KETAMINE HYDROCHLORIDE injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

KETAMINE HYDROCHLORIDE

Composition:

KETAMINE 100 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. 8.1 Pregnancy 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

Product summary:

How Supplied Ketamine Hydrochloride Injection, USP is a clear colorless solution supplied as the hydrochloride in concentrations equivalent to ketamine base. Storage and Handling Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

KETAMINE HYDROCHLORIDE- KETAMINE HYDROCHLORIDE INJECTION, SOLUTION,
CONCENTRATE
GENERAL INJECTABLES & VACCINES, 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
RX ONLY
CIII
RECENT MAJOR CHANGES
Warnings and Precautions, Drug Induced Liver Injury (5.6)
8/2020
INDICATIONS AND USAGE
Ketamine Hydrochloride Injection is a general anesthetic indicated:
(2)
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) (3)
--Intramuscular Route: Initially, 6.5 to 13 mg/kg. (2.2) (3)
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: 500 mg/10 mL (50 mg/mL) and 500 mg/5 mL (100 mg/mL)
multiple-dose vials. (3) (4)
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)