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HEMABATE is a brand name for Carboprost, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations HEMABATE STERILE SOLUTION must not be given intravenously. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Recommended Dose and Dosage Adjustment HEMABATE STERILE SOLUTION (carboprost tromethamine) is administered by deep intramuscular injection. Initially a 250 μg (1 mL, the entire contents of the ampoule) dose of HEMABATE STERILE SOLUTION is given.
In clinical trials, 80% of successful cases responded to < 250 μg and 95% of successful cases responded to < 500 μg. In some cases, multiple dosing of 250 μg at intervals of 15 to 90 minutes 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 physician as dictated by the course of clinical events.
The total dose of HEMABATE STERILE SOLUTION should not exceed 2 mg (8 doses). OVERDOSAGE Overdosage with HEMABATE STERILE SOLUTION (carboprost tromethamine) should result in the accentuation of expected side effects such as nausea, vomiting and diarrhea.
Elevated blood pressure and body temperature may occur. Supportive therapy, particularly fluid replacement, should be given if serious vomiting and diarrhea occur. Although prostaglandin antagonists are known to exist, no experience has been obtained at the present time with their usage in overdosage.
Therefore, no specific therapy for overdosage is available. For management of a suspected drug overdose, contact your regional Poison Control Centre. HEMABATE (carboprost tromethamine) Product Monograph Page 12 of 23 ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action HEMABATE STERILE SOLUTION (carboprost tromethamine) given intramuscularly during the immediate postpartum period stimulates myometrial contractions.
The result of postpartum contractions provides effective hemostasis at the site of placentation. The mechanism of action of these contractions has not been determined. Pharmacodynamics Uterine atony is the leading cause of postpartum hemorrhage.
Extensive clinical experience with prostaglandins in term labour induction trials and pregnancy termination has established them as effective uterotonic agents. Prostaglandins appear to be involved in postpartum hemostatic mechanisms by virtue of their pharmacodynamic properties relative to myometrial stimulation, vasoactive effects and platelet function.
1. Hypersensitivity to any of the components of the preparation (carboprost, tromethamine, sodium chloride, benzyl alcohol). 2. Patients with known active cardiac, pulmonary, renal, or hepatic disease. 3. Acute pelvic inflammatory disease.
WARNINGS AND PRECAUTIONS General HEMABATE STERILE SOLUTION (carboprost tromethamine), like other potent oxytocic agents, should be used with strict adherence to recommended dosages, by medically trained personnel in hospital surroundings with appropriate intensive care and acute surgical facilities.
HEMABATE STERILE SOLUTION should not be used for induction of labour. HEMABATE STERILE SOLUTION must not be given intravenously. HEMABATE STERILE SOLUTION should not be used during pregnancy (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women).
HEMABATE STERILE SOLUTION is not indicated in pediatric patients. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants (see WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics).
Cardiovascular HEMABATE STERILE SOLUTION should be used cautiously in patients with a history of hypo- or hypertension, or cardiovascular disease. On rare occasions, cardiovascular collapse has been reported with some of the prostaglandins, so this should always be considered when using HEMABATE STERILE SOLUTION.
Nine of 248 patients (4%) treated for postpartum hemorrhage 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 STERILE SOLUTION 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. HEMABATE (carboprost tromethamine) Product Monograph Page 5 of 23 In a post-marketing trial of 333 cases of postpartum hemorrhage, investigator's considered 17 cases (5%) of increased blood pressure to be drug related.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Carboprost tromethamine, a methylated analogue of PGF2 , has been shown to be a more potent uterotonic agent with longer duration of action than the parent compound. Carboprost tromethamine also stimulates the smooth muscle of the human gastrointestinal tract.
This activity may produce the vomiting and/or diarrhea that is common when carboprost tromethamine is used. In laboratory animals and humans, carboprost tromethamine can elevate body temperature. With the clinical doses of carboprost tromethamine, some patients do experience transient temperature increases.
In laboratory animals, and in humans, large doses of carboprost tromethamine can raise blood pressure, probably by contracting the vascular smooth muscle. With the doses of carboprost tromethamine used for terminating pregnancy, this effect has not been clinically significant.
In some patients, carboprost tromethamine may cause transient bronchoconstriction. Pharmacokinetics Five women who had spontaneous vaginal deliveries (at term) were treated immediately postpartum with a single intramuscular injection of 250 μg carboprost tromethamine.
Peripheral blood samples were collected at several times during the four hours following treatment and carboprost tromethamine plasma levels were determined by radioimmunoassay. The highest plasma concentration of carboprost tromethamine was observed at 15 minutes in two patients (3009 and 2916 picograms/mL); at 30 minutes in two patients (3097 and 2792 picograms/mL); and at 60 minutes in one patient (2718 picograms/mL).
STORAGE AND STABILITY HEMABATE STERILE SOLUTION (carboprost tromethamine) must be refrigerated at 2° to 8°C. HEMABATE (carboprost tromethamine) Product Monograph Page 13 of
Endocrine and Metabolism HEMABATE STERILE SOLUTION should be used cautiously in patients with a history of diabetes. Hematologic Prostaglandins in general affect platelet aggregation by inhibiting it. Clinical experience on the effect of HEMABATE STERILE SOLUTION on human coagulation factors is limited.
Due to this lack of information, it is advised that coagulation parameters be measured. HEMABATE STERILE SOLUTION should be used cautiously in patients with a history of anemia. Hepatic/Biliary/Pancreatic HEMABATE STERILE SOLUTION should be used cautiously in patients with a history of hepatic disease or jaundice.
Immune Chorioamnionitis was identified as a complication contributing to postpartum uterine atony and hemorrhage in eight of 115 patients, 3 of which failed to respond to HEMABATE STERILE SOLUTION. This complication during labour may have an inhibitory effect on the uterine response to HEMABATE STERILE SOLUTION similar to what has been reported for other oxytocic agents.
Musculoskeletal 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 (carboprost tromethamine) can cause similar bone effects. Neurologic HEMABATE STERILE SOLUTION should be used cautiously in patients with a history of epilepsy.
Ophthalmologic HEMABATE STERILE SOLUTION should be used with caution in patients with a history of glaucoma or raised intra-ocular pressure. HEMABATE (carboprost tromethamine) Product Monograph Page 6 of 23 Renal HEMABATE STERILE SOLUTION should be used cautiously in patients with a history of renal disease.
Respiratory HEMABATE STERILE SOLUTION should be used cautiously in patients with a history of asthma. Bronchoconstriction has been reported after exposure to HEMABATE STERILE SOLUTION, but it is rarely clinically important except in asthmatic patients.
Sensitivity/Resistance Cases of hypersensitivity reactions including anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, and angioedema have been reported in patients treated with HEMABATE STERILE SOLUTION in the post-marketing experience (see ADVERSE REACTIONS – Post-Market Adverse Drug Reactions).
Sexual Function/Reproduction HEMABATE STERILE SOLUTION should be used cautiously in patients with previously compromised (scarred) uteri. Other Use of HEMABATE STERILE SOLUTION is associated with transient pyrexia that may be due to hypothalamic thermoregulation.
Fever was reported by 8 of 115 (7%) patients treated in an open-label clinical trial of patients with postpartum hemorrhage due to uterine atony who had not responded to conventional non-surgical treatment of fundal massage, intravenous oxytocin and/or intramuscular methylergonovine.
Special Populations Pregnant Women:
Animal studies have shown reproductive toxicity and any dose of carboprost that produces increased uterine tone could put the embryo or fetus at risk. HEMABATE STERILE SOLUTION is indicated in the postpartum period. It is not indicated for use during pregnancy.
HEMABATE STERILE SOLUTION contains benzyl alcohol which can cross the placenta.
Nursing Women:
Human pharmacokinetics studies were not conducted on the excretion of HEMABATE STERILE SOLUTION in breast milk. However based on plasma clearance rates it is recommended that breast feeding not occur for at least 6 hours after administration.
Pediatrics:
The safety and efficacy of HEMABATE STERILE SOLUTION in the pediatric population have not been established. HEMABATE STERILE SOLUTION is not indicated in pediatric patients. HEMABATE (carboprost tromethamine) Product Monograph Page 7 of 23 HEMABATE STERILE SOLUTION contains benzyl alcohol.
Benzyl alcohol has been associated with […]