CAS RN: 71195-58-9

Toxicity Summary

IDENTIFICATION AND USE: Alfentanil is a Schedule II Controlled Substance. An opioid analgesic, alfentanil may be useful for anesthesia, analgesia, or sedation similar to fentanyl. HUMAN STUDIES: Alfentanil injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Acute overdose with Alfentanil injection can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations. Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. When alfentanil was given in high doses for anesthesia induction, chest wall rigidity occurred frequently. Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of Alfentanil injection with serotonergic drugs. ANIMAL STUDIES: Alfentanil is a potent and short-acting mu opioid agonist that produces both antinociceptive effects and muscle rigidity. Male and female Beagle dogs were administered 0, 0.08, 0.31 or 1.25 mg/kg IV alfentanil daily for 4 weeks. There was a dose-related incidence of ataxia, catatonia, and apnea during the first few days. Dogs in the high-dose group experienced sporadic apnea, convulsions and dyskinesia. Alfentanil was administered daily to male and female rats in doses of 0, 0.08, 0.31 and 1.25 mg/kg IV for 4 weeks. Death occurred within 2 hours of alfentanil administration and were attributed to suffocation. Transient muscle rigidity, exophthalmos and loss of righting reflex were observed in all groups. Female rats were administered IV alfentanil 0, 0.08, 0.31 or 1.25 mg/kg from day 16 of pregnancy through a 3-week lactation period. Cannibalism occurred in 2 of 19 high-dose litters. Birth weight was lower in the 0.31 mg/kg group. Survival rates were lower in the offspring of the 0.31 and 1.25 mg/kg groups, but no teratogenic effects were observed. The mutagenicity potential of alfentanil was assessed in the Ames test, micronucleus test and the mouse dominant lethal test. There was no evidence of mutagenicity in any test.
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