EVAPROST Carboprost Trometamol 250mcg / mL Solution for IM Injection 1mL 1's
Indications/Uses
Dosage/Direction for Use
Contraindications
Warnings
Evaprost does not appear to directly affect the fetoplacental unit. Therefore, the possibility does exist that the previable fetus aborted by Evaprost could exhibit transient life signs. Evaprost is not indicated if the fetus in utero has reached the stage of viability. It 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 Evaprost is teratogenic, any pregnancy termination with Evaprost that fails should be completed by some other means.
Evaprost contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal 'Gasping syndrome' in premature infants.
Special Precautions
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.
Use In Pregnancy & Lactation
Adverse Reactions
In patients studied, approximately 2/3 experienced 1/2 vomiting and diarrhea, approximately 1/3 had nausea, 1/8 had a temperature increase >20°F and 1/14 experienced flushing.
The pretreatment or concurrent administration of antiemetic and antidiarrheal drugs decreases considerably the very high incidence of gastrointestinal effects common with all prostaglandins used for abortion. Their uses should be considered an integral part of the management of patients undergoing abortion with Evaprost.
Of those patients experiencing temperature elevations, approximately 1/16 had a clinical diagnosis of endometritis. The remaining temperature elevations returned to normal within several hours after the last injection. The adverse effects observed during the use of Evaprost for abortion and for hemorrhage, not all of which are clearly drug-related, in decreasing order of frequency include: Vomiting, diarrhea, nausea, flushing or hot flashes, chills or shivering, coughing, headaches, endometritis, hiccough, dysmenorrhea-like pain, paresthesia, backache, muscular pain, breast tenderness, eye pain, drowsiness, dystonia, asthma, injection site pain, tinnitus, vertigo, vaso-vagal syndrome, dry mouth, hyperventilation, respiratory distress, hematemesis, taste alterations, urinary tract infection, septic shock, torticollis, lethargy, hypertension, tachycardia, pulmonary edema, endometritis from IUCD, nervousness, nosebleed, sleep disorders, dyspnea, tightness in chest, wheezing, posterior cervical perforation, weakness, diaphoresis, dizziness, blurred vision, epigastric pain, excessive thirst, twitching eyelids, gagging or retching, dry throat, choking sensation, thyroid storm, syncope, palpitations, rash, upper respiratory infection, leg cramps, perforated uterus, anxiety, chest pain, retained placental fragment, shortness of breath, fullness of throat, uterine sacculation, faintness or light-headedness and uterine rupture.
The most common complications when Evaprost was utilized for abortion, requiring additional treatment after discharge from the hospital were endometritis, retained placental fragments, and excessive uterine bleeding, occurring in about 1 in every 50 patients.
Potentially Fatal: Severe cardiovascular system disorders including fatal hypertension, tachypnea, pyrexia and myocardial infarction (in patients with high risk factors) following intra-amniotic or intravaginal administration. Convulsion and electrocardiogram (ECG) changes, amniotic fluid embolism and uterine rupture, fetal distress and rarely fetal death during induction of labor.
Drug Interactions
Action is enhanced by prior injection of hyperosmolar urea.
Potentially Fatal: Enhances action of oxytocin, hence, both drugs should be used sequentially and carefully monitored.
Storage
Shelf-Life: 24 months.
Action
Carboprost trometamol also stimulates the smooth muscle of the human gastrointestinal tract. This activity may produce the vomiting or diarrhea or both that is common when it is used to terminate pregnancy and for use in postpartum. In laboratory animals and also in humans, carboprost trometamol can elevate body temperature. With the clinical doses of Evaprost used for terminating pregnancy and for use postpartum, some patients do experience transient bronchoconstriction. In laboratory animals and humans, large doses of Evaprost can raise blood pressure, probably by containing the vascular smooth muscle. With the doses of Evaprost used for terminating pregnancy, this effect has not been clinically significant.
MedsGo Class
Features
- Carboprost