"2>Alcohol and Pregnancy: Why Take the Risk?
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Fetal alcohol spectrum disorders (FASDs) are a group of conditions that can occur in a "...
HEMABATE Sterile Solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. HEMABATE (carboprost tromethamine) should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.
HEMABATE (carboprost tromethamine) does not appear to directly affect the fetoplacental unit. Therefore, the possibility does exist that the previable fetus aborted by HEMABATE (carboprost tromethamine) could exhibit transient life signs. HEMABATE (carboprost tromethamine) is not indicated if the fetus in utero has reached the stage of viability. HEMABATE (carboprost tromethamine) should not be considered a feticidal agent.
Evidence from animal studies has suggested that certain other prostaglandins have some teratogenic potential. Although these studies do not indicate that HEMABATE (carboprost tromethamine) is teratogenic, any pregnancy termination with HEMABATE (carboprost tromethamine) that fails should be completed by some other means.
This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.
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 (carboprost tromethamine) 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 (carboprost tromethamine) should be used cautiously.
As with any oxytocic agent, HEMABATE (carboprost tromethamine) 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 (carboprost tromethamine) may be expected to be incomplete in about 20% of cases.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:
|Endometritis pyrexia||Pyrexia induced by HEMABATE|
|1. Time of onset: Typically, on third post-abortional day (38° C or higher).||Within 1 to 16 hours after the first injection.|
|2. Duration: Untreated pyrexia and infection continue and may give rise to other pelvic infections.||Temperatures revert to pretreatment levels after discontinuation of therapy without any other treatment.|
|3. Retention: Products of conception are often retained in the cervical os or uterine cavity.||Temperature elevation occurs whether or not tissue is retained.|
|4. Histology: Endometrium is infiltrated with lymphocytes and some areas are necrotic and hemorrhagic.||Although the endometrial stroma may be edematous and vascular, it is not inflamed.|
|5. The uterus: Often remains boggy and soft with tenderness over the fundus, and pain on moving the cervix on bimanual examination.||Uterine involution normal and uterus is not tender.|
|Discharge: Often associated with foul-smelling lochia and leukorrhea.||Lochia normal.|
|7. Cervical culture: The culture of pathol ogicalorganisms 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.|
| 8. Blood count: Leukocytosis and differential white
cell counts do not distinguish between endometritis and hyperthermia caused
by HEMABATE (carboprost tromethamine) 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 (carboprost tromethamine) 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 (carboprost tromethamine) 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 (carboprost tromethamine) , 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 (carboprost tromethamine) . This complication during labor may have an inhibitory effect on the uterine response to HEMABATE (carboprost tromethamine) similar to what has been reported for other oxytocic agents.1
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenic bioassay studies have not been conducted in animals with HEMABATE (carboprost tromethamine) 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: Teratogenic Effects: Pregnancy Category C
Animal studies do not indicate that HEMABATE (carboprost tromethamine) 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. 147, no. 4, October 15, 1983 pp 391-395.
Last reviewed on RxList: 5/7/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Hemabate Information
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