNINGS: Do not use in horses intended for human consumption. Keep out of the reach of children. In case of accidental ingestion, contact a physician immediately. Ingestion of Aeropulmin Syrup may cause undesirable reactions. Clenbuterol, like other beta adrenergic agonists, can produce significant cardiovascular effects in some people as evidenced by elevated pulse rate, blood pressure changes and/or ECG changes.

Dosage and Administration

Administer orally twice a day (b.i.d.). Initial dose is 0.5 mL/100 lbs body weight (0.8 mcg/kg) twice daily.

DOSAGE SCHEDULE:

Initial dosage: administer 0.5 mL/100 lbs (0.8 mcg/kg) for 3 days (6 treatments);

If no improvement, administer 1.0 mL/100 lbs (1.6 mcg/kg) for 3 days (6 treatments);

If no improvement, administer 1.5 mL/100 lbs (2.4 mcg/kg) for 3 days (6 treatments);

If no improvement, administer 2.0 mL/100 lbs (3.2 mcg/kg) for 3 days (6 treatments);

If no improvement, horse is non-responder to clenbuterol and treatment should be discontinued.

Recommended duration of treatment at effective dose is 30 days. At the end of this 30-day treatment period, drug should be withdrawn to determine recurrence of signs. If signs return, the 30-day treatment regimen may be repeated. If repeating treatment, the step-wise dosage schedule should be repeated.

DOSAGE CALCULATION CHART

Administer two treatments per day.

DIRECTIONS FOR ADMINISTRATION: Remove safety cap and seal; replace with enclosed plastic dispensing cap. Remove cover from dispensing tip and connect syringe (without needle). Draw out appropriate volume of Aeropulmin Syrup. Administer orally to the horse. Replace cover on dispensing tip to prevent leakage.

PRECAUTION: The safety cap should be placed on the bottle when not in use.

Adverse Reactions

Mild sweating, muscle tremor, restlessness, urticaria and tachycardia may be observed in some horses during the first few days of treatment. May cause elevated creatine kinase (CK) serum levels. Ataxia was observed in 3 out of 239 horses (1.3%) in clinical studies.

How Supplied

Aeropulmin Syrup is available in 100 mL and 330 mL plastic bottles containing 72.5 mcg clenbuterol HCl per mL.

Storage

Store at controlled room temperature, 59-86°F (15-30°C).

Avoid freezing.

Made in Mexico

VetUS™

Distributed Exclusively by Henry Schein Animal Health, Dublin, OH 43017

www.HenryScheinVet.com

CPN: 1082235.3