EVAPROST Carboprost Trometamol 250mcg / mL Solution for IM Injection 1mL 1's
RXDRUG-DR-XY43304-1
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of oxytocin IV, manipulative techniques eg, uterine massage and, unless contraindicated IM ergot preparations.
Dosage/Direction for Use
Refractory Postpartum Uterine Bleeding: Initial Dose: 250 mcg given in deep IM. In clinical trials, it was found that the majority of successful cases (73%) responded to single injections. In some selected cases, however, multiple dosing at intervals of 15-90 min was carried out with successful outcome. The need for additional injections and the interval at which these should be given, can be determined only by the attending physicians as dictated by the course of clinical events. The total dose of Evaprost should not exceed 2 mg (8 doses).
Contraindications
Hypersensitivity to carboprost or any of the components of Evaprost. Acute pelvic inflammatory disease; patients with active cardiac, pulmonary, renal or hepatic disease.
Warnings
Evaprost injection eg, other potent oxytocic agents should be used only with strict adherence to recommended dosage. It should be used by medically-trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.
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.
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
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.
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
Use in Pregnancy: Teratogenic Effects: Category C.
Adverse Reactions
The adverse effects of Evaprost are generally dose-related, transient and reversible when therapy ends. The most frequent adverse reactions observed are related to its contractile effects on smooth muscle ie, vomiting, diarrhea, hyperpyrexia and flushing.
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.
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
Evaprost may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended.
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.
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
Store between 2-8°C (in a refrigerator). Do not freeze.
Shelf-Life: 24 months.
Shelf-Life: 24 months.
Action
Pharmacology: Carboprost trometamol administered IM stimulates the graviduterus myometrial contractions similar to labor contractions at the end of a full term pregnancy. Whether or not these contractions result from a direct effect of carboprost on the myometrium has not been determined. Nonetheless, they evacuate the products of conception from the uterus in most cases. Postpartum, the resultant myometrial contractions provides hemostasis at the site of placentation.
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.
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
Drugs Acting on the Uterus
Features
Brand
Evaprost
Full Details
Dosage Strength
125 mcg / 0.5 ml and 250 mcg / 1
Drug Ingredients
- Carboprost
Drug Packaging
Solution for Injection (I.M.) 1ml x 1's
Generic Name
Carboprost Trometamol
Dosage Form
Solution for Injection (I.M.)
Registration Number
DR-XY43304
Drug Classification
Prescription Drug (RX)
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