KETAMINE HYDROCHLORIDE- ketamine hydrochloride injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Fresenius Kabi USA, LLC

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Ketamine Hydrochloride Injection is indicated: - as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. - for the induction of anesthesia prior to the administration of other general anesthetic agents. - as a supplement to other anesthetic agents. - Ketamine Hydrochloride Injection is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see Warnings and Precautions (5.1)] . - Ketamine Hydrochloride Injection is contraindicated in patients with known hypersensitivity to ketamine or to any excipient [see Adverse Reactions (6)] . Risk Summary There are no adequate and well-controlled studies of Ketamine Hydrochloride Injection in pregnant women. In animal reproduction studies in rats developmental delays (hypoplasia of skeletal tissues) were noted at 0.3 times the human intramuscular dose of 10 mg/kg. In rabbits, developmental delays and increased fetal resorptions were noted at 0.6 times the

leaflet_short:

How Supplied Ketamine Hydrochloride Injection, USP is a clear, colorless to slightly yellow solution supplied as the hydrochloride salt in concentrations equivalent to ketamine base, as follows: Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. This container closure is not made with natural rubber latex.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

KETAMINE HYDROCHLORIDE - KETAMINE HYDROCHLORIDE INJECTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KETAMINE
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
KETAMINE HYDROCHLORIDE INJECTION.
KETAMINE HYDROCHLORIDE INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR
USE, CIII
INITIAL U.S. APPROVAL: 1970
INDICATIONS AND USAGE
Ketamine Hydrochloride Injection is a general anesthetic indicated:
as the sole anesthetic agent for diagnostic and surgical procedures
that do not require skeletal muscle
relaxation (1)
for the induction of anesthesia prior to the administration of other
general anesthetic agents (1)
as a supplement to other anesthetic agents (1).
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for important dosage and
administration instructions. (2)
Induction of anesthesia:
--
--
Maintenance of anesthesia: Increments of one-half to the full
induction dose may be repeated as
needed (2.2). Adjust the dose according to the patient's anesthetic
needs and whether an additional
anesthetic agent is employed. (2.2)
Supplement to other anesthetic agents: The regimen of a reduced dose
of Ketamine Hydrochloride
Injection supplemented with diazepam can be used to produce balanced
anesthesia by combination
with other agents. (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 200 mg/20 mL (10 mg/mL) and 500 mg/10 mL (50 mg/mL)
multiple-dose vials (3).
CONTRAINDICATIONS
In patients for whom a significant elevation of blood pressure would
be a serious hazard (4).
Known hypersensitivity to ketamine or to any excipient (4).
WARNINGS AND PRECAUTIONS
Hemodynamic Instability: Monitor vital signs and cardiac function
during Ketamine Hydrochloride
Injection administration. (5.1)
Emergence Reactions: Postoperative confusional states may occur during
the recovery period. Reduce
by minimizing verbal, tactile, and visual stimulation of the patient.
(5.2)
Risk of Respiratory Depression: May occur with overd