OnabotulinumtoxinA (Botox)

بوتاکس (اونابوتولینوم‌توکسین A)

⚠ Unverified

🦴 Musculo-Skeletal SystemBotulinum neurotoxin

Market / country: 🇺🇸 USA

Botox (US)

🧮 Dose calculator

Migraine prophylaxis · Regimen source: FDA Botox · 2.5

  • • Botox units are not interchangeable with other botulinum products. In any 3 months: adults max 400 Units; children the lesser of 10 Units/kg or 340 Units. FDA Botox · 2.1FDA Botox · 2

Enter age (weight is optional for this regimen).

🛡️ Safety & information

Contraindications

  • ⛔ Hypersensitivity to any botulinum toxin product; infection at the injection site; intradetrusor injection with UTI or urinary retention (PVR >200 mL) without clean intermittent catheterisation. FDA Botox · 4

Warnings

  • • Boxed warning: distant spread of toxin effect (generalised weakness, diplopia, ptosis, swallowing and breathing difficulty — can be fatal), hours to weeks later; highest risk in children treated for spasticity. FDA Botox · Boxed Warning
  • • Dysphagia and breathing difficulties; UTI and urinary retention after bladder injection; corneal ulceration in blepharospasm; autonomic dysreflexia. FDA Botox · 5

Formulations

👥 Special populations

  • 🤰 PregnancyUse with caution

    Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Botox · 8.1

    “Risk Summary There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX in pregnant women.”
  • 🤱 BreastfeedingUse with caution

    Label: use with caution while breastfeeding; see the label text. FDA Botox · 8.2

    “Risk Summary There are no data on the presence of BOTOX in human or animal milk, the effects on the breastfed infant, or the effects on milk production.”
  • 👶 ChildrenUse with caution

    Label: established for some indications (spasticity, neurogenic bladder from 5 y); toxin-spread risk is greatest in children treated for spasticity. FDA Botox · 8.4

    “The safety and effectiveness of BOTOX for detrusor overactivity associated with a neurologic condition have been established in pediatric patients 5 years of age and older.”
  • 👴 Older adultsNo specific problem stated

    Label: no specific difference or dose adjustment stated for older adults. FDA Botox · 8.5

    “No overall differences in safety were observed between elderly patients and adult patients younger than 65 years of age.”
  • ⚥ Females & males of reproductive potentialNo data

    The source for this drug has no section for this group.

📚 Reference status for this drug

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