botulinum A toxin (Botox, Dysport, Xeomin)
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Indications
- treatment of strabismus & blepharospasm[22] associated with dystonia
- spasticity resulting from cerebral palsy
- spastic hemiparesis due to stroke or traumatic brain injury[23]
- focal dystonias, cervical dystonia[22]
- spasticity in the flexor muscles of the elbow, wrist, & fingers in adults[9]
- torticollis
- essential tremor[19]
- sialorrhea from cerebral palsy
- hyperhidrosis
- for use by or in consultation with neurologist, psychiatrist, ophthalmologist, head & neck surgeon
- wrinkles[3]
- 6 units dissolved in 0.1 mL of normal saline
- 6 units dissolved in 0.3 mL of normal saline may elicit a larger area of wrinkle reduction[12]
- migraine prophylaxis, benefit modest[10][13][22]
- neuropathic pain ?
- male balding pattern ?[11]
- depression: decreased depressive facial expression through use of Botox in the glabellar region may be of benefit[14]
- overactive bladder & urge incontinence[16][20]
Contraindications
- absolute: hypersensitivity to botulinum A toxin
- relative
- diseases of neuromuscular transmission
- coagulopathy, including anticoagulant therapy
- concurrent use of aminoglycoside
- LUTS in patients with BPH[20]
- urinary retension
Dosage
- strabismus:
- 1.25 to 5 units (0.05-0.15 mL) injected into any one muscle
- blepharospasm:
- 1.25 to 5 units (0.05-0.15 mL) injected into obicularis oculi
- cumulative dose should not exceed 200 units in 30 days
- to eliminate spatial disorientation or double vision in patients with strabismus, cover affected eye
- administered to submandibular gland (bilaterally) under general anesthesia for sialorrhea
- epinephrine should be available for hypersensitivity reactions
- wrinkles 20 units Botox (total)
- 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
- strabismus
- onset of action: 1-2 days after injection
- duration of paralysis: 2-6 weeks
- blepharospasm
- onset: 3 days after injection
- peak effect: 1-2 weeks
- duraton of paralysis: 3 months
Adverse effects
- common (> 10%)
- dry eyes, lagophthalmos, ptosis, photophobia, vertical deviation
- less common (1-10%)
- diffuse skin rash, swelling of eyelid, blepharospasm,
- 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
- 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]
More general terms
More specific terms
Additional terms
References
- ↑ Kaiser Permanente Northern California Regional Drug Formulary, 1998
- ↑ Journal Watch 20(21):170, 2000 Fehlings et al J Pediatr 137:331, 2000 Graham J Pediatr 137:300, 2000
- ↑ 3.0 3.1 3.2 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: https://www.ncbi.nlm.nih.gov/pubmed/17097394
- ↑ 4.0 4.1 FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#botox
- ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/18458229
- ↑ FDA MedWatch http://www.fda.gov/medwatch/safety/2009/safety09.htm#Botox
- ↑ Yuan RY et al. Botulinum toxin for diabetic neuropathic pain: A randomized double-blind crossover trial. Neurology 2009 Apr 28; 72:1473. PMID: https://www.ncbi.nlm.nih.gov/pubmed/19246421
- ↑ 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
- ↑ 9.0 9.1 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
- ↑ 10.0 10.1 FDA News release FDA approves Botox to treat chronic migraine http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229782.htm
- ↑ 11.0 11.1 Freund BJ and Schwartz M. Treatment of male pattern baldness with botulinum toxin: A pilot study. Plast Reconstr Surg 2010 Nov; 126:246e. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21042071
- ↑ 12.0 12.1 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: https://www.ncbi.nlm.nih.gov/pubmed/22250248
- ↑ 13.0 13.1 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: https://www.ncbi.nlm.nih.gov/pubmed/22535858
- ↑ 14.0 14.1 Wollmer MA et al. Facing depression with botulinum toxin: A randomized controlled trial. J Psychiatr Res 2012 May; 46:574 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22364892
- ↑ 15.0 15.1 Smith L et al. Botulinum toxin-A for the treatment of Raynaud syndrome. Arch Dermatol 2012 Apr; 148:426 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22508867
- ↑ 16.0 16.1 FDA News Release: Jan. 18, 2013 FDA approves Botox to treat overactive bladder. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336101.htm
- ↑ Medical Knowledge Self Assessment Program (MKSAP) 16 American College of Physicians, Philadelphia 2012
- ↑ Comella CL, Pullman SL. Botulinum toxins in neurological disease. Muscle Nerve. 2004 May;29(5):628-44. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15116366
- ↑ 19.0 19.1 Deprecated Reference
- ↑ 20.0 20.1 20.2 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. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24508634 <Internet> http://www.jurology.com/article/S0022-5347%2814%2900249-3/abstract
- ↑ 21.0 21.1 21.2 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25996589 <Internet> 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25996497 <Internet> http://archfaci.jamanetwork.com/article.aspx?articleid=2293060 - ↑ 22.0 22.1 22.2 22.3 22.4 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27164716 <Internet> http://www.neurology.org/content/early/2016/04/15/WNL.0000000000002560.full.pdf+html
- ↑ 23.0 23.1 Gracies JM, Esquenazi A, Brashear A et al. Efficacy and safety of abobotulinumtoxinA in spastic lower limb. Neurology 2017 Nov 1. PMID: https://www.ncbi.nlm.nih.gov/pubmed/29093068
- ↑ Geriatric Review Syllabus, 11th edition (GRS11) Harper GM, Lyons WL, Potter JF (eds) American Geriatrics Society, 2022
- ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/27701661 PMCID: PMC5399419 Free PMC article https://jamanetwork.com/journals/jama/fullarticle/2565290
- ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/23036134 PMCID: PMC3543828 Free PMC article https://www.nejm.org/doi/full/10.1056/NEJMoa1208872