Ventipulmin® Syrup (clenbuterol HCl)

Product Type: PRESCRIPTION ANIMAL DRUG LABEL
Autor Name: Boehringer Ingelheim Vetmedica, Inc.
Code Source: 0010-3017
Route of Administration: ORAL

Ventipulmin

Generic: clenbuterol

Ingredients:

• CLENBUTEROL HYDROCHLORIDE CLENBUTEROL : Active ingredient - basis of strength - 0.0725 mg in 1 mL

Package Description:

• 50 mL in 1 BOTTLE, PLASTIC
• 100 mL in 1 BOTTLE, PLASTIC
• 330 mL in 1 BOTTLE, PLASTIC
• 460 mL in 1 BOTTLE, PLASTIC

NADA 140-973, Approved by FDA
For oral use in horses only

Caution

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

Caution

Federal law prohibits the extralabel 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. 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 F 2 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

Not for human use. 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 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-responsive 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)	mL/treatment at 1.5 mL/100# (2.4 mcg/kg)	mL/treatment at 2.0 mL/100# (3.2 mcg/kg)
500 600 700 800 900 1000 1100 1200 1300 1400 1500 1600 1700 1800	2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0	5.0 6.0 7.0 8.0 9.0 10.0 11.0 12.0 13.0 14.0 15.0 16.0 17.0 18.0	7.5 9.0 10.5 12.0 13.5 15.0 16.5 18.0 19.5 21.0 22.5 24.0 25.5 27.0	10.0 12.0 14.0 16.0 18.0 20.0 22.0 24.0 26.0 28.0 30.0 32.0 34.0 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 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. To report suspected adverse reactions, to obtain a Material Safety Data Sheet (MSDS), or for technical assistance, call 1-866-638-2226.

How Supplied

Ventipulmin Syrup is available in 50 mL, 100 mL, 330 mL and 460 mL plastic bottles containing 72.5 mcg clenbuterol HCl per mL.
NDC 0010-3017-01 - 50 mL, NDC 0010-3017-02 - 100 mL
NDC 0010-3017-03 - 330 mL, NDC 0010-3017-04 - 460 mL

Storage

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

Ventipulmin is a registered trademark of Boehringer Ingelheim Vetmedica GmbH.
Manufactured for:
Boehringer Ingelheim Vetmedica, Inc.
St. Joseph, MO 64506 U.S.A.
Made in Mexico
301721L-02-1008
Code 301735

330 mL Bottle Label

Picture of 330 mL Bottle Label.

330 mL Display Carton (Part 1)

Front panel, side panel and bottom flap

Picture of front panel, side panel and bottom flap of 330 mL display carton.

330 mL Display Carton (Part 2)

Back panel, second side panel and top flap

Picture of back panel, second side panel and top flap of 330 mL display carton.