PROMACE- acepromazine maleate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACEPROMAZINE MALEATE (UNII: 37862HP2OM) (ACEPROMAZINE - UNII:54EJ303F0R)

Available from:

Boehringer Ingelheim Animal Health USA Inc.

INN (International Name):

ACEPROMAZINE MALEATE

Composition:

ACEPROMAZINE MALEATE 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Dogs and Cats: PROMACE Injectable can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antiemetic to control vomiting associated with motion sickness. PROMACE Injectable is particularly useful as a preanesthetic agent (1) to enhance and prolong the effects of barbiturates, thus reducing the requirements for general anesthesia; (2) as an adjunct to surgery under local anesthesia. Horses: PROMACE Injectable can be used as an aid in controlling fractious animals during examination, treatment, loading and transportation. Particularly useful when used in conjunction with local anesthesia for firing, castration, neurectomy, removal of skin tumors, ocular surgery and applying casts. Phenothiazines may potentiate the toxicity of organophosphates and the activity of procaine hydrochloride. Therefore, do not use PROMACE Injectable to control tremors associated with organic phosp

Product summary:

PROMACE Injectable is supplied in 50 mL multiple dose vials. NDC 0010-3827-01 - 10 mg/mL - 50 mL vial

Authorization status:

New Animal Drug Application

Summary of Product characteristics

PROMACE- ACEPROMAZINE MALEATE INJECTION
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
----------
PROMACE® INJECTABLE
(ACEPROMAZINE MALEATE INJECTION)
Approved by FDA under NADA # 015-030
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
PROMACE Injectable, a potent neuroleptic agent with a low order of
toxicity, is of
particular value in the tranquilization of dogs, cats and horses. Its
rapid action and lack
of hypnotic effect are added advantages. According to Baker,
the scope of possible
applications for this compound in veterinary practice is only limited
by the imagination of
the practitioner.
EACH ML CONTAINS: acepromazine maleate 10 mg, sodium citrate 0.36%,
citric acid
0.075%, benzyl alcohol 1% and water for injection.
Acepromazine [10-[3-(dimethylamino) propyl] phenothiazin-2-yl-methyl
ketone] Maleate,
USP has the following chemical structure:
PROMACE Injectable has a depressant effect on the central nervous
system and,
therefore, causes sedation, muscular relaxation and a reduction in
spontaneous activity.
It acts rapidly, exerting a prompt and pronounced calming effect.
INDICATIONS:
DOGS AND CATS: PROMACE Injectable can be used as an aid in controlling
intractable
animals during examination, treatment, grooming, x-ray and minor
surgical procedures;
to alleviate itching as a result of skin irritation; as an antiemetic
to control vomiting
associated with motion sickness.
PROMACE Injectable is particularly useful as a preanesthetic agent (1)
to enhance and
prolong the effects of barbiturates, thus reducing the requirements
for general
anesthesia; (2) as an adjunct to surgery under local anesthesia.
HORSES: PROMACE Injectable can be used as an aid in controlling
fractious animals
1
during examination, treatment, loading and transportation.
Particularly useful when used
in conjunction with local anesthesia for firing, castration,
neurectomy, removal of skin
tumors, ocular surgery and applying casts.
DOSAGE AND ADMINISTRATION:
The dosage should be indiv