TOXICOLOGY: 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 Tablets did not demonstrate adverse reactions even when administered at three times the upper limit of the recommended daily dosage (3.0 mg/lb of 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 an adverse reaction during numerous clinical trials was a very mild respiratory distress (reverse sneeze) which was transient in nature and did not have an effect on the desired action of the drug.
INDICATIONS: As an aid in tranquilization and as a pre-anesthetic agent in dogs.
Acepromazine Maleate Tablets can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures.
CONTRAINDICATIONS: 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.
WARNING: Federal Law prohibits the use of this product in animals intended for human consumption.
CAUTIONS: Tranquilizers are potent central nervous system depressants, and they can cause marked sedation with suppression of the sympathetic nervous system.
Tranquilizers can produce prolonged depression or motor restlessness when given in excessive amounts or when given to sensitive animals.
Tranquilizers are additive in action to the actions of other depressants and will potentiate general anesthesia. Tranquilizers should be administered in smaller doses and with greater care during general anesthesia and also to animals exhibiting symptoms of stress, debilitation, cardiac disease, sympathetic blockade, hypovolemia or shock. Acepromazine, like other phenothiazine derivatives, is detoxified in the liver; therefore, it should be used with caution on animals with a previous history of liver dysfunction or leukopenia.
Epinephrine is contraindicated for the treatment of acute hypotension produced by phenothiazine-derivative tranquilizers since further depression of blood pressure can occur.
Phenothiazines should be used with caution when followed by epidural anesthetic procedures because they may potentiate the arterial hypotensive effects of local anesthetics.
A few rare but serious occurrences of idiosyncratic reactions to acepromazine may occur in dogs following oral or parenteral administration. These potentially serious adverse reactions include behavioral disorders in dogs such as aggression, biting/chewing, and nervousness.
DOSAGE AND ADMINISTRATION:
Dogs: 0.25-1.0 mg lb of body weight. Dosage may be repeated as required.
HOW SUPPLIED: Acepromazine Maleate Tablets are available in 10 & 25 mg concentrations, and are quarter scored for convenience of administration. Both concentrations are available in bottles of 100 and 500 tablets.