Prolisina VR

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Medically reviewed

Rosario Oropesa

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 Prolisina VR

Quick Facts

Property Description
Active ingredient Alprostadil (synthetic Prostaglandin E1)
Form Lyophilized powder for injection (solution)
Pharmacological class Prostaglandin, Vasodilator, Antiplatelet agent
General purpose To increase local blood flow and improve circulation
Origin Synthetic analog

What Type of Medicine is Prolisina VR?

Prolisina VR is a highly specialized, prescription-only medication that is clinically recognized as a vasodilator and a member of the prostaglandin pharmacological class. Its identity is defined by its single-ingredient product, Alprostadil. The preparation is supplied as a sterile lyophilized powder for injection in a vial, designed to be reconstituted into a solution for injection prior to parenteral administration. Alprostadil functions as a prostaglandin E1 analog used for its systemic effects on the vascular system. This medicine functions to expand blood vessels and improve blood flow.

Alprostadil: Composition and Origin of the Active Ingredient

The action of Prolisina VR is wholly reliant on Alprostadil, which is a synthetic analog of the essential biological mediator known as Prostaglandin E1 (PGE1). Although chemically synthesized, Alprostadil is pharmacologically identical to the natural PGE1 lipid compound, which regulates vascular tone and platelet activity. The drug's presentation as a lyophilized powder is a distinct feature, designed to ensure the stability of this complex molecule until reconstitution. Alprostadil acts as a substance that inhibits platelet aggregation. Consequently, the medication is structured to ensure smoother blood movement by inhibiting the initial steps of clotting.

What is the General Purpose of This Vasodilator?

The fundamental purpose of Prolisina VR is to improve local blood flow and enhance circulation, particularly in scenarios where vascular impairment is a concern. This is achieved because Alprostadil causes smooth muscle relaxation within blood vessel walls, widening them and leading to peripheral vasodilation. The combined effect of strong vasodilation and its simultaneous role as an antiplatelet agent contributes to better blood fluidity. The resulting increase in blood and nutrient supply is the primary benefit Prolisina VR helps achieve when circulation is impaired.

Regulatory References

  1. Alprostadil Urogenital: MedlinePlus Drug Information

What side effects are possible with Prolisina VR?

Possible Side Effects and Safety Information

The safety profile of Prolisina VR, which contains Alprostadil, is defined by regulatory documents based on the medicine's potent systemic effects as a vasodilator and antiplatelet agent. The official prescribing information classifies potential adverse reactions by their frequency and the organ systems affected.

Reactions categorized as Very Common (ge 10%) in the regulatory data typically include Fever (Pyrexia) and Flushing (reddening of the skin). Effects classified as Common (ge 1% to < 10%) can involve Headache, Hypotension (low blood pressure), changes in heart rate (Bradycardia or Tachycardia), Seizures, and Diarrhea. Less frequent reactions, categorized as Uncommon (< 1%), include serious events such as Cardiac arrest and Cerebral haemorrhage.

The adverse events are officially grouped into System-Organ Classes, covering Vascular disorders, Cardiac disorders, Nervous system disorders, and Respiratory, Thoracic, and Mediastinal disorders. For specific patient populations, such as neonates, regulatory labels note an increased risk of Apnea (temporary cessation of breathing), which is often observed during the first hour of infusion.

Safety limitations stated in the prescribing information include high-level contraindications for use in individuals with known hypersensitivity to the drug or pre-existing conditions that pose an increased risk of bleeding or severe cardiac failure. Furthermore, specific effects like Cortical proliferation of the long bones are associated with the duration of therapy in some populations, a pattern explicitly noted in regulatory safety data.

Overdose and Emergency Response

The regulatory overdose profile for Prolisina VR (Alprostadil) is defined by documented signs of exaggerated pharmacological effects, classified into severe systemic and local vascular risks.

Overdose Risk & Manifestations Regulator-Mandated Action
Systemic Overexposure Discontinue infusion or reduce infusion rate.
Manifestations: Hypotension, Bradycardia, Apnea, Pyrexia, Flushing. Provide symptomatic and supportive treatment under medical supervision.
Local Tissue Damage Risk Seek immediate medical assistance for an erection persisting longer than four hours.
Manifestations: Prolonged erection or Priapism (lasting >6 hours). Treatment of priapism is time-critical to prevent irreversible tissue damage and permanent loss of potency.

In neonatal patients, apnea is a specific life-threatening risk, particularly in those weighing less than 2 kg. Management protocols emphasize continuous monitoring of respiratory status, and urgent medical care is required if apnea or signs of severe cardiovascular collapse occur.

Official regulatory documents confirm that overdose management is supportive, as no specific antidote for Prolisina VR is documented.

Therapeutic Uses of Prolisina VR

What Prolisina VR Treats: Main Uses and Benefits

Prolisina VR is commonly used across conditions characterized by periods of heightened symptoms related to severe restriction of blood flow to the limbs. The medication is applied in cases where patients experience symptoms related to physical discomfort, like ischemic rest pain, and advanced tissue damage (ulcers or necrosis). It is considered relevant for managing serious vascular issues, including Critical Limb Ischemia (CLI), certain forms of peripheral arterial occlusive disease, and circulatory-dependent erectile dysfunction. The therapeutic benefit provides support that helps ease the overall symptom burden and may assist with managing symptoms that create noticeable physiological strain.


“It supports the patient during difficult episodes by easing distress and managing symptoms that interfere with daily functioning.”


In a highly specialized clinical setting, Prolisina VR is also considered relevant for providing temporary support for newborns diagnosed with ductal-dependent congenital heart defects. This is applied in clinical settings that involve acute or unstable symptom patterns, helping to manage functional stability related to systemic or pulmonary circulation until surgical intervention may be performed.


Quick Fact: Relief for Severe Circulatory Symptoms
Therapeutic Focus Provides support that helps ease the overall symptom burden associated with critical blood flow restrictions.
Symptom Focus Ischemic rest pain, non-healing arterial ulcers, and functional impairment due to vascular issues.
Patient Benefit May assist with managing functional stability and supporting general well-being in challenging symptomatic phases.

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

The eligibility for Prolisina VR is strictly defined by regulatory labeling, with use permitted only in Adult Males (for circulatory conditions) and Neonates (for specialized cardiac support). The medicine is contraindicated and must not be used in women or the non-neonatal pediatric population.

Absolute Non-Eligibility

Use is prohibited for men with known hypersensitivity to the active ingredient or who have conditions that predispose them to priapism (a prolonged erection), such as sickle cell anemia or leukemia. Men with penile implants or fibrotic conditions of the penis, including Peyronie's disease, are also contraindicated. Additionally, neonates with Respiratory Distress Syndrome are excluded from use.

Restricted and Conditional Use

Official labeling mandates caution for patients with renal impairment (kidney disease) or hepatic insufficiency (liver disease), as this may require special clinical management. Neonates weighing less than 2 kg require close monitoring for apnea. Male patients whose partner is pregnant must use a condom barrier during sexual activity, as stated in the product labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Prolisina VR (Alprostadil) is primarily defined by warnings against additive effects with other drugs, rather than by pharmacokinetic interactions.

Contraindicated and Restricted Combinations

The most significant interaction constraint is the prohibition on combining Prolisina VR with other vasoactive agents injected locally, including certain smooth muscle relaxants. The safety and effectiveness of such combinations have not been established in clinical studies, and their use is not recommended by regulatory authorities. This restriction extends to Phosphodiesterase-5 (PDE5) inhibitors (such as Sildenafil and Tadalafil), as co-administration may increase the risk of severe, prolonged erection or systemic hypotension.

Pharmacodynamic Interactions

Product Category Officially Documented Effect
Anticoagulants (e.g., Warfarin, Heparin) Increased propensity for injection site bleeding or haematuria.
Antihypertensive Drugs Potential for systemic hypotension due to additive blood pressure-lowering effects.

Pharmacokinetic Profile and Other Notes

Regulatory documents confirm that the potential for pharmacokinetic drug-drug interactions with other agents, such as those involving CYP enzymes, has not been formally studied and is considered unlikely due to the rapid local metabolism and clearance of Alprostadil. One formulation note advises that the product is not intended to be mixed or co-administered with any other products during preparation or injection. The risk of hypotension when combined with antihypertensives is specifically noted to be a concern in elderly patients.

Mechanism of Action

The mechanism of action for Prolisina VR (Alprostadil) is defined by its ability to act as a synthetic agonist of the naturally occurring lipid mediator Prostaglandin E₁ (PGE₁), driving specific physiological changes.

Molecular Target Activation and cAMP Signaling

Alprostadil binds to and activates Prostaglandin E receptors (primarily the EP2 and EP4 subtypes) on cell surfaces. This action stimulates the enzyme Adenylate Cyclase, causing a rapid and significant rise in the intracellular secondary messenger, cyclic Adenosine Monophosphate ( cAMP). The resulting cAMP cascade is the central mechanism that drives the drug's physiological responses.

Dual Modulation of Vascular Tone and Platelet Activity

This domain addresses the simultaneous physiological consequences of the cAMP signal on two different cell types. In vascular smooth muscle, elevated cAMP leads to a reduction of intracellular calcium levels, resulting in smooth muscle relaxation and vasodilation (vessel widening). Concurrently, the same cAMP rise in platelets inhibits their activation and prevents aggregation. This combination results in a concurrent reduction in vascular resistance and inhibition of platelet activity.

Dosage and Administration Information

How to Use Prolisina VR: Official Administration Guidelines

Prolisina VR is a highly specialized medication whose use is governed by established protocols, focusing on the approved routes of administration, dose ranges, and delivery procedures. As its active ingredient, Alprostadil, is supplied as a lyophilized powder, the medication requires parenteral administration via injection or infusion.


Administration Routes and Preparation

Established protocols designate two primary routes: Continuous Intravenous (IV) Infusion for systemic support in conditions like Critical Limb Ischemia (CLI) and neonatal ductal patency, and Intracavernosal Injection for specific local indications. Prior to infusion, the powder must be reconstituted and subsequently diluted using approved solutions, such as 0.9% Sodium Chloride or 5% Dextrose Injection. Due to the compound's rapid metabolism, administration for systemic use requires a controlled infusion pump and must occur within a specialist clinical setting.


Dosing Patterns and Time Course

Administration schedules and doses are defined by the treatment context. For adult systemic use (e.g., CLI), the daily dose is typically administered as an intermittent infusion, often ranging from 40 mcg to 120 mcg total per day. This treatment is generally prescribed as a short-term course, usually lasting 14 to 28 days.

For neonatal systemic use (ductal patency), the dosing is highly sensitive and weight-based, starting as a continuous IV infusion at a rate of 0.05 to 0.1 mcg/kg/min. The dose is then meticulously titrated down to the lowest effective maintenance rate. For the neonatal regimen, specific dose adjustments for renal or hepatic impairment are often not required. The medication is used only temporarily until corrective surgical procedures can be performed.

Recent Clinical Evidence

Prolisina VR: Recent Clinical Evidence

Prolisina VR (alprostadil) is a synthetic form of Prostaglandin E1 (PGE1). Clinical evidence regarding this specific formulation focuses primarily on its established roles as a potent vasodilator and inhibitor of platelet aggregation. While research continues to investigate the anti-inflammatory and immunomodulatory properties associated with prostaglandins, the approved therapeutic indications are strictly defined by regulatory bodies based on evidence from controlled trials.

Key Findings in Approved Indications

  • Ductal Patency in Neonates: Studies confirm the use of Prolisina VR for the palliative, temporary maintenance of the patency of the ductus arteriosus in neonates with congenital heart defects. This temporary measure helps ensure adequate pulmonary or systemic blood flow until corrective surgery can be performed. Its effectiveness is highest when administered shortly after birth.
  • Erectile Dysfunction (ED): For the treatment of ED, clinical data supports its local application (intracavernosal injection or intraurethral suppository). The evidence indicates that the localized vasodilation and smooth muscle relaxation promoted by alprostadil facilitate the engorgement of the corpus cavernosum, leading to penile rigidity.

Research Profile and Safety

Evidence from clinical practice and observational studies suggests that when used in its approved pediatric application, alprostadil is rapidly metabolized and excreted, with systemic adverse effects being managed in a controlled environment. Research continues to explore the effects of PGE1 and its analogues on conditions outside the approved uses, such as certain hepatic disorders and transplant procedures, though these uses remain investigational.

Frequently Asked Questions (FAQ)

Common questions about Prolisina VR (FAQ)


Q: What is the main difference between Prolisina VR and older treatments for this condition?

A: Prolisina VR contains Alprostadil, which is a synthetic form of a naturally occurring substance called Prostaglandin E1 (PGE1). Regulatory documents describe this compound as a potent vasodilator, meaning it widens blood vessels, and a platelet aggregation inhibitor, which prevents initial steps of blood clotting. This defines it as a specific pharmacological class used for certain circulatory issues and specialized cardiac support.


Q: How long does it usually take to notice any effects from Prolisina VR?

A: Since this medicine is administered via infusion in a controlled setting, its physiological effects are typically observed soon after the start of the infusion. For its specialized cardiac use in neonates, a positive change in blood oxygenation or pressure is generally seen shortly after the start of the infusion, often within the first 10 minutes to several hours, depending on the patient’s clinical status.


Q: Is it okay to take Prolisina VR if I occasionally drink alcohol?

A: Official documentation does not provide instructions on combining Prolisina VR with alcohol. However, due to the drug's composition and function (which can include ethanol in certain formulations and a potential for lowering blood pressure), the effects of alcohol may need to be considered by the treating physician during the clinical assessment.


Q: Can Prolisina VR be used by people with a history of heart problems?

A: Regulatory documents state that this medication should be used with caution in patients with a history of unstable cardiovascular disorders or transient ischaemic attacks. The medicine is generally contraindicated (not recommended for use) in individuals who have severe heart failure or specific conditions that may be aggravated by the drug's action.


Q: Can elderly patients (over 65) use Prolisina VR safely?

A: Official labeling confirms that use in the elderly population is possible. However, it notes that older patients are more likely to have age-related kidney problems. For this reason, management with closer clinical review may be implemented to monitor how the medicine is cleared from the body.


Q: What happens if I forget to take a dose of Prolisina VR?

A: Prolisina VR is typically administered in a clinical setting via a continuous or intermittent infusion, not self-administered at home. If there is a concern that a scheduled dose or infusion period has been missed, this circumstance should be communicated to the healthcare professional managing the treatment, as continuous drug presence is often required for therapeutic effect.


Q: Is Prolisina VR known to cause weight gain or weight loss?

A: Weight gain or weight loss are not listed among the most common adverse reactions reported in the official product information for Prolisina VR's active ingredient, Alprostadil.


Q: How quickly does Prolisina VR leave the body after the last dose?

A: Alprostadil is very rapidly metabolized (broken down) in the body. Official regulatory information indicates that a significant amount of the circulating drug is cleared in a single pass through the lungs, which explains why continuous infusion is often necessary for a sustained effect.


Q: Is there a risk of dependence or addiction with Prolisina VR?

A: Regulatory documents defining the safety profile of Prolisina VR (Alprostadil) do not list or warn about dependence, misuse, or addiction potential.


Q: Does Prolisina VR affect blood sugar levels?

A: Official safety data lists that both Hypoglycemia (low blood sugar) and Hyperglycemia (high blood sugar) have been reported as adverse reactions in patients treated with the active ingredient, Alprostadil, although these effects occur infrequently.


Q: Is there a warning about using Prolisina VR with herbal remedies?

A: Official prescribing information focuses mainly on other prescription drugs. Information regarding all concurrent therapies, including herbal remedies, is generally part of the required clinical assessment by a treating physician.


Q: Why do some official sources list different potential side effects for Prolisina VR?

A: Differences in side effect lists occur because each regulatory agency (e.g., FDA, EMA) reviews separate clinical data sets to define the safety profile in its respective region. Variations may also arise from differences in reporting requirements, the specific patient populations studied, or the use of different drug formulations globally.


Q: Is Prolisina VR covered by most standard insurance plans?

A: Prolisina VR is classified as a prescription-only medication that must be used under medical supervision. Information regarding coverage and reimbursement by individual insurance plans or public healthcare systems is not provided in regulatory documents.


Q: Does Prolisina VR cause changes to mood or energy levels?

A: Official safety information lists infrequent central nervous system effects such as lethargy, hyperirritability, and jitteriness among the reported reactions in some patients. These reported effects suggest the potential for slight changes in energy or state.


Q: Is Prolisina VR available as a generic version?

A: Regulatory records confirm that the active ingredient, Alprostadil, has approved generic versions available for certain formulations in the United States and other regions, in addition to the brand-name Prolisina VR product.


Q: What is the purpose of the different strengths Prolisina VR is available in?

A: Different product strengths are made available by manufacturers to support precise dosing requirements for different patients and medical conditions. This allows healthcare professionals to tailor the medicine's dosage and preparation to specific needs, such as weight-based dosing for neonates.


Q: What is the recommended duration of treatment with Prolisina VR?

A: The duration of use is strictly dependent on the medical condition being treated. For adult use, treatment is typically a short-term course lasting around 14 to 28 days. For its specialized use in neonates, it is used only temporarily until corrective surgical procedures can be performed.


Q: Are there any restrictions on strenuous exercise while taking Prolisina VR?

A: Official information does not specify restrictions on strenuous exercise. Because Prolisina VR is a potent vasodilator that can cause hypotension (low blood pressure), activities that significantly alter circulation are typically managed within a clinical setting and reviewed by the treatment team.


Q: Does Prolisina VR interact with caffeine?

A: Specific warnings for dietary caffeine are not detailed in regulatory documents. However, clinical studies involving Alprostadil in neonates have examined the co-administration of Caffeine Citrate, and clinical co-administration is noted, indicating it is an area that must be professionally reviewed.


Q: How is Prolisina VR different from other 'VR' labeled drugs?

A: The 'VR' component is simply part of a proprietary brand name used by the manufacturer and does not represent a universal pharmacological class or meaning. Regulatory documents confirm that the medicine's action and identity are solely defined by its active ingredient, Alprostadil.


Q: Can Prolisina VR affect the results of common lab tests?

A: Yes, official safety data lists several effects on laboratory parameters in some patients. These include changes such as increased Blood Creatinine and alterations in potassium and cholesterol levels, among others.


Q: Is there any evidence suggesting Prolisina VR has been misused?

A: Regulatory documents address specific safety concerns such as the danger of overdose and prohibitions on combination with other drugs. However, official regulatory labeling does not contain sections or warnings discussing generalized drug misuse or diversion.


Q: Is Prolisina VR approved in European countries (EMA) as well as the US (FDA)?

A: Yes, regulatory documents confirm the active ingredient, Alprostadil, has been approved by the U.S. Food and Drug Administration (FDA). It is also authorized and subject to periodic safety assessments by the European Medicines Agency (EMA) in EU member states.


Q: Is it normal to feel a mild stomach upset when first starting Prolisina VR?

A: While the most commonly reported gastrointestinal reaction is diarrhea (in about 2% of patients), official safety data also lists infrequent reactions such as nausea. This suggests the potential for mild stomach discomfort may occur in some patients.


Q: How does Prolisina VR get eliminated from the body?

A: Prolisina VR is rapidly cleared primarily through metabolism (chemical breakdown) by the body's enzyme systems, with significant metabolism occurring in the lungs. The remaining inactive breakdown products are then typically excreted from the body, mostly through the urine.


Q: Why is the drug sometimes called by a different name in other countries?

A: The active ingredient, Alprostadil, maintains its international non-proprietary name regardless of location. However, the brand name (like Prolisina VR) is often specific to the manufacturer and country where it is marketed. The same active ingredient may be marketed under many different brand names globally.


Q: Does the efficacy of Prolisina VR decrease over time?

A: Regulatory documents do not state a general decrease in efficacy with approved, short-term use. For its specialized cardiac use in neonates, the drug is noted to be most effective when started soon after birth, which indicates that the underlying patient condition and responsiveness may change over time.


Q: Can Prolisina VR be used for conditions not listed on its main indication?

A: Official regulatory indications strictly define the conditions for which Prolisina VR is approved. Use for any condition outside of the established indications, such as specific circulatory issues or specialized cardiac support, is not supported by the product’s regulatory label.


Q: Is Prolisina VR considered a high-alert medication?

A: While the specific term 'high-alert' is not used in official labels, the product's serious safety warnings, including a requirement for use only in a controlled clinical setting and the potential for events like Apnea in neonates, classify it as a medicine that requires the highest level of clinical caution and monitoring.


Q: Do I need to avoid any specific foods or drinks while using Prolisina VR?

A: The official product information does not list any specific foods or non-alcoholic drinks that must be avoided. As with any specialized medication, information regarding all intake is typically part of the ongoing clinical assessment by the healthcare team.


Q: Can I start or stop taking Prolisina VR without discussing it with a healthcare professional?

A: No. Prolisina VR is a prescription-only medication administered in a specialist clinical setting. The decision to start, adjust, or stop this medicine is strictly managed by a qualified healthcare team due to the critical nature of the conditions it treats.


Q: Do I need a special prescription or monitoring to get Prolisina VR?

A: Yes. This is a prescription-only medication that requires a physician's order and must be administered in a specialist clinical setting. For neonates, the official label specifically mandates that cardio-respiratory monitoring and ventilatory assistance must be immediately available.


Q: What are the most commonly reported mild side effects of Prolisina VR?

A: According to regulatory data, the most frequently reported adverse reactions, classified as Very Common (ge 10%) in clinical trials, are fever (pyrexia) and flushing (reddening of the skin).


Q: Is Prolisina VR safe for people who have mild kidney problems?

A: Official labeling mandates that Prolisina VR be used with caution in patients with any degree of renal impairment (kidney disease). This is because kidney function may affect the body's ability to clear the medicine, and management may be reviewed during clinical monitoring.


Q: Are there any known issues with taking Prolisina VR and common vitamin supplements?

A: The official interaction profile focuses mainly on prescription drugs. Information regarding all concurrent vitamins and supplements is typically part of the overall clinical review conducted by the treatment team.


Q: Does Prolisina VR make you drowsy or affect your ability to drive?

A: The official product information for some formulations indicates that the drug would not be expected to have an influence on the ability to drive or operate machines. However, patients should be aware that infrequent central nervous system effects such as lethargy have been reported.


Q: Does Prolisina VR need to be taken with food, or can it be taken on an empty stomach?

A: This medication is administered parenterally (via injection or infusion), not orally, so instructions regarding taking it with food or on an empty stomach do not apply to Prolisina VR.


Q: Is the condition likely to return after stopping Prolisina VR treatment?

A: Prolisina VR is often used as a temporary or palliative measure. For its cardiac indication, it is used only until surgery can be performed. For other conditions, official evidence relates to short-term improvement, which suggests the underlying condition will require continued management or a definitive long-term plan.

How should Prolisina VR be stored and disposed of?

Storage and Disposal: Official Regulatory Information

Labeled Storage Temperature Requirements Unreconstituted powder: Store at Controlled Room Temperature (20 C to 25 C) with excursions permitted up to 30 C. Do not freeze.
Stability After Reconstitution The solution is for single use only. It must be used immediately or discarded within 24 hours when stored at or below 25 C, depending on the specific product presentation.
Handling and Protection Requirements Store the product in its original container/carton to protect it from light. The solution must be clear and colorless; discard the vial if precipitation or discoloration is observed.
Disposal Instructions Discard all unused or expired medicine according to local regulations. Used needles and syringes must be immediately placed in a safe, designated sharps disposal container [Source: FDA/EMA Labeling].
Child-Protection Storage The medicine must be kept out of the sight and reach of children [Source: FDA Labeling].

Official regulatory documents define how the product must be stored, protected, handled, and disposed of. This includes strict temperature controls for the powder, time limits for the reconstituted solution, and mandatory safe disposal of all injection supplies via a sharps container.

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

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