hemabate
Pharmaranks rates Hemabate 3.2/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Hemabate (Carboprost Tromethamine) is a prostaglandin analog used to treat Incomplete Abortion, Cystitis, Fetal Death, Postpartum Hemorrhage.
Carboprost Tromethamine · by Pfizer
Available as a generic: Carboprost Tromethamine
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
- Strength
- Carboprost Tromethamine EQ 0.25MG BASE/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- incomplete abortion, cystitis, fetal death
- Manufacturer
- Pfizer
- FDA application
- NDA017989
- FDA boxed warning
- Yes — see the boxed warning
What is Hemabate?
From the FDA label: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 in HEMABATE. 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 slightly off-white crystalline powder. It generally melts between 95° and 105° C, depending on the rate of heating. Carboprost tromethamine dissolves readily in water at room temperature at a concentration greater than 75 mg/mL. HEMABATE Sterile Solution contains carboprost tromethamine equivalent to 250 mcg/mL of carboprost, and also contains tromethamine 83 mcg, sodium chloride 9 mg, and benzyl alcohol 9.45 mg added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile. Chemical Structure
How to use
1. Abortion and Indications 1–4 An initial dose of 1 mL of HEMABATE 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 HEMABATE Sterile Solution (1 mL of HEMABATE) 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 of HEMABATE should not exceed 2 milligrams (8 doses). Parenteral drug…
Side effects
The adverse effects of HEMABATE 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 HEMABATE. 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 HEMABATE 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 Weakness Hiccough Diaphoresis Dysmenorrhea-like…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Sterile Solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. HEMABATE should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.
Warnings
Important safety information
Sterile Solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. HEMABATE should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities. HEMABATE does not appear to directly affect the fetoplacental unit. Therefore, the possibility does exist that the previable fetus aborted by HEMABATE could exhibit transient life signs. HEMABATE is not indicated if the fetus in utero has reached the stage of viability. HEMABATE 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 HEMABATE is teratogenic, any pregnancy termination with HEMABATE 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 Hemabate
1. Hypersensitivity (including anaphylaxis and angioedema) to HEMABATE Sterile Solution [ see ADVERSE REACTIONS, Post-marketing Experience ] 2. Acute pelvic inflammatory disease 3. Patients with active cardiac, pulmonary, renal or hepatic disease
Interactions
HEMABATE may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended.
Drug class
How this class works, per Latanoprost - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Hemabate ranks — best-rated prostaglandin analog for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Hemabate treat?
- Hemabate (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 Hemabate work?
- Hemabate 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 Hemabate rated?
- pharmaranks gives Hemabate a composite score of 3.2 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 Hemabate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Hemabate. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Hemabate?
- Hemabate is marketed by Pfizer. You can see Pfizer's full profile, rating, and other products on pharmaranks.
- Is Hemabate a brand-name or generic drug?
- Hemabate is a brand-name product with the active ingredient Carboprost Tromethamine. Lower-cost generic equivalents containing Carboprost Tromethamine are available — ask your pharmacist.
- Is Hemabate available over the counter?
- No. Hemabate 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 Hemabate come in?
- Hemabate is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Hemabate?
- Hemabate is classified as prostaglandin analog, per the FDA's Established Pharmacologic Class.
- Is Hemabate FDA-registered?
- Hemabate is on record with the U.S. FDA under application number NDA017989. You can verify this on its official FDA label.
- Has Hemabate been recalled by the FDA?
- Hemabate 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 Hemabate safe?
- There's no single safe-or-not verdict. pharmaranks gives Hemabate a recall-safety score of 64/100, 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 Hemabate?
- Hemabate's side effects are taken directly from its FDA label. From the label: The adverse effects of HEMABATE 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,… 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.
Reviews
No reviews yet. Be the first to write one.
People also viewed
cervidil
Dinoprostone
durysta
Bimatoprost
latisse
Bimatoprost
carboprost tromethamine
Carboprost Tromethamine
lumigan
Bimatoprost
tafluprost
Tafluprost
Compare Hemabate head-to-head
More prostaglandin analog drugs
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
hemabate
64/100