Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
ALFENTANIL HYDROCHLORIDE (UNII: 11S92G0TIW) (ALFENTANIL - UNII:1N74HM2BS7)
Hospira, Inc.
ALFENTANIL HYDROCHLORIDE
ALFENTANIL 500 ug in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Alfentanil injection is indicated: - as an analgesic adjunct given in incremental doses in the maintenance of anesthesia with barbiturate/nitrous oxide/oxygen. - as an analgesic administered by continuous infusion with nitrous oxide/oxygen in the maintenance of general anesthesia. - as a primary anesthetic agent for the induction of anesthesia in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required. - as the analgesic component for monitored anesthesia care (MAC). Alfentanil injection is contraindicated in patients with: - Hypersensitivity to alfentanil (e.g., anaphylaxis) [see Adverse Reactions (6)] Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with alfentanil injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, alfentanil reduced pup birth weights and increased pup mortality w
Alfentanil Injection, USP for intravenous use contains alfentanil hydrochloride equivalent to 500 mcg/mL of alfentanil base and is available as: Alfentanil Injection, USP is supplied in individually sealed dosage forms which pose no known risk to health care providers having incidental contact. Accidental dermal exposure to alfentanil should be treated by rinsing the affected area with water. Storage: Protect from light. Retain in carton until time of use. Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature].
Abbreviated New Drug Application
ALFENTANIL HYDROCHLORIDE- ALFENTANIL HYDROCHLORIDE INJECTION, SOLUTION HOSPIRA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALFENTANIL INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALFENTANIL INJECTION. ALFENTANIL INJECTION, USP (ALFENTANIL HYDROCHLORIDE) FOR INTRAVENOUS USE, CII INITIAL U.S. APPROVAL: 1986 WARNING: ADDICTION, ABUSE, AND MISUSE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ ALFENTANIL INJECTION EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT'S RISK BEFORE PRESCRIBING AND MONITOR CLOSELY FOR THESE BEHAVIORS AND CONDITIONS. (5.1) INDICATIONS AND USAGE Alfentanil injection is an opioid indicated: as an analgesic adjunct given in incremental doses in the maintenance of anesthesia with barbiturate/nitrous oxide /oxyge n. as an analgesic administered by continuous infusion with nitrous oxide/oxygen in the maintenance of general ane sthe sia. as a primary anesthetic agent for the induction of anesthesia in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required. as the analgesic component for monitored anesthesia care (MAC). (1) DOSAGE AND ADMINISTRATION Alfentanil injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids. Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available. (2.1). Individualize dosing based on factors such as age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved. (2.1) Doses of alfentanil injection vary depending on circumstances .(see dosing chart 2.2) Reduce the dose of alfentanil injection in elderly, debilitated and obese patients. (2.4, 2.5) Reduce the dose of alfentanil injection when admin Lire le document complet