Contents

Search

botulinum A toxin (Botox, Dysport, Xeomin)

Indications: 1) treatment of strabismus & blepharospasm [22] associated with dystonia 2) spasticity resulting from cerebral palsy 3) spastic hemiparesis due to stroke or traumatic brain injury [23] 4) focal dystonias, cervical dystonia [22] 5) spasticity in the flexor muscles of the elbow, wrist, & fingers in adults [9] - Raynaud's syndrome [15] 6) torticollis 7) essential tremor [19] 8) sialorrhea from cerebral palsy 9) hyperhidrosis 10) for use by or in consultation with neurologist, psychiatrist, ophthalmologist, head & neck surgeon 11) wrinkles [3] a) 6 units dissolved in 0.1 mL of normal saline b) 6 units dissolved in 0.3 mL of normal saline may elicit a larger area of wrinkle reduction [12] 12) migraine prophylaxis, benefit modest [10,13,22] - attacks lasting >= 4 hours >= 15 days/month for 3 months [22] 13) neuropathic pain ? 14) male balding pattern ? [11] 15) depression: decreased depressive facial expression through use of Botox in the glabellar region may be of benefit [14] 16) overactive bladder & urge incontinence [16,20] Contraindications: 1) absolute: hypersensitivity to botulinum A toxin 2) relative a) diseases of neuromuscular transmission b) coagulopathy, including anticoagulant therapy c) concurrent use of aminoglycoside d) LUTS in patients with BPH [20] e) urinary retension Dosage: 1) strabismus: - 1.25 to 5 units (0.05-0.15 mL) injected into any one muscle 2) blepharospasm: - 1.25 to 5 units (0.05-0.15 mL) injected into obicularis oculi 3) cumulative dose should not exceed 200 units in 30 days 4) to eliminate spatial disorientation or double vision in patients with strabismus, cover affected eye 5) administered to submandibular gland (bilaterally) under general anesthesia for sialorrhea 6) epinephrine should be available for hypersensitivity reactions 7) wrinkles 20 units Botox (total) 8) migraine: every 12 weeks as multiple injections around the head & neck One unit corresponds to LD50 in mice. Injection: - powder for injection, lyophilized, preservative-free: Clostridium botulinum type A toxin: 100 units - onabotulinumtoxinA (Botox) - incobotulinumtoxinA 20 units of Botox roughly = 50 units Dysport [3] Pharmacokinetics: 1) strabismus a) onset of action: 1-2 days after injection b) duration of paralysis: 2-6 weeks 2) blepharospasm a) onset: 3 days after injection b) peak effect: 1-2 weeks c) duraton of paralysis: 3 months Adverse effects: 1) common (> 10%) - dry eyes, lagophthalmos, ptosis, photophobia, vertical deviation 2) less common (1-10%) - diffuse skin rash, swelling of eyelid, blepharospasm, 3) uncommon (< 1%) - ectropion, keratitis, diplopia, entropion - hypersensitivity reactions: epinephrine should be available - cases of respiratory compromise & death [4] mostly in children treated for cerebral palsy- associated limb spasticity 4) cystoscopic injection: urinary retention, cystitis Drug interactions: - toxicity may be potentiated by aminoglycosides Mechanism of action: - zinc metalloprotease specific for synaptobrevin-2 - inhibitor of neurotransmitter release - short-lived increases in skin pliability & elasticity [21]* * effects appear to be opposite those of dermatoheliosis & skin aging [21]

Related

Clostridium botulinum

Specific

Botox Cosmetic Botulinum A Toxin Parenteral letibotulinumtoxinA-wlbg (Letybo) prabotulinumtoxinA-xvfs (Jeuveau)

General

botulinum toxin

References

  1. Kaiser Permanente Northern California Regional Drug Formulary, 1998
  2. Journal Watch 20(21):170, 2000 Fehlings et al J Pediatr 137:331, 2000 Graham J Pediatr 137:300, 2000
  3. Lowe P et al, Comparison of two formulations of botulinum toxin type A for the treatment of glabellar lines: A double blind, randomized trial. J Am Acad Dermatol 2006, 55:975 PMID: 17097394
  4. FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#botox
  5. Simpson DM et al, Assessment: Botulinum neurotoxin for the treatment of spasticity (an evidence-based review): Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008, 70:1691 PMID: 18458229
  6. FDA MedWatch http://www.fda.gov/medwatch/safety/2009/safety09.htm#Botox
  7. Yuan RY et al. Botulinum toxin for diabetic neuropathic pain: A randomized double-blind crossover trial. Neurology 2009 Apr 28; 72:1473. PMID: 19246421
  8. FDA MedWatch Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164255.htm
  9. FDA NEWS RELEASE: March 9, 2010 FDA Approves Botox to Treat Spasticity in Flexor Muscles of the Elbow, Wrist and Fingers http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm203776.htm
  10. FDA News release FDA approves Botox to treat chronic migraine http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229782.htm
  11. Freund BJ and Schwartz M. Treatment of male pattern baldness with botulinum toxin: A pilot study. Plast Reconstr Surg 2010 Nov; 126:246e. PMID: 21042071
  12. Abbasi NR et al. A small study of the relationship between abobotulinum toxin A concentration and forehead wrinkle reduction. Arch Dermatol 2012 Jan; 148:119. PMID: 22250248
  13. Jackson JL et al. Botulinum toxin A for prophylactic treatment of migraine and tension headaches in adults: A meta-analysis. JAMA 2012 Apr 25; 307:1736. PMID: 22535858
  14. Wollmer MA et al. Facing depression with botulinum toxin: A randomized controlled trial. J Psychiatr Res 2012 May; 46:574 PMID: 22364892
  15. Smith L et al. Botulinum toxin-A for the treatment of Raynaud syndrome. Arch Dermatol 2012 Apr; 148:426 PMID: 22508867
  16. FDA News Release: Jan. 18, 2013 FDA approves Botox to treat overactive bladder. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336101.htm
  17. Medical Knowledge Self Assessment Program (MKSAP) 16 American College of Physicians, Philadelphia 2012
  18. Comella CL, Pullman SL. Botulinum toxins in neurological disease. Muscle Nerve. 2004 May;29(5):628-44. PMID: 15116366
  19. Deprecated Reference
  20. McVary KT et al. A multicenter, randomized, double-blind, placebo controlled study of onabotulinumtoxinA 200 U to treat lower urinary tract symptoms in men with benign prostatic hyperplasia. J Urol 2014 Jul; 192:150. PMID: 24508634 http://www.jurology.com/article/S0022-5347%2814%2900249-3/abstract
  21. Bonaparte JP, Ellis D Alterations in the Elasticity, Pliability, and Viscoelastic Properties of Facial Skin After Injection of Onabotulinum Toxin A. JAMA Facial Plast Surg. Published online May 21, 2015 PMID: 25996589 http://archfaci.jamanetwork.com/article.aspx?articleid=2293061 - Winslow CP Furthering the Understanding of Actions of Botulinum Toxin A. JAMA Facial Plast Surg. Published online May 21, 2015 PMID: 25996497 http://archfaci.jamanetwork.com/article.aspx?articleid=2293060
  22. Simpson DM, Hallett M, Ashman EJ et al Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. April 18, 2016 PMID: 27164716 http://www.neurology.org/content/early/2016/04/15/WNL.0000000000002560.full.pdf+html
  23. Gracies JM, Esquenazi A, Brashear A et al. Efficacy and safety of abobotulinumtoxinA in spastic lower limb. Neurology 2017 Nov 1. PMID: 29093068
  24. Geriatric Review Syllabus, 11th edition (GRS11) Harper GM, Lyons WL, Potter JF (eds) American Geriatrics Society, 2022
  25. Amundsen CL, Richter HE, Menefee SA et al. OnabotulinumtoxinA vs sacral neuromodulation on refractory urgency urinary incontinence in women: a randomized clinical trial of onabotulinumtoxinA vs sacral neuromodulation for urgency urinary incontinence. JAMA. 2016;316(13):1366-1374 PMID: 27701661 PMCID: PMC5399419 Free PMC article https://jamanetwork.com/journals/jama/fullarticle/2565290
  26. Visco AG, Brubaker L, Richter HE et al. Anticholinergic therapy vs. onabotulinumtoxin A for urgency urinary incontinence. N Engl J Med. 2012;367(19):1803-1813 PMID: 23036134 PMCID: PMC3543828 Free PMC article https://www.nejm.org/doi/full/10.1056/NEJMoa1208872