Prostinfenem (Carboprost Tromethamine)
Prostaglandin analogue for postpartum hemorrhage and pregnancy termination
Quick Facts About Prostinfenem
Key Takeaways About Prostinfenem
- Hospital use only: Prostinfenem must be administered exclusively by healthcare professionals in a clinical or hospital setting with resuscitation equipment available
- Two main indications: Treatment of postpartum hemorrhage unresponsive to conventional therapy, and pregnancy termination (13–20 weeks)
- Intramuscular injection only: Must never be given intravenously – only deep intramuscular injection is permitted
- Caution in asthma patients: Bronchospasm is a known serious adverse effect; Prostinfenem is contraindicated in active pulmonary disease
- Transient side effects: Nausea, vomiting, diarrhea, and fever are very common but usually resolve after treatment is discontinued
What Is Prostinfenem and What Is It Used For?
Prostinfenem is a prescription medication containing carboprost tromethamine, a synthetic prostaglandin F2-alpha analogue. It is used in hospital settings to treat severe postpartum hemorrhage (heavy bleeding after childbirth) and to induce pregnancy termination between 13 and 20 weeks of gestation.
Prostinfenem belongs to a group of medicines known as prostaglandins. Prostaglandins are naturally occurring hormone-like substances in the body that play critical roles in inflammation, blood flow regulation, and smooth muscle contraction. Carboprost tromethamine, the active substance in Prostinfenem, is a synthetic analogue of prostaglandin F2-alpha (specifically 15-methyl PGF2-alpha) that has been modified to have enhanced potency and a longer duration of action compared to the naturally occurring prostaglandin.
The primary mechanism of action involves direct stimulation of the myometrium (uterine muscle), causing strong, sustained contractions similar to those experienced during labor. This uterotonic effect makes Prostinfenem particularly valuable in two clinical scenarios where powerful uterine contractions are therapeutically necessary.
Postpartum Hemorrhage (PPH)
Postpartum hemorrhage remains one of the leading causes of maternal mortality worldwide, accounting for approximately 25% of all maternal deaths according to the World Health Organization (WHO). Prostinfenem is indicated for the treatment of postpartum hemorrhage due to uterine atony (failure of the uterus to contract adequately after delivery) that has not responded to first-line conventional management, including oxytocin infusion and bimanual uterine massage. The American College of Obstetricians and Gynecologists (ACOG) and the International Federation of Gynecology and Obstetrics (FIGO) both recognize carboprost as a second-line uterotonic agent in the management of refractory postpartum hemorrhage.
When the uterus fails to contract sufficiently after delivery of the placenta, the open blood vessels at the placental site continue to bleed. Prostinfenem acts rapidly to cause firm uterine contractions that compress these blood vessels, thereby reducing or stopping the hemorrhage. In most cases of postpartum hemorrhage, a single intramuscular dose of Prostinfenem is sufficient to achieve adequate uterine contractility.
Pregnancy Termination
Prostinfenem is also used for the induction of abortion in pregnancies between 13 and 20 weeks of gestation. The drug stimulates strong uterine contractions that lead to expulsion of the uterine contents. For this indication, repeated doses are administered at intervals of 1.5 to 3 hours, depending on the uterine response. The treating physician carefully monitors the patient throughout the procedure and adjusts the dosing interval and amount based on the strength and frequency of contractions.
Carboprost tromethamine, the active ingredient in Prostinfenem, may also be approved for other medical conditions not described in this information. Always follow the instructions given by your healthcare provider and consult them if you have any additional questions about your treatment.
What Should You Know Before Receiving Prostinfenem?
Prostinfenem is contraindicated in patients with active cardiac, pulmonary, renal, or hepatic disease, serious urinary tract infections, and known hypersensitivity to carboprost. Several medical conditions require special precautions, particularly asthma, as bronchospasm is a known serious adverse effect.
Before Prostinfenem is administered, your healthcare provider will conduct a thorough assessment of your medical history to determine whether this medication is appropriate for you. It is essential that your treating physician has complete information about all your current and past medical conditions, as several conditions either contraindicate the use of Prostinfenem entirely or require heightened vigilance during administration.
Contraindications
You must not receive Prostinfenem if any of the following apply to you:
- Hypersensitivity: Known allergy to carboprost tromethamine or any of the other ingredients in this medicine (listed in the composition section below)
- Serious urinary tract infection: Active, clinically significant pelvic inflammatory disease or severe urinary tract infection
- Active cardiac disease: Significant heart disease, including coronary artery disease, heart failure, or severe valvular disease
- Active pulmonary disease: Severe lung disease, including active asthma that is poorly controlled
- Active renal disease: Significant kidney impairment or active kidney disease
- Active hepatic disease: Significant liver impairment or active liver disease
Inform your healthcare provider immediately if any of the above conditions apply to you, as Prostinfenem must not be used in these circumstances.
Warnings and Precautions
Tell your healthcare provider if any of the following apply to you, as they will help determine whether Prostinfenem is suitable and whether additional monitoring is needed:
- Asthma or history of asthma: Even a past history of asthma is important to disclose, as Prostinfenem can cause bronchospasm (narrowing of the airways). Patients with asthma are at significantly higher risk of this complication
- High or low blood pressure: Prostinfenem can affect blood pressure, causing either hypertension or hypotension
- Cardiovascular disease: Any history of heart or blood vessel problems, including hypertension, angina, or peripheral vascular disease
- Pulmonary, hepatic, or renal disease: Even mild or controlled forms of these conditions may increase the risk of adverse effects
- Visual disturbances or glaucoma: Raised intraocular pressure or existing eye conditions should be reported
- Anemia: Low blood count may worsen with treatment, particularly in the setting of hemorrhage
- Jaundice: Existing liver conditions manifesting as jaundice require careful evaluation
- Diabetes mellitus: Blood sugar levels may be affected during treatment
- Epilepsy: Seizure risk may be increased in susceptible individuals
- Uterine scarring: Previous cesarean section, uterine surgery, or other conditions causing uterine scarring increase the risk of uterine rupture during treatment
In patients with a scarred uterus (e.g., from previous cesarean delivery or uterine surgery), there is an increased risk of uterine rupture when using potent uterotonics like Prostinfenem. The treating physician must carefully weigh the benefits against the risks and ensure close monitoring throughout treatment.
Pregnancy and Breastfeeding
Prostinfenem should not be used during pregnancy except for the specific indications described above (postpartum hemorrhage treatment and pregnancy termination). It is a potent uterotonic agent that causes strong uterine contractions and must only be used under strict medical supervision for its approved indications.
When used for postpartum hemorrhage, the short-term, single-dose administration is generally considered compatible with breastfeeding because the drug is rapidly metabolized and eliminated. However, the decision should always be made by the treating physician on a case-by-case basis, considering the clinical situation and the patient's overall condition.
Prostinfenem contains benzyl alcohol as a preservative. Large amounts of benzyl alcohol can accumulate in the body and may cause metabolic acidosis. Your healthcare provider will take this into consideration, particularly if you have impaired liver or kidney function.
Driving and Operating Machinery
Side effects such as dizziness, vertigo, and somnolence (excessive drowsiness) have been reported with Prostinfenem. Given the clinical setting in which this drug is administered (hospital care during postpartum hemorrhage or pregnancy termination), patients are typically under medical supervision and will not be driving. However, upon discharge, patients should be advised not to drive or operate machinery until they are certain that Prostinfenem has not affected their ability to do so safely.
Excipients of Special Interest
Benzyl alcohol: Prostinfenem contains 9 mg of benzyl alcohol per 1 ml of solution (9 mg/ml). Benzyl alcohol may cause allergic reactions in susceptible individuals. In large accumulated amounts, it may cause metabolic acidosis. Your healthcare provider will consider this, especially if you have impaired liver or kidney function.
Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per ampoule and is therefore essentially sodium-free.
How Does Prostinfenem Interact with Other Drugs?
Prostinfenem can interact with other uterotonic agents, potentially causing excessive uterine stimulation. It may also interact with drugs affecting blood pressure and bronchial tone. Always inform your healthcare provider about all medications you are currently taking or have recently taken.
Drug interactions with Prostinfenem are particularly important to consider because the medication is used in acute clinical settings where patients may be receiving multiple drugs simultaneously. The most clinically significant interaction is with other uterotonic agents, which can potentiate the effects of Prostinfenem and increase the risk of uterine hyperstimulation, tetanic contractions, or uterine rupture.
The table below summarizes the most important known drug interactions with Prostinfenem. Your healthcare provider will review your current medication list before administering this drug and make appropriate adjustments as necessary.
| Drug / Drug Class | Interaction Type | Clinical Effect | Recommendation |
|---|---|---|---|
| Oxytocin | Synergistic | Enhanced uterotonic effects; risk of uterine hyperstimulation, tetanic contractions, or uterine rupture | Use with caution; allow adequate time between agents; monitor uterine tone closely |
| Ergometrine / Methylergonovine | Synergistic | Additive uterotonic effects; increased risk of sustained uterine contraction and hypertension | Sequential use with caution; monitor blood pressure and uterine activity |
| Misoprostol | Synergistic | Combined prostaglandin effects may cause excessive uterine stimulation | Avoid concurrent use; if sequential use is needed, allow adequate washout period |
| NSAIDs (e.g., ibuprofen, aspirin) | Antagonistic | NSAIDs inhibit prostaglandin synthesis and may reduce the uterotonic effects of carboprost | Avoid NSAIDs during treatment if possible; use alternative analgesics |
| Antihypertensives | Variable | Blood pressure effects may be unpredictable; both hypertension and hypotension have been reported with carboprost | Monitor blood pressure frequently; adjust antihypertensive doses as needed |
Additional Considerations
Patients who have recently received other agents that stimulate uterine contractions should be carefully evaluated before Prostinfenem is administered. The cumulative effects of multiple uterotonic agents can lead to dangerous levels of uterine stimulation. When Prostinfenem is being considered as a second-line agent (as is common in postpartum hemorrhage management), the treating physician will assess the timing and doses of all previously administered uterotonic drugs.
General and regional anesthesia may interact with the cardiovascular effects of Prostinfenem. Patients receiving spinal or epidural anesthesia may experience more pronounced blood pressure changes when carboprost is administered. The anesthesia team should be informed of Prostinfenem administration so that appropriate hemodynamic monitoring and management can be implemented.
What Is the Correct Dosage of Prostinfenem?
Prostinfenem is administered by deep intramuscular injection only. For postpartum hemorrhage, the standard dose is 0.25 mg (1 ml), with a single dose usually sufficient. For pregnancy termination, 0.25 mg is given every 1.5 to 3 hours. The maximum total dose should not exceed 12 mg (48 doses).
Prostinfenem is exclusively administered in hospital settings by qualified healthcare professionals. The dosage and frequency of administration are determined by the treating physician based on the clinical indication, the patient's response, and the development of any adverse effects. Because this is a hospital-administered injectable medication, you will not need to manage dosing yourself.
For Postpartum Hemorrhage
Standard Dosing – Postpartum Hemorrhage
The healthcare provider or nurse will inject the recommended dose of 0.25 mg (1 ml) by deep intramuscular injection. In most cases, a single dose is sufficient to achieve adequate uterine contractility and control bleeding. If the initial dose is insufficient, additional doses of 0.25 mg may be administered at intervals of no less than 15 minutes. The total dose for postpartum hemorrhage should generally not exceed 2 mg (8 doses).
For Pregnancy Termination
Standard Dosing – Pregnancy Termination
The initial dose of 0.25 mg (1 ml) is administered by deep intramuscular injection. Subsequent doses of 0.25 mg are given at intervals of 1.5 to 3 hours, depending on the uterine response. If contractions are considered unsatisfactory after several doses, the physician may increase the dose to 0.5 mg, although this is rarely necessary. The intervals between doses may also be shortened to 1.5 hours if the response is inadequate.
The maximum total dose should not exceed 12 mg, and treatment should not continue beyond 2 days.
| Indication | Standard Dose | Frequency | Maximum Dose | Route |
|---|---|---|---|---|
| Postpartum hemorrhage | 0.25 mg (1 ml) | Single dose; may repeat every 15–90 min if needed | 2 mg (8 doses) | Deep IM injection |
| Pregnancy termination | 0.25 mg (1 ml) | Every 1.5–3 hours | 12 mg (48 doses) over 2 days | Deep IM injection |
Special Populations
Elderly patients: Prostinfenem is primarily used in women of childbearing age. Use in elderly patients is not expected for the approved indications.
Pediatric patients: Prostinfenem is not indicated for use in children. Its clinical indications (postpartum hemorrhage and pregnancy termination) are restricted to women of reproductive age.
Renal or hepatic impairment: Prostinfenem is contraindicated in patients with active renal or hepatic disease. In patients with mild impairment, careful benefit-risk assessment is required, and additional monitoring should be provided.
Overdose
Because Prostinfenem is administered by healthcare professionals in a controlled clinical setting, the risk of accidental overdose is very low. However, if an overdose were to occur, the most likely manifestations would include exaggerated versions of the known side effects: severe nausea, vomiting, diarrhea, uterine hypertonicity, bronchospasm, and cardiovascular instability including severe hypertension or hypotension. Treatment would be supportive and symptomatic, with particular attention to maintaining airway patency, circulatory support, and management of uterine hypertonicity. There is no specific antidote for carboprost overdose.
Prostinfenem must ONLY be given by deep intramuscular injection. It must NEVER be administered intravenously. Intravenous administration of carboprost can cause severe bronchospasm, cardiovascular collapse, and potentially fatal reactions.
What Are the Side Effects of Prostinfenem?
Like all medicines, Prostinfenem can cause side effects, although not everyone experiences them. The most common effects are nausea, vomiting, diarrhea, and fever, which are usually transient and resolve after treatment ends. Serious but less common effects include bronchospasm, blood pressure changes, and uterine rupture.
The side effects of Prostinfenem are primarily related to its prostaglandin activity, which affects not only the uterus but also the gastrointestinal tract, respiratory system, and cardiovascular system. Most adverse effects are dose-dependent and transient, meaning they are more likely at higher doses and typically resolve once the drug is cleared from the body. The following classification is based on frequency as reported in clinical trials and post-marketing surveillance.
Very Common
Affects more than 1 in 10 patients
- Nausea
- Vomiting
- Diarrhea
- Fever (38°C or higher)
Common
Affects 1 in 10 to 1 in 100 patients
- Headache
- Flushing, hot flushes, chills
- Coughing
- Vaginal bleeding
- Retained placenta or fetal membranes
- Endometritis (uterine infection with inflammation and pain)
Uncommon
Affects 1 in 100 to 1 in 1,000 patients
- Septic shock, urinary tract infection
- Sleep disturbance, somnolence, lethargy
- Dizziness, vertigo
- Dystonia (involuntary muscle movements)
- Generalized muscle pain, numbness, tingling
- Neck stiffness (torticollis)
- Taste disturbance
- Excessive sweating
- Chest tightness, asthma-like symptoms, dyspnea, tachypnea, wheezing, hiccups
- Upper abdominal pain, back pain, pelvic pain
- Breast tenderness
- Blurred vision, eye pain
- Dry mouth
- Tinnitus (ringing in the ears)
- Tachycardia (rapid heartbeat)
- Hypertension or hypotension
- Hematemesis (vomiting blood)
- Uterine rupture, cervical laceration
- Injection site pain
Frequency Not Known
Reported from post-marketing experience (frequency cannot be estimated)
- Severe hypersensitivity reactions (anaphylaxis): sudden wheezing, difficulty breathing, swollen eyelids, face or lips, rash or itching, tissue swelling
- Thyrotoxicosis
- Anxiety, nervousness
- Syncope (fainting due to blood pressure drop)
- Palpitations
- Bronchospasm, pharyngeal edema, choking sensation, epistaxis (nosebleed), dry throat, upper respiratory tract infection
- Retching
- Skin rash
- Muscle cramps, blepharospasm (involuntary eyelid closure)
- Irregular or heavy menstrual periods
- Chest pain, asthenia (weakness), thirst
The gastrointestinal side effects (nausea, vomiting, diarrhea) are among the most frequently reported and are a direct consequence of prostaglandin activity on the smooth muscle of the gastrointestinal tract. These effects are usually self-limiting but can be managed with antiemetic medications if necessary. The fever that commonly occurs is believed to be a prostaglandin-mediated pyrogenic response and typically resolves within hours of drug clearance.
Bronchospasm is a particularly important adverse effect to be aware of, especially in patients with a history of asthma. Even patients without a history of asthma may develop bronchospasm, although this is less common. Healthcare providers should have bronchodilator medications readily available when administering Prostinfenem.
It is important to report suspected adverse reactions after the medicine has been authorized. This allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients can report suspected adverse reactions to their national pharmacovigilance authority.
How Should You Store Prostinfenem?
Prostinfenem must be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). It is a hospital-administered medication, and storage is handled by healthcare facility staff. The solution should not be used after the expiration date.
Prostinfenem is stored and managed by healthcare professionals in hospital pharmacies and clinical units. Proper storage is critical to maintaining the stability and efficacy of this prostaglandin preparation. The following storage requirements must be observed:
- Temperature: Store at 2°C to 8°C (36°F to 46°F) in a refrigerator
- Light protection: Keep in the original packaging to protect from light
- Expiration: Do not use after the expiration date (EXP) printed on the vial. The expiration date refers to the last day of that month
- Safety: Keep out of the sight and reach of children
- Disposal: Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment
Once removed from refrigeration, Prostinfenem should be used promptly. The solution should be visually inspected before use and should not be administered if it is discolored, contains particulate matter, or if the container shows any signs of damage.
What Does Prostinfenem Contain?
Each 1 ml ampoule of Prostinfenem contains 0.25 mg of carboprost (as carboprost tromethamine). Inactive ingredients include sodium chloride, benzyl alcohol (preservative), tromethamine, sodium hydroxide/hydrochloric acid for pH adjustment, and sterile water for injections.
Active Ingredient
The active substance is carboprost tromethamine. Each 1 ml of solution contains 0.25 mg of carboprost. Carboprost tromethamine is the tromethamine (THAM) salt of 15-methyl prostaglandin F2-alpha, a synthetic analogue of the naturally occurring prostaglandin F2-alpha. The 15-methyl modification significantly increases the potency and duration of action compared to the natural prostaglandin, making it suitable for clinical use as a uterotonic agent.
Inactive Ingredients
The other ingredients in Prostinfenem are:
- Sodium chloride – provides isotonicity to make the solution compatible with body tissues
- Benzyl alcohol – serves as a preservative (9 mg/ml). See the warnings section for important information about this excipient
- Tromethamine (THAM) – acts as a buffering agent to maintain the pH of the solution
- Sodium hydroxide and/or hydrochloric acid – used for pH adjustment to pH 7.4
- Sterile water for injections – the vehicle for dissolving all other components
Appearance and Packaging
Prostinfenem is supplied as a clear, colorless to slightly yellow solution in 1 ml glass ampoules. Each ampoule contains 0.25 mg of carboprost in 1 ml of solution. The product is presented as individual ampoules within a carton.
Frequently Asked Questions About Prostinfenem
References and Medical Sources
- World Health Organization (WHO). WHO recommendations for the prevention and treatment of postpartum haemorrhage. Geneva: WHO; 2023. Available from: who.int
- American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin No. 183: Postpartum Hemorrhage. Obstetrics & Gynecology. 2017;130(4):e168-e186. doi:10.1097/AOG.0000000000002351
- International Federation of Gynecology and Obstetrics (FIGO). Prevention and treatment of postpartum haemorrhage in low-resource settings. International Journal of Gynecology & Obstetrics. 2022;157(Suppl 1):S1-S50.
- British National Formulary (BNF). Carboprost. NICE Evidence Services. 2024. Available from: bnf.nice.org.uk
- European Medicines Agency (EMA). Summary of Product Characteristics: Carboprost tromethamine. 2023.
- Gallos ID, Papadopoulou A, Man R, et al. Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis. Cochrane Database of Systematic Reviews. 2018;12:CD011689. doi:10.1002/14651858.CD011689.pub3
- Hofmeyr GJ, Gulmezoglu AM, Novikova N, Lawrie TA. Postpartum misoprostol for preventing maternal mortality and morbidity. Cochrane Database of Systematic Reviews. 2018;7:CD008982.
- Mousa HA, Blum J, Abou El Senoun G, Shakur H, Alfirevic Z. Treatment for primary postpartum haemorrhage. Cochrane Database of Systematic Reviews. 2014;(2):CD003249. doi:10.1002/14651858.CD003249.pub3
About Our Medical Editorial Team
This article has been written and medically reviewed by our editorial team of licensed physicians with expertise in obstetrics, gynecology, and clinical pharmacology. All medical content follows the GRADE evidence framework and is based on peer-reviewed research, international clinical guidelines, and authoritative pharmacological references.