KETAMINE HYDROCHLORIDE injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

KETAMINE HYDROCHLORIDE (UNII: O18YUO0I83) (KETAMINE - UNII:690G0D6V8H)

Available from:

Physicians Total Care, Inc.

INN (International Name):

KETAMINE HYDROCHLORIDE

Composition:

KETAMINE 50 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ketamine hydrochloride injection is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine hydrochloride injection is best suited for short procedures but it can be used, with additional doses, for longer procedures. Ketamine hydrochloride injection is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents. Ketamine hydrochloride injection is indicated to supplement low-potency agents, such as nitrous oxide. Specific areas of application are described in the CLINICAL PHARMACOLOGY section. Ketamine is contraindicated in those in whom a significant elevation of blood pressure would constitute a serious hazard and in those who have shown hypersensitivity to the drug. Ketamine has been reported being used as a drug of abuse. Reports suggest that ketamine produces a variety of symptoms including, but not limited to anxiety, dysphoria, disorientation, insomnia, flashbacks, hallucination

Product summary:

Ketamine Hydrochloride Injection, USP is supplied as the hydrochloride in concentrations equivalent to ketamine base. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

KETAMINE HYDROCHLORIDE - KETAMINE HYDROCHLORIDE INJECTION, SOLUTION,
CONCENTRATE
PHYSICIANS TOTAL CARE, INC.
----------
KETAMINE
HYDROCHLORIDE
INJECTION, USP
CIII
R only
_SPECIAL NOTE_
EMERGENCE REACTIONS HAVE OCCURRED IN APPROXIMATELY 12 PERCENT OF
PATIENTS.
THE PSYCHOLOGICAL MANIFESTATIONS VARY IN SEVERITY BETWEEN PLEASANT
DREAM-LIKE STATES, VIVID IMAGERY, HALLUCINATIONS, AND EMERGENCE
DELIRIUM. IN SOME CASES THESE STATES HAVE BEEN ACCOMPANIED BY
CONFUSION, EXCITEMENT, AND IRRATIONAL BEHAVIOR WHICH A FEW PATIENTS
RECALL AS AN UNPLEASANT EXPERIENCE. THE DURATION ORDINARILY IS NO
MORE THAN A FEW HOURS; IN A FEW CASES, HOWEVER, RECURRENCES HAVE
TAKEN PLACE UP TO 24 HOURS POSTOPERATIVELY. NO RESIDUAL
PSYCHOLOGICAL EFFECTS ARE KNOWN TO HAVE RESULTED FROM USE OF
KETAMINE.
THE INCIDENCE OF THESE EMERGENCE PHENOMENA IS LEAST IN THE ELDERLY
(OVER 65 YEARS OF AGE) PATIENT. ALSO, THEY ARE LESS FREQUENT WHEN THE
DRUG IS GIVEN INTRAMUSCULARLY AND THE INCIDENCE IS REDUCED AS
EXPERIENCE WITH THE DRUG IS GAINED.
THE INCIDENCE OF PSYCHOLOGICAL MANIFESTATIONS DURING EMERGENCE,
PARTICULARLY DREAM-LIKE OBSERVATIONS AND EMERGENCE DELIRIUM, MAY
BE REDUCED BY USING LOWER RECOMMENDED DOSAGES OF KETAMINE IN
CONJUNCTION WITH INTRAVENOUS DIAZEPAM DURING INDUCTION AND
MAINTENANCE OF ANESTHESIA. (SEE DOSAGE AND ADMINISTRATION.) ALSO,
THESE REACTIONS MAY BE REDUCED IF VERBAL, TACTILE AND VISUAL
STIMULATION OF THE PATIENT IS MINIMIZED DURING THE RECOVERY PERIOD.
THIS DOES NOT PRECLUDE THE MONITORING OF VITAL SIGNS.
IN ORDER TO TERMINATE A SEVERE EMERGENCE REACTION THE USE OF A SMALL
HYPNOTIC DOSE OF A SHORT-ACTING OR ULTRASHORT-ACTING BARBITURATE
MAY BE REQUIRED.
WHEN KETAMINE IS USED ON AN OUTPATIENT BASIS, THE PATIENT SHOULD NOT
BE RELEASED UNTIL RECOVERY FROM ANESTHESIA IS COMPLETE AND THEN
SHOULD BE ACCOMPANIED BY A RESPONSIBLE ADULT.
DESCRIPTION
Ketamine hydrochloride is a nonbarbiturate anesthetic chemically
designated (±)-2-(_o_-Chlorophenyl)-2-
(methylamino) cyclohexanone hydrochloride. It is formulated as a
slightly acid (pH 3.5 to