Animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone. Such 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 HEMABATE Sterile Solution 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, HEMABATE should be used cautiously.
As with any oxytocic agent, HEMABATE should be used with caution in patients with compromised (scarred) uteri.
As with spontaneous abortion, a process which is sometimes incomplete, abortion induced by HEMABATE 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.
Use of HEMABATE is associated with transient pyrexia that may be due to its effect on hypothalamic thermoregulation. Temperature elevations exceeding 2°F (1.1°C) were observed in approximately one-eighth of the patients who received the recommended dosage regimen. In all cases, temperature returned to normal when therapy ended. Differentiation of post-abortion endometritis from drug-induced temperature elevations is difficult, but with increasing clinical experience, the distinctions become more obvious and are summarized as follows: See Table 1.
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Increased blood pressure. In the postpartum hemorrhage series, 5/115 (4%) of patients had an increase of blood pressure reported as a side effect. The degree of hypertension was moderate and it is not certain as to whether this was in fact due to a direct effect of HEMABATE or a return to a status of pregnancy associated hypertension manifest by the correction of hypovolemic shock. In any event the cases reported did not require specific therapy for the elevated blood pressure.
Use in patients with chorioamnionitis. During the clinical trials with HEMABATE, chorioamnionitis was identified as a complication contributing to postpartum uterine atony and hemorrhage in 8/115 (7%) of cases, 3 of which failed to respond to HEMABATE. This complication during labor may have an inhibitory effect on the uterine response to HEMABATE similar to what has been reported for other oxytocic agents.
HEMABATE may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Carcinogenic bioassay studies have not been conducted in animals with HEMABATE due to the limited indications for use and short duration of administration. No evidence of mutagenicity was observed in the Micronucleus Test or Ames Assay.
Use in Pregnancy: Teratogenic Effects:
Animal studies do not indicate that HEMABATE 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 Children:
Safety and effectiveness in pediatric patients have not been established.