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CARBOPROST TROMETHAMINE 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 .................................................................................................. 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General Carboprost Tromethamine Injection, 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.
Carboprost Tromethamine Injection should not be used for induction of labour. Carboprost Tromethamine Injection must not be given intravenously. Carboprost Tromethamine Injection should not be used during pregnancy (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women).
Carboprost Tromethamine Injection 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 Carboprost Tromethamine Injection 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 Carboprost Tromethamine Injection.
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 carboprost tromethamine injection 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. 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.
Endocrine and Metabolism Carboprost Tromethamine Injection 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 carboprost tromethamine injection on human coagulation factors is limited.
Due to this lack of information, it is advised that coagulation parameters be measured. Carboprost Tromethamine Injection should be used cautiously in patients with a history of anemia. Carboprost Tromethamine Injection (carboprost tromethamine) Product Monograph Page 5 of 20 Hepatic/Biliary/Pancreatic Carboprost Tromethamine Injection should be used cautiously in patients with a history of hepatic disease or jaundice.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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 carboprost tromethamine injection. This complication during labour may have an inhibitory effect on the uterine response to Carboprost Tromethamine Injection 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 carboprost tromethamine injection can cause similar bone effects. Neurologic Carboprost Tromethamine Injection should be used cautiously in patients with a history of epilepsy. Ophthalmologic Carboprost Tromethamine Injection should be used with caution in patients with a history of glaucoma or raised intra-ocular pressure.
Renal Carboprost Tromethamine Injection should be used cautiously in patients with a history of renal disease. Respiratory Carboprost Tromethamine Injection should be used cautiously in patients with a history of asthma. Bronchoconstriction has been reported after exposure to carboprost tromethamine injection, 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 carboprost tromethamine injection in the post-marketing experience (see ADVERSE REACTIONS – Post-Market Adverse Drug Reactions).
Sexual Function/Reproduction Carboprost Tromethamine Injection should be used cautiously in patients with previously compromised (scarred) uteri. Carboprost Tromethamine Injection (carboprost tromethamine) Product Monograph Page 6 of 20 Other Use of carboprost tromethamine injection 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. Carboprost Tromethamine Injection is indicated in the postpartum period. It is not indicated for use during pregnancy.
Carboprost Tromethamine Injection contains benzyl alcohol which can cross the placenta.
Nursing Women:
Human pharmacokinetics studies were not conducted on the excretion of carboprost tromethamine 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 carboprost tromethamine injection in the pediatric population have not been established. Carboprost Tromethamine Injection is not indicated in pediatric patients. Carboprost Tromethamine Injection contains benzyl alcohol.
Benzyl alcohol has been associated with serious adverse events, including fatal “gasping syndrome” in pediatric patients. Manifestations of the disease […]