Leaflet VITAROS 2mg / g cream


Indicated for: erectile dysfunction; maintenance of ductus arteriosus patency

Route of administration: cutaneous

Substance: alprostadil (vasodilator)

ATC: G04BE01 (Genito urinary system and sex hormones | Urologicals | Drugs used in erectile dysfunction)

Alprostadil is a medication primarily used for the treatment of erectile dysfunction and certain vascular conditions. It is a synthetic form of prostaglandin E1 (PGE1), which works by relaxing smooth muscles and dilating blood vessels, thereby improving blood flow.

For erectile dysfunction, alprostadil can be administered either via intracavernosal injection directly into the penis or as a urethral suppository. It induces an erection by increasing blood flow to the corpora cavernosa. Additionally, it is used in newborns with congenital heart defects to maintain the patency of the ductus arteriosus until surgical intervention can be performed.

Common side effects include pain at the injection site, dizziness, low blood pressure, or prolonged erections (priapism). Rarely, allergic reactions or penile fibrosis may occur.

Alprostadil should be used with caution in patients with cardiovascular diseases, bleeding disorders, or a predisposition to priapism. Administration must strictly follow medical instructions, and patients should be properly trained in its use.

General data about VITAROS 2mg / g

  • Substance: alprostadil
  • Date of last drug list: 01-01-2016
  • Commercial code: W62134001
  • Concentration: 2mg / g
  • Pharmaceutical form: cream
  • Quantity: 4
  • Product type: original
  • Prescription restrictions: P-6L - Medicines prescription that isn't retained in the pharmacy (can be renewed); the prescription can be used for 6 months from the moment of release.

Marketing authorisation

  • Manufacturer: RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. - ITALIA
  • Holder: RECORDATI IRELAND LIMITED - IRLANDA
  • Number: 12797/2019/01
  • Shelf life: 9 months-after packing for marketing;after the first opening-it is used immediately

Concentrations available for alprostadil

  • 1000mcg
  • 125mcg
  • 20mcg
  • 20mcg/ml
  • 250mcg
  • 2mg/g
  • 3mg/g
  • 500mcg
  • 500mcg/1ml
  • 500mcg/ml