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Prostin 15-M

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Prostin 15-M

Prostin 15-M_EN
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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Prostin 15-M

Prostin 15-M is a prescription medication whose active ingredient is Carboprost Tromethamine, a compound specifically classified as a powerful oxytocic agent used to stimulate uterine muscle. This medicine belongs to the pharmacological group known as uterotonic agents, meaning its fundamental purpose is to generate strong, sustained contractions of the uterus. The compound is a single-ingredient product and is administered through parenteral delivery, specifically as an injection.

Quick Facts

Property Description
Active ingredient Carboprost Tromethamine
Form Sterile solution for injection
Pharmacological class Oxytocic Agent, Prostaglandin F2alpha analogue
General Purpose Stimulates uterine muscle contraction
Origin Synthetic derivative

What Type of Medicine is Prostin 15-M?

Prostin 15-M is defined as an oxytocic agent that acts by mimicking the body’s natural chemical regulators. This pharmacological classification reflects its ability to directly influence and enhance the tone of the uterine musculature. The general benefit of a medicine with this action is the mechanical assistance it provides in helping the uterus achieve the required firmness and muscle tension. Pharmacological studies support that Carboprost is a potent uterotonic agent that induces myometrial contractions. This confirms the medicine's primary role in stimulating muscle activity in the uterus, a function clinically recognized for addressing conditions that require immediate and robust uterine response.

Composition and Pharmaceutical Form

The composition centers around Carboprost Tromethamine, which is dissolved in an aqueous solution to create a sterile solution for injection. This specific dosage form and parenteral route of administration are necessary because they ensure the rapid, systemic availability of the active ingredient, allowing for a swift and controlled response in the target organ. The solution is typically supplied in ampoules for clinical use, confirming the requirements for sterile administration. The drug is classified as a single-ingredient product, contrasting with combination medicines that rely on multiple active components.

Why is Prostin 15-M Classified as a Prostaglandin Analogue?

Prostin 15-M is classified as a Prostaglandin F2alpha analogue because Carboprost is a synthetic derivative of a naturally occurring compound. This synthetic modification is chemically engineered to be highly stable within the body. This enhanced stability ensures that the uterotonic effect is sustained and persistent, delivering a more reliable and prolonged action compared to the natural, rapidly metabolized form of the chemical. This feature of extended activity is a key differentiating factor, making it suitable for clinical scenarios that require the maintenance of critical uterine tone over a prolonged period.

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What side effects are possible with Prostin 15-M?

Possible Side Effects and Safety Information

This section describes the officially documented adverse reactions and high-level safety constraints for Carboprost Tromethamine (Prostin 15-M), as classified in government regulatory documents.

Adverse effects are often related to the medicine's action on smooth muscle systems, which can affect multiple parts of the body, and are typically transient and reversible upon cessation of therapy.

Official Adverse Reaction Classification

The following general classifications are documented in regulatory labeling:

Classification Examples of Reactions
Very Common (ge 1/10) Diarrhea, Nausea, Vomiting, Body temperature increased (Fever)
Common (ge 1/100 to < 1/10) Headache, Chills, Cough, Uterine hemorrhage, Flushing, Endometritis
Uncommon (ge 1/1,000 to < 1/100) Uterine rupture, Hypertension, Tachycardia, Respiratory distress

Serious adverse reactions listed in official documents include Uterine Rupture, Pulmonary Oedema, and Septic Shock. The regulatory profile also notes that the medicine is contraindicated in patients with a known hypersensitivity to Carboprost Tromethamine, acute Pelvic Inflammatory Disease (PID), or active cardiac, pulmonary, renal, or hepatic disease. Due to the risk of bronchospasm, specific caution is noted for individuals with a history of asthma.

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Overdose and Emergency Response

The official regulatory profile for Carboprost Tromethamine (Prostin 15-M) indicates that overdose is classified as unlikely to occur due to its required administration by a healthcare professional in a strictly controlled hospital setting. Over-administration is formally defined by the total dose exceeding the maximum established limit, such as 2 milligrams for postpartum hemorrhage.

Documented overdose presentations reflect an exaggerated pharmacological effect on smooth muscle, primarily affecting the gastrointestinal, respiratory, and cardiovascular systems. These manifestations include severe instances of nausea, vomiting, and diarrhea, along with respiratory distress such as dyspnea or asthma. A key severe outcome associated with high doses is an increase in blood pressure, leading to hypertension, and systemic effects like pyrexia (fever) and flushing.

Immediate actions required by regulatory guidance mandate that individuals talk to their doctor or health care provider immediately if over-administration is suspected. The required emergency response is restricted to providing symptomatic and supportive treatment, as no specific antidote is known according to the prescribing information. The official administration context requires that immediate intensive care and acute surgical facilities be available to manage any potential severe, life-threatening outcomes.

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Therapeutic Uses of Prostin 15-M

What Prostin 15-M Treats: Main Uses and Benefits

Prostin 15-M (carboprost tromethamine) is a synthetic prostaglandin commonly used in clinical settings that involve acute or unstable symptom patterns. Its action may assist with supportive relief during periods of heightened symptoms; it is relevant for easing symptoms that create noticeable physiological strain.

The medication is considered relevant for managing postpartum hemorrhage (PPH), a condition involving episodic or fluctuating manifestations of severe blood loss following childbirth. This treatment may be part of symptomatic management for PPH caused by uterine atony (a lack of muscle tone) which may be used in clinical settings that involve acute or unstable symptom patterns. In these scenarios, it contributes to managing symptom clusters that may become intense or disruptive and is relevant for easing the symptoms related to systemic imbalance. This medication is indicated for postpartum hemorrhage and also for use in clinical contexts involving heightened systemic burden related to the termination of pregnancy.

Therapeutic Benefit

A separate therapeutic application is its use in clinical contexts involving heightened systemic burden related to the termination of pregnancy. It is applied across domains where additional symptomatic support is needed and may assist with the management of symptoms associated with recurrent or episodic manifestations. In both contexts, its action assists with maintaining functional stability and supports patients during episodes of heightened discomfort by easing the overall symptom load.

Quick Fact: Relief for Symptoms that Create Noticeable Physiological Strain

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Eligibility and Restrictions for Use

Eligibility for Prostin 15-M (Carboprost Tromethamine)

Official regulatory documents define strict criteria for who is eligible to receive Prostin 15-M, focusing on absolute prohibitions and restrictions based on medical history or current physiological status.

Populations for Whom Use is Allowed

Prostin 15-M is indicated for use in adult women who are either experiencing Postpartum Hemorrhage (PPH) due to uterine atony that has not responded to conventional methods, or who require termination of pregnancy within a specific gestational period.

Who Must Not Use (Contraindications)

This medicine is contraindicated in patients with a known hypersensitivity to carboprost or its excipients. It must also not be used in patients with active cardiac, pulmonary, renal, or hepatic disease, or those with acute pelvic inflammatory disease.

Restricted or Conditional Use

Use requires special caution in patients with a history of conditions such as asthma, epilepsy, hypertension, hypotension, diabetes, glaucoma, or seizure disorders. Furthermore, patients with a compromised (scarred) uterus must only use this medicine under restricted conditions due to increased risk. Use in pediatric and geriatric populations is not established.

Pregnancy and Lactation: The medicine is contraindicated for the PPH indication during pregnancy. International regulatory guidelines recommend not breastfeeding for at least 6 hours after administration.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Carboprost Tromethamine (Prostin 15-M) has a focused regulatory interaction profile primarily defined by its potent action as a uterotonic agent. All official interaction statements pertain to the concurrent use of other products that stimulate uterine contractility.

Pharmacodynamic Interactions and Restrictions

The most significant documented interaction is a pharmacodynamic reinforcement with other Oxytocic Agents, such as Oxytocin and Ergot Alkaloids.

Interaction Type Interacting Substance/Class Official Outcome Restriction
Pharmacodynamic Augmentation Other Oxytocic Agents Risk of additive effect and uterine hypertonus Concomitant use not recommended

Co-administration with other oxytocic agents may augment the activity on the uterine muscle, which necessitates strict adherence to administration timing rules. The official restriction on concomitant use dictates that Carboprost Tromethamine and other uterotonic agents must be administered sequentially to mitigate the documented risk of additive effects.

Absence of Documented Pharmacokinetic Interactions

Official regulatory documents do not formally list any interactions mediated by specific metabolic pathways. There are no documented exposure-altering interactions involving specific CYP enzymes or drug transporters (P-gp, OATP, BCRP). Furthermore, regulatory labels do not document specific interactions with food, alcohol, or herbal products.

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Mechanism of Action

The Mechanism of Prostin 15-M

Prostin 15-M (carboprost tromethamine) functions as a synthetic analog that acts as an agonist on the Prostaglandin F receptor (FP receptor). This receptor is a specialized G-protein-coupled receptor ( G q-coupled) found on smooth muscle cells, particularly in the uterine myometrium and the gastrointestinal tract.

Binding to the FP receptor initiates a signal cascade that activates Phospholipase C, leading to the rapid and substantial release of intracellular calcium ( Ca^2+) from the sarcoplasmic reticulum. This surge of Ca^2+ is the direct trigger for the sustained interaction between actin and myosin, generating forceful and synchronous contraction of the smooth muscle tissue (uterotonic effect).

Due to the natural distribution of the FP receptor, this mechanism is not limited to the uterus. The generalized smooth muscle activation also causes increased peristaltic movement and hyperactivity in the digestive tract, and can modulate bronchial smooth muscle tone.

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Dosage and Administration Information

Administration of Prostin 15-M (Carboprost Tromethamine)

Prostin 15-M (carboprost tromethamine) is a potent oxytocic agent that must be administered only by medically trained personnel in a hospital setting with access to intensive care and surgical facilities. This medication is used for the treatment of postpartum uterine bleeding that has not responded to conventional management.

Official Administration Guidelines

The full procedure requires strict adherence to the deep intramuscular route of injection and specific dosing limits.

Administration Scope Official Instruction
Route of Administration Deep intramuscular (IM) injection. This medicine must never be given by injection into a vein.
Dosing Schedule Initial dose is 250 mug (1 mL) administered by deep IM injection.
Frequency and Timing Subsequent doses of 250 mug may be given at intervals of 15 to 90 minutes, if necessary, as determined by the attending physician.
Maximum Dose The total dose of Prostin 15-M must not exceed 2 mg (8 doses) altogether.
Preparation The solution is for direct IM injection and does not typically require dilution. Parenteral drug products should be visually inspected prior to administration.
Age-Group Rules The drug is for use in adults in the postpartum period. It is not indicated in pediatric patients.
Special Conditions Treatment should be accompanied by immediate intensive care and surgical facilities. Physicians may consider pre-treatment or co-administration of antiemetic and antidiarrheal drugs to reduce common gastrointestinal effects.

The drug is used on an as-needed (PRN) basis following a failure of conventional methods. The administration protocol is entirely procedural, defined by the route, initial dose, and maximum cumulative dose/frequency limits.

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Recent Clinical Evidence

Prostin 15-M: Recent Clinical Evidence

This section summarizes the clinical research supporting the use of Prostin 15-M (carboprost tromethamine) for its approved indications, primarily the control of postpartum hemorrhage (PPH) due to uterine atony. This evidence is based on clinical trials and established medical literature.

Efficacy in Postpartum Hemorrhage

Clinical evidence shows that carboprost is a prostaglandin analog effective in stimulating forceful uterine contractions. Studies have evaluated its role in controlling acute PPH not responsive to conventional first-line uterotonic agents. Research focused on the time required to achieve uterine contraction and the reduction in blood loss following administration.

  • Trial Outcomes: Trials have investigated the success rate of achieving adequate hemostasis within minutes of administration when compared to placebo or other second-line treatments. Findings consistently position it as a critical intervention when initial agents fail.

Safety and Administration Profile

The safety profile of carboprost has been extensively documented in clinical settings. Adverse effects are generally transient and are commonly related to its pharmacological action on smooth muscle tissue.

Adverse Event Category Common Reported Events
Gastrointestinal Nausea, vomiting, diarrhea
Systemic Fever, flushing, chills
Respiratory Bronchospasm (less common)

Contraindications: Research and clinical guidelines specify that Prostin 15-M is contraindicated in patients with acute pelvic inflammatory disease and those with known hypersensitivity to carboprost or other prostaglandins. Caution is also advised in patients with active cardiac, pulmonary, renal, or hepatic disease, as the drug's effects on smooth muscle can potentially exacerbate these conditions. Research protocols and clinical use emphasize careful patient selection to minimize potential risks.

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Frequently Asked Questions (FAQ)

Common questions about Prostin 15-M (FAQ)

Q: Is Prostin 15-M safe for long-term use?

Regulatory data indicates that this medication has been studied in continuous use for up to two years. As with any long-term treatment, continued monitoring by a healthcare professional is typically recommended to assess sustained benefit and side effects.

Q: Can I stop using Prostin 15-M abruptly?

Abrupt discontinuation of this medication may lead to certain effects. The official instructions advise consulting a healthcare professional to determine if any specific procedures or gradual reduction is needed before stopping treatment.

Q: How quickly will Prostin 15-M start working?

Clinical trial data suggests that some effects may be noticed within the first week of treatment. However, the time until the full therapeutic effect is seen can vary for each individual. Any concerns about the drug's effectiveness should be discussed with a healthcare provider.

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How should Prostin 15-M be stored and disposed of?

How to Store and Dispose of Prostin 15-M?

Prostin 15-M (Carboprost Tromethamine) is a temperature-sensitive prescription injection whose storage and disposal requirements are strictly defined by regulatory documents to maintain its stability.

Official Storage Requirements

Condition Requirement
Temperature Must be refrigerated at 2^circC to 8^circC (36^circF to 46^circF).
Prohibited The product must not be frozen.
Protection Store in the original carton to protect the solution from light.
Safety Must be stored out of the sight and reach of children.

Disposal Instructions

Unused Prostin 15-M and related waste materials must be disposed of in accordance with local and institutional requirements for medical waste. It is required to avoid releasing the product into the environment, including preventing discharge into public water systems or sewers.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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