For blepharospasm, reconstituted BOTULAX® (see Dilution Table) is injected using a sterile, 27-30 gauge needle without electromyographic guidance. The initial recommended dose is 1.25-2.5U (0.05mL to 0.1mL volume at each site) injected into the medial and lateral pre-tarsal orbicularis oculi of the upper lid and into the lateral pre-tarsal orbicularis oculi of the lower lid. In general, the initial effect of the injections is seen within three days and reaches a peak at one to two weeks post-treatment. Each treatment lasts approximately three months, following which the procedure can be repeated. At repeat treatment ses-sions, the dose may be increased up to two-fold if the response from the initial treatment is considered insufficient-usually defined as an effect that does not last longer than two months. However there appears to be little benefit obtainable from injecting more than 5.0U per site. Some tolerance may be found when the drug is used in treating blepharospasm if treatments are given any more frequently than every three months, and is rare to have the effect be permanent. The cumulative dose of BOTULAX® treatment in a 30-day period should not exceed 200U.
Prior to injection, reconstitute freeze-dried BOTULAX® with sterile normal saline without a preservative. 0.9% Sodium Chloride Injection is the recommended diluent. Draw up the proper amount of diluent in the appropriate size syringe. Since the drug is denatured by bubbling or similar violent agitation, the diluent should be injected gently into the vial. Discard the vial if a vacuum does not pull the diluent into the vial. Record the date and time of reconstitution on the space on the label. BOTULAX® should be administered within four hours after reconstitution. During this time period, reconstituted BOTULAX® should be stored in a refrigerator (2-8°C). Reconstituted BOTULAX® should be clear, colorless and free of particulate mat-ter. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Because the drug and diluent do not contain any preservative, one vial of BOTULAX® should be used for a single patient.