BOTOX COSMETIC PP
Generic Name and Formulations:
OnabotulinumtoxinA 50 Units, 100 Units; per vial; vacuum-dried pwd for IM inj after reconstitution; contains human albumin; preservative-free.
Indications for BOTOX COSMETIC:
Temporary improvement in the appearance of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity, moderate-to-severe lateral canthal lines associated with orbicularis oculi activity, and moderate-to-severe forehead lines associated with frontalis muscle activity.
Should be administered and managed by experienced physicians. Max cumulative dose: 400 Units in a 3-month interval. Glabellar (avoid inj near the levator palpebrae superioris or closer than 1cm above central eyebrow): give 4 Units/0.1mL IM into each of 5 sites (2 in each corrugator muscle and 1 in the procerus muscle); total of 20 Units/0.5mL per treatment session. Lateral canthal: give 4 Units/0.1mL IM into 3 sites per side (6 total inj points) in the lateral orbicularis muscle; total of 24 Units/0.6mL per session; for simultaneous treatment w. glabellar lines: total of 44 Units. Forehead (treat in conjunction with glabellar lines to minimize brow ptosis): give 4 Units/0.1mL into 5 sites in the frontalis muscle (total of 20 Units/0.5mL) + glabellar (total of 20 Units/0.5mL) for a complete total of 40 Units/1mL per session. Simultaneous treatment (forehead, glabellar, and lateral canthal lines): total of 64 Units per session. Repeat treatments more frequently than every 3 months: not evaluated.
<18yrs: not established.
Infection at proposed inj site.
Distant spread of toxin effect.
Not interchangeable with other botulinum toxin products. Risk of distant spread of toxin effect (esp. in children treated for spasticity); see full labeling. Increased risk of serious adverse reactions (including excessive weakness, dysphagia, aspiration pneumonia) with unapproved use. Pre-existing cardiovascular disease, dysphagia, or breathing difficulties. Neuromuscular disorders (eg, ALS, myasthenia gravis, Lambert-Eaton syndrome); monitor closely. Compromised respiratory status; monitor. Presence of inflammation, ptosis, excessive weakness or atrophy at the inj site. Monitor for ocular effects or visual changes; refer to ophthalmologist if persist. Contains human albumin; monitor for possible viral disease and Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.
May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds). May potentiate anticholinergic effects with concomitant anticholinergic drugs. Concomitant other botulinum toxin products or muscle relaxants may potentiate neuromuscular weakness.
Local inj reactions (eg, pain, infection, inflammation, tenderness, erythema), eyelid ptosis, facial pain, muscular weakness, eyelid edema, headache, brow ptosis; dysphagia, breathing difficulties, hypersensitivity reactions (discontinue if occur), possible antibody formation.