BOTOX® Cosmetic (onabotulinumtoxinA)
The FDA have approved Botox for the following uses. Unless otherwise specified, the approval is for use in people 18 or older:
- upper limb spasticity, in anyone older than 2 years
- crossed eyes, or strabismus, in those older than 12 years
- severe underarm sweating, or hyperhidrosis
- preventing migraine in people whose migraine headaches last at least 4 hours on 15 or more days per month
- reducing symptoms of an overactive bladder due to a neurological condition if anticholinergic medications do not help
- eyelid spasms, or blepharospasm, due to dystonia
- a neurological movement disorder called cervical dystonia that affects the head and causes neck pain
Some people also have Botox injections for off-label, or unapproved uses including as treatments for:
- alopecia
- sialorrhea Trusted Source, which involves producing too much saliva
- psoriasis
- dyshidrotic eczema, which affects the palms of the hands and soles of the feet
- anismus, a dysfunction of the anal muscle
- post-herpetic neuralgia
- vulvodynia, pain and discomfort in the vagina without a clear cause
- Raynaud’s disease, which affects circulation
- achalasia, an issue with the throat that makes swallowing difficult
Preparation and Dilution Technique
BOTOX Cosmetic is supplied in single-dose 50 Units and 100 Units per vial. Prior to intramuscular injection, reconstitute each
vacuum-dried vial of BOTOX Cosmetic with sterile, preservative-free 0.9% Sodium Chloride Injection USP (see Table 1). Draw up
the proper amount of diluent in the appropriate size needle and 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 for glabellar lines, 24 Units in 0.6 mL for lateral canthal lines, and
40 Units in 1 mL for forehead lines and glabellar lines. Then slowly inject the diluent into the vial. Discard the vial if a vacuum does
not pull the diluent into the vial. Gently mix BOTOX Cosmetic with the saline by rotating the vial. Record the date and time of
reconstitution on the space on the label. BOTOX Cosmetic should be administered within 24 hours after reconstitution. During this
time period, reconstituted BOTOX Cosmetic should be stored in a refrigerator (2° to 8°C). BOTOX Cosmetic vials are for single-dose
only. Discard any remaining solution.
Table 1: Dilution Instructions for BOTOX Cosmetic Vials (100 Units and 50 Units)
Diluent* Added to
100 Unit Vial = 2.5mL
Resulting Dose
Units per 0.1 mL = 4 Units
