Мьюз

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Мьюз

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Overview of Мьюз

Quick Facts

Property Description
Active Ingredient Alprostadil (Prostaglandin E1)
Form Urethral Suppository
Pharmacological Class Vasodilator, Prostaglandin Analogue
Route of Administration Transurethral (Local)
Origin Synthetic

Defining Мьюз: Active Ingredient and Classification

Мьюз (MUSE) is a prescription pharmaceutical preparation containing Alprostadil, a potent local vasodilator. Alprostadil is the generic name for Prostaglandin E1 (PGE1), a synthetic compound categorized pharmacologically as a prostaglandin analogue. This substance acts as a vasoactive agent, exerting a direct effect on local vascular tissues to facilitate increased blood flow. It is characterized by its ability to act as a direct muscle relaxant, which supports localized circulation.

The Unique Transurethral Delivery System

A defining feature of Мьюз is its pharmaceutical form: a specialized urethral suppository administered via the Medicated Urethral System for Erection (MUSE) device. This preparation is a single-ingredient product designed for transurethral delivery, where a small, solid pellet is placed directly into the urethra. The suppository consists of Alprostadil within an inert macrogol vehicle. This vehicle is formulated to melt at body temperature, allowing for the rapid, local-acting absorption of the active compound. This delivery method concentrates the vasoactive agent at the target site through a non-invasive route.

General Purpose and Mechanism Summary

The general pharmaceutical purpose of Мьюз is to support the physiological responses required to achieve or maintain an erection through targeted local action. The active ingredient, Alprostadil, functions as a smooth muscle relaxant on the arterial walls within the penis. Pharmacologically, it is utilized in the management of specific functional deficits that require an increase in penile blood flow. By inducing the relaxation and widening of these blood vessels, the medication promotes a significant increase in local circulation, which serves as the basis for its therapeutic use.

Regulatory References

  1. EMA
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What side effects are possible with Мьюз?

Possible side effects and safety information

The safety profile for Mьюз (Alprostadil Urethral Suppository) is based on official government regulatory documents, which categorize adverse reactions by frequency and physiological system affected. As a locally administered vasodilator, the most frequent reactions are generally local and transient.


Adverse Reaction Classifications

Classification Examples of Documented Reactions
Very Common (Occurring in ge1 in 10 patients) Penile pain, Urethral burning or pain.
Common (Occurring in ge1 in 100 to <1 in 10 patients) Headache, Dizziness, Symptomatic Hypotension (low blood pressure), Minor urethral bleeding or spotting, Testicular pain, Penile fibrosis, or Penile angulation.

Systemic and Serious Safety Considerations

Adverse effects documented in the official labeling involve the Reproductive System and Vascular/Nervous Systems. Systemic reactions include dizziness and headache. Due to its vasodilatory action, Symptomatic Hypotension and Syncope (fainting) have been reported, with syncope typically occurring within one hour of administration.

Serious Adverse Reactions officially listed include Priapism (a prolonged erection lasting four to six hours or longer) and the development of anatomical changes such as Penile Fibrosis (e.g., Peyronie's disease), which may necessitate discontinuation of the medicine.

Safety Constraints and Restrictions

Regulatory documents outline specific contraindications for use. The medication is not recommended for men with certain blood disorders predisposing them to priapism (e.g., sickle cell disease or multiple myeloma) or men with anatomical abnormalities (e.g., urethral stricture or severe penile curvature). Co-administration with other treatments for erectile dysfunction, such as oral PDE5 inhibitors, is restricted due to the potential risk of severe hypotension and priapism.

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Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information for Мьюз

Overdose Scope Detail
Documented Overdose Presentations: Priapism (a prolonged, painful erection) is the primary local manifestation. Systemic signs may include hypotension (low blood pressure), dizziness, lightheadedness, and syncope (fainting) due to systemic absorption.
Physiological Systems Affected: Local penile vasculature (leading to priapism) and the Cardiovascular System (leading to systemic hypotension).
Dose-Related or Exposure Factors: Overdose classification is primarily based on the resulting clinical manifestation; the critical factor is an erection lasting longer than four hours.
Population-Specific Overdose Notes: No specific population-based considerations (e.g., geriatric, renal, hepatic) related to overdose management are explicitly stated in official labeling.
Emergency-Response Statements: The mandated action is to seek immediate medical attention or contact a doctor immediately.
When Immediate Medical Help Is Required: Immediate medical help is required if the patient experiences an erection that persists for longer than four hours.

Overdose Management and Constraints

Official Overdose Statements:

  • The onset of priapism, defined as an erection lasting longer than four hours, mandates that the patient seek immediate medical attention.
  • Untreated priapism carries the regulatory-documented risk of severe outcomes, including permanent damage to the penis and loss of potency.
  • Management of overdose is officially limited to symptomatic and supportive treatment.
  • No specific antidote is known or documented in the official prescribing information for reversing the effects of the active ingredient.

The regulatory guidance defines the overdose profile primarily by the duration of the erection, establishing the four-hour threshold as the critical condition that triggers the mandatory need to seek immediate medical help. The profile identifies permanent penile tissue damage as the most severe, documented outcome of untreated priapism. Management is officially limited to supportive care against potential systemic effects and local complications.

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Therapeutic Uses of Мьюз

What Мьюз Treats: Main Uses and Benefits

This medication is commonly used to help manage symptoms related to Erectile Dysfunction (ED), or sexual impotence. This condition is characterized by the persistent inability to achieve or maintain an erection firm enough for satisfactory sexual performance. It is applied in clinical settings where patients experience symptoms of deficient penile rigidity or the premature loss of erection, and is used for managing the primary therapeutic benefit of contributing to achieving functional rigidity on an on-demand basis.


Мьюз is generally utilized as a second-line treatment for adult men whose symptoms of ED may not have been adequately managed by first-line oral medications. This use is relevant for easing symptoms that create noticeable functional strain in those who cannot achieve the necessary rigidity with systemic therapy, offering an effective, localized alternative that supports the patient during difficult episodes by easing distress. The key indications include Erectile Dysfunction of primarily organic etiology, as well as use as an adjunct to diagnostic tests. The treatment is considered relevant for managing dysfunction stemming from underlying organic etiologies, including those linked to local vascular issues or post-surgical changes. It assists with functional stability during symptomatic periods, supporting the patient’s ability to achieve and maintain rigidity despite the underlying condition.

“This approach provides supportive relief when symptoms interfere with routine activities.”

Quick Fact: Support for Deficient Penile Rigidity

This medication may assist with managing symptoms related to the inability to achieve or sustain a firm erection, particularly in contexts where additional symptomatic support is deemed appropriate.

Regulatory References

  1. NIH MedlinePlus Drug Information
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Eligibility and Restrictions for Use

The eligibility for Мьюз (Alprostadil Urethral Suppository) is strictly defined by regulatory authorities and centers on adult men with Erectile Dysfunction (ED).

Eligibility Status Population Group Regulatory Classification
Allowed Adult men (typically 18 years of age) Approved use for ED
Not Recommended Pediatric patients (under 18) Safety and effectiveness not established
Insufficient Data Older adults (65 years) No information available on age relationship to effects

Absolute Contraindications

The medicine must not be used by men with known hypersensitivity to alprostadil or any of its components. It is also contraindicated in patients with specific anatomical issues, including urethral stricture, severe penile curvature, or balanitis (inflammation/infection). Absolute non-eligibility extends to those with conditions that predispose to priapism (a prolonged erection), such as sickle cell disease, polycythaemia, or multiple myeloma. Use is also prohibited if sexual activity is medically inadvisable due to cardiovascular or cerebrovascular instability.


Conditional Use and Restrictions

Caution is required for patients with pulmonary disease, hypotension (low blood pressure), or a bleeding disorder. If the male user's sexual partner is pregnant, a condom barrier must be used as mandated by the drug's label.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Pharmacokinetic Interaction Profile

The interaction profile of Мьюз^circledR (Alprostadil) is significantly influenced by its localized route of administration. Official regulatory documents state that systemic drug-drug interactions are unlikely because low or undetectable levels of the active component are found in the peripheral venous circulation. Consequently, interactions mediated by metabolic enzymes (e.g., CYP450) or drug transporters are not officially documented.


Pharmacodynamic Interaction Constraints

The documented interactions focus on additive effects, classified by regulatory authorities as Use with Caution combinations:

  • Antihypertensive Medications: Co-administration may result in an additive vasodilatory effect, increasing the risk of low blood pressure (hypotension) and syncope. This potential risk is noted to be more common in the elderly population.
  • Anticoagulants and Platelet Aggregation Inhibitors: Concomitant use increases the risk of local urethral bleeding or spotting, which is related to the anti-hemostatic properties of Alprostadil combined with the potential for local abrasion.
  • Other Treatments for Erectile Dysfunction: Мьюз^circledR is not recommended for co-administration with other vasoactive agents used to treat erectile dysfunction, as the safety of these combinations in compounding vasodilatory effects has not been established.

Non-Drug Substances

Official labeling states there are no known interactions with food or drinks. The interaction between Мьюз^circledR and alcohol is currently unknown and has not been established in regulatory-cited studies.

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Mechanism of Action

The mechanism of action for Alprostadil relies on a direct, highly localized chemical action, acting independently of upstream neurological input to produce its resulting physiological consequence.

Direct Agonism at Local Prostaglandin Receptors

The action is initiated by Alprostadil functioning as an agonist at specific Prostaglandin E2 Receptors (primarily EP2 and EP4) found on the vascular and trabecular smooth muscle cells. This binding immediately engages the intracellular cAMP signaling cascade, resulting in the modulation of the muscle cell's contractile state.

Cascade for Smooth Muscle Relaxation and Vasodilation

Receptor agonism stimulates the enzyme Adenylyl Cyclase, causing a rapid increase in the secondary messenger, cyclic AMP (cAMP), inside the smooth muscle cells. The resulting molecular cascade causes a dramatic reduction in intracellular calcium ions ( Ca^2+). This leads directly to the profound relaxation of arterial walls and trabecular structures, which increases the capacity for local blood volume.

Hemodynamic Consequence: Inflow and Veno-Occlusion

The relaxation of arterial and smooth muscle tissue facilitates a rapid and substantial increase in local blood inflow (vasodilation) into the corporal structures. This mechanical engorgement compresses the subtunical venules, which facilitates the veno-occlusive mechanism and is characterized by increased tissue turgidity.

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Dosage and Administration Information

How to use Мьюз (Alprostadil Urethral Suppository) — Administration Guidelines

The following instructions describe the correct administration of this product. It is essential to use this medication exactly as directed by a healthcare provider.


Administration Scope

Classification Instruction
Route of Administration Transurethral (into the urethra)
Age-Group Rules Use is authorized for adult males only. Safety and effectiveness in pediatric patients have not been established.
Dosing Rule Each patient must be individually titrated by a healthcare professional to the lowest effective dose (250 mcg, 500 mcg, or 1000 mcg strength) that produces a satisfactory response.
Frequency & Timing Administer as needed to achieve an erection. The maximum frequency of use is no more than 2 systems in a 24-hour period.
Missed-Dose Rules This medication is for as-needed use only and is not for a regular schedule; therefore, the concept of a missed dose does not apply.

Resulting Procedural Structure

The transurethral delivery system involves several explicit procedural steps to ensure proper absorption and effectiveness:

  1. Preparation: Immediately prior to use, the patient must urinate and gently shake the penis to remove excess urine. A moist urethra is required to help dissolve the pellet.
  2. Insertion: The penis must be stretched to its full length before gently inserting the applicator stem into the urethra up to the collar.
  3. Delivery: The patient must fully depress the button on the applicator and hold it for approximately 5 seconds to ensure the medicated pellet is completely released into the urethra.
  4. Dispersion: After removing the applicator, the penis must be rolled firmly between the hands for at least 10 seconds. This step helps the medication disperse and cover the urethral wall for optimal absorption.
  5. Post-Administration: The patient should sit, stand, or walk for the first 10 minutes following administration to aid in blood flow and the development of the erection.

Connection to the Overall Use Protocol:

This delivery system is an as-needed intra-urethral administration method, with a limit of two doses per 24 hours. The process requires specific steps, including pre-urination and post-insertion penile rolling, to facilitate the dissolution and local absorption of the medication, supporting its intended single-use function.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Мьюз

Evidence for Use in Erectile Dysfunction (ED)

The main body of evidence involving Мьюз was studied for adult men experiencing Erectile Dysfunction (ED), a condition marked by functional limitations in achieving or maintaining an erection. Research examined the medication in randomized controlled trials (RCTs), which compared the treatment to a non-active placebo. These studies focused on short-term changes and outcomes related to functional measures, specifically the ability to achieve an erection sufficient for sexual intercourse.

The findings from these trials describe patterns observed in the studies regarding the achievement of a successful functional response during a defined, short-term at-home period. However, the research reports that the rate of functional response during at-home use was observed to differ from the response observed during titration in the clinic. Evidence is limited regarding the durability of the response and consistency of use over extended periods.


Evidence for Use as an Adjunct to Diagnostic Testing

In addition to its use for managing symptoms of ED, the active ingredient in Мьюз was also evaluated in acute diagnostic studies. This research explored the use of the medication as a vasoactive agent to assist in other clinical tests. The studies focused on physiological outcomes and research examined how blood flow and vessel size changed immediately following administration.

These specialized studies involved diagnostic imaging studies that provided measured physiological parameters. The findings consistently data show patterns related to the intended local vascular response, describing the medication's role in eliciting physiological changes in blood flow used to assess the penile vascular system during the diagnostic procedure. These studies were not designed to predict whether an individual will respond similarly when using the medication therapeutically for sexual performance.


Uncertainties, Research Gaps, and Study Limitations

Long-term effects are not fully established regarding the sustained consistency of the functional response or patient satisfaction with continued use beyond the initial study period. The primary controlled trials compared the medication against a placebo, meaning comparative evidence is lacking against other active treatments commonly used for ED. Furthermore, data for certain groups remain insufficient, and the overall results apply only to the populations studied.

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Frequently Asked Questions (FAQ)

Common questions about Мьюз (FAQ)

Q: How quickly should I expect to see an effect after starting Мьюз?

A: Official documents describe the onset of the intended local action beginning within 5 to 10 minutes following administration. This rapid timing is related to the specific way the medicine is absorbed directly at the site of use.

Q: What are the signs of a rare but serious side effect of Мьюз described in official warnings?

A: Official regulatory documents list Priapism (a prolonged erection) as a serious reaction. This is defined as an erection lasting 4 hours or longer. Another serious concern is the potential development of Penile Fibrosis, which may be indicated by changes in penile anatomy, such as new curvature or hardening.

Q: What is the non-directive guidance for using alcohol while taking Мьюз?

A: The interaction between Мьюз and alcohol has not been established in regulatory-cited studies. Regulatory information notes that alcohol can cause dizziness, which is also listed as a common documented side effect of this medication.

Q: What research is available regarding the long-term safety of Мьюз?

A: Studies and official information indicate that evidence is limited regarding the durability and consistency of use over extended periods. The long-term effects and sustained safety consistency of the medication are not fully established based on the primary clinical trials.

Q: If I stop using Мьюз suddenly, are there any general withdrawal effects described?

A: Because this medication is administered only as needed and has a highly localized action, regulatory information does not describe specific withdrawal effects upon the cessation of its use.

Q: Can I take Мьюз if I am already taking medication for high blood pressure?

A: Official documents describe co-administration of Мьюз with antihypertensive (blood pressure) medications as a Use with Caution combination. This is due to the potential for an additive vasodilatory effect, which may increase the risk of low blood pressure (hypotension).

Q: Is there a certain time of day that is best for using Мьюз?

A: Official guidance states that Мьюз is for as-needed use only. Therefore, there is no specified time of day documented as being best or required for its administration.

Q: Does Мьюз interact with common over-the-counter pain relievers like ibuprofen?

A: Systemic drug-drug interactions are considered unlikely because very low levels of the active component are typically found in the rest of the body's circulation. Interactions with common over-the-counter pain relievers such as ibuprofen are not documented in the official regulatory profile.

Q: Can people with a history of heart problems safely use Мьюз?

A: Official regulatory documents indicate that Мьюз is contraindicated (should not be used) if sexual activity is medically inadvisable due to cardiovascular or cerebrovascular instability.

Q: Is Мьюз known to cause weight gain or weight loss?

A: Weight gain or weight loss are not listed among the commonly reported side effects in the official regulatory documentation for Мьюз.

Q: Is it common to feel tired or dizzy when first starting Мьюз?

A: Dizziness and headache are listed as common systemic side effects in the official documentation. However, regulatory documents do not specify if these effects are more common exclusively when a patient begins treatment.

Q: Is Мьюз safe to use for an extended period, such as several years?

A: Research summarized in official labeling indicates that evidence is limited regarding sustained functional response beyond the initial study period. Long-term effects regarding use for several years are not fully established in the primary controlled trials.

Q: Can people with kidney or liver issues use Мьюз, and is an adjustment needed?

A: As Мьюз is a locally administered product with low systemic absorption, regulatory documents do not generally mandate dose adjustments for patients with mild to moderate kidney or liver impairment.

Q: Are there any known interactions between Мьюз and common herbal supplements?

A: No specific interactions between Мьюз and common herbal supplements are currently documented in the official regulatory labeling.

Q: Does Мьюз have a high potential for drug-drug interactions?

A: Official documents state that systemic drug-drug interactions are considered unlikely. This is primarily because low or undetectable levels of the active component are found in the peripheral venous circulation.

Q: What is the general percentage of patients who experience the most common side effect?

A: The most common side effects, such as penile pain, are officially categorized as 'Very Common.' This classification means they occur in ge 1 in 10 patients according to the official regulatory documents.

Q: Is it possible for Мьюз to lose its effectiveness over time (tolerance)?

A: Regulatory evidence from clinical trials does not indicate that tolerance, or a loss of effectiveness due to chronic use, occurs over the period studied.

Q: Are there any known effects of Мьюз on fertility in men or women?

A: Official documents do not contain specific research findings on the effect of Мьюз on fertility in men or women. However, the product label describes the need for a barrier method if the female partner is pregnant.

Q: What are the general expectations about laboratory monitoring while using Мьюз?

A: Given the low systemic absorption of the active ingredient, official regulatory documents do not generally specify the need for routine laboratory blood monitoring during use.

Q: Does the efficacy of Мьюз depend on taking it with food?

A: The efficacy of Мьюз is not documented to be dependent on food intake, as the medication is locally administered and has no known interaction with food or drinks.

Q: Is it possible to be allergic to one of the inactive ingredients in Мьюз?

A: Yes, official regulatory documents list a known hypersensitivity to the active ingredient, Alprostadil, or any of its components as an absolute contraindication for use.

Q: Does Мьюз have different effectiveness for different demographics, such as age or gender?

A: Regulatory evidence is limited regarding the relationship between age and the effects of Мьюз in older adults (65 years and older). The drug is only authorized for use in adult males.

Q: Can Мьюз affect my ability to drive or operate machinery?

A: Because Мьюз can cause dizziness or symptomatic low blood pressure (hypotension) as documented side effects, official labeling describes that the ability to drive or operate machinery may be affected.

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How should Мьюз be stored and disposed of?

How to Store and Dispose of Muse (Alprostadil Urethral Suppository)

The storage and disposal of Muse must strictly follow the requirements documented in official regulatory labeling.

Storage Requirements

Condition Requirement
Long-Term Temperature Store in a refrigerator between 2 C to 8 C (36 F to 46 F) until the expiration date.
Short-Term Stability May be stored at room temperature (below 25 C or 77 F) for a maximum of 14 days. After 14 days, the product must be returned to refrigeration or discarded.
Protection Keep the product in its original sealed pouch and ensure it is not exposed to temperatures exceeding 25 C.
Child Safety Store the medicine and its components out of the sight and reach of children.

Disposal Instructions

Unused or expired Muse must be disposed of in accordance with local requirements. Official regulatory documents state that this medicine must not be disposed of via wastewater or household trash.

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

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