VENTIPULMIN- clenbuterol syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLENBUTEROL HYDROCHLORIDE (UNII: GOR5747GWU) (CLENBUTEROL - UNII:XTZ6AXU7KN)

Available from:

Boehringer Ingelheim Animal Health USA Inc.

INN (International Name):

CLENBUTEROL HYDROCHLORIDE

Composition:

CLENBUTEROL HYDROCHLORIDE 0.0725 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic 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). VENTIPULMIN Syrup antagonizes the effects of prostaglandin F2 α 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.

Product summary:

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

Authorization status:

New Animal Drug Application

Summary of Product characteristics

VENTIPULMIN- CLENBUTEROL SYRUP
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
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VENTIPULMIN® SYRUP
(CLENBUTEROL HCL)
Approved by FDA under NADA # 140-973
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 α 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 use in humans. Do not use in horses intended for human
consumption. Keep
out of 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) t