Evaprost Special Precautions

General Precautions: Animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce bone proliferation. These effects have also been noted in newborn infants who have received prostaglandin E1 during prolonged treatment. There is no evidence that short-term administration of Evaprost can cause similar bone effects.
In patients with a history of asthma, hypo- or hypertension, cardiovascular, renal or hepatic disease, anemia, jaundice, diabetes or epilepsy Evaprost should be used with caution. As with oxytocic agents, Evaprost should also be used with caution in patients with compromised (scarred) uteri.
Abortion: As with spontaneous abortion, a process which is sometimes incomplete abortion induced by Evaprost may be expected to be incomplete in about 20% of cases. Although the incidence of cervical trauma is extremely small, the cervix should always be carefully examined immediately post-abortion.
The use of Evaprost is associated with transient pyrexia that may be due to its effect on hypothalamic thermoregulation.
Postpartum Hemorrhage: Increased Blood Pressure: In the postpartum hemorrhage, series 5/155 (4%) of patients had an increase of blood pressure reported (see Adverse Reactions). The degree of hypertension was moderate and it is not certain as to whether this was in fact due to direct effect of Evaprost or a return to a status of pregnancy-associated hypertension manifested by the correction of hypovolemic shock. In any event, the cases reported did not require specific therapy for the elevated blood pressure.
Chorioamnionitis: During the clinical trials with Evaprost, chorioamnionitis was identified as a complication contributing to postpartum uterine atony and hemorrhage in 8/115 (7%) cases, 3 of which failed to respond to Evaprost. This complication during labor may have an inhibitory effect on the uterine response to carprost trometamol similar to what has been reported for other oxytocic agents.
Carcinogenicity, Mutagenecity, Teratogenicity & Impairment of Fertility: Carcinogenic bioassay studies with Evaprost have not been conducted in animals due to limited indications for use and short duration of administration. No evidence of mutagenicity was observed in the micronucleus test or Ames assay.
Animal studies do not indicate that Evaprost is teratogenic; however, it has been shown to be embryotoxic in rats and rabbits, and any dose which produces increased uterine tone could put the embryo or fetus at risk.
Use in Pregnancy: Teratogenic Effects: Category C.
Use in Children: Safety and effectiveness in pediatric patients have not been established.