Details on the pathology
Benefits
Administration guidelines
Patient profiles

Vitaros

Before any treatment with Vitaros you need to refer to a Healthcare Professional. This Product has to be prescribed by a Medical Doctor and delivered by a Pharmacist.

Access To Vitaros Summary of Product Characteristics
Pathology - Erectile dysfunction (ED)

Overview on erectile dysfunction

The incidence of erectile dysfunction increases with age (reference to full study here).

Up to
10%

IN MEN AGED BETWEEN 40 AND 50 YEARS

Up to
40%

IN MEN AGED 60 TO 70 YEARS

Up to
50%

IN MEN OVER THE AGE OF 70

Men with Erectile Dysfunction experience negative consequences on both sexual experience and emotional well-being.

‍Several comorbidities are associated with Erectile Dysfunction including cardiovascular disease, diabetes and prostate disease.

First-line treatment options, according to Erectile Dysfunction guidelines, include psychosexual counselling and oral therapy with phosphodiesterase type-5 (PDE5i) inhibitors. Other treatments include vacuum devices, intracavernosal or transurethral drug treatments. As therapeutic paradigms evolve, experts are recognising topical alprostadil as a first-line alternative for certain patients with Erectile Dysfunction.

Benefits

Local applications reduce risk of systemic interactions1,2

Retained in the fossa navicularis

Approximately 98% of the administered dose of Vitaros® is retained in the fossa navicularis of the penis, thus minimising systemic diffusion of the drug.

No known drug-drug interactions

No apparent interference with efficacy or safety has been reported with concomitant use of Vitaros®.

No interference with food or alcohol

Vitaros® eliminates the need to coordinate the timing of meals around sexual activity as there are no special warnings or precautions around interactions with food or alcohol.

Minimal systemic side effects

The most frequently reported adverse events in treatment with Vitaros® are local. There is no clear indication that alprostadil increases the risk of cardiovascular events, other than the vasodilative effects.

(1) Vitaros Summary of product characteristics
(2) Edgardo Becher (2004) Topical alprostadil cream for the treatment of erectile dysfunction, Expert Opinion on Pharmacotherapy, 5:3, 623-632, DOI: 10.1517/14656566.5.3.623

the rigHT administration for vitaros

Apply Vitaros® in 3 steps...

1
Prepare

With washed hands, remove the single-dose container from the foil pouch by fully tearing down the seal from the middle of top edge.

Bring the content to room temperature by rolling the container between your hands.

Twist the plunger several times to make sure it will glide easily before moving the cap from the single-dose container.

Grasp the tip of the penis and gently squeeze to widen the opening while holding it in an upright vertical position, retracting the foreskin if uncircumcised.

2
Apply and Hold

Place the tip of the container as close as possible to the opening at the tip of the penis, slowly, but firmly, pushing down the plunger until all the cream is expelled into the opening and down the urethra.

Hold the penis in an upright position for approximately 30 seconds to allow the cream to penetrate, pushing any excess cream into the opening with the tip of your finger.

3
Stimulate

To reach an erection, physical and visual sexual stimulation is encouraged.

Condom use is recommended for men whose partners are of childbearing potential, pregnant or lactating women as there is no data on the use of this product in these circumstances.

Vitaros patient profiles


Vitaros topical cream is a therapeutic option for certain patients with Erectile Dysfunction.

Prefers a topical therapy
Concerned about systemic effects or food / alcohol interactions
Taking nitrates or alpha-blockers
Not appropriate for PDE5 inhibitor therapy

Local and rapid onset of action, starting as early as 5 minutes1,2.

Statistically significant improvements in all efficacy parameters (EF-IIEF scores, SEP 2 and 3, Global Assessment Questionnaire)1,3,4*.

Positive Global Assessment Questionnaire response for patients with co-morbidities1*.

No interference with food or alcohol1,3*.

Drug-drug interactions are considered unlikely1,3.

Well-established pharmacodynamic and safety profile, with a low patient discontinuation rate due to adverse events (4.3%)3,5,6.

Contraindications (non-exhaustive list)

Vitaros® should not be used in patients:

With underlying disorders such as orthostatic hypotension, myocardial infarction and syncope (fainting)2.

With known hypersensitivity to alprostadil or any of the ingredients2.

For whom sexual activity is inadvisable as in men with unstable cardiovascular or unstable cerebrovascular conditions2.

*EF - Erectile Function; IIEF - International Index of Erectile Function; SEP- Sexual Encounter Profile; GAQ - Global Assessment Questionnaire
**Drug-drug interactions are considered unlikely due to the nature of metabolism of VITAROS®, although no drug-drug interaction studies have been conducted1-3
‍
(1) Moncada I and Cuzin B. Urologia 2015;85(2):84-92 (2) Vitaros Summary of product characteristics 2016 (3) Cuzin B. Ther Adv Urol 2016;8(4):249-256 (4) Padma-Nathan H et al.Intl J of Impot Res 2003;15(1):10-17 (5) Becher E. Expert Opin Pharmacother 2004;5(3):623-632 (6) Rooney M et al. J Sex Med 2009;6(2):520–534.
‍

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