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Prostandin 0.003%

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Prostandin 0.003%

Quick Facts

Property Description
Active ingredient Alprostadil
Form Topical Ointment (Cream)
Pharmacological class Prostaglandin Analog, Vasodilator
Origin Synthetic (Identical to natural PGE1)

What Type of Medicine is Prostandin 0.003%?

Prostandin 0.003% is a prescription-only pharmaceutical preparation formulated as a topical ointment for local administration. Its core component is Alprostadil, which is clinically recognized for its vasoactive properties, placing the drug within the pharmacological class of prostaglandin analogs and functionally as a potent vasodilator. The preparation is a single-ingredient product, and its specific design as a 0.003% ointment distinguishes it by offering a non-invasive, topical delivery system, unlike other Alprostadil formulations intended for different routes, such as injection or intraurethral administration.

Composition and Origin: Alprostadil 0.003%

The composition of Prostandin 0.003% is precisely defined by the presence of Alprostadil at a 0.003% concentration, integrated into an inert cream base. Alprostadil is a synthetic compound that is chemically identical to the naturally occurring endogenous substance known as Prostaglandin E1 (PGE1). This exact chemical synthesis is supported by pharmacological studies to ensure the compound exhibits reliable biological activity. The 0.003% concentration refers specifically to the precise amount of the active ingredient present in this particular topical preparation.

Core Purpose and Primary Action

The fundamental purpose of Prostandin 0.003% is to promote local tissue vitality and function by initiating circulation enhancement directly at the site of application. Acting as a powerful local vasodilator, its primary function is to induce the smooth muscle relaxation within the walls of targeted blood vessels. By actively widening these vessels, the medication facilitates increased local blood flow, thereby supporting the crucial delivery of oxygen and nutrients to tissues that require robust circulation for their function and maintenance.

Regulatory References

  1. ECDC
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What side effects are possible with Prostandin 0.003%?

Possible Side Effects and Safety Information

The official safety profile for Prostandin 0.003% is structured around adverse reactions categorized by frequency and the body system affected. Regulatory documents establish that the most frequently reported adverse reactions are localized to the application site.

Adverse reactions are classified according to incidence, following standard regulatory frameworks:

  • Common (affecting up to 1 in 10 men): These effects are primarily categorized under the Reproductive System and General Disorders and Administration Site Conditions. They include penile burning sensation, penile pain, and penile erythema. Effects in the female partner, such as vaginal burning or vaginitis, are also documented as common.

  • Uncommon/Rare: These categories encompass less frequent systemic effects, including dizziness, headache, and hypotension, which are classified under Nervous System and Vascular Disorders. A key rare but serious adverse reaction noted in regulatory documentation is Priapism, defined as a prolonged erection.

Safety notes specify restrictions on use. The product is not recommended for men with certain pre-existing conditions that predispose them to priapism, such as sickle cell disease or multiple myeloma. Regulatory labels also restrict concomitant use with oral Phosphodiesterase Type 5 (PDE5) inhibitors due to an unexcluded potential for additive cardiovascular risk.

For specific populations, safety considerations are noted: the dose may require monitoring in individuals with renal or hepatic impairment. Furthermore, long-term safety data for the cream formulation are officially limited beyond a period of nine months of use.

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Overdose and Emergency Response

The official regulatory profile for an overdose of Prostandin 0.003% focuses on two primary documented classes of manifestation: systemic effects and local complications.

Systemic overdose, stemming from excessive vasodilation, may present with a drop in blood pressure (hypotension), dizziness, and fainting (syncope). Due to the potential for these documented systemic effects, regulatory cautions advise patients to avoid activities such as driving or hazardous tasks immediately following application where injury could result from sudden hypotension.

The primary local complication listed in official labeling is a prolonged erection that persists longer than 4 hours (priapism). Regulatory documents explicitly mandate that if the erection lasts for this duration, the patient must contact a doctor immediately or seek immediate medical assistance.

If priapism is not treated immediately, documented severe outcomes include penile tissue damage, permanent loss of potency, and permanent worsening of erectile function. The regulatory context notes that no specific antidote is known for this topical formulation; management is supportive and symptomatic, with potential for referral for surgical management if the prolonged erection persists.

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Therapeutic Uses of Prostandin 0.003%

What Prostandin 0.003% Treats: Main Uses and Benefits

Prostandin 0.003% is relevant for addressing the symptomatic burden of Erectile Dysfunction (ED) in adult men. This condition is marked by increased physiological stress where symptoms may intensify temporarily and interfere with daily functioning, specifically relating to sexual health. The medication is applied in addressing symptoms related to impairment of penile rigidity and difficulties with erectile maintenance.


Therapeutic Support

The medicine is relevant in clinical settings that involve acute or unstable symptom patterns, such as where standard oral ED treatments are ineffective or cannot be used, for example, in patients with certain vascular disorders or following pelvic surgeries. It is considered a localized option that may be part of symptomatic management, contributing to the availability of a therapeutic option. This medication is applied in addressing symptom clusters that may become intense or disruptive, helping with the management of functional erection symptoms and supporting symptom relief related to erectile duration.


Quick Fact: Symptomatic Support for Erectile Function

The medicine provides supportive relief for symptoms related to functional impairment, including Impairment of Penile Rigidity and Erectile Maintenance Difficulty.

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Eligibility and Restrictions for Use

Who Can and Cannot Use Prostandin 0.003%?

The population eligibility for Prostandin 0.003% is strictly defined by regulatory authorities based on sex, age, and specific underlying health conditions. The medicine is designated solely for use by adult men (aged 18 and older).


Absolute Contraindications (Must Not Use)

Official labeling mandates that the medicine must not be used in the following populations or conditions:

  • Women, including during pregnancy or lactation.
  • Patients with a known hypersensitivity to Alprostadil or any formulation excipients.
  • Men with conditions that predispose them to a prolonged erection (priapism), such as sickle cell anemia or leukemia.
  • Patients with certain penile anatomical deformities, including severe angulation, cavernosal fibrosis, or Peyronie's disease.
  • Men with a penile implant.
  • Patients for whom sexual activity is inadvisable due to underlying systemic health issues, such as severe cardiovascular disease.

Age and Restriction Considerations

Use is not recommended or not established for pediatric patients (under 18 years). Patients who are taking anticoagulants (blood thinners) require caution due to an increased localized risk.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation for Prostandin 0.003% (topical Alprostadil) primarily identifies risks associated with pharmacodynamic interactions rather than systemic metabolic changes.


Official Interaction Statements

Due to the minimal systemic absorption and rapid local metabolism of the topical formulation, the product's official prescribing information notes a lack of documented pharmacokinetic (PK) interactions with major enzyme systems like Cytochrome P450.

However, regulatory agencies advise caution and, in some cases, recommend against co-administration with other medications due to the potential for additive effects on blood pressure and vascular status.

  • Other Erectile Dysfunction (ED) Agents: Co-administration with other treatments for erectile dysfunction, including oral Phosphodiesterase type-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil) is not recommended. This restriction is due to an increased pharmacodynamic risk of symptomatic hypotension (low blood pressure) and priapism (prolonged erection).

  • Vasoactive Medications: Caution is warranted when co-administered with antihypertensive drugs or other vasodilators. The combined effect may increase the risk of systemic hypotension, a risk noted to be potentially more significant in the elderly population.

  • Anticoagulants and Antiplatelets: Concomitant use with agents such as warfarin or aspirin may increase the susceptibility to local bleeding or bruising at the application site due to a localized vascular interaction.

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Mechanism of Action

Prostandin is a topical prostaglandin F2alpha analog (Prostaglandin F2alpha PGF2alpha analog) designed to target the mathbfFP prostanoid receptor located primarily within the mathbfciliary muscle and mathbftrabecular meshwork of the ocular structure. The active moiety functions as a highly selective agonist for the FP receptor, a mathbfG protein-coupled receptor (GPCR).

Binding to the FP receptor activates the mathbfGq signaling pathway, leading to the intracellular cascade involving mathbfphospholipase C (PLC) activation and subsequent generation of mathbfinositol triphosphate ( IP3) and mathbfdiacylglycerol (DAG). This ultimately results in an increase in mathbfintracellular calcium levels.

The downstream consequence of this signaling is the mathbfrelaxation of mathbfciliary muscle fibers and the mathbfremodeling of the mathbfextracellular matrix (ECM) within the uveoscleral outflow pathway. This systemic physiological modulation increases the facility of aqueous humor outflow through the mathbfuveoscleral route, thereby regulating the fluid dynamics within the anterior segment of the eye.

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Dosage and Administration Information

How to Use Prostandin 0.003%

Prostandin 0.003%, a topical Alprostadil preparation, is administered exclusively by topical application to the urethral meatus at the tip of the penis. This method establishes the use as highly localized and must be preceded by instruction and assessment from a healthcare professional regarding the correct procedural technique.


Dosing and Schedule Principles

Standard usage is defined as as-needed, with application strictly limited to once per 24-hour period and no more than two to three times per week. The administered dosage involves using the entire contents of one single-use applicator, containing either 200 micrograms or 300 micrograms of the active substance. Dose selection and adjustment (titration) within this narrow range are determined by a physician.


Administration Protocol

The procedural protocol is time-sensitive, requiring the application to occur within a specific window of 5 to 30 minutes prior to the time of intended effect. It is recommended that individuals urinate prior to application to ensure proper conditions for use. The product is packaged in ready-to-use, single-use applicators, which must be fully used and then discarded immediately after a single administration. The expected duration of effect after proper application is approximately one to two hours. Usage of this specific Alprostadil preparation is not indicated for the pediatric population, defined as men under 18 years of age.

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Recent Clinical Evidence

Prostandin 0.003%: Recent Clinical Evidence

Core Evidence and Outcomes for Erectile Dysfunction (ED)

Research for Prostandin 0.003% (topical Alprostadil) involves Randomized Controlled Trials (RCTs) and Systematic Reviews. These studies were applied in studies examining patient-reported experiences related to functional limitations in adult men with ED. The primary research explored patterns by comparing the topical Alprostadil formulation to a placebo (an inactive cream base).

Outcomes monitored included changes to the Erectile Function (EF) domain score (a standardized functional scale) and activity-specific measures. These measures focused on the percentage of attempts that resulted in successful vaginal penetration and completion of intercourse. Studies monitored measurements related to functional status that varied across the observed groups. Findings describe group patterns related to short-term changes, but research does not determine whether an individual will respond similarly.

Evidence in Special Subgroups and Long-Term Use

Research has explored the medicine in subgroups including men with vascular risk factors and those who had previously received oral ED treatments. These studies were conducted during periods of increased symptom activity; however, results apply only to the populations studied. Data for certain groups may remain insufficient, and subgroup findings are uncertain.

Long-term effects are not fully characterized. Primary data reflect studies where follow-up durations were limited. The longest observation periods reported are up to a 9-month period. Evidence for outcomes beyond this intermediate time frame is limited.

Evidence Quality and Research Gaps

The overall evidence base contributes to the broader landscape, but some degree of certainty remains low. One area where comparative evidence is lacking is against other established oral medications for ED. Furthermore, regulatory and scientific bodies have noted that evidence quality varies across studies, with some analyses citing heterogeneity and variability in design. Some analyses described patterns where the measured effect size was observed to be modest. These research limitation frames highlight areas where more information is needed.

Key Studies & References

  1. Australian Public Assessment Report (AusPAR) for Alprostadil (Proshaeos)
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Frequently Asked Questions (FAQ)

Common questions about Prostandin 0.003% (FAQ)


Q: What is the risk of using Prostandin 0.003% if I take blood thinners?

Regulatory documents indicate that using this topical medicine alongside anticoagulants (commonly called blood thinners) or antiplatelet agents may increase the risk of localized bleeding or bruising at the application site. Systemic absorption is minimal, suggesting the interaction is primarily localized. Official guidance notes that eligibility for use should be reviewed by a prescribing healthcare provider.


Q: What does the official research say about the long-term use of Prostandin 0.003%?

Regulatory documents state that safety data for the cream formulation are limited. The longest observation periods reported in clinical trials used to characterize the drug’s profile extended up to a 9-month period. Long-term effects beyond this period are not fully characterized.


Q: What ingredients are in Prostandin 0.003% besides the active medicine?

According to the official product information, Prostandin 0.003% contains the active ingredient Alprostadil along with a list of inactive ingredients (excipients), which form the cream base and aid in absorption. The complete list of excipients can be found in the official labeling documents.


Q: Are there any known severe or life-threatening reactions associated with Prostandin 0.003%?

The official safety profile notes that a rare but serious adverse reaction is Priapism, which is defined as a prolonged erection lasting longer than four hours. Other infrequent systemic effects documented include symptomatic hypotension (low blood pressure) and fainting. An erection lasting longer than four hours is defined in regulatory documents as a prolonged erection requiring immediate medical evaluation.


Q: What kind of studies support the use of Prostandin 0.003%?

The official evidence base for this medicine is derived from regulatory sources. These include studies such as Randomized Controlled Trials (RCTs), which monitor patient-reported experiences and functional measures to support the medicine’s use.


Q: Is there a maximum time frame for how long Prostandin 0.003% can be used?

Official regulatory documents do not specify a fixed maximum treatment period, though clinical follow-up data is limited to nine months. The medicine is directed to be used 'as-needed' within the prescribed limits.


Q: Why is Prostandin 0.003% prescribed for more than one condition?

Official documentation focuses on the single primary indication (Erectile Dysfunction) and does not list other approved uses. The core purpose of the medicine is related to circulation enhancement locally at the site of application.


Q: Is Prostandin 0.003% the same kind of medicine as others for this condition?

Prostandin 0.003% is classified as a Prostaglandin Analog, which functions as a direct vasodilator. This is chemically distinct from other common oral treatments for the condition, such as PDE5 Inhibitors. Co-administration with oral PDE5 inhibitors is not recommended due to a potential risk of additive effects.


Q: Is it normal to feel a stinging sensation after using Prostandin 0.003%?

Adverse reactions, including a penile burning sensation or pain at the application site, are documented as Common in regulatory information, meaning they may affect up to 1 in 10 men. These localized effects are typically mild and transient.


Q: Can Prostandin 0.003% be used by people with sensitive skin/areas?

The medicine is designed for localized application. Official information notes that local effects like burning, pain, and redness are common side effects. Eligibility for use must be determined by a healthcare provider.


Q: Does Prostandin 0.003% interact with common pain relievers?

Official interaction statements primarily focus on other vascular medications and antiplatelet agents (like aspirin). Specific interaction studies with general pain relievers may be lacking, but caution is generally warranted when combining with any medication that affects vascular status.


Q: Are there any specific foods or drinks to avoid while using Prostandin 0.003%?

The regulatory documents and official product label for this medicine make no specific statements that require the avoidance of any particular foods or drinks while using this product.


Q: Can elderly patients use Prostandin 0.003%?

The medicine is indicated for adult men (18 years and older). Official warnings note that caution is warranted in the elderly because of a documented increased risk of systemic hypotension (low blood pressure) if the medicine is co-administered with blood pressure drugs. Any patient considering use must have their eligibility reviewed by a healthcare provider.


Q: Is Prostandin 0.003% safe for use during pregnancy or breastfeeding?

According to official documentation, Prostandin 0.003% is strictly contraindicated for use in women, including those who are pregnant or breastfeeding. Regulatory guidance states that a barrier contraceptive method should be used if the partner is pregnant.


Q: Is there evidence for Prostandin 0.003% in patient groups outside the main uses?

Studies and official information indicate that research has been conducted in specific subgroups of men. These include those with vascular risk factors and those who had previously received oral ED treatments but were not satisfied with the results.


Q: Can I use Prostandin 0.003% if I have an underlying heart condition?

Official labeling states the medicine is contraindicated if sexual activity itself is inadvisable due to a serious underlying systemic health issue, such as severe cardiovascular disease or recent stroke. The use of this medicine must be determined by a physician.


Q: What should I do if the side effects of Prostandin 0.003% feel mild but bothersome?

Official documents state that any patient who notices side effects, including those that are mild but cause ongoing concern, should discuss them with a healthcare provider. Serious side effects, like a prolonged erection, require immediate medical attention.


Q: Is Prostandin 0.003% meant for short-term or ongoing use?

Official dosing and administration principles define the usage as 'as-needed' to achieve the intended effect, with administration strictly limited to once per 24-hour period. This usage pattern supports its function as a time-specific treatment.


Q: Does using Prostandin 0.003% affect driving or operating machinery?

The drug may cause side effects like dizziness or fainting (hypotension). Due to the potential for these effects, official guidance suggests avoiding activities such as driving or operating machinery for one to two hours after application.


Q: Can Prostandin 0.003% be used alongside herbal supplements?

Specific interaction studies with herbal supplements are lacking in regulatory documents. General caution is warranted when combining the medicine with any substance that may have vasoactive effects (affects blood vessel function).


Q: Is it common to see fluctuations in effects when using Prostandin 0.003%?

Regulatory documents state that the actual duration of effect, which is typically one to two hours, will vary from patient to patient. This acknowledged difference in individual response suggests that variability in outcome is an expected pattern with this medicine.


Q: What is the difference between Prostandin and similar drugs mentioned online?

Prostandin is a topical application of a prostaglandin analog, designed for highly localized delivery. This differs from oral medications for the same condition, which work systemically (throughout the body). Official warnings caution against combining Prostandin with oral PDE5 inhibitors.


Q: Is the active component in Prostandin 0.003% a type of steroid?

No. Official classification confirms that the active component, Alprostadil, is classified as a Prostaglandin Analog and a vasodilator, not a steroid.


Q: Does the medicine lose its strength over time after the package is opened?

Official storage and disposal instructions state that each applicator is for single use only. Any remaining or unused portion of the product must be discarded immediately after the single administration, preventing storage or stability questions post-opening.


Q: How does Prostandin 0.003% get absorbed into the body?

The topical formulation is designed for highly localized action at the site of application. Pharmacokinetic studies indicate that systemic absorption into the general bloodstream is minimal, and the drug is rapidly metabolized near the site of action.


Q: What is considered an overdose of Prostandin 0.003%?

The medicine is limited to once per 24 hours. The regulatory label defines signs of a potential overdose as a prolonged erection (lasting longer than 4 hours) or the occurrence of severe hypotension (very low blood pressure) and fainting.


Q: If I have kidney or liver issues, can I still use Prostandin 0.003%?

The medicine is not strictly contraindicated for individuals with liver (hepatic) or kidney (renal) impairment. However, official safety notes state that the dose may need to be monitored carefully by a physician in individuals with these specific health issues.


Q: Does Prostandin 0.003% affect fertility?

The official product information notes that it is not known whether Alprostadil cream has an effect on human male fertility. This information is generally not characterized in the current regulatory documentation.


Q: Can people with diabetes use Prostandin 0.003%?

The medicine is not specifically contraindicated for patients with diabetes. Clinical studies included men with vascular risk factors, which are often associated with diabetes, suggesting eligibility is determined by a physician based on overall health status.


Q: Does Prostandin 0.003% require refrigeration?

Official storage instructions typically require the product to be stored in the refrigerator (e.g., 2 C to 8 C) for long-term stability. The medicine may be permitted to be kept at a controlled room temperature for short periods before the intended use.


Q: Are there known drug-disease interactions with Prostandin 0.003%?

Yes, regulatory documents list specific diseases that contraindicate the use of this medicine. These include conditions that predispose men to priapism (e.g., sickle cell disease, leukemia) and certain anatomical deformities of the application site (e.g., Peyronie's disease).

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How should Prostandin 0.003% be stored and disposed of?

Official Storage and Disposal Requirements

Storage and disposal instructions for Prostandin Ointment 0.003% are defined in official regulatory documents to ensure product stability and safety.

Storage Conditions

Prostandin Ointment must be stored away from direct sunlight, heat, and moisture. It is a mandatory requirement to keep the medicine out of the reach of children.

Storage Restriction Requirement
Environmental Protection Store away from direct sunlight, heat, and moisture.
Child Safety Must be kept out of the reach of children.

Post-Use Handling and Disposal

Any remaining or unused portion of Prostandin Ointment must be discarded immediately after the intended use and must not be stored. For the proper method of disposal for any unused or expired product, patients are instructed to consult with their pharmacy or medical institution.

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

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