BOTOX blocks neuromuscular transmission by binding to acceptor sites on motor or autonomic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine.

BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication, Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication, Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication, Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer), Treatment of spasticity in patients 2 years of age and older (See Full Prescribing Information.)

Follow indication-specific dosage and administration recommendations. In a 3 month interval, do not exceed a total dose of: Adults: 400 Units, Pediatrics: the lesser of 10 Units/kg or 340 Units (See Full Prescribing Information.)

The most common adverse reactions (≥5% and >placebo, if applicable) are: OAB: urinary tract infection, dysuria, urinary retention; Adult Detrusor Overactivity associated with a neurologic condition: urinary tract infection, urinary retention; Pediatric Detrusor Overactivity associated with a neurologic condition: urinary tract infection, leukocyturia, bacteriuria; Chronic Migraine: neck pain, headache; Adult Spasticity: pain in extremity; Pediatric Spasticity: upper respiratory tract infection; Cervical Dystonia: dysphagia, upper respiratory infection, neck pain, headache, increased cough, flu syndrome, back pain, rhinitis; Axillary Hyperhidrosis: injection site pain and hemorrhage, non-axillary sweating, pharyngitis, flu syndrome

Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation. Infection at the proposed injection site. Intradetrusor Injections: Urinary tract infection or urinary retention.

Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur. Potency Units of BOTOX are not interchangeable with other preparations of botulinum toxin products. Potential serious adverse reactions after BOTOX injections for unapproved uses. Concomitant neuromuscular disorder may exacerbate clinical effects of treatment. Use with caution in patients with compromised respiratory function. Corneal exposure and ulceration due to reduced blinking may occur with BOTOX treatment of blepharospasm. Retrobulbar hemorrhages and compromised retinal circulation may occur with BOTOX treatment of strabismus. Bronchitis and upper respiratory tract infections in patients treated for spasticity. Urinary tract infections in patients treated for OAB. (See Full Prescribing Information.)