ACEPROMAZINE MALEATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MWI/VetOne

INN (International Name):

ACEPROMAZINE MALEATE

Composition:

ACEPROMAZINE MALEATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

As an aid in tranquilization and as a preanesthetic agent in dogs. Acepromazine Tablets can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures. Phenothiazines may potentiate the toxicity of organophosphates. Therefore, do not use acepromazine maleate to control tremors associated with organic phosphate poisoning. Do not use in conjunction with organophosphorus vermifuges or ectoparasiticides, including flea collars. Do not use with procaine hydrochloride.

Product summary:

Acepromazine maleate tablets are available in 10 and 25 mg quarter-scored tablets and are supplied in bottles containing 100 and 500 tablets. NDC 13985-583-10 10 mg – 100 tablets NDC 13985-583-50 10 mg – 500 tablets NDC 13985-582-25 25 mg – 100 tablets NDC 13985-582-50 25 mg – 500 tablets

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ACEPROMAZINE MALEATE- ACEPROMAZINE MALEATE TABLET
MWI/VETONE
----------
ACEPROMAZINE MALEATE TABLETS
10 MG
Approved by FDA under NADA # 117-532
For use in dogs only.
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
Acepromazine maleate, a potent neuroleptic agent with a low order of
toxicity, is of
particular value in the tranquilization of dogs. Its rapid action and
lack of hypnotic effect
are added advantages.
CHEMISTRY:
2-acetyl-10-(3-dimethylaminopropyl) phenothiazine hydrogen maleate.
MODE OF ACTION:
Acepromazine maleate 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. It
is an effective
preanesthetic agent and lowers the dosage requirement of general
anesthetics.
INDICATIONS:
As an aid in tranquilization and as a preanesthetic agent in dogs.
Acepromazine Tablets can be used as an aid in controlling intractable
animals during
examination, treatment, grooming, x-ray and minor surgical procedures.
DOSAGE AND ADMINISTRATION:
Dogs: 0.25 - 1.0 mg/lb of body weight. Dosage may be repeated as
required.
ANIMAL SAFETY:
Acute and chronic toxicity studies have shown a very low order of
toxicity for
acepromazine maleate.
A safety study using elevated dosages of acepromazine maleate
demonstrated no
adverse reactions even when administered at three times the upper
limit of the
recommended daily dosage (3.0 mg/lb body weight). The clinical
observation for this
high dosage was mild depression which disappeared in most dogs 24
hours after
termination of dosing.
The only occurrence of adverse reaction during numerous clinical
trials was a very mild
respiratory distress (reverse sneeze) which was transient in nature
and had no effect on
the desired action of the drug.
CONTRAINDICATIONS:
Phenothiazines may potentiate the toxicity of organophosphates.
Therefore, do not use
acepromazine maleate to control tremor