Allergan Botox, Botulinum Toxin ; The provision of general information regarding what we offer is of paramount importance to ensure that our customers be sure of what they’re purchasing and how they can do it. BOTOX Cosmetics is an acetylcholine-releasing inhibitor and a neuromuscular blocking drug that is prescribed to patients of all ages to improve the appearance across various areas of the body.
-Moderate to very severe glabellar lines that are associated with procerus and/or corrugator muscle activity.
– Extremely severe to moderate lateral canthal lines linked with orbicularisoculi activation
– Moderate-to severe forehead wrinkles that are associated with the frontalis muscle
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not contain all the necessary information for the use of BOTOX
Cosmetics safely and efficiently. Find all prescribing information on
BOTOX Cosmetic. BOTOX Cosmetic (onabotulinumtoxinA) for injection,
for intramuscular use in accordance with the original U.S. Approval for intramuscular use as per Initial U.S. Approval
Allergan Botox DOSAGE AND ADMINISTRATION
* Botox Cosmetic is administered through intramuscular injection
* Glabellar Lines Administration: 0.1 milliliters (4 Units) into each of five sites for an
Total dosage of 20 units (2.3)
* Lateral Canthal Lines Administration: 0.1 milliliters (4 Units) into each of the 3 sites
each for each side (6 to total injector points) each side, for an overall total of 24 Units (2.3)
* Forehead Lines Administration: 0.1 mL (4 Units) into each of five foreheads
Line site (20 units) with 0.1 milliliters (4 Units) into 5 lines. Glabellar line sites.
(20 Units) (for a recommended total of 40 units (2.3)
Make sure you follow the dosage and administration guidelines. For treating adults for
More than one approved indication that work with BOTOX in addition to BOTOX Cosmetic,
Don’t exceed a maximum dosage of 400 Units within a 3-month period
* Refer to the the preparation and Dilution Method for directions regarding BOTOX
The reconstitution and storage of the cosmetic and preparation prior to injection (2.2)
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Preparation and Dilution Technique:
BOTOX Cosmetic is supplied in one-dose 50 Units or 100 units per vial. Prior to intramuscular injection, reconstitute each vacuum-dried vial of BOTOX Cosmetic with sterile, preservative-free0.9% Sodium ChlorideInjection USP (see Table 1). Draw up
The correct amount of diluent to the correct size needle and syringe in order to create the reconstituted solution that has the appropriate concentration
4 Units/0.1 milliliter and a total amount of 20 Units within 0.5 milliliters for the glabellar lines, and 24, Units per 0.6 milliliters for lateral canthal lines and
40 Units per milliliters for forehead lines as well as lines of glabellar. Slowly inject the diluent inside the vial. The vial should be discarded if there is there is a vacuum
Don’t force the diluent back into the vial. Make a gentle mix of BOTOX Cosmetic and the saline using a rotation of the vial. Note the date and time of
reconstitution is based on the space that is on the label. BOTOX Cosmetic is to be administered within 24 hours of reconstitution. This is the time to administer BOTOX Cosmetic.
Time period, reconstituted BOTOX Cosmetic must be stored in a fridge (2deg between 8 and 2degC). BOTOX Cosmetic vials can be used for a single dose.
only. Remove any remaining solution.
Dilution Instructions for BOTOX Cosmetic Vials (100 Units and 50 Units)
|Diluent* Added to 100Unit Vial||Resulting Dose Unites per 0.1mL||Diluent* Added to 150Unit Vial||Resulting Dose Unites per 0.1mL|
*Preservative-free 0.9 percent Sodium Chloride Injection, USP Only
Reconstituted BOTOX Cosmetics should be colorless, clear and free of any particulate matter. The parenteral drug product must be examined visually for discoloration and particles prior to administration, and whenever the solution and container allow.
Do not refrigerate reconstituted BOTOX Cosmetic