Vitaros

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Vitaros on Prescriptsy

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Vitaros is a topical cream containing alprostadil 300 micrograms (prostaglandin E1, PGE1) in a single-dose AccuDose applicator, designed for direct application to the tip of the penis for the treatment of erectile dysfunction (ED) in adult men.

Alprostadil is a naturally occurring prostaglandin that acts as a local vasodilator, increasing blood flow to the penis by relaxing smooth muscle in the corpora cavernosa.

Unlike oral PDE5 inhibitors such as sildenafil and tadalafil, which work systemically through the nitric oxide-cGMP pathway, Vitaros works locally through the prostaglandin-cAMP pathway and can produce an erection with or without sexual stimulation.

Vitaros is manufactured by Majorelle and is classified as a prescription-only medicine (POM) in the United Kingdom.

Erectile dysfunction affects an estimated 4.3 million men in the United Kingdom.

While oral PDE5 inhibitors are the first-line pharmacological treatment, they are not suitable or effective for all men.

Approximately 30% to 40% of men do not respond adequately to PDE5 inhibitors, and others cannot take them due to contraindications (particularly concurrent nitrate therapy) or intolerable side effects.

Vitaros offers an alternative that bypasses the oral route and the nitric oxide pathway, making it a valuable option for men who cannot use or have not responded to oral ED treatments.

This page provides a comprehensive clinical guide to Vitaros, covering its mechanism of action, how to use it, side effects, safety warnings, and how to obtain a prescription in the United Kingdom.

Important safety information about Vitaros

Before reading further, note these essential safety points.

• Using a condom during sexual intercourse is recommended to prevent transfer of alprostadil to your partner, which can cause vaginal irritation. A condom is essential if your partner is or may be pregnant.
• If an erection lasts more than 4 hours, seek emergency medical treatment immediately by calling 999 or attending Accident and Emergency.
• Do not use Vitaros in combination with other ED treatments unless directed by a specialist.
• Store Vitaros in the refrigerator (2 to 8 degrees Celsius) until ready to use.

Understanding erectile dysfunction and the role of topical treatments

Erectile dysfunction is a common condition with prevalence increasing with age.

The majority of ED has an organic (physical) basis, most commonly vasculogenic, where atherosclerosis and endothelial dysfunction impair the arterial blood supply to the penis.

Other organic causes include neurogenic (nerve damage from diabetes, prostate surgery, spinal cord injury), hormonal (hypogonadism), and drug-induced (antihypertensives, antidepressants, antiandrogens).

Psychogenic factors (anxiety, depression, relationship difficulties) often coexist with organic causes.

The treatment pathway for ED in the United Kingdom, as recommended by NICE and specialist guidelines, follows a stepwise approach.

First-line treatment consists of lifestyle modifications (weight loss, exercise, smoking cessation, alcohol reduction) and oral PDE5 inhibitors (sildenafil, tadalafil, vardenafil, avanafil).

Second-line treatments, for men who do not respond to or cannot take oral PDE5 inhibitors, include topical alprostadil (Vitaros), intraurethral alprostadil pellets (MUSE), vacuum erection devices, and intracavernosal injection therapy (using alprostadil, papaverine, or combination regimens).

Third-line treatment is penile prosthesis surgery, reserved for men who have failed or are unsuitable for all medical treatments.

Vitaros occupies an important position in this pathway as a non-invasive, non-oral, second-line option that avoids the discomfort of injection and the inconvenience of vacuum devices.

Its local mechanism of action means it does not interact with nitrates in the same way as oral PDE5 inhibitors, though it is still not recommended to combine treatments without specialist guidance.

How Vitaros works

Alprostadil is the synthetic form of prostaglandin E1 (PGE1). It is a potent local vasodilator that acts through a different biochemical pathway from PDE5 inhibitors.

When applied to the urethral meatus, alprostadil is absorbed through the urethral epithelium and reaches the smooth muscle of the corpus spongiosum and corpora cavernosa.

Alprostadil binds to EP2 and EP4 prostaglandin receptors on smooth muscle cell membranes, activating the enzyme adenylate cyclase, which converts adenosine triphosphate (ATP) to cyclic adenosine monophosphate (cAMP).

Elevated cAMP activates protein kinase A, which phosphorylates proteins that reduce intracellular calcium and promote smooth muscle relaxation.

This causes dilatation of the helicine arteries and relaxation of trabecular smooth muscle within the corpora cavernosa, allowing blood to fill the sinusoidal spaces and produce an erection.

A critical feature of alprostadil is that it does not depend on the nitric oxide-cGMP pathway that PDE5 inhibitors enhance.

This means Vitaros can work in men with impaired nitric oxide signalling, such as those with severe endothelial dysfunction, diabetic neuropathy affecting NANC nerve fibres, or radical prostatectomy patients in whom the cavernous nerves have been damaged.

It also means that, unlike PDE5 inhibitors, Vitaros can produce an erectile response independently of sexual stimulation, though sexual stimulation may still enhance the response.

The Vitaros formulation includes a permeation enhancer called DDAIP (dodecyl dimethyl ammonium isopropyl chlorophosphate) that disrupts the lipid bilayer of the urethral epithelium, facilitating transmucosal absorption of alprostadil.

This allows effective delivery of the drug without the need for injection.

Systemic absorption is very low: plasma alprostadil levels after topical application remain close to endogenous baseline levels, which means systemic cardiovascular effects are minimal.

Clinical evidence for Vitaros

Vitaros was evaluated in Phase III clinical trials involving men with erectile dysfunction of various aetiologies.

In the pivotal study, approximately 70% of men using Vitaros achieved an erection sufficient for vaginal penetration, compared with approximately 40% with placebo.

The responder rate was consistent across subgroups including men with diabetes, post-prostatectomy ED, and those who had previously failed PDE5 inhibitor therapy.

A significant proportion of PDE5 non-responders (approximately 50% to 60%) responded to Vitaros, confirming its value as a second-line option.

Patient satisfaction scores improved significantly compared with placebo, and the majority of men who responded to Vitaros in the initial trials continued using it in the open-label extension period.

The most common reason for discontinuation was local penile pain (burning or stinging), which led approximately 5% to 10% of trial participants to stop treatment.

How to use Vitaros

Vitaros comes in a single-dose AccuDose applicator contained within a sealed foil pouch. Each applicator delivers 300 micrograms of alprostadil in a cream base.

Remove the applicator from the refrigerator and allow it to reach room temperature (this takes approximately 15 to 20 minutes, or the applicator can be warmed briefly in the hands).

Open the foil pouch and remove the applicator. Remove the cap. Gently hold the tip of the penis to open the urethral meatus.

Place the applicator tip against the urethral opening and depress the plunger slowly over 5 to 10 seconds.

After delivering the cream, gently massage the tip of the penis for approximately 30 seconds to help distribute the medication.

An erection typically develops within 5 to 30 minutes.

Do not use more than one applicator per 24 hours, and do not use Vitaros more than 2 to 3 times per week. Using a condom during intercourse is recommended to prevent transfer of the cream to your partner.

Side effects of Vitaros

Common local side effects

Penile pain or a burning/stinging sensation at the application site is the most commonly reported side effect, occurring in approximately 30% to 40% of users.

This typically peaks within a few minutes of application and resolves within 30 to 60 minutes. Many men find the sensation becomes less intense with repeated use.

Erythema (redness) of the glans penis and a sensation of warmth are expected pharmacological effects related to local vasodilation.

Less common local side effects

Prolonged erection (more than 2 hours but less than 4 hours) occurs in approximately 3% to 5% of users.

Priapism (more than 4 hours) is rare but is a medical emergency. If an erection lasts more than 4 hours, call 999 or attend Accident and Emergency.

Penile swelling, urethral bleeding (minor spotting), and balanitis (inflammation of the glans) have been reported uncommonly.

Systemic side effects

Because the systemic absorption of alprostadil from Vitaros is very low, systemic side effects are uncommon.

Headache, dizziness, and flushing can occur but are less frequent than with oral PDE5 inhibitors. Significant hypotension or syncope is very rare with the topical route.

Partner effects

Female partners may experience vaginal burning, itching, or irritation if Vitaros is transferred during unprotected intercourse. Using a condom prevents this.

Report suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk.

Warnings and precautions

Priapism risk

Vitaros must not be used in men with conditions predisposing to priapism, including sickle cell anaemia, thrombocythaemia, polycythaemia, multiple myeloma, and leukaemia. If an erection persists beyond 4 hours, this is a medical emergency requiring immediate treatment.

Penile conditions

Vitaros should not be used in men with penile implants, severe penile deformity (Peyronie disease, cavernosal fibrosis), or active urethritis.

Any penile condition that might impair the integrity of the urethral mucosa (such as balanitis or urethral stricture) should be evaluated before starting treatment.

Partner protection

Always use a condom if your partner is or may be pregnant.

Although the systemic absorption from vaginal exposure is very low, the theoretical risk to a developing foetus has not been excluded.

A condom also prevents vaginal irritation from the alprostadil cream.

Combination with other ED treatments

Do not combine Vitaros with oral PDE5 inhibitors, intracavernosal injections, or intraurethral pellets unless specifically directed by a urologist or specialist. Combining vasodilatory ED treatments increases the risk of prolonged erection and priapism.

Cardiovascular fitness

Although Vitaros has minimal systemic cardiovascular effects, sexual activity itself places demands on the cardiovascular system. Men with significant heart disease should be assessed for fitness for sexual activity by their prescriber.

How to get Vitaros in the UK

Vitaros is available on NHS prescription from your GP, a urologist, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Your prescriber may consider Vitaros if oral PDE5 inhibitors have not worked for you, if you cannot take oral PDE5 inhibitors due to contraindications (such as nitrate use), or if you prefer a topical treatment.

Sources

• Vitaros 300 micrograms cream, Summary of Product Characteristics (EMC)
• Alprostadil, British National Formulary (BNF)
• Erectile dysfunction, NICE CKS
• Erectile dysfunction (impotence), NHS
• MHRA Yellow Card Scheme