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alfentanil injection, USP Highlights

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/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). (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 administered with CNS depressants. (2.6)

DOSAGE FORMS AND STRENGTHS

Solution for injection (sterile): eq. to 500 mcg/mL alfentanil base; 2 mL and 5 mL ampules. (3)

CONTRAINDICATIONS

Hypersensitivity to alfentanil. (4)

WARNINGS AND PRECAUTIONS

  • Risks of Muscle Rigidity and Skeletal Muscle Movement: Manage with neuromuscular blocking agent. See full prescribing information for more detail on managing these risks. (5.4)
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, and Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.2)
  • Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue alfentanil injection if serotonin syndrome is suspected. (5.6)
  • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, and Head Injury: Monitor for sedation and respiratory depression. (5.9)

ADVERSE REACTIONS

Most common adverse reactions were apnea, rigidity, and bradycardia. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Concomitant Use of CNS Depressants: May decrease pulmonary arterial pressure and may cause hypotension. See FPI for management instructions. For post-operative pain, start with the lowest effective dosage and monitor for potentiation of CNS depressant effects. (5.5, 7)
  • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with alfentanil injection because they may reduce analgesic effect of alfentanil injection or precipitate withdrawal symptoms. (7)

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm. (8.1)
  • Lactation: Infants exposed to alfentanil injection through breast milk should be monitored for excess sedation and respiratory depression. (8.2)

Revised: 10/2020

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