VENTIPULMIN^® SYRUP

Rx

Boehringer Ingelheim

(clenbuterol HCl)

NADA 140-973, Approved by FDA

For use in horses not intended for food.

Each mL contains Clenbuterol HCl 72.5 mcg.

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

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. VENTIPULMIN Syrup (clenbuterol hydrochloride) is antagonized by beta-adrenergic blocking agents.

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

Contraindications: VENTIPULMIN Syrup antagonizes the effects of prostaglandin F₂ alpha and oxytocin. VENTIPULMIN Syrup should not be used in pregnant mares near term. Because tachycardia may occur, VENTIPULMIN 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 VENTIPULMIN 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 VENTIPULMIN 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: VENTIPULMIN 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 (15-30°C) (59-86°F). Avoid freezing.

301701L-00-9803
BI 3017-5 5/98

Product Information

Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. NAC No.: 10281131