Label: PROMACE- acepromazine maleate tablet
- NDC Code(s): 0010-6704-01, 0010-6704-02
- Packager: Boehringer Ingelheim Vetmedica, Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Updated February 27, 2013
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- SPL UNCLASSIFIED SECTION
NADA 117-532, Approved by FDA
For use in dogs only.Close
Federal law restricts this drug to use by or on the order of a licensed veterinarian.Close
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.Close
2-acetyl-10-(3-dimethylaminopropyl) phenothiazine hydrogen maleate.Close
- 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.Close
As an aid in tranquilization and as a preanesthetic agent in dogs. PromAce Tablets can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures.Close
- Dosage and Administration
Dogs: 0.25 - 1.0 mg/lb of body weight. Dosage may be repeated as required.Close
- 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.Close
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.Close
Do not use in animals intended for human consumption.Close
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.Close
- 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.Close
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F).Close
- How Supplied
PromAce (acepromazine maleate) Tablets are available in 10 and 25 mg quarter-scored tablets and are supplied in bottles containing 100 and 500 tablets.
NDC 0010-6703-01 – 10 mg – 100 tablets
NDC 0010-6703-02 – 10 mg – 500 tablets
NDC 0010-6704-01 – 25 mg – 100 tablets
NDC 0010-6704-02 – 25 mg – 500 tabletsClose
- SPL UNCLASSIFIED SECTION
PromAce is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.
© 2012 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.
- Bottle Label, 25 mg, 500 count
- INGREDIENTS AND APPEARANCE
acepromazine maleate tablet
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0010-6704 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACEPROMAZINE MALEATE (UNII: 37862HP2OM) (ACEPROMAZINE - UNII:54EJ303F0R) ACEPROMAZINE MALEATE 25 mg Product Characteristics Color YELLOW Score 4 pieces Shape ROUND Size 8mm Flavor Imprint Code 0221 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0010-6704-01 100 in 1 BOTTLE, PLASTIC 2 NDC:0010-6704-02 500 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA117532 02/13/2013 Labeler - Boehringer Ingelheim Vetmedica, Inc. (007134091)