Aeropulmin Syrup

Manufacturer: Clipper (Phoenix Pharm.)

(clenbuterol Hcl)

NADA 140-973, Approved by FDA

For use in horses not intended for food

Each Ml Contains

Clenbuterol HCl 72.5 mcg

Aeropulmin Syrup Caution

Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

Federal (U.S.A.) law prohibits the extralabel use of this drug in food animals.

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 F₂ alpha 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

This product is not for human use or for use in animals intended for food. 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.

Aeropulmin Syrup 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

Lbs. Body Weight	mL/treatment at 0.5 mL/100# (0.8 mcg/kg)	mL/treatment at 1.0 mL/100# (1.6 mcg/kg)
500	2.5	5.0
600	3.0	6.0
700	3.5	7.0
800	4.0	8.0
900	4.5	9.0
1000	5.0	10.0
1100	5.5	11.0
1200	6.0	12.0
1300	6.5	13.0
1400	7.0	14.0
1500	7.5	15.0
1600	8.0	16.0
1700	8.5	17.0
1800	9.0	18.0

Lbs. Body Weight	mL/treatment at 1.5 mL/100# (2.4 mcg/kg)	mL/treatment at 2.0 mL/100# (3.2 mcg/kg)
500	7.5	10.0
600	9.0	12.0
700	10.5	14.0
800	12.0	16.0
900	13.5	18.0
1000	15.0	20.0
1100	16.5	22.0
1200	18.0	24.0
1300	19.5	26.0
1400	21.0	28.0
1500	22.5	30.0
1600	24.0	32.0
1700	25.5	34.0
1800	27.0	36.0

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.

Aeropulmin Syrup is manufactured and licensed by Boehringer Ingelheim Vetmedica, Inc.

Phoenix™ Pharmaceutical, Inc.

Manufactured For: Clipper Distributing Company, Llc, St. Joseph, Mo 64507

Net Contents:	NDC
100 mL	57319-501-05	301709L-00-0410
330 mL	57319-501-58	301711L-00-0410

Nac No.

12561331