Botox/Vistabel Factsheet
For more detailed information please download the Patient Information Leaflet here http://www.medicines.org.uk/emc/PIL.17544.latest.pdf
Product Summary
[Vistabel - Botulinum Toxin Type A] Currently the number one non-surgical aesthetic treatment in the U.S., Botox® is also the leading brand of botulinum toxin type - A in terms of documented clinical trials and practical use around the world.
Botox®, manufactured by Allergan, was the first botulinum toxin to gain a cosmetic licence endorsing its use for glabellar lines and wrinkles in the US in 2002. It was also eventually licenced for this use in the U.K. in March 2006 under the new brand name of Vistabel® (with a vial dose specific to treat glabellar lines) and was the first brand of botulinum toxin to receive a license for cosmetic use in this country.
Although Botox® is still readily available and used by many UK cosmetic clinics, Vistabel® (although identical in formulation to Botox) is technically the first brand of botulinum toxin type A licensed for cosmetic use in the UK.
Generic name of Vistabel®
Clostridium botulinum type - A neurotoxin complex.
How is it manufactured?
Vistabel® is made from purified type - A neurotoxin produced by the bacteria Clostridium botulinum.
How does Vistabel ® work?
It temporarily prevents the release of acetycholine from sympathetic nerve terminals. To learn in detail how Vistabel® injections work, please click on Botulinum Toxin Treatment FAQ.
Licenced status
Prescription only medicine
Who can perform Vistabel® treatment?
It should be used by trained members of the medical profession only.
Licenced UK indications for Vistabel®
In March 2006, Vistabel® was granted a licence in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA) for the "temporary improvement in the appearance of moderate to severe glabellar lines (vertical `frown` lines between the eyebrows) in adult women and men aged 65 and younger, when the severity of these lines has a psychological impact for the patient" .
Who should not have Vistabel® treatment?
Individuals with a known hypersensitivity to any component of the formulation.
Patients who have generalised disorders of muscle activity (e.g. myasthenia gravis).
Patients where aminoglycoside antibiotics or spectinomycin are already being used or are likely to be used.
Patients who have bleeding disorders of any type.
Pregnant or lactating women.
Reported side effects associated with Vistabel® include
Bruising or bleeding at the site of injection, headache, and rarely eyelid ptosis or diplopia, and brow droop.
Click on Botulinum Toxin Side Effects to learn more about the risks or side effects associated with Vistabel®.
Costs
Most clinics and practitioners charge by area of the face treated, such as the glabellar lines (frown lines between the eyes).
Practitioners may charge from around £175 - £300 per treatment.
Clinical results
Most of the literature on Botulinum Toxin, and hence the clinical evidence and statistics, are based on Botox® as this brand represents around 80% of the world’s use of Botulinum Toxin.
Because it is a prescription only medicine; it had to undergo strict clinical trials in the U.S., where it is approved for cosmetic use, in order to gain a license. Remember, the drug has been licensed in the U.S. since the late 1980s.
Her are the results of a study published in 2001.
500 patients were injected three times in a year with Botox®.They were injected on days 0, 120 and 240.The graph shows that over 70% of the patients showed significant improvement in their glabellar frown lines (i.e. the appearance of their wrinkles when trying not to frown) 30 days after their first injections.This improvement continued after repeat Botox® injections at days 120 and 240.
On the basis of this evidence, most practitioners would now recommend an initial course of Botox® treatment every 3 or 4 months for the first year. It now appears that after this, the time between future injections may lengthen, with practitioners reporting that some patients may only need to return twice a year to maintain results.
Vistabel ® is a registered trademarks of Allergan Inc.
This summary is copyright of http://www.consultingroom.com/treatments/vistabel