Zinol Use In Pregnancy & Lactation

Pregnancy: Reproduction studies in mice, rats, and rabbits during organogenesis did not reveal any teratogenic potential to butorphanol. However. pregnant rats treated subcutaneously with butorphanol at 1 mg/kg (5.9 mg/m²) had a higher frequency of stillbirths than controls.
Butorphanol at 30 mg/kg/oral (5.1 mg/m²) and 60 mg/kg/oral (10.2 mg/m²) also showed higher incidences of post-implantation loss in rabbits. There are no adequate and well-controlled studies of Butorphanol Tartrate Injection in pregnant women before 37 weeks of gestation. Butorphanol Tartrate Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the infant.
There have been rare reports of infant respiratory distress/apnea following the administration of Butorphanol Tartrate Injection during labor. The reports of respiratory distress/apnea have been associated with administration of a dose within 2 hours of delivery, use of multiple doses, use with additional analgesic or sedative drugs, or use in preterm pregnancies.
In a study of 119 patients, the administration of 1 mg of IV Butorphanol Tartrate Injection during labor was associated with transient sinusoidal fetal heart rate patterns, but it was not associated with adverse neonatal outcomes. In the presence of an abnormal fetal heart rate pattern, Butorphanol Tartrate Injection should be used with caution.
Nursing Mothers: Butorphanol has been detected in milk following administration of Butorphanol Tartrate Injection to nursing mothers. The amount an infant would receive is probably clinically insignificant (estimated 4 mcg/L of milk in a mother receiving 2 mg IM four times a day).