国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
Ketamine Hydrochloride (UNII: O18YUO0I83) (Ketamine - UNII:690G0D6V8H)
Sagent Pharmaceuticals
INTRAVENOUS
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)] . 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
How Supplied Ketamine Hydrochloride Injection, USP is a clear, colorless to very slight yellow color solution supplied as the hydrochloride salt in concentrations equivalent to ketamine base, as follows: Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.
Abbreviated New Drug Application
KETAMINE HYDROCHLORIDE- KETAMINE HYDROCHLORIDE INJECTION, SOLUTION SAGENT PHARMACEUTICALS ---------- 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) 06/2022 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: -- -- 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: 200 mg per 20 mL (10 mg per mL), 500 mg per 10 mL (50 mg per mL), and 500 mg per 5 mL (100 mg per 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 Hemodynamic Instability: Monitor vital signs and cardiac function during ketamine hydrochloride injection administration. (5.1) Emergence Reactions: Postoperative confusional states may occur during the recovery period. Reduce by minimi 完全なドキュメントを読む