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1 Indications And Usage 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 ( 1.1 ) 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 ( 1.1 ) Prophylaxis Of Headaches In Adult Patients With Chronic Migraine (≥15 Days Per Month With Headache Lasting 4 Hours A Day Or Longer) ( 1.2 ) Treatment Of Spasticity In Patients 2 Years Of Age And Older ( 1.3 ) Treatment Of Cervical Dystonia In Adult Patients, To Reduce The Severity Of Abnormal Head Position And Neck Pain ( 1.4 ) Treatment Of Severe Axillary Hyperhidrosis That Is Inadequately Managed By Topical Agents In Adult Patients ( 1.5 ) Treatment Of Blepharospasm Associated With Dystonia In Patients 12 Years Of Age And Older ( 1.6 ) Treatment Of Strabismus In Patients 12 Years Of Age And Older ( 1.6 ) Important Limitations: Safety And Effectiveness Of Botox Have Not Been Established For: Prophylaxis Of Episodic Migraine (14 Headache Days Or Fewer Per Month) ( 1.2 ) Treatment Of Hyperhidrosis In Body Areas Other Than Axillary ( 1.5 ) 1.1 Bladder Dysfunction Overactive Bladder Botox (Onabotulinumtoxina) For Injection Is Indicated For The Treatment Of Overactive Bladder With Symptoms Of Urge Urinary Incontinence, Urgency, And Frequency, In Adults Who Have An Inadequate Response To Or Are Intolerant Of An Anticholinergic Medication. Detrusor Overactivity Associated With A Neurologic Condition Botox Is Indicated For The Treatment Of Urinary Incontinence Due To Detrusor Overactivity Associated With A Neurologic Condition (E.g., Sci, Ms) In Adults Who Have An Inadequate Response To Or Are Intolerant Of An Anticholinergic Medication. 1.2 Chronic Migraine Botox Is Indicated For The Prophylaxis Of Headaches In Adult Patients With Chronic Migraine (≥15 Days Per Month With Headache Lasting 4 Hours A Day Or Longer). Limitations Of Use Safety And Effectiveness Have Not Been Established For The Prophylaxis Of Episodic Migraine (14 Headache Days Or Fewer Per Month) In Seven Placebo-Controlled Studies. 1.3 Spasticity Botox Is Indicated For The Treatment Of Spasticity In Patients 2 Years Of Age And Older. Limitations Of Use Botox Has Not Been Shown To Improve Upper Extremity Functional Abilities, Or Range Of Motion At A Joint Affected By A Fixed Contracture. 1. 4 Cervical Dystonia Botox Is Indicated For The Treatment Of Adults With Cervical Dystonia, To Reduce The Severity Of Abnormal Head Position And Neck Pain Associated With Cervical Dystonia. 1. 5 Primary Axillary Hyperhidrosis Botox Is Indicated For The Treatment Of Severe Primary Axillary Hyperhidrosis That Is Inadequately Managed With Topical Agents. Limitations Of Use The Safety And Effectiveness Of Botox For Hyperhidrosis In Other Body Areas Have Not Been Established. Weakness Of Hand Muscles And Blepharoptosis May Occur In Patients Who Receive Botox For Palmar Hyperhidrosis And Facial Hyperhidrosis, Respectively. Patients Should Be Evaluated For Potential Causes Of Secondary Hyperhidrosis (E.g., Hyperthyroidism) To Avoid Symptomatic Treatment Of Hyperhidrosis Without The Diagnosis And/or Treatment Of The Underlying Disease. Safety And Effectiveness Of Botox Have Not Been Established For The Treatment Of Axillary Hyperhidrosis In Pediatric Patients Under Age 18. 1. 6 Blepharospasm And Strabismus Botox Is Indicated For The Treatment Of Strabismus And Blepharospasm Associated With Dystonia, Including Benign Essential Blepharospasm Or Vii Nerve Disorders In Patients 12 Years Of Age And Older.
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