carboprost tromethamine
Pharmaranks rates Carboprost Tromethamine 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Carboprost Tromethamine is a prostaglandin analog used to treat Incomplete Abortion, Cystitis, Fetal Death, Postpartum Hemorrhage.
Prostaglandin Analog · by Eugia Pharma
Generic of Hemabate
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Carboprost Tromethamine
- Drug class
- Prostaglandin Analog
- Form
- Injectable, Solution
- Strength
- Carboprost Tromethamine EQ 0.25MG BASE/ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- incomplete abortion, cystitis, fetal death
- Manufacturer
- Eugia Pharma
- FDA application
- ANDA216939
What is Carboprost Tromethamine?
From the FDA label:Carboprost tromethamine injection, USP sterile solution, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient. Four other chemical names are: 1. (15S)-15-methyl prostaglandin F2α tromethamine salt 2. 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl- trans -1-octenyl]-1α-cyclopentyl]- cis - 5 -heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol 3. (15S)-9α,11α,15-trihydroxy-15-methylprosta- cis -5, trans -13-dienoic acid tromethamine salt 4. (15S)-15-methyl PGF2α-THAM The structural formula is represented below: The molecular formula is C 25 H 47 O 8 N. The molecular weight of carboprost tromethamine is 489.64. It is a white to off-white powder. It generally melts between 95° and 105° C, depending on the rate of heating. Carboprost tromethamine, USP dissolves readily in water at room temperature at a concentration greater than 75 mg/mL. Each mL of carboprost tromethamine injection, USP sterile solution contains carboprost tromethamine, USP equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, and 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile.…
How to use
Carboprost Tromethamine is sold in more than one form (Injectable and Solution), and each is dosed differently. The instructions below come from the FDA label for application ANDA216939 — follow the label that came with the product you were actually prescribed.
1. Abortion and Indications 1 to 4 An initial dose of 1 mL of carboprost tromethamine injection sterile solution (containing the equivalent of 250 micrograms of carboprost) is to be administered deep in the muscle with a tuberculin syringe. Subsequent doses of 250 micrograms should be administered at 1½ to 3½ hour intervals depending on uterine response. An optional test dose of 100 micrograms (0.4 mL) may be administered initially. The dose may be increased to 500 micrograms (2 mL) if uterine contractility is judged to be inadequate after several doses of 250 micrograms (1 mL). The total dose administered of carboprost tromethamine should not exceed 12 milligrams and continuous administration of the drug for more than two days is not recommended. 2. For Refractory Postpartum Uterine Bleeding An initial dose of 250 micrograms of carboprost tromethamine injection sterile solution (1 mL of carboprost tromethamine injection) is to be given deep, intramuscularly. 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 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 physicians as dictated by the course of clinical events. The total dose…
Side effects
The adverse effects of carboprost tromethamine sterile solution are generally transient and reversible when therapy ends. The most frequent adverse reactions observed are related to its contractile effect on smooth muscle. In patients studied, approximately two-thirds experienced vomiting and diarrhea, approximately one-third had nausea, one-eighth had a temperature increase greater than 2° F, and one-fourteenth 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 use should be considered an integral part of the management of patients undergoing abortion with carboprost tromethamine. Of those patients experiencing a temperature elevation, approximately one-sixteenth had a clinical diagnosis of endometritis. The remaining temperature elevations returned to normal within several hours after the last injection. Adverse effects observed during the use of carboprost tromethamine for abortion and for hemorrhage, not all of which are clearly drug related, in decreasing order of frequency include: Vomiting Nervousness Diarrhea Nosebleed Nausea Sleep disorders Flushing or hot flashes Dyspnea Chills or shivering Tightness in chest Coughing Wheezing Headaches Posterior cervical perforation Endometritis…
Warnings
Important safety information
Carboprost tromethamine injection sterile solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Carboprost tromethamine should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities. Carboprost tromethamine does not appear to directly affect the fetoplacental unit. Therefore, the possibility does exist that the previable fetus aborted by carboprost tromethamine could exhibit transient life signs. Carboprost tromethamine is not indicated if the fetus in utero has reached the stage of viability. 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 carboprost tromethamine is teratogenic, any pregnancy termination with 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.
Who should not take Carboprost Tromethamine
1. Hypersensitivity (including anaphylaxis and angioedema) to carboprost tromethamine sterile solution [see ADVERSE REACTIONS, Post-marketing Experience ] 2. Acute pelvic inflammatory disease 3. Patients with active cardiac, pulmonary, renal or hepatic disease
Drug class
How this class works, per Latanoprost - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Carboprost Tromethamine ranks — best-rated prostaglandin analog for:
Dosage forms
Injectable and Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- What does Carboprost Tromethamine treat?
- Carboprost Tromethamine (Carboprost Tromethamine) may be used to treat incomplete abortion, cystitis, fetal death, postpartum hemorrhage, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Carboprost Tromethamine work?
- Carboprost Tromethamine is a prostaglandin analog. Prostaglandin analogs (used as eye drops for glaucoma) activate FP receptors that relax the eye's drainage tissues, helping fluid flow out more easily. This lowers the pressure inside the eye and protects the optic nerve.
- How is Carboprost Tromethamine rated?
- pharmaranks gives Carboprost Tromethamine a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Carboprost Tromethamine?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Carboprost Tromethamine. To pay less, Carboprost Tromethamine is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Carboprost Tromethamine?
- Carboprost Tromethamine is marketed by Eugia Pharma. You can see Eugia Pharma's full profile, rating, and other products on pharmaranks.
- Is Carboprost Tromethamine a brand-name or generic drug?
- Carboprost Tromethamine is a generic medication; its active ingredient is Carboprost Tromethamine. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Carboprost Tromethamine available over the counter?
- No. Carboprost Tromethamine is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Carboprost Tromethamine come in?
- Carboprost Tromethamine is currently marketed as injectable and solution, per the FDA's National Drug Code Directory.
- What class of drug is Carboprost Tromethamine?
- Carboprost Tromethamine is classified as prostaglandin analog, per the FDA's Established Pharmacologic Class.
- Is Carboprost Tromethamine FDA-registered?
- Carboprost Tromethamine is on record with the U.S. FDA under application number ANDA216939. You can verify this on its official FDA label.
- Has Carboprost Tromethamine been recalled by the FDA?
- Carboprost Tromethamine has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Carboprost Tromethamine safe?
- There's no single safe-or-not verdict. pharmaranks gives Carboprost Tromethamine a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Carboprost Tromethamine?
- Carboprost Tromethamine's side effects are taken directly from its FDA label. From the label: The adverse effects of carboprost tromethamine sterile solution are generally transient and reversible when therapy ends. The most frequent adverse reactions observed are related to its contractile effect on smooth muscle. In patients studied,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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carboprost tromethamine
70/100