KETAMINE HYDROCHLORIDE injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

REMEDYREPACK INC.

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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,

Dettagli prodotto:

Ketamine Hydrochloride Injection, USP is supplied as the hydrochloride in concentrations equivalent to ketamine base. NDC: 70518-2787-00 NDC: 70518-2787-01 PACKAGING: 10 in 1 CARTON PACKAGING: 20 mL in 1 VIAL, TYPE 0 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

KETAMINE HYDROCHLORIDE- KETAMINE HYDROCHLORIDE INJECTION, SOLUTION
REMEDYREPACK INC.
----------
RX ONLY
For intravenous and intramuscular use
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 HYDROCHLORIDE INJECTION.
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
HYDROCHLORIDE INJECTION 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 HYDROCHLORIDE INJECTION 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 injection, USP is a nonbarbiturate general
anesthetic chemically
designated _dl_ 2-(o-chlorophenyl)-2-(methylamino) cyc