Urinary retention: Post-void residual urine volume should be monitored in patients treated for OAB or adult detrusor overactivity associated with a neurologic condition who do not catheterize routinely, particularly patients with multiple sclerosis or diabetes mellitus.Urinary tract infections in patients treated for OAB ( 5.12).Bronchitis and upper respiratory tract infections in patients treated for spasticity ( 5.10).Retrobulbar hemorrhages and compromised retinal circulation may occur with BOTOX treatment of strabismus ( 5.9).Corneal exposure and ulceration due to reduced blinking may occur with BOTOX treatment of blepharospasm ( 5.8).Use with caution in patients with compromised respiratory function ( 5.6, 5.7, 5.10).Concomitant neuromuscular disorder may exacerbate clinical effects of treatment ( 5.5).Potential serious adverse reactions after BOTOX injections for unapproved uses ( 5.3).Potency Units of BOTOX are not interchangeable with other preparations of botulinum toxin products ( 5.2, 11).Seek immediate medical attention if respiratory, speech or swallowing difficulties occur ( 5.1, 5.6) Spread of toxin effects swallowing and breathing difficulties can lead to death.Strabismus: The dose is based on prism diopter correction or previous response to treatment with BOTOX ( 2.11).Blepharospasm: 1.25 Units-2.5 Units into each of 3 sites per affected eye ( 2.10).Axillary Hyperhidrosis: 50 Units per axilla ( 2.9).Cervical Dystonia: Base dosing on the patient’s head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history use lower initial dose in botulinum toxin naïve patients ( 2.8).Pediatric Lower Limb Spasticity: Recommended total dose 4 Units/kg to 8 Units/kg (maximum 300 Units) divided among affected muscles ( 2.7).Pediatric Upper Limb Spasticity: Recommended total dose 3 Units/kg to 6 Units/kg (maximum 200 Units) divided among affected muscles ( 2.7).Adult Lower Limb Spasticity: Recommended total dose 300 Units to 400 Units divided across ankle and toe muscles ( 2.6).Adult Upper Limb Spasticity: Recommended total dose up to 400 Units divided among affected muscles ( 2.6).Chronic Migraine: Recommended total dose 155 Units, as 0.1 mL (5 Units) injections per each site divided across 7 head/neck muscles ( 2.5).Less than 34 kg: Recommended total dose is 6 Units/kg.Greater than or equal to 34 kg: Recommended total dose is 200 Units.Pediatric Detrusor Overactivity associated with a Neurologic Condition: 0.5 mL injections across 20 sites into the detrusor ( 2.4).Adult Detrusor Overactivity associated with a Neurologic Condition: Recommended total dose 200 Units, as 1 mL (~6.7 Units) injections across 30 sites into the detrusor ( 2.3).Overactive Bladder: Recommended total dose 100 Units, as 0.5 mL (5 Units) injections across 20 sites into the detrusor ( 2.3).See Preparation and Dilution Technique for instructions on BOTOX reconstitution, storage, and preparation before injection ( 2.2).Pediatrics: the lesser of 10 Units/kg or 340 Units ( 2.1).In a 3 month interval, do not exceed a total dose of: Follow indication-specific dosage and administration recommendations.Treatment of hyperhidrosis in body areas other than axillary ( 1.6).Prophylaxis of episodic migraine (14 headache days or fewer per month) ( 1.3).Safety and effectiveness of BOTOX have not been established for: Treatment of strabismus in patients 12 years of age and older ( 1.7).Treatment of blepharospasm associated with dystonia in patients 12 years of age and older ( 1.7).Treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients ( 1.6).Treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain ( 1.5).Treatment of spasticity in patients 2 years of age and older ( 1.4).Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer) ( 1.3).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.Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition in adults who have an inadequate response to or are intolerant of an anticholinergic medication ( 1.1).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 ( 1.1).BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:
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