Proprietary Name:
Acepromazine Maleate Injection
e. Dosage Form:
Injection (solution)
f. How Supplied:
50 mL glass bottles
g. How Dispensed:
?
h. Amount of Active Ingredients:
10 mg acepromazine maleate/mL
i. Route of Administration:
Intravenous, Intramuscular, or Subcutaneous
Injection
j. Species: Canine, Feline and Equine k. Labeled Dosage:
The dosage should be individualized,
depending upon the degree of tranquilization
required. As general rule, the dosage
requirement in mg/lb of body weight
decreases as the weight of the animal
increases. Acepromazine Maleate Injection
may be given intravenously, intramuscularly
or subcutaneously. The following schedule
may be used as guide to IV, IM or SC
injections:
2
Dogs:
0.25-0.5 mg/lb of body weight
Cats:
0.5-1 mg/lb of body weight
Horses:
2-4 mg/100lb of body weight
IV doses should be administered slowly, and
period of at least 15 minutes should be allowed for
the drug to take full effect. l. Pharmacological Category:
Anesthetic
m. Indications For Use:
Dogs and Cats
: Acepromazine Maleate Injection
can be used as an aid in controlling intractable
animals during examination, treatment, grooming, x-
ray and minor surgical procedures; to alleviate
itching as result of skin irritation; as an antiemetic
to control vomiting associated with motion sickness.
Acepromazine Maleate Injection is particularly
useful as preanesthetic agent to enhance and
prolong the effects of barbiturates, thus reducing the
requirements for general anesthesia; as an
adjunct to surgery under local anesthesia.
Horses:
Acepromazine Maleate Injection can be
used as an aid in controlling fractious animals during
examination, treatment, loading and transportation.
Particularly useful when used in conjunction with
local anesthesia for firing, castration, neurectomy,
removal of skin tumors, ocular surgery and applying
casts.
n. Pioneer Product
PromAce
?
Injectable NADA 015-030 (Fort Dodge Animal Health, Inc.)
3
2.
TARGET ANIMAL SAFETY and DRUG EFFECTIVIENESS
Under the provisions of the Federal F
ood, Drug, and Cosmetic Act, as amended
by the Generic Animal Drug and Patent
Term Restoration Act, (53 FR 50460,
December 15, 1988, First GADPTRA Policy Letter) an Abbreviated New Animal
Drug Application (ANADA) may be subm
itted for generic version of an
approved new animal drug (pioneer product). New target animal safety data, drug
effectiveness data, and human food safety data (other than tissue residue data) are
not required for approval of an ANADA.
Ordinarily, the ANADA sponsor shows that the generic product is bioequivalent
to the pioneer, which has been shown to be safe and effective. If bioequivalence
is demonstrated through clinical end-
point study, then tissue residue study to
establish the withdrawal time for the gene
ric product is also required. For certain
dosage forms, the agency will grant wa
iver from the requirement of conducting
an
in vivo
bioequivalence study (55 FR 24645, June 18, 1990; Fifth GADPTRA
Policy Letter, Bioequivalence Guideline, October 2000).
Based upon the formulation characteristic
s of the generic product, Phoenix
Scientific, Inc. was granted waiver from conducting an
in vivo
bioequivalence
study for Acepromazine Maleate In
jection on October 20, 1997 (JINAD 010-181
R0000). The generic and pioneer products
contain the same active and inactive
ingredients in the same concentrations.
3. HUMAN SAFETY
:
None required as Acepromazine Maleate Injection is labeled for use in dogs, cats,
and horses. The labeling also contains the statement, ?Warning: Not for use in
animals intended for food?.
Human Safety Relative to Possession, Handling and Administration:
Labeling contains adequate caution/warning statements.
