국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
REMIFENTANIL HYDROCHLORIDE (UNII: 5V444H5WIC) (REMIFENTANIL - UNII:P10582JYYK)
Fresenius Kabi USA, LLC
REMIFENTANIL HYDROCHLORIDE
REMIFENTANIL 1 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Remifentanil hydrochloride (HCl) for injection is indicated for intravenous (IV) administration: - As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. - For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. - As an analgesic component of monitored anesthesia care in adult patients. Remifentanil HCl is contraindicated: - For epidural or intrathecal administration due to the presence of glycine in the formulation [see Nonclinical Toxicology (13)] . - In patients with hypersensitivity to remifentanil (e.g., anaphylaxis) [see Adverse Reactions (6.2)] . Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with remifentanil hydrochloride in pregnant women are insufficient to
Remifentanil HCl for injection should be stored at 2° to 25°C (36° to 77°F). Remifentanil HCl for IV use is supplied as follows: Strength Discard unused portion. The container closure is not made with natural rubber latex. The brand names mentioned in this document are the trademarks of their respective owners.
Abbreviated New Drug Application
REMIFENTANIL HYDROCHLORIDE- REMIFENTANIL HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION REMIFENTANIL HYDROCHLORIDE - REMIFENTANIL HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION FRESENIUS KABI USA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE REMIFENTANIL HYDROCHLORIDE FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR REMIFENTANIL HYDROCHLORIDE FOR INJECTION. REMIFENTANIL HYDROCHLORIDE FOR INJECTION, FOR INTRAVENOUS USE, CII INITIAL U.S. APPROVAL: 1996 WARNING: ADDICTION, ABUSE, AND MISUSE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_. REMIFENTANIL HYDROCHLORIDE FOR INJECTION EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. (5.1) RECENT MAJOR CHANGES Warnings and Precautions (5.4) 6/2020 INDICATIONS AND USAGE Remifentanil hydrochloride for injection is an opioid agonist indicated for intravenous administration: As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. (1) For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. (1) As an analgesic component of monitored anesthesia care in adult patients. (1) DOSAGE AND ADMINISTRATION Monitor patients closely for respiratory depression when initiating therapy and following dosage increases and adjust the dosage accordingly. (2.1) Initial Dosage in Adults: See full prescribing information for recommended doses in adult patients. (2.2, 2.3) Initial Dosage in Pediatric Patients: See full prescribing information for recommended doses in pediatric patients. (2.2) Geriatric Patients: The starting doses should be decreased by 50% in elderly patients (> 65 years). (2.6) DOSAGE FORMS AND STRENGTHS For injection: 1 mg, 2 mg, and 5 mg for intravenous administration af 전체 문서 읽기