- Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan
- Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences
- Dysport (abobotulinumtoxinA), a new FDA-approved product marketed by Ipsen Biopharm Ltd.
Dilution Technique: Using a 21-gauge needle and an appropriately sized syringe draw up a total of 2.5 mL/100 Unit vial or 1.25 mL/50 Unit vial of 0.9% sterile saline without a preservative…….
Injection Technique: GlabellarUsing a 30-gauge needle, inject a dose of 0.1 mL into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units. Typically the initial doses of reconstituted BOTOX® Cosmetic induce chemical denervation of the injected muscles one to two days after injection, increasing in intensity during the first week.
The recommended initial dose of MYOBLOC® for patients with a prior history of tolerating botulinum toxin injections is 2500 to 5000 U divided among affected muscles. Patients without a prior history of tolerating botulinum toxin injections should receive a lower initial dose. The duration of effect in patients responding to MYOBLOC® treatment has been observed in studies to be between 12 and 16 weeks at doses of 5000 U or 10,000 U.
The units of Dysport are specific to the preparation and are not interchangeable with other preparations of botulinum toxin.
Glabellar lines DosageThe dosage is dependant on the severity of the lines and the specific muscle being treated.For the corrugator and procerus muscles 40 to 60 units divided between injection sites as follows:8 to 12 units in each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 60 unitsImprovement of severity of glabellar lines generally occurs within 72 hours after treatment and persists for 3 to 6 months.
- Online: www.fda.gov/MedWatch/report.htm
- Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 800-FDA-0178 (the same form you would mail)
- Phone: 800-FDA-1088