KETAMINE- ketamine hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ketamine Hydrochloride (UNII: O18YUO0I83) (Ketamine - UNII:690G0D6V8H)

Available from:

Butler Animal Health Supply, LLC dba Covetrus North America

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Ketamine HCl injection, USP may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedure that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint. Ketamine hydrochloride is contraindicated in cats and subhuman primates suffering from renal or hepatic insufficiency. Ketamine hydrochloride is detoxified by the liver and excreted by the kidneys; therefore, any preexistent hepatic or renal pathology or impairment of function can be expected to result in prolonged anesthesia; related fatalities have been reported.

Product summary:

Ketamine HCl injection, USP is supplied as the hydrochloride in concentrations equivalent to ketamine base. Each 10 mL vial contains 100 mg/mL. NDC 11695-6840-1 - 10 mL - vial

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

KETAMINE- KETAMINE HYDROCHLORIDE INJECTION, SOLUTION
BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA
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KETAMINE HYDROCHLORIDE INJECTION, USP CIII
For Intramuscular Use in Cats and Subhuman Primates Only
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
DESCRIPTION:
Ketamine hydrochloride is a rapid-acting, nonnarcotic, nonbarbiturate
agent for
anesthetic use in cats and for restraint in subhuman primates. It is
chemically
designated DL 2-(o-chlorophenyl) - 2 - (methylamino) cyclohexanone
hydrochloride and
is supplied as a slightly acid (pH 3.5 to 5.5) solution for
intramuscular injection in a
concentration containing the equivalent of 100 mg ketamine base per
milliliter and
contains 0.1 mg/mL benzethonium chloride as a preservative.
ACTION:
Ketamine hydrochloride is a rapid-acting agent whose pharmacological
action is
characterized by profound analgesia, normal pharyngeal-laryngeal
reflexes, mild cardiac
stimulation and respiratory depression. Skeletal muscle tone is
variable and may be
normal, enhanced or diminished. The anesthetic state produced does not
fit into the
conventional classification of stages of anesthesia, but instead
ketamine hydrochloride
produces a state of unconsciousness which has been termed
“dissociative” anesthesia
in that it appears to selectively interrupt association pathways to
the brain before
producing somesthetic sensory blockade.
In contrast to other anesthetics, protective reflexes, such as
coughing and swallowing,
are maintained under ketamine hydrochloride anesthesia. The degree of
muscle tone is
dependent upon level of dose; therefore, variations in body
temperature may occur. At
low dosage levels there may be an increase in muscle tone and a
concomitant slight
increase in body temperature. However, at high dosage levels there is
some diminution
in muscle tone and a resultant decrease in body temperature, to the
point where
supplemental heat may be advisable.
In cats, there is usually some transient cardiovasc