LD₅₀: 18.7 mg/kg (IV in mice) MSDS

A Note on Respiratory Depression

Major, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even in cases where it is used as recommended. Respiratory depression may lead to respiratory arrest and death if not diagnosed and treated appropriately. This drug should be administered only by persons specifically trained in the use of anesthetic drugs and the management of the respiratory effects of potent opioids, including respiration and cardiac resuscitation of patients in the age group being treated. This training must include the establishment and maintenance of a patent airway and assisted ventilation ^{FDA label}.

Carcinogenesis
Long-term studies in animals to evaluate the carcinogenic potential of sufentanil have not been conducted ^{FDA label}.

Mutagenesis
Sufentanil was not found to be genotoxic in the in vitro bacterial reverse mutation assay (Ames assay) or in the in vivo rat bone marrow micronucleous assay ^{FDA label}.

Reproductive Toxicity

Sufentanil caused embryolethality in rats and rabbits treated for 10-30 days during pregnancy with 2.5 times the maximum human dose by intravenous administration. The embryolethal effect was thought to be secondary to the toxicity for the mother animal model. No negative effects were noted in another study in rats that were treated with 20 times the maximum human dose in the period of organogenesis. The preclinical effects were only seen following administrations of levels significantly above the maximum human dose, which is therefore of minimal relevance for clinical use ^F2009.

Pregnancy

May cause fetal harm ^{FDA label}

The Use in Lactation

Infants exposed to this drug through breast milk should be monitored for excess sedation and respiratory depression ^{FDA label}.