How is It Ok to Use Botox As Multidose,when It is Labeled "Single Patient Use"

Question

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?

Ron Shelton, MD · Answer

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 while mixing the botox, use aseptic technique, and use up the bottle in a day or two as they have busy cosmetic practices so that all patients get full benefit. Studies have shown effectiveness of stored botox in such a manner for more than two weeks, but again, this is rarely the situation in offices that treat a lot of patients with Botox and open many bottles per day or per week.

David Shafer, MD, FACS · Answer

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 uncontaminated Botox every time they have a treatment. 

	 

	Good Luck.

Kenneth D. Steinsapir, MD · Answer

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 course the other apparent conflict is that Allergan recommends that once reconstituted, the BOTOX be used within 4 hours.  Allergan has introduced a 50 unit vial to reduce the risk of wastage in offices that tend to use less BOTOX.  Again this is actually less of an issue because reconstituted BOTOX does not degrade at a rate first thought.  In fact some studies suggest that it remains just as strong even 2 weeks later when stored refrigerated.  This is not really an issue for a busy office.  We generally rapidly go through a vial but some office do these treatments less frequently than you might image so the longevity of the stored product is good to understand.  Again the FDA package insert reflects very little of the reality of how physicians use this product.  It is just so expensive for a drug company to change their package insert, it simply is not done unless they are compelled to do so.

Stephen Prendiville, MD · Answer

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.

Monika Soni, MD · Answer

Thank you for your question. Most Botox vials are either 50 or 100 units therefore it is not uncommon to use the same vial for more than one patient. However, the top of the vial should be sterilized with alcohol and change needles for each syringe. It is common to use a different needle for withdrawing the Botox than for injecting. If you have any concerns please discuss with your injector. Best of Luck!

How is It Ok to Use Botox As Multidose,when It is Labeled "Single Patient Use"

Answers (10)

Answer: Everyone Uses Botox as a Multidose Vial

Answer: Everyone Uses Botox as a Multidose Vial

Answer: Most Botox vials are either 50 or 100 units therefore it is not uncommon to use the same vial for more than one patient.

Answer: Most Botox vials are either 50 or 100 units therefore it is not uncommon to use the same vial for more than one patient.

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How is It Ok to Use Botox As Multidose,when It is Labeled "Single Patient Use"

Answers (10)

Answer: Everyone Uses Botox as a Multidose Vial

Answer: Everyone Uses Botox as a Multidose Vial

Answer: Most Botox vials are either 50 or 100 units therefore it is not uncommon to use the same vial for more than one patient.

Answer: Most Botox vials are either 50 or 100 units therefore it is not uncommon to use the same vial for more than one patient.

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Recommended reading

Everything you need to know about Botox

Our mission is to create a world where every investment in modern beauty is Worth It.