KETAMINE HYDROCHLORIDE injection

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Medical Purchasing Solutions, LLC

Administreringssätt:

INTRAMUSCULAR

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 wer

Produktsammanfattning:

How Supplied Ketamine Hydrochloride Injection, USP is a clear, colorless to slightly yellowish solution supplied as the hydrochloride salt in concentrations equivalent to ketamine base, as follows: Unit of sale Strength NDC 0143-9508-10 Unit of 10 500 mg in 10 mL multiple- dose vial (50 mg/mL) 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) NDC 0143-9509-10 Unit of 10 500 mg in 5 mL multiple- dose vial (100 mg/mL) 100 mg ketamine base (equivalent to 115.34 mg ketamine hydrochloride) Storage and Handling Ketamine Hydrochloride Injection, USP 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.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

KETAMINE HYDROCHLORIDE- KETAMINE HYDROCHLORIDE INJECTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
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 ( 5.6) 8/2020
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:
-- _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)
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
• 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