Tranquilizer

Indications:

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

ACEPROMAZINE MALEATE INJECTION and TABLETS can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures; as a pre-anesthetic agent. Acepromazine maleate has a depressant effect on the central nervous system and therefore causes sedation, muscular relaxation and a reduction in spontaneous activity.

ACEPROMAZINE MALEATE INJECTION is particularly useful as a preanesthetic agent:

1. to enhance and prolong the effects of barbiturates, thus reducing the requirements of general anesthesia;

2. as an adjunct to surgery under local anesthesia.

Pharmacology:

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.

Dosage and Administration:

Injection: 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.

Tablets: 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.

Dogs: 0.25-1.0 mg/lb. of body weight.

Contraindication(s):

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.

Caution(s):

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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 blockage, 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.

Warning(s):

Federal law prohibits the use of this product in animals intended for human consumption.

Toxicology: Acute and chronic toxicity studies have shown a very low order of toxicity for acepromazine maleate.

Side Effects: A safety study using elevated dosages of ACEPROMAZINE MALEATE INJECTION demonstrated no adverse reactions even when administered at three times the upper limit of the recommended daily dosage (1.5 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.

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

Active Ingredient(s):

Each mL contains:

Each tablet contains: