Leaflet VITAROS 3mg / 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)

Precautions:
Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Hypotension / fall risk
Hypotension / fall risk

May lower blood pressure and increase the risk of falls.

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 3mg / g

  • Substance: alprostadil
  • Date of latest medicines list: 01-06-2026
  • Product code: W62135001
  • Concentration: 3mg / g
  • Pharmaceutical form: cream
  • Quantity: 4
  • Product type: Original
  • Price: 202.06 RON
  • Prescription status: P-6L - Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

  • Manufacturer: RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. - ITALIA
  • Holder: RECORDATI IRELAND LIMITED - IRLANDA
  • Number: 12798/2019/01
  • Shelf life: 1 year-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