País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
KETAMINE HYDROCHLORIDE (UNII: O18YUO0I83) (KETAMINE - UNII:690G0D6V8H)
General Injectables & Vaccines, Inc
KETAMINE HYDROCHLORIDE
KETAMINE 100 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
KETAMINE HYDROCHLORIDE- KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE GENERAL INJECTABLES & VACCINES, INC ---------- 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) Llegiu el document complet