ACEPROTABS- 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:

Henry Schein Animal Health

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

As an aid in tranquilization and as a preanesthetic agent in dogs. AceproTabs 10 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:

AceproTabs are available in 10 and 25 mg quarter-scored tablets and are supplied in bottles containing 100 and 500 tablets. NDC 11695-0086-1 – 10 mg – 100 tablets NDC 11695-0086-5 – 10 mg – 500 tablets NDC 11695-0072-1 – 25 mg – 100 tablets NDC 11695-0072-5 – 25 mg – 500 tablets 670133-04 80733593 80728638, R.1 Revised 08/2013

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ACEPROTABS- ACEPROMAZINE MALEATE TABLET
HENRY SCHEIN ANIMAL HEALTH
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ACEPROTABS 10
ACEPROMAZINE MALEATE TABLETS, USP
NADA 117-532, Approved by FDA
For use in dogs only.
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DES CRIPTION:
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.
CHEMIS TRY:
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.
AceproTabs 10 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 contr