Vitaros

Vitaros is a cream for local application to the glans of the penis that contains the active ingredient alprostadil (prostaglandin E1). It is an alternative to PDE-5 inhibitors (tablets) for erectile dysfunction.

Alprostadil has a local vasodilating effect and promotes blood flow into the penis. The cream is applied directly to the urethral opening and enables an erection within 5-30 minutes.

Vitaros is particularly suitable for men who cannot take PDE-5 inhibitors or for whom these do not work sufficiently. It is supplied in the AccuDose single-dose system.

Alprostadil has a local vasodilating effect:

Mechanism of action: 1. Alprostadil is applied to the glans 2. It reaches the erectile tissue via the urethral opening 3. Activates adenylate cyclase and increases cAMP 4. The smooth muscle of the erectile tissue relaxes 5. Arterial blood inflow increases 6. An erection develops

Time course:

• Onset of action: 5-30 minutes
• Duration of action: 1-2 hours

Difference from PDE-5 inhibitors: Alprostadil works independently of sexual stimulation and acts directly on the erectile tissue. PDE-5 inhibitors require sexual arousal.

Vitaros is suitable for:

• Erectile dysfunction in adult men
• Men who do not tolerate PDE-5 inhibitors
• Men with contraindications to PDE-5 inhibitors (e.g., taking nitrates)
• When PDE-5 inhibitors do not work sufficiently

Advantages:

• Local application (fewer systemic side effects)
• Works independently of sexual stimulation
• Can be used while taking nitrates
• Alternative if PDE-5 inhibitors fail

Not suitable:

• In penile deformities (Peyronie's disease)
• Urethral abnormalities
• Balanitis (inflammation of the glans)

Vitaros cream:

• 300 µg alprostadil per AccuDose single dose

Dosage:

• 1 single dose 5-30 minutes before sexual intercourse
• Maximum: 1 application per 24 hours
• Maximum: 2-3 applications per week

AccuDose system: Each single-dose container contains 100 mg of cream and is intended for single use only.

Application: 1. Take the AccuDose container out of the pack 2. Turn the plunger several times, then remove the cap 3. Press all of the cream into the urethral opening (tip of the glans) without inserting the tip of the container 4. Hold the penis upwards for about 30 seconds and push any excess cream into the opening with your fingertip 5. Wait 5-30 minutes

Important notes:

• Use a condom if your partner is pregnant/could become pregnant
• Do not apply to damaged skin
• If an erection lasts > 4 hours (priapism), call an emergency doctor immediately!
• Store in a cool place (refrigerator)

Do not use in case of:

• Hypersensitivity to alprostadil
• Penile implant
• Balanitis or urethritis
• Sickle cell anemia
• Risk factors for priapism
• Penile deformities

Use with caution in case of:

• Coagulation disorders
• Antiplatelet/anticoagulant therapy

Partner protection: Use a condom during sexual intercourse with a pregnant woman (alprostadil can trigger labor contractions).

Common (1-10%):

• Burning at the application site
• Redness of the glans
• Pain in the penis
• Genital itching
• Swelling of the penis (penile edema)
• Vaginal burning in the female partner

Uncommon:

• Dizziness
• Fainting
• Drop in blood pressure (hypotension)

Rare but serious:

• Priapism (prolonged erection > 4 hours) – EMERGENCY!

Note: The local burning often occurs at the beginning and decreases with repeated use.

Interactions:

• Other erectile dysfunction medications – do not use at the same time
• Anticoagulants – increased local bleeding tendency

Increased risk of low blood pressure:

• With simultaneous treatment with blood pressure-lowering and vasoactive medicines, especially in older patients

Other medications:

• Interactions with most other medications are unlikely

Advantage: Alprostadil has fewer systemic interactions than oral PDE-5 inhibitors.