Botox: Q&A
Ask a QuestionHow is It Ok to Use Botox As Multidose,when It is Labeled "Single Patient Use"
I see that most physicians use their botox as multidose which makes perfect sense. So why is it sold in a vial marked "single patient use" when the standard of care seems to be to use the vial for more than 1 patient. Single dose vial is defined as "a vial wth one dose" The only recommended dose for cosmetic use is 20 units in the glabella. Doesn't this seem to be a conflict?
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9 Doctor Answers |
Asked by
scyr
in Las Vegas, NV
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Botox with preservative saline
If a sterile bottle of Botox is mixed with unpreserved saline, and if it sits around for weeks, and if the bottle top is not cleaned with alcohol during the first mixing with saline or withdrawl, or subsequent withdrawls, then bacteria may grow. Also, board certified physicians observe OSHA guidelines and never cross contaminate the vial by placing a non-sterile needle or syringe in the bottle.
The standard of care across the country is that most doctors use saline with preservative...
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Multiple
The dosage language was developed at the time of fda approval and to get a change would cosr millions of dollars for fda presentations. The standar of practice it to dilute 100 units in a sterile fazhion annd the withdraw the correct amount for each patient.
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This is a Las Vegas regulation.
There was a problem with contamination of multiuse bottles in Las Vegas, so this regulation was created. In most places and multiuse bottle is used safely without problems.
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Single Use Vials of Botox
The labeling of the Botox vial has to do with FDA approval. Botox comes in 100 unit and 50 unit vials. For my patients, I open up a new 50 unit or 100 unit vial for each patient depending on which areas they are having treated. I show the patient the unopened vial and they can watch me reconstitute it before injecting them. While my profit margin may be less by doing it this way, my patients can rest assured that they are receiving fresh, undiluted and...
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BOTOX® is reconstituted using normal saline with preservative
BOTOX® is reconstituted by almost all physicians using normal saline with preservative, so as a practical matter the BOTOX® remains stable and sterile while several doses are withdrawn from the vial.
Normal saline with preservative is used mainly because the preservative [0.9% benzyl alcohol] is also a mild local anesthetic, and so reduces the discomfort when BOTOX® [or other formulations of BTX-A] is injected.
When BOTOX® was licensed, it was reconstituted using...
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This is a non issue.
It is standard of care to treat multiple patients from a single vial of BOTOX or Dysport. Of course the sterility of the vial is carefully preserved so there is never any cross contamination. I think the single use issue may be more of a historical fluke from the strictly medical use of BOTOX for conditions like blepharospasm where it is much more common to use an entire vial for a single treatment. This is virtually never the case with cosmetic applications. Of...
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Botox used as multi dose vial
As stated before by the other physicians Allergan would not want to spend the money for new trials and label changes for FDA approval once they already have approval for a product. It is a very expensive process. You will see this with their Latisse product for eyelash growth they kept it in it's original eye drop bottle and added brushes and packaging changes. There is no problem using Botox for multiple patients as each syringe is drawn up with sterile technique. It is important to use the...
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Everyone Uses Botox as a Multidose Vial
You won't find any Botox cosmetic provider who consistently uses the vial for single use purposes. Dr. Oppenheim is correct in his explanation regarding FDA approval. FDA approval is an expensive, time consuming exercise and it is very unlikely Allergan will ever seek a multi use exception for their 100 unit vial.
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Off Label Like A Lot We Do
This is preceptive of you.
When Allergan submitted their clinical trial to the FDA, this was how it was designated, perhaps to impress them with the absolute sterility of the product. Once FDA approval was obtained, Allergan would be reluctant to alter its original wording since that would require another round with the FDA.
Of course, nearly all physicians ignore this proviso, except when administering Botox for hyperhidrosis (excessive sweating). Since that Botox comes in a...
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These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.
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