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ACEPROMAZINE MALEATE tablet
[Clipper Distributing Company, LLC]


Category DEA Schedule Marketing Status
PRESCRIPTION ANIMAL DRUG LABEL New Animal Drug Application
Drug Label Sections

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.

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.

Picture of chemical formula.

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 Maleate 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 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:

Do not use in animals intended for human consumption.

Precautions:

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 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.

Adverse Reactions:

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.

To report suspected adverse reactions, to obtain a Material Safety Data Sheet or for technical assistance, call 1-866-638-2226.

Storage:

Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F).

How Supplied:

Acepromazine Maleate Tablets are available in 10 and 25 mg concentrations, and are quarter-scored for convenience of administration. Both concentrations are available in bottles containing 100 and 500 tablets.

NDC 57319-445-13 – 10 mg – 100 tablets

NDC 57319-445-15 – 10 mg – 500 tablets

NDC 57319-446-13 – 25 mg – 100 tablets

NDC 57319-446-15 – 25 mg – 500 tablets

670113-04

80733607

80728662, R.0

Revised 06/2012

Bottle Label, 10 mg. 500 tablets

Picture of 10 mg, 500 ct label.]

ACEPROMAZINE MALEATE 
acepromazine maleate tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:57319-445
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACEPROMAZINE MALEATE (ACEPROMAZINE) ACEPROMAZINE MALEATE10 mg
Product Characteristics
ColorPINKScore4 pieces
ShapeROUNDSize8mm
FlavorImprint Code 0220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57319-445-13100 in 1 BOTTLE, PLASTIC
2NDC:57319-445-15500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA11753205/31/2013
Labeler - Clipper Distributing Company, LLC (150711039)

Revised: 11/2013
 
Clipper Distributing Company, LLC

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