Vasoprost

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Vasoprost

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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 Vasoprost

Quick Facts

Property Description
Active ingredient Alprostadil (INN)
Form Lyophilized powder for solution for infusion
Pharmacological class Peripheral Vasodilator, Prostaglandin Analogue
General purpose Enhancing blood flow and tissue perfusion
Origin Synthetic analogue of Prostaglandin E1

What is Vasoprost and its Active Component, Alprostadil?

Vasoprost is a specialized, prescription-only pharmaceutical preparation whose primary active ingredient is Alprostadil (INN). Alprostadil is a synthetic analogue of the naturally occurring biological compound Prostaglandin E1 (PGE1), belonging to the class of local regulators known as Eicosanoids. The unique characteristic of Vasoprost is its formulation as a sterile lyophilized powder intended for reconstitution into an aqueous solution for parenteral delivery, a design that supports its clinical application in scenarios requiring precise systemic delivery. This pharmaceutical strategy is clinically recognized for providing high bioavailability of the active compound.

What is the Pharmacological Class and Dosage Form of Vasoprost?

Vasoprost is categorized within the high-level pharmacological class of vasodilators, functioning specifically as a potent peripheral vasodilator. The dosage form is designed exclusively for parenteral administration via infusion, marking a key difference from other forms of Alprostadil intended for localized injection. The specific classification of Alprostadil as a prostaglandin analogue confirms its role in relaxing vascular smooth muscle. This principle is well-established in vascular pharmacology.

What is the General Purpose of Vasoprost?

The general therapeutic purpose of Vasoprost is to significantly enhance blood flow by promoting the relaxation of the arterial walls, a process called vasodilation. By inducing this widespread relaxation, the medicine increases the diameter of the vessels, thereby elevating the perfusion, or delivery, of oxygen and vital nutrients to tissues that are compromised due to diminished peripheral circulation. A typical use scenario involves conditions where blood vessel narrowing severely limits circulation to the limbs.

What side effects are possible with Vasoprost?

Possible Side Effects and Safety Information

The safety profile of Vasoprost (Alprostadil infusion) reflects its classification as a potent peripheral vasodilator, with potential adverse reactions generally organized by frequency and the body system affected, according to regulatory documents like the FDA and SmPC.

Frequency-Classified Adverse Reactions

The most commonly reported effects arise from the medicine's systemic action:

Classification Examples of Reactions
Very Common (ge 1/10) Transient Pyrexia (Fever), Apnea, Flushing (Cutaneous Vasodilatation)
Common (ge 1/100 to <1/10) Hypotension, Bradycardia, Tachycardia, Seizures, Edema, Diarrhea, Sepsis

Serious Adverse Reactions and Safety Patterns

The official labeling documents certain serious adverse reactions, which include Apnea, Cardiac Arrest, and Cerebral Bleeding. Structural alterations, such as the weakening of the pulmonary artery or ductus arteriosus walls, are also documented safety concerns. Specific time-related patterns are noted: Apnea is typically observed during the first hour of infusion, while events like Gastric Outlet Obstruction and cortical bone proliferation are associated with the duration of therapy and cumulative dose in relevant patient groups.

Population-Specific Considerations

Safety statements often relate to neonates, who may experience an increased risk of apnea if they have a low birth weight. The risks of gastric outlet obstruction and cortical bone changes are tied to the long-term use of the infusion in this population. The regulatory documents also list high-level constraints, noting that severe hypotension, fever, or bradycardia may be potential signs of drug overdosage.

Overdose and Emergency Response

️ Overdose and when to seek help

The official regulatory profile for Vasoprost (Alprostadil) overdose focuses on recognizing severe manifestations of excessive vasodilation and ensuring mandatory emergency actions are taken.

Manifestation Type Documented Signs and Outcomes
Systemic Effects Hypotension, Pyrexia, Flushing, Dizziness, Fainting.
Critical Risks Apnea (cessation of breathing), Bradycardia, permanent loss of potency (due to untreated Priapism).
Mandated Actions Discontinue or reduce infusion rate; Seek immediate medical assistance.

Official Overdose Statements

  • Signs of overdosage, such as Apnea or Bradycardia, require immediate discontinuation of the infusion and necessary medical intervention.
  • Hypotension and Pyrexia are documented signs of overdosage that mandate reducing the rate of infusion.
  • A Prolonged Erection (lasting over four hours) or Priapism is a documented sign of overdose that requires immediate medical assistance to mitigate the risk of permanent tissue damage.
  • The regulatory guidance indicates that management is purely symptomatic and supportive, as no specific antidote is known.

Connection to the Overall Overdose Profile

Regulatory documents define the overdose profile primarily through two critical systems: severe systemic effects (hypotension, apnea) and local vascular complications (priapism). The required emergency actions are strictly procedural, mandating the discontinuation or reduction of the infusion for systemic effects, and mandating immediate medical consultation for the time-sensitive local vascular complications.

Therapeutic Uses of Vasoprost

What Vasoprost Treats: Main Uses and Benefits

Vasoprost may assist patients in managing periods of heightened symptomatic distress, and is commonly used to address symptoms that interfere with daily functioning. This supportive role is considered relevant in clinical settings where short-term symptomatic assistance is needed. The medication's active component is considered relevant in clinical settings to manage conditions associated with significant physiological strain, particularly when additional management of discomfort is required in patients with chronic symptomatic conditions.

The medication helps address symptom clusters that may become intense or disruptive and is used for conditions characterized by periods of heightened symptoms or those involving episodic manifestations. It supports general well-being by easing distress and assists with maintaining functional stability.

“It contributes to improved day-to-day comfort during symptomatic periods, helping patients cope more steadily with symptom fluctuations.”

Quick Fact: Supports Symptomatic Discomfort

Support in Acute or Recurrent Symptom Episodes

Vasoprost is used in situations involving certain distressing symptoms that involve acute or unstable symptom patterns. It is relevant when symptoms create noticeable physiological strain and short-term symptom stabilization may be helpful.

Eligibility and Restrictions for Use

Vasoprost (Alprostadil Infusion) is strictly limited by regulatory documents to a specific population and clinical condition. Use is allowed only in neonates who have ductal-dependent congenital heart defects, where the temporary maintenance of a patent ductus arteriosus is required until corrective or palliative surgery can be performed.

The medicine is contraindicated and must not be used in neonates with a known hypersensitivity to alprostadil or any of its excipients. It is also contraindicated in neonates diagnosed with Respiratory Distress Syndrome or certain complex cardiac or pulmonary circulatory conditions, such as persistent fetal circulation.

Eligibility is restricted in several instances requiring special consideration. Neonates weighing less than 2.0 kg at birth require close monitoring due to an increased risk of complications. Caution is advised for those with bleeding tendencies, or when treatment duration exceeds 120 hours. Additionally, the medicine's use is not established or no data is available for children, adolescents, adults, or geriatric patients for this specific indication. Conditions like severe liver disease or epilepsy require special consideration due to the formulation's excipients.

What should I know about interactions with other medicines?

Vasoprost Interactions with other medicines and products

Official regulatory information describes interactions for Vasoprost (Alprostadil) primarily based on pharmacodynamic reinforcement and specific administration restrictions.

Documented Pharmacodynamic Interactions

Co-administration with certain agents may enhance their effects, as noted in official prescribing information:

Interacting Class Documented Interaction Outcome
Antihypertensives or Vasodilators May enhance the effect, increasing the risk of hypotension (low blood pressure).
Anticoagulants (e.g., Warfarin, Heparin) May increase the propensity for local bleeding at the administration site due to additive anti-platelet effects.
Sympathomimetics These agents may lead to a reduction of Vasoprost's effect.

Interaction Restrictions and Limitations

Official labeling includes specific restrictions on use and notes on interaction studies:

  • Contraindicated Combination: Co-administration with other vasoactive treatments for erectile dysfunction is restricted to prevent the risk of a prolonged erection.
  • Pharmacokinetic Interactions: The potential for pharmacokinetic drug-drug interactions (such as those mediated by CYP enzymes or transporters) has not been formally studied by regulators and is not documented.
  • Excipient Consideration: A caution is noted for the excipient Benzyl Alcohol. In patients with hepatic or renal impairment, there is a documented risk of accumulation and toxicity from this preservative.

Mechanism of Action

How Vasoprost Works

Vasoprost acts by modulating core biological pathways that regulate blood vessel tone and flow dynamics. Its action is primarily segmented into two mechanistic domains.


Molecular Agonism Leading to Vascular Relaxation

The active component functions as a direct agonist at specific Prostanoid Receptors (EP Receptors), predominantly EP2 and EP4, found on arterial smooth muscle cells. Receptor binding rapidly activates Adenylate Cyclase, which causes an increase in the intracellular messenger cyclic AMP (cAMP). This cAMP cascade reduces the concentration of free calcium ions ( Ca^2+) within the smooth muscle cells, forcing the tissue to relax and resulting in significant peripheral vasodilation (widening of blood vessels).


Modulation of Microcirculatory Dynamics

Simultaneously, the same cAMP pathway is engaged in platelets, where its elevation acts to inhibit their activation and aggregation. This dual mechanism—reducing vascular resistance through vasodilation while inhibiting micro-clot formation—results in a significant increase in arterial inflow and tissue perfusion (delivery of blood and nutrients).


Functional Constraints of the Mechanism

The vasodilatory effect is mechanistically constrained in peripheral areas where blood vessels have suffered severe, irreversible structural damage, as the necessary receptors or functional smooth muscle may be absent. Furthermore, the mechanism's sustained intensity is limited by the drug's rapid enzymatic clearance.

Dosage and Administration Information

Vasoprost is administered solely through the parenteral route via either Intravenous Infusion (IV) or Intra-arterial Infusion (IA), and its use requires administration in a supervised healthcare setting. It is supplied as a lyophilized powder that requires specialized preparation: the powder must first be reconstituted with a sterile diluent and then further diluted in a suitable infusion solution, such as isotonic saline or a 5% glucose solution, prior to delivery. The final solution must not be mixed with other medicinal products.

The standard adult regimen is determined by the chosen route and frequency. For intravenous infusion, the total daily dose is typically 40 mcg to 60 mcg of Alprostadil, which may be administered once or divided into twice-daily infusions. The IV administration is delivered slowly over a period of approximately two hours. For the intra-arterial route, the standard dose is often 10 mcg to 20 mcg, administered once daily, with the infusion lasting between 30 and 60 minutes.

The overall use of Vasoprost is defined by a finite treatment course, generally lasting three to four weeks of consecutive daily use. This cyclical pattern requires formal assessment after the initial course; the treatment is instructed to be discontinued if a satisfactory result is not achieved within this period. Dosing for older adults generally adheres to the standard adult regimen, with no explicit, universal dose reduction mandated in regulatory summaries.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Vasoprost

Evidence for Use in Advanced Peripheral Circulatory Deficit

The clinical evaluation of Vasoprost has primarily focused on the evaluation of the treatment in adults experiencing advanced peripheral circulatory deficit, a condition where blood flow to the limbs is severely compromised. The evidence base includes several randomized controlled trials (RCTs), which compared the treatment to a placebo control, alongside systematic reviews and meta-analyses. These studies centered on individuals presenting with outcomes related to physical discomfort, such as chronic ischemic rest pain, and tissue issues like non-healing ulcers. Research has examined the condition in patients who had either exhausted options for surgical revascularization or were not suitable candidates for those procedures.

Types of Studies and Outcomes Examined

The research explored how symptoms evolved in the observed populations during and after short-term treatment. The main clinical outcomes researchers measured included evaluation of the intensity of ischemic rest pain and monitoring tissue status, examining outcomes related to the healing of non-major ulcers. The research also examined major clinical outcomes, including the frequency of a major amputation and the frequency of overall mortality.

Study Populations and Cohorts

Vasoprost was studied for populations composed primarily of adults, with a high representation of older adults. These studies evaluated individuals with the most severe classification of peripheral arterial disease, including patients with significant coexisting conditions such as diabetes and hypertension. The results apply only to these specific populations studied, and subgroup findings are uncertain.

Long-Term Studies and Follow-up Durations

The treatment phase in the studies was often short-term (e.g., a few weeks). Researchers monitored major clinical events over intermediate to long-term follow-up periods, frequently tracking outcomes up to six months or one year. However, data related to outcomes over periods longer than one year remains limited.

What is Still Uncertain About the Research

The evidence base for Vasoprost is not fully established, and certainty remains low in certain areas. Findings were mixed when examining the impact on the most serious clinical endpoint, the avoidance of major amputation, with research noting evidence has been observed to show inconsistent findings across key studies. Furthermore, information regarding patient-reported outcomes reflecting daily functioning or quality of life are not consistently available from the primary trials.

Frequently Asked Questions (FAQ)

Common questions about Vasoprost (FAQ)

Q: What is the main ingredient in Vasoprost?

The primary substance in Vasoprost is Alprostadil. Regulatory documents describe Alprostadil as the active ingredient responsible for the drug's intended effects.

Q: Are there different strengths of Vasoprost available?

Vasoprost is supplied as a lyophilized powder that requires preparation before use. Official product information indicates it is typically available in vials containing a specific strength of the active substance, often listed as 20 mug or 50 mug.

Q: How long does the effect of one Vasoprost dose typically last in the body?

Studies on the drug's behavior in the body show that Alprostadil has a very short half-life, meaning it is broken down and eliminated quickly, often within minutes after the infusion is finished. This is characteristic of how the drug is designed to work.

Q: What is the main reason doctors prescribe Vasoprost?

Regulatory documents describe Vasoprost as indicated for the long-term management of chronic occlusive arterial disease, specifically affecting the limbs.

Q: Is Vasoprost a type of antibiotic or pain reliever?

According to official sources, Vasoprost is classified as a prostaglandin E1 analog, which means it is related to naturally occurring body compounds. It primarily acts as a vasodilator, working to widen blood vessels.

Q: Is Vasoprost considered a 'blood thinner'?

Official documents describe Vasoprost as having properties that help inhibit (prevent) the aggregation of platelets, which is similar to how some 'blood thinners' work. However, its primary classification is based on its structure as a prostaglandin analog, and its main effect is widening blood vessels.

Q: Can Vasoprost be used by people who have high blood pressure?

Regulatory warnings indicate that caution and close monitoring may be required when Vasoprost is used in people with pre-existing cardiovascular issues, including severe or uncontrolled high blood pressure. This information is provided in the drug’s official warnings and precautions section.

Q: Are there any common foods or supplements that should be avoided while taking Vasoprost?

Regulatory documents concerning Vasoprost interactions primarily focus on concurrent use with other medications. Specific warnings regarding common food or supplement restrictions are not typically listed in the official product information.

Q: Does Vasoprost cause weight gain or loss, according to research?

Changes in body weight are not listed among the common or very common side effects described in the official regulatory documents for Vasoprost. The full list of reported adverse reactions is contained in the product’s official safety information.

Q: Is it normal to feel slightly dizzy when first starting Vasoprost?

Regulatory documents acknowledge that dizziness is one of the common adverse reactions associated with Vasoprost. Other common reactions listed in official sources include flushing and headache.

Q: Can Vasoprost affect how someone drives or operates machinery?

The official regulatory text advises that this medication may cause a temporary drop in blood pressure. This effect is described as potentially impairing a person's ability to drive or operate complex machinery.

Q: Is Vasoprost something that needs to be taken long-term?

Vasoprost is indicated in regulatory documents for the 'long-term treatment' of chronic occlusive arterial disease. This means that, depending on the specific condition, the treatment is typically intended for an extended duration.

Q: What kinds of patient conditions disqualify someone from using Vasoprost?

The official product information specifies several contraindications, which are conditions where the drug should not be used. These include a known hypersensitivity (severe allergic reaction) to Alprostadil, acute or subacute cardiac failure, and having recently experienced a stroke or heart attack.

Q: What does 'contraindicated' mean in relation to Vasoprost?

'Contraindication' is a medical term used to describe a specific circumstance or patient condition where the use of a medication is described as potentially harmful. Regulatory sources use this term to clearly list situations in which Vasoprost should not be administered.

Q: Does Vasoprost interact with alcohol?

Official drug information documents do not typically list a specific, formal interaction between Vasoprost and alcohol. However, warnings often exist regarding the concurrent use of other agents that cause vasodilation (blood vessel widening).

Q: Do studies suggest Vasoprost is effective for its primary purpose?

Regulatory documents include summaries of controlled clinical trials that contained results relevant to the drug's intended use. These studies described improvement in various measurable outcomes related to peripheral arterial disease.

Q: Is Vasoprost a prescription-only medication?

The regulatory status across jurisdictions confirms that Vasoprost is classified as a Prescription-Only Medicine (POM).

Q: What are the key findings from the clinical trials for Vasoprost?

Summaries within the regulatory documents describe the findings relevant to the drug’s intended use. Key findings from clinical trials often include data on measurements such as pain reduction, the healing rates of ulcers, and the time to any necessary amputations.

How should Vasoprost be stored and disposed of?

Storage and Disposal Requirements for Alprostadil (Vasoprost)

The unreconstituted powder must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). It must be kept in its original container, tightly closed, and protected from excessive heat, moisture, and freezing.

Stability and Handling

Once reconstituted, the solution has a short stability period, typically up to 24 hours, and should be used immediately or discarded if not used within the time specified by the labeling. The solution must be visually inspected for discoloration or particles before use.

Disposal

Alprostadil must be kept out of the sight and reach of children and pets. All used needles and syringes are considered sharps and must be placed immediately in an FDA-cleared sharps disposal container. Unused or expired medication and remaining vials should be disposed of in accordance with local regulations or medication take-back programs.

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

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