DOSAGE AND ADMINISTRATION
For Intramuscular Injection Only
BOTOX
®
Cosmetic is to be reconstituted only with 0.9% sterile, non-preserved saline prior to intramuscular injection. Per the dilution table below, draw up the required amount of 0.9% sterile non-preserved sodium chloride solution into a syringe to obtain a reconstituted solution at a concentration of 4 Units/0.1 mL and a total treatment dose of 20 Units in 0.5 mL. The duration of activity of BOTOX
®
Cosmetic for glabellar lines is approximately 3-4 months. The safety and effectiveness of more frequent dosing with BOTOX
®
Cosmetic has not been clinically evaluated and is not recommended.
Dilution Table
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Diluent Added to 100 Unit Vial (0.9% Sodium Chloride Injection Only)
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Resulting Dose Units per 0.1 mL
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Diluent Added to 50 Unit Vial (0.9% Sodium Chloride Injection Only)
|
Resulting Dose Units per 0.1 mL
|
| 2.5 mL
|
4 Units
|
1.25 mL
|
4 Units
|
Reconstituted BOTOX
®
Cosmetic should be clear, colorless, and free of particulate matter.
BOTOX
®
Cosmetic is supplied as a single use vial. The product and diluent do not contain a preservative. Once opened and reconstituted it should be stored in a refrigerator (2° to 8°C) and used within 24 hours. Discard any remaining solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not freeze reconstituted BOTOX
®
Cosmetic.
Dilution Technique
Using a 21-gauge needle and an appropriately sized syringe draw up a total of 2.5 mL/100 Unit vial or 1.25 mL/50 Unit vial of 0.9% sterile saline without a preservative. Insert the needle at a 45° angle and slowly inject into the BOTOX
®
Cosmetic vial. Discard the vial if a vacuum does not pull the diluent into the vial. Gently rotate the vial and record the date and time of reconstitution on the space on the label.
Draw at least 0.5 mL of the properly reconstituted toxin into the sterile syringe, preferably a tuberculin syringe and expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach a 30-33 gauge needle. Confirm the patency of the needle.
Injection Technique
Glabellar facial lines arise from the activity of the corrugator and orbicularis oculi muscles. These muscles move the brow medially, and the procerus and depressor supercilii pull the brow inferiorly. This creates a frown or "furrowed brow". The location, size, and use of the muscles vary markedly among individuals. Lines induced by facial expression occur perpendicular to the direction of action of contracting facial muscles. An effective dose for facial lines is determined by gross observation of the patient's ability to activate the superficial muscles injected.
In order to reduce the complication of ptosis the following steps should be taken:
- Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
- Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
- Ensure the injected volume/dose is accurate and where feasible kept to a minimum.
- Do not inject toxin closer than 1 cm above the central eyebrow.
Using a 30-33 gauge needle, inject a dose of 0.1 mL into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units. Typically the initial doses of reconstituted BOTOX
®
Cosmetic induce chemical denervation of the injected muscles one to two days after injection, increasing in intensity during the first week.
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