KETALAR- ketamine hydrochloride injection

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

General Injectables & Vaccines, Inc

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

KETALAR (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. - KETALAR is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see Warnings and Precautions(5.1)]. - KETALAR is contraindicated in patients with known hypersensitivity to ketamine or to any excipient [see Adverse Reactions(6)]. 8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of KETALAR 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 d

Product samenvatting:

How Supplied KETALAR injection is a clear, colorless solution supplied as the hydrochloride salt in concentrations equivalent to ketamine base, as follows: Storage and Handling KETALAR injection should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.

Autorisatie-status:

New Drug Application

Productkenmerken

KETALAR- KETAMINE HYDROCHLORIDE INJECTION
GENERAL INJECTABLES & VACCINES, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KETALAR® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KETALAR.KETALAR
(KETAMINE HYDROCHLORIDE)
INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR USE, CIII
INITIAL U.S. APPROVAL: 1970
RECENT MAJOR CHANGES
Warnings and Precautions (5.6)
8/2020
INDICATIONS AND USAGE
KETALAR is a general anesthetic indicated: (1)
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:
--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 KETALAR 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), 500 mg/10 mL (50 mg/mL), and 500
mg/5 mL (100 mg/mL) multiple-
dose vials (3). (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 KETALAR adm