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.

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 Injection did not demonstrate adverse reactions even when administered at three times the upper limit of the recommended daily dosage (1.5 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.

When administered intramuscularly, acepromazine maleate causes a brief sensation of stinging comparable with that observed with other phenothiazine tranquilizers.

INDICATIONS: As an aid in tranquilization and as a pre-anesthetic agent in dogs.

Acepromazine Maleate Injection can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures.

Acepromazine Maleate Injection is particularly useful as a pre-anesthetic 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.

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.

Hypotension can occur after rapid intravenous injection causing cardiovascular collapse.

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: Acepromazine Maleate Injection is a sterile solution which may be given intravenously, intramuscularly or subcutaneously. The dosage should be individualized, depending upon the degree of tranquilization required. As a general rule, the dosage requirement in mg/lb of body weight decreases as the weight of the animal increases. The following schedule may be used as a guide to intravenous, intramuscular or subcutaneous injections:

Dogs: 0.25-0.5 mg per lb of body weight.

Intravenous doses should be administered slowly, and a period of at least 15 minutes should be allowed for the drug to take full effect.

HOW SUPPLIED: 50 mL vials:

Each mL contains 10 mg acepromazine maleate, sodium citrate 0.36%, citric acid 0.075%, benzyl alcohol 1.0% and water for injection q.s., pH adjusted with 40% sodium hydroxide and/or hydrochloric acid.

Store at controlled room temperature, 59°-86°F (15°-30°C).

Keep out of reach of children

670010L-00-9909

CPN: 1386000.0