What is the FDA-approved protocol for reconstitution of BOTOX® prior to injection for pain management?

Updated: Jun 19, 2018
  • Author: Anthony H Wheeler, MD; Chief Editor: Meda Raghavendra (Raghu), MD  more...
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An FDA-approved treatment protocol for chronic migraine includes very precise, standardized methods for reconstitution of BOTOX® and structured injection techniques. Allergan advocates 100 U of BOTOX® diluted in 2 cc of preservative-free normal saline, which results in a concentration of 5 U/per 0.1 mL.

Reconstitution is performed using a vial of BOTOX®, which must remain upright. A 21-gauge, 2-inch needle is attached to a 5 mm syringe. Dilution of 100 unit vial of BOTOX® is accomplished using 2 mL of preservative-free 0.9% sodium chloride (saline); therefore a 200-U vial is diluted with 4 mL of preservative-free saline. Each vial contains a vacuum, which should pull the saline into the vial. Do not use a BOTOX® vial if the vacuum is absent or reduced and does not pull all the saline freely from the syringe. Leave the reconstitution needle and syringe in the bottle while gently rotating the vial to mix the BOTOX® and saline.

Next, hold the hub of the needle and remove the reconstitution syringe and replace it with a 1-mL injection syringe. Do not invert the BOTOX® vial while withdrawing the solution into the 1-mL injection syringe. Withdraw 1 mL of the reconstituted solution into the 1-mL injection syringe. Disconnect the first 1-mL injection syringe from the hub of the needle and then attach a sterile 30-gauge 0.5-inch needle to the syringe for injection. Repeat the BOTOX® withdrawal procedure with 3 additional 1-mL injection syringes and then attach 30-gauge, 0.5-inch needles per the Allergan, FDA-approved protocol. An off-label suggestion by the author is to consider attachment of 30-gauge, 1-inch needles to 2 of the syringes for use with the cervical and trapezius injections.

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