KETAMINE HYDROCHLORIDE injection, solution, concentrate

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Ketamine Hydrochloride (UNII: O18YUO0I83) (KETAMINE - UNII:690G0D6V8H)

Disponible depuis:

Hospira, Inc.

DCI (Dénomination commune internationale):

KETAMINE HYDROCHLORIDE

Composition:

KETAMINE 100 mg in 1 mL

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Ketamine Hydrochloride Injection is indicated: 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 human dose. Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defe

Descriptif du produit:

How Supplied Ketamine Hydrochloride Injection, USP is a clear colorless solution supplied as the hydrochloride in concentrations equivalent to ketamine base. NDC 0409-2051-05 Box of 10 5 mL Multiple-dose Fliptop Vial 500 mg/5 mL (100 mg/mL) NDC 0409-2053-10 Box of 10 10 mL Multiple-dose Fliptop Vial 500 mg/10 mL (50 mg/mL) Storage and Handling Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect from light.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

KETAMINE HYDROCHLORIDE- KETAMINE HYDROCHLORIDE INJECTION, SOLUTION,
CONCENTRATE
HOSPIRA, INC.
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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
RECENT MAJOR CHANGES
Warnings and Precautions, Drug Induced Liver Injury (5.6)
7/2022
INDICATIONS AND USAGE
Ketamine Hydrochloride Injection is a general anesthetic indicated:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: 500 mg/10 mL (50 mg/mL) and 500 mg/5 mL (100 mg/mL)
multiple-dose vials. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
See Full Prescribing Information for important dosage and
administration instructions. (2)
Induction of Anesthesia:
--_Intravenous Route_: Initially, 1 to 4.5 mg/kg administered slowly
(over a period of 60 seconds).
Alternatively, administer a dose of 1 to 2 mg/kg at a rate of 0.5
mg/kg/min. (2.2)
--_Intramuscular Route_: Initially, 6.5 to 13 mg/kg. (2.2)
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)
In patients for whom a significant elevation of blood pressure would
be a serious hazard. (4)
Known hypersensitivity to