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
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 below:
||Pyrexia induced by HEMABATE
|1. Time of onset: Typically, on third postabortional
day (38° C or higher).
||Within 1 to 16 hours after the first injection.
Duration: Untreated pyrexia and infection
continue and may give rise to other pelvic
||Temperatures revert to pretreatment levels
after discontinuation of therapy without any
Retention: Products of conception are
often retained in the cervical os or uterine
||Temperature elevation occurs whether or
not tissue is retained.
Histology: Endometrium is infiltrated with
lymphocytes and some areas are necrotic
||Although the endometrial stroma may be
edematous and vascular, it is not inflamed.
The uterus : Often remains boggy and soft
with tenderness over the fundus, and pain
on moving the cervix on bimanual
||Uterine involution normal and uterus is not
|6. Discharge: Often associated with foulsmelling
lochia and leukorrhea.
Cervical culture: The culture of pathological organisms from the cervix or uterine cavity
after abortion alone does not warrant the diagnosis of septic abortion in the absence of
clinical evidence of sepsis. Pathogens have been cultured soon after abortion in patients
with no infections. Persistent positive culture with clear clinical signs of infections are
significant in the differential diagnosis.
Blood count: Leukocytosis and differential white cell counts do not distinguish between
endometritis and hyperthermia caused by HEMABATE since total WBC's may increase
during infection and transient leukocytosis may also be drug-induced.
Fluids should be forced in patients with drug-induced fever and no clinical or
bacteriological evidence of intrauterine infection. Any other simple empirical measures
for temperature reduction are unnecessary because all fevers induced by HEMABATE
have been transient or self-limiting.
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
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.
Pregnancy Category C
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.
Safety and effectiveness in pediatric patients have not been established.
1Duff, Sanders, and Gibbs; The course of labor in term patients with chorioamnionitis; Am. J. Obstet. Gynecol.; vol. 14 7, no. 4 , October 15, 1983 pp 391–395.