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BOTOX COSMETIC
Aesthetic medicine
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Drug Name:

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.

Company:
Allergan

Therapeutic Use:

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.

Adult:

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.

Children:

<18yrs: not established.

Contraindications:

Infection at proposed inj site.

Warnings/Precautions:

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. Contains human albumin; monitor for possible viral disease and Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.

Interactions:

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.

Pharmacological Class:

Neuromuscular blocker.

Adverse Reactions:

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.

Generic Availability:

NO

How Supplied:

Single-use vial—1

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