REMS
Absorption: Minimal systemic absorption; action is primarily local.
Distribution: Unknown.
Half-Life: Unknown.
(improvement)
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| IM‡ | 12 days | unknown | 34 mo |
| IM‡ | 34 days | unknown | 34 mo |
| IM* | 2 wk | unknown | 34 mo |
| IM‡‡ | <2 wk | unknown | 34 mo |
| IM** | 12 days | unknown | 26 wk |
| IM^ | unknown | unknown | 200 days |
| IM^^ | unknown | unknown | 3 mo |
‡Cosmetic; ‡ Blepharospasm; * Cervical dystonia; ‡‡ Spasticity; ** Strabismus; ^ Axillary hyperhidrosis; ^^Migraines.
Contraindicated in:
Use Cautiously in:
EENT: dry eye, eye irritation, photophobia, temporary eyelid droop, visual changes
GI: dysphagia, nausea
GU: urinary retention, urinary tract infection
Local: discomfort at injection sites
MS: arthralgia, local muscle weakness, myalgia
Neuro: fatigue, headache
Resp: upper respiratory tract infection, bronchitis, dyspnea
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), SPREAD OF TOXIN EFFECT
Drug-drug:
Botox Cosmetic
Botox
Monitor for signs of the spread of toxin effects (asthenia, general muscle weakness, diplopia, ptosis, dysphagia, dysphonia, urinary incontinence, dyspnea). Pre-existing motor neuropathic or neuromuscular disorders ↑ risk of generalized muscle weakness.If difficulties with swallowing, speech, or respiration occur, immediately stop injections and provide appropriate medical care.
Inform patient that effects of onabotulinumtoxinA may spread beyond the site of local injection. Advise patient to notify health care provider immediately if problems swallowing, speaking, or breathing occur or if signs and symptoms of spread (asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysarthria, urinary incontinence, breathing difficulties) occur. May occur hours to weeks after injection.
NDC Code