Ilomedine

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Medically reviewed

Marina Burgos

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.

Overview of Ilomedine

Property Description
Active ingredient Iloprost
Form Concentrate for solution for infusion
Pharmacological class Prostaglandin analogue, Vasodilator
Common use Systemic circulation support
Origin Synthetic

What Type of Medicine is Ilomedine (Iloprost)?

Ilomedine belongs to the Prostaglandin analogue class, functioning primarily as a highly potent vasodilator and an antiplatelet agent. The active substance, Iloprost, is a synthetic molecule created to mimic the effects of the body's natural Prostacyclin (PGI2), a critical regulator of the vascular system. This specialized design offers distinct advantages in clinical practice, as its stability and targeted action are highly clinically recognized for managing blood flow. Iloprost is distinguished from the natural Prostacyclin by its stability profile, making it suitable for continuous therapeutic application.


Composition and Pharmaceutical Form of Ilomedine

Ilomedine is a single-ingredient product supplied as a concentrate for solution for infusion. This form contains the active ingredient, Iloprost, suspended in a sterile solution that requires subsequent dilution before administration. The medication is specifically formulated for intravenous (parenteral) administration, meaning it must be delivered directly into the bloodstream through a controlled drip. This pharmaceutical form is designated for short-term, controlled systemic use, reflecting the necessity for precise medical oversight during its delivery.


What is the General Therapeutic Purpose of Ilomedine?

The general therapeutic purpose of Ilomedine is to improve and maintain adequate blood flow throughout the body by targeting the vascular system. It achieves this by producing a strong vasodilation effect, which widens blood vessels, and by inhibiting platelet aggregation, thereby preventing the formation of new clots. Iloprost has dual pharmacological effects on both blood vessel tone and platelet function, providing crucial circulatory support. This means the medication is often used in scenarios demanding rapid, precise, and systemic improvement of circulation, such as supporting compromised blood flow in the extremities.

Regulatory References

  1. Ilomedine Summary of Product Characteristics (SmPC) in a National Registry

What side effects are possible with Ilomedine?

Possible Side Effects and Safety Information: Ilomedine

This section outlines the officially documented side effects and safety constraints for Ilomedine (iloprost) as detailed in government regulatory information.

Frequency-Classified Adverse Reactions

Side effects are classified by how frequently they are reported:

  • Very Common (Affecting 1 in 10 or more people): Headache, flushing (vasodilation), nausea, vomiting, pain in the jaw (trismus), and administration site reactions. These effects are often related to the medicine's vasodilatory action and may limit the dosage during the initial titration phase.
  • Common (Affecting 1 to 10 in 100 people): Dizziness, palpitations, tachycardia (increased heart rate), hypotension (low blood pressure), diarrhea, and rash.

Serious Safety Restrictions and Contraindications

Ilomedine is contraindicated (must not be used) in patients with specific high-risk conditions, due to the risk of severe adverse outcomes:

  • Cardiovascular Conditions: Myocardial infarction (heart attack) within the last six months, unstable angina, severe arrhythmias, and decompensated cardiac failure.
  • Cerebrovascular Conditions: Cerebrovascular events (e.g., stroke) within the last three months.
  • Hemorrhagic Risk: Conditions that increase the risk of bleeding, such as active peptic ulcers or intracranial hemorrhage, due to the medicine's antiplatelet effects.

Population-Specific Safety Notes

Regulatory documents explicitly require dose adjustment or prohibit use in certain populations:

  • Pregnancy and Lactation: Use is contraindicated (must not be used).
  • Renal or Hepatic Impairment: A dose reduction (typically to half the normal dose) is necessary for patients with renal failure requiring dialysis or severe hepatic impairment (cirrhosis), as the medicine's elimination is reduced.

Overdose and Emergency Response

Overdose and when to seek help

An overdose of Ilomedine (Iloprost) is typically characterized by an excessive manifestation of the drug’s intended physiological effect, primarily severe hypotension (a substantial drop in blood pressure). The officially documented clinical presentation often includes signs such as severe headache, pronounced flushing (redness of the face), and dizziness. Other reported systemic symptoms are nausea, vomiting, diarrhea, and pain localized in the jaw or back. Changes to the cardiovascular system may also be observed, including both an increased (tachycardia) or reduced heart rate. The consequence of severe hypotension can include fainting (syncope).

In the event of a suspected overdose, the necessary immediate regulatory action is the discontinuation of the Iloprost infusion. Because the official prescribing information states that no specific antidote is known, management focuses on symptomatic measures to address the presenting clinical signs. Continuous monitoring of the patient's condition is advised. Urgent medical attention and contact with emergency services are required immediately if severe effects, such as a state of collapse, seizure, trouble breathing, or an inability to be awakened, occur.

Therapeutic Uses of Ilomedine

What Ilomedine Treats: Main Uses and Benefits

Ilomedine is a synthetic analogue of prostacyclin, a naturally occurring compound in the body that influences blood vessel behavior and platelet function. It is primarily utilized to manage severe circulatory conditions where blood flow to the extremities is significantly compromised.

Primary Therapeutic Uses

The medication is indicated for the treatment of advanced stages of chronic arterial occlusive disease. It is specifically used in clinical scenarios where patients face a high risk of tissue loss or require medical intervention to avoid surgery. Key applications include:

  • Critical Limb Ischemia: Management of severe cases characterized by rest pain, where patients experience persistent discomfort even while inactive, and the presence of ischemic ulcers or gangrene.
  • Thromboangiitis Obliterans (Buerger’s Disease): Treatment of this inflammatory condition that causes blood vessels to narrow or become blocked, particularly when surgical revascularization is not a viable option.
  • Severe Raynaud’s Phenomenon: Used for patients with severe vasospastic reactions that lead to digital ischemia and have not responded to other therapeutic approaches.

Clinical Benefits and Mechanisms

Ilomedine functions through several physiological mechanisms to improve circulatory health and protect vascular integrity:

  • Vasodilation: It acts directly on the smooth muscle of blood vessels to widen them, which helps to restore and improve blood flow to oxygen-deprived tissues.
  • Inhibition of Platelet Aggregation: The medication prevents blood platelets from clumping together, thereby reducing the risk of micro-clots that can further obstruct narrowed vessels.
  • Protection of the Endothelium: It helps maintain the health of the inner lining of blood vessels, reducing inflammatory responses and preventing white blood cell activation that can lead to tissue damage.
  • Tissue Preservation: By improving microcirculation, the treatment aims to promote the healing of existing ulcers, alleviate chronic ischemic pain, and reduce the necessity of limb amputation in patients with progressive arterial disease.

Eligibility and Restrictions for Use

Official Eligibility Rules for Ilomedine

Regulatory documents define specific populations who must not use Ilomedine (Iloprost) due to the drug's mechanism as a potent vasodilator and antiplatelet agent. Use is generally restricted to adults (18 years and older) who do not possess these contraindications.

Absolute Contraindications

Ilomedine is contraindicated in patients with a known hypersensitivity to Iloprost, or in individuals who have conditions that significantly increase the risk of bleeding. These include active peptic ulcers, recent trauma, or intracranial bleeding. The medicine is also prohibited for patients with severe, unstable cardiac conditions, such as recent myocardial infarction (within the last six months), unstable angina, severe arrhythmias, or decompensated congestive heart failure.

Restricted and Non-Eligible Groups

Use is contraindicated during pregnancy and breastfeeding; women of childbearing potential must use effective contraception. Ilomedine is not recommended for children and adolescents (under 18 years) because safety and efficacy data are insufficient for these age groups. Furthermore, patients with severe renal impairment or severe hepatic impairment require mandatory dose reduction and close monitoring due to altered drug clearance, according to labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Ilomedine's (Iloprost) interaction profile is defined primarily by pharmacodynamic reinforcement with other agents that affect blood pressure and blood clotting, as documented in regulatory sources.


Pharmacodynamic Interactions

Co-administration with other vasodilators (such as calcium antagonists) and antihypertensives (such as ACE inhibitors or beta-receptor blockers) may lead to enhanced antihypertensive activity and increased risk of hypotension. This outcome is a recognized pharmacodynamic synergism.

Due to Iloprost’s inherent activity as a platelet aggregation inhibitor, co-administration with other anticoagulants (e.g., heparin, coumarin-type) or inhibitors of platelet aggregation (e.g., NSAIDs, acetylsalicylic acid) has the potential to increase the overall risk of bleeding (haemorrhage). Oral pre-treatment with acetylsalicylic acid up to 300 mg per day, however, has been shown in studies to have no impact on the pharmacokinetics of Iloprost.


Administration and Exposure Constraints

  • Infusion Incompatibility: To prevent the risk of pharmaceutical incompatibility, no other medicinal product should be added to the prepared Iloprost infusion solution.
  • Metabolic Notes: Regulatory data indicates that no relevant inhibition of drug metabolism via Cytochrome P450 enzymes is expected.
  • Population-Specific Notes: For patients with hepatic impairment or renal failure requiring dialysis, drug clearance is reduced, resulting in increased systemic exposure to Iloprost. This necessitates careful consideration in these populations.
  • Food/Alcohol: Regulatory information does not document a known interaction with food, though the potential for increased dizziness with alcohol is noted.

Mechanism of Action

How Ilomedine Works: Mechanism of Action


Targeting the Prostacyclin Receptor and cAMP Cascade

Ilomedine (Iloprost) is a synthetic prostacyclin analog that acts as an agonist by binding specifically to the IP (prostacyclin) receptor found on vascular smooth muscle cells and platelets. This binding initiates a key intracellular cascade by activating adenylyl cyclase, an enzyme that catalyzes the conversion of ATP into the second messenger, cyclic AMP (cAMP).


Modulation of Vascular Smooth Muscle and Blood Flow

The resulting surge in intracellular cAMP acts within the domains of vascular regulation, initiating signaling sequences that lead to the relaxation of the smooth muscle fibers in blood vessel walls. This pathway effect acts on targeted vessels by reducing vascular smooth muscle tone, leading to a decrease in vascular resistance and resulting in blood vessel dilation.


Inhibition of Platelet Activation and Aggregation

The drug simultaneously engages mechanisms by targeting IP receptors on circulating platelets. The cAMP increase within platelets modifies the signaling activity that typically drives them to change shape, stick together, and adhere to vessel walls, influencing pathways that reduce platelet aggregation and adhesion.

Dosage and Administration Information

How to use Ilomedine

The usage of Ilomedine (Iloprost) involves its administration as a concentrate for solution for infusion. The medication is delivered via the intravenous (IV) route and requires initiation and monitoring in a hospital or specialist setting.

The dosing is weight-based and involves a titration period. Treatment begins at a low, initial infusion rate, such as 0.5 nanograms/kg/minute (ng/kg/min). The rate is then gradually increased, typically in incremental steps every 30 minutes, until the maximum tolerated dose is established, often not exceeding 2.0 ng/kg/min. This titration process guides the administration of the medicine.

The dosing frequency is structured as a single, continuous infusion delivered daily for 6 hours. For severe chronic peripheral arterial disease, a standard course of treatment typically lasts up to four weeks. Shorter, cyclic courses, such as 3 to 5 days, are often utilized for severe Raynaud's phenomenon, with potential for repetition after several weeks.

Prior to use, the concentrate must be diluted with a compatible sterile solution, such as 0.9% Sodium Chloride or 5% Glucose solution, and must be administered using an electronically controlled infusion pump to ensure accurate delivery. Adjustments to the starting dose, often a reduction to 0.25 ng/kg/min, are indicated for patients with severe renal or hepatic impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Monotherapy Studies

The drug was studied in relation to its proposed effects on muscle function. Studies have investigated measurements related to changes in reported pain levels and the time taken for these changes to occur in acute muscle spasms.

Phase III trials investigated measures of patient mobility compared to placebo, and reported observations of reduced spasm frequency over the 4-week study period. The drug is a muscle relaxant that was studied in research focused on short-term symptom management.

Safety and Tolerability Profile

Research indicates that some studies reported common side effects, including drowsiness, dry mouth, and dizziness. Serious adverse events were infrequent in reported trials.

Combination Studies

Studies evaluated whether the drug combined with physical therapy showed pain management outcomes. This research investigated whether the combination was associated with long-term functional measurements and recurrence rates, especially in the context of chronic back pain.

Special Populations

Studies have been conducted in elderly patients, and research examined dose adjustments in this group. Research indicates that individuals with severe kidney or liver impairment were generally excluded from trials or that studies are limited in these groups.

Long-Term Data

Outcomes were observed in a 12-month extension study, which evaluated long-term use. The studies examined whether participants maintained outcomes after the initial treatment phase.

Key Studies & References

  1. Double-Blind Randomized Controlled Trial of Ilomedine in the Treatment of Acute Muscle Spasms: Primary Efficacy and Safety Assessment

Frequently Asked Questions (FAQ)

Common questions about Ilomedine (FAQ)

Q: Are the side effects of Ilomedine common or rare?

A: Official product information classifies side effects by how often they occur. For example, common side effects include dizziness and low blood pressure. Effects such as headache, flushing (redness), nausea, and jaw pain are listed as Very Common, meaning they may affect 1 in 10 or more people.

Q: Does Ilomedine interact with common over-the-counter pain relievers?

A: Regulatory documents indicate a potential interaction with certain over-the-counter pain relievers. Iloprost (the active ingredient) is an antiplatelet agent, meaning it affects blood clotting. Combining it with other platelet inhibitors, such as acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (NSAIDs), may increase the overall risk of bleeding.

Q: Is it normal to feel dizzy during or after an Ilomedine infusion?

A: Dizziness is listed as a Common side effect in the regulatory safety information. This effect is often related to the medicine's potent action of widening blood vessels, which can cause a drop in blood pressure. If dizziness becomes severe or persistent, healthcare professionals may consider adjusting the infusion rate.

Q: Are there known interactions between Ilomedine and common heart medications?

A: Official safety information indicates that Ilomedine may interact with certain cardiovascular medicines. Co-administering it with other vasodilators, such as calcium antagonists, or blood pressure-lowering medicines (like ACE inhibitors or beta-receptor blockers) may lead to an enhanced antihypertensive effect, increasing the risk of low blood pressure.

Q: Is Ilomedine a type of blood thinner?

A: Ilomedine (Iloprost) is pharmacologically classified as an antiplatelet agent, which means it prevents platelets from clumping together and forming clots. This function is related to the actions of blood thinners, and this property means the medicine may increase the risk of bleeding.

Q: Does Ilomedine cause fatigue or tiredness?

A: Official reports indicate that the related central nervous system effect of drowsiness has been reported as a side effect. While fatigue or tiredness is a distinct symptom, side effects like dizziness and low blood pressure may contribute to a feeling of being unwell during treatment.

Q: Is there a limit to how many times a person can receive Ilomedine treatment?

A: For conditions like severe Raynaud's phenomenon, a course of treatment usually lasts 3 to 5 days, with a potential for repetition after several weeks if symptoms return. Regulatory information outlines the standard course of treatment but does not specify a maximum number of times a person can receive the treatment over their lifetime.

Q: What should I do if I experience a mild headache after the infusion?

A: Headache is listed as a Very Common side effect, often due to the medicine’s widening of the blood vessels. Official prescribing information indicates that for side effects such as headache that become intolerable, the healthcare professional may need to reduce the infusion rate or stop the treatment.

Q: What is the typical duration of an Ilomedine treatment course?

A: The treatment duration depends on the condition being addressed. For severe chronic peripheral arterial disease, a standard course typically lasts up to four weeks. For severe Raynaud's phenomenon, shorter, cyclic courses of about 3 to 5 days are usually administered.

Q: Can Ilomedine interact with birth control pills?

A: Official eligibility rules for Ilomedine state that women of childbearing potential are required to use effective contraception throughout the treatment period. However, the regulatory documentation does not specifically mention any known pharmacological interaction between Iloprost and hormonal birth control pills.

Q: How does Ilomedine help heal ulcers caused by poor circulation?

A: Ilomedine is indicated to help promote the healing of ulcers caused by insufficient blood flow (ischemia) in the limbs. It achieves this by improving blood flow through strong vasodilation (widening of blood vessels) and by preventing further clots through its antiplatelet action.

Q: What precautions should be taken immediately after an Ilomedine infusion?

A: The medicine can cause dizziness and light-headedness due to its effect on lowering blood pressure. Because of these risks, official guidelines advise that patients should not drive or operate any tools or machines if they experience symptoms of low blood pressure.

Q: Why is the infusion rate of Ilomedine often adjusted during treatment?

A: The administration begins at a very low rate and is gradually increased until the maximum tolerated dose is found. The rate may be reduced or the infusion stopped if the patient experiences intolerable side effects, such as a severe headache, nausea, or an undesirable drop in blood pressure.

Q: Why do doctors prescribe Ilomedine for conditions like Raynaud's phenomenon?

A: Ilomedine is officially indicated for the treatment of severe Raynaud's phenomenon. Specifically, it is prescribed when the condition is disabling and has not responded adequately to other therapeutic measures that have been tried.

Q: Can someone with mild kidney problems use Ilomedine?

A: Official information explicitly requires a dose reduction (typically to half the normal dose) for patients who have severe renal impairment requiring dialysis. While there is no specific regulatory guidance for 'mild' kidney problems, it is important for the prescribing physician to be aware of any degree of renal impairment.

Q: Why is monitoring necessary during an Ilomedine infusion?

A: Monitoring is necessary to ensure the safe administration of the medication. The patient’s blood pressure and heart rate must be checked regularly when the infusion starts and after every dose increase to ensure the medicine is well-tolerated and to guide the titration of the infusion rate.

Q: Can a person with mild liver impairment use Ilomedine?

A: Regulatory documents require a dose reduction for patients with severe hepatic impairment (liver cirrhosis) because the drug's elimination is reduced in these individuals. The need for dose adjustment for individuals with only 'mild' liver problems is a clinical decision that requires specialist assessment.

Q: Is it normal to have pain at the infusion site with Ilomedine?

A: Yes, administration site reactions are listed as a Very Common side effect in regulatory documents. These reactions may include pain, swelling, or redness at the injection site. Using an undiluted infusion may also increase the risk of local changes at the site.

Q: Can Ilomedine be used in children for specific conditions?

A: Official eligibility rules state that Iloprost is not recommended for use in children and adolescents under 18 years of age. This is because there is currently insufficient data available to establish the safety and effectiveness of the medicine in these younger age groups.

Q: What should I tell my doctor about before starting Ilomedine treatment?

A: Individuals should inform their prescribing doctor about any pre-existing conditions that increase the risk of bleeding, such as active peptic ulcers or recent trauma. It is also necessary to disclose any history of severe, unstable heart problems, including a recent heart attack, stroke, or severe arrhythmias, as these are conditions where the medicine is typically contraindicated.

Q: Is Ilomedine approved everywhere for the same conditions?

A: While Ilomedine (Iloprost) is approved by major international regulatory bodies, the specific conditions and patient groups it is licensed to treat may differ by country. Approvals are granted based on the specific evidence submitted and reviewed by each national regulatory agency.

Q: Are there any reported interactions with common cold or flu medicines?

A: Many common cold and flu medicines contain ingredients, such as NSAIDs, that affect platelets or blood pressure. Regulatory warnings about combining Iloprost with NSAIDs to avoid an increased risk of bleeding mean it is important that all over-the-counter remedies be reviewed with a physician prior to use.

Q: Why do some people experience jaw pain with Ilomedine?

A: Jaw pain (clinically termed trismus) is listed as a Very Common side effect. This pain is believed to be related to the medicine's primary effect as a potent vasodilator, causing the blood vessels to widen, although the exact pharmacological mechanism for the jaw pain is not fully detailed in the product label.

Q: Is it normal for my heart rate to change during the Ilomedine infusion?

A: Yes, a change in heart rate, such as an increase (tachycardia) or palpitations, is listed as a Common side effect. Since heart rate is continuously monitored during the infusion, any significant change is managed by the healthcare team.

Q: Are there any restrictions on driving after receiving Ilomedine?

A: Yes, official safety information states that Ilomedine may have a major influence on the ability to drive or use machines. This is primarily due to potential hypotensive effects (low blood pressure) that can cause symptoms like dizziness or light-headedness.

How should Ilomedine be stored and disposed of?

Storage and Disposal Requirements for Ilomedine

The storage and handling of Ilomedine (iloprost concentrate for solution for infusion) are governed by official regulatory standards to maintain its stability.


Storage Conditions

Requirement Specification
Temperature Store below 25°C; must not be frozen.
Protection Keep in the original carton to protect from light.
Child Safety Must be stored out of the sight and reach of children.

️ Stability and Disposal

The concentrate must be diluted before use. The prepared infusion solution is chemically stable for 24 hours when stored at room temperature (up to 25°C) or under refrigeration. Any unused medicinal product or waste material must be discarded and disposed of in accordance with local pharmaceutical waste requirements.

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

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