KETAMINE HYDROCHLORIDE injection, solution, concentrate

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

General Injectables & Vaccines, Inc

Կառավարման երթուղին:

INTRAMUSCULAR

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 hydrochloride 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,

Ապրանքի ամփոփագիր:

Ketamine Hydrochloride Injection, USP is supplied as the hydrochloride in concentrations equivalent to ketamine base. Color of solution may vary from colorless to very slightly yellowish and may darken upon prolonged exposure to light. This darkening does not affect potency. Do not use if a precipitate appears. Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from light.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

KETAMINE HYDROCHLORIDE- KETAMINE HYDROCHLORIDE INJECTION, SOLUTION,
CONCENTRATE
GENERAL INJECTABLES & VACCINES, INC
----------
KETAMINE HYDROCHLORIDE INJECTION, USP
RX ONLY
CIII
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 Section).
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 ULTRA SHORT-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 general anesthetic
chemically designated dl
2-(o-Chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride. It is
formulated as a
slig