Botox®
GoodRxOnabotulinumtoxinA · powder for injection
Misc., Injections & Implants
Approved uses
Blepharospasm associated with dystonia, age 12 and over
1.25 to 2.5 Units injected into each of 3 sites per affected eye
Watch for exposure keratopathy afterwards: reduced blinking is the mechanism, not a coincidence
Strabismus, age 12 and over
Dose selected from the prism dioptre correction required, or from the previous response to treatment
Contraindications
BOTOX is contraindicated: In patients who are hypersensitive to any botulinum toxin product or to any of the components in the formulation. In the presence of infection at the proposed injection site(s).
Available FormsInjection, vials of 50, 100 and 200 Units of onabotulinumtoxinA for reconstitution.
Mechanism of ActionBOTOX blocks neuromuscular transmission by binding to acceptor sites on motor or autonomic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings. When injected intramuscularly at therapeutic doses, BOTOX produces partial chemical denervation of the muscle resulting in a localized reduction in muscle activity. In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop.
Warnings & Precautions
- Distant spread of toxin effect: swallowing and breathing difficulties can be life-threatening and have been reported hours to weeks after injection. This carries a boxed warning.
- Do not use in the presence of infection at the proposed injection site.
- Dry eye has been reported with blepharospasm treatment; reduced blinking can lead to corneal exposure, persistent epithelial defect and ulceration.
- Ecchymosis and ptosis are common after periocular injection.
- Do not exceed a total of 400 Units in adults in any 3-month interval.
Common Side Effects
Blepharospasm: ptosis, dry eye, superficial punctate keratitis, eyelid oedema and ecchymosis. Strabismus: ptosis and vertical deviation. Systemically: dysphagia, upper respiratory infection, neck pain and headache.
Pregnancy & LactationPregnancy: No adequate and well-controlled studies in pregnant women.
Lactation: No data on presence in human milk; a decision should weigh the mother's clinical need.
Pediatric UseDetrusor Overactivity associated with a Neurologic Condition The safety and effectiveness of BOTOX for detrusor overactivity associated with a neurologic condition have been established in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication.