VENTIPULMIN- clenbuterol syrup

Ventipulmin by

Drug Labeling and Warnings

Ventipulmin by is a Animal medication manufactured, distributed, or labeled by Boehringer Ingelheim Animal Health USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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 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:

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.

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.

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.

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 100 mL and 330 mL plastic bottles containing 72.5 mcg clenbuterol HCl per mL.

NDC: 0010-3017-02 - 100 mL
NDC: 0010-3017-03 - 330 mL

Storage:

Store at or below 25°C (77°F). Avoid freezing.

SPL UNCLASSIFIED SECTION

Ventipulmin is a registered trademark of Boehringer Ingelheim Vetmedica GmbH.

Manufactured for:
Boehringer Ingelheim Vetmedica, Inc.
St. Joseph, MO 64506 U.S.A.

301704-05

090330771/2

Principal Display Panel – 330 mL Container Label

NDC: 0010-3017-03

Ventipulmin® Syrup

Clenbuterol HCl 72.5 mcg/mL

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.

For oral use in horses only

Net Contents: 330 mL

NADA 140-973, Approved by FDA

Principal Display Panel – 330 mL Display Carton – Front and Side Panel

NDC: 0010-3017-03

Ventipulmin® Syrup

Clenbuterol HCl 72.5 mcg/mL

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.

For oral use in horses only

Net Contents: 330 mL

NADA 140-973, Approved by FDA

Principal Display Panel - 330 mL Display Carton – Back and Side Panel

INGREDIENTS AND APPEARANCE

VENTIPULMIN 
clenbuterol syrup

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 0010-3017
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLENBUTEROL HYDROCHLORIDE (UNII: GOR5747GWU) (CLENBUTEROL - UNII:XTZ6AXU7KN)	CLENBUTEROL HYDROCHLORIDE	0.0725 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0010-3017-02	1 in 1 CARTON
1		100 mL in 1 BOTTLE, PLASTIC
2	NDC: 0010-3017-03	1 in 1 CARTON
2		330 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140973	01/12/2011

Labeler - Boehringer Ingelheim Animal Health USA Inc. (007134091)

Registrant - Boehringer Ingelheim Animal Health USA Inc. (007134091)