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Botox Cosmetic
onabotulinumtoxinA
Black Box Warnings .
Distant Spread of Toxin Effect
effects of all botulinum toxin products may spread beyond tx area to produce sx consistent w/ botulinum toxin; sx incl. asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties; life-threatening swallowing and breathing difficulties can occur; deaths reported; sx may occur hours to weeks after injection; risk greatest in children treated for spasticity but can occur in adults, esp. if underlying risk factors; in unapproved uses and in approved indications, spread of effect reported at doses comparable to tx doses for cervical dystonia and spasticity, and at lower doses
Adult Dosing .
Dosage forms: INJ
glabellar lines, moderate-severe
- [20 units IM divided equally in 5 sites x1]
- Max: 20 units/tx session; Info: may repeat no more frequently than q3mo
lateral canthal lines, moderate-severe
- [24 units IM divided equally in 6 sites x1]
- Max: 24 units/tx session; Info: may repeat no more frequently than q3mo
forehead lines, moderate-severe
- [20 units IM divided equally in 5 sites x1]
- Max: 40 units/tx session for forehead and glabellar lines; Info: treat w/ glabellar lines to decr. brow ptosis; may repeat no more frequently than q3mo
platysma bands, moderate-severe
- [1 neck band on each side]
- Dose: 8 units IM divided equally in 4 sites per each jawline x1 (16 units total); 5 units IM divided equally in 5 sites per each neck band x1 (10 units total); Max: 26 units/tx session; Info: may repeat no more frequently than q3mo
- [1 neck band on one side, 2 neck bands on other side]
- Dose: 8 units IM divided equally in 4 sites per each jawline x1 (16 units total); 5 units IM divided equally in 5 sites per each neck band x1 (15 units total); Max: 31 units/tx session; Info: may repeat no more frequently than q3mo
- [2 neck bands on each side]
- Dose: 8 units IM divided equally in 4 sites per each jawline x1 (16 units total); 5 units IM divided equally in 5 sites per each neck band x1 (20 units total); Max: 36 units/tx session; Info: may repeat no more frequently than q3mo
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.