Animal NDC 57319-446-15 Acepromazine Maleate

Acepromazine Maleate

Animal NDC Product Code 57319-446-15

Field Name Field Value
Animal NDC Code 57319-446-15
Proprietary Name Acepromazine Maleate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Acepromazine Maleate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Clipper Distributing Company, Llc.
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Acepromazine Maleate
Inactive Ingredient(s)
  • MICROCRYSTALLINE CELLULOSE (OP1R32D61U)
  • MAGNESIUM STEARATE (70097M6I30)
  • STARCH, CORN (O8232NY3SJ)
  • DEXTROSE MONOHYDRATE (LX22YL083G)
  • MICROCRYSTALLINE CELLULOSE (OP1R32D61U)
  • MAGNESIUM STEARATE (70097M6I30)
  • STARCH, CORN (O8232NY3SJ)
  • DEXTROSE MONOHYDRATE (LX22YL083G)
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA117532 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Acepromazine Maleate Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

NADA 117-532, Approved by FDAFor use in dogs only.

670230-008073227980728743, R.0Revised 04/2012

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.

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 quarter-scored tablets and are supplied in bottles containing 100 and 500 tablets.NDC 57319-445-13 – 10 mg – 100 tabletsNDC 57319-445-15 – 10 mg – 500 tabletsNDC 57319-446-13 – 25 mg – 100 tabletsNDC 57319-446-15 – 25 mg – 500 tablets

* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.

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