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?
How is It Ok to Use Botox As Multidose,when It is Labeled "Single Patient Use"
Doctor Answers (9)
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 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.
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.
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 uncontaminated Botox every time they have a treatment.
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 normal saline without preservative, and that probably accounts for the single patient use label.
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 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.
Botox used as multi dose vial
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.
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 different vial, not Botox Cosmetic, you could see this is nearly universally ignored. Since the precious liquid is so expensive, only the most profligate physician is going to administer their Botox to a single patient and toss the remainder.
If you check the labeling further, you will also see that we are to use only non-preserved saline when diluting Botox. I have a patient allergic to the preservative, Benzyl Alcohol. I had quite a task finding non-presrved saline. I called all the pharmacies and finally had to purchase some from one of our local hospitals. I can assure you that, all the injectors in our city are not running down to this hospital to obtain their saline.
By the way, since this batch sat over the weekend, I was afraid to use it on another patient. Three weeks later, rather than throw it out, I had the non-preserved saline/Botox injected into myself. Lo and Behold not only did I not get infected, but it worked fine and I too was wrinkle free, if not worry free.