KETAMINE HYDROCHLORIDE injection, solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

General Injectables and Vaccines, Inc.

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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, in

Ürün özeti:

Ketamine Hydrochloride Injection, USP is supplied as the hydrochloride in concentrations equivalent to ketamine base. NDC 67457-181-20      carton containing 10, 20 mL multi-dose vials with 10 mg/mL  NDC 67457-001-10      carton containing 10, 10 mL multi-dose vials with 50 mg/mL  NDC 67457-108-10      carton containing 10, 10 mL multi-dose vials with 100 mg/mL Store at 20 ° to 25 °C (68 ° to 77 °F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

KETAMINE HYDROCHLORIDE- KETAMINE HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
----------
KETAMINE HYDROCHLORIDE
200 mg/20mL (10 mg/mL), 500 mg/10mL (50 mg/mL) and 1,000 mg/10 mL (100
mg/mL)
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 RECTION, 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 hydrochlo