|BOTULINUM TOXIN TYPE A
Botox, BOTOX Cosmetic
Classifications: skeletal muscle relaxant; antispasmodic; Therapeutic: muscle relaxant; antispasmodic
Pregnancy Category: C
100 units powder for injection
Botulinum toxin type A blocks neuromuscular transmission by binding to receptor sites on motor nerve terminals, entering
the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin splits a protein
molecule integral to the successful docking and releasing of acetylcholine from storage areas located within nerve endings.
When injected intramuscularly at therapeutic doses, botulinum toxin type A produces partial chemical denervation of the
muscle resulting in a localized reduction in muscle activity.
Treatment of blepharospasm, cervical dystonia, strabismus, glabellar frown wrinkles, severe axillary hyperhidrosis.
Treatment of other types of wrinkles, migraine headache, achalasia, focal spasticity associated with cerebral palsy with
concurrent equinus gait, spasticity associated with stroke.
Presence of infection at the proposed injection site(s); hypersensitivity to Botox. Patients with dysphagia or respiratory
compromise; pregnancy (category C).
Hypersensitivity to albumin; individuals with peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis,
or motor neuropathy), or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome); neuromuscular
disorders; ocular disease; cardiovascular disease; elderly; inflammation at the proposed injection site; weakness in the
target muscle(s), lactation.
Route & Dosage
Adult/Child (>12 y): Intradermal 1.252.5 U injected at each site, may repeat in 3 mo if needed; cumulative dose should not exceed 200 U in a 30-d period
Adult/Adolescent (>16 y): IM 198300 U divided among affected muscles
Adult: IM 25 U divided among affected muscles in 5 step doses, may repeat in 34 mo if needed
Adult: SC 12 U per site
Adult: IM 2050 U per affected site
Child (218 y): IM 4 U/kg (max: 200 U per treatment) every 3 mo
Adult: IM 50 U per site, may repeat in 4 mo
AdministrationIntramuscular, Intradermal, Subcutaneous
- Slowly inject required amount of nonpreserved NS (see dilution calculation) into vial. Discard vial if a vacuum does not
pull diluent into vial. Gently rotate to mix. Discard if not clear, colorless, and free of particulate matter. Dilution
calculation: add 1, 2, 4, or 6 mL of NS to yield, respectively, 10 U/0.1 mL, 5 U/0.1 mL, 2.5 U/0.1 mL, 1.25 U/0.1 mL.
- Note: Injection intervals of BOTOX® Cosmetic should be at least 3 mo apart.
- Store at 2°8° C (36°46° F) (refrigerated). Administer within 4 h of reconstitution.
INCOMPATIBILITIES Do not mix with other solutions/additives.
Adverse Effects (≥1%) Body as a Whole:
Injection site reactions (localized pain, tenderness, bruising), neck pain, flu-like symptoms
, hypertonia, asthenia, fever. CNS: Headache,
drowsiness. GI: Dysphagia,
dry mouth, fever, nausea, vomiting. Hematologic:
Local muscle weakness, dysarthria. Respiratory:
Cough, rhinitis, upper respiratory infection
. Special Senses: Ptosis,
superficial punctate keratitis, dry eyes, ocular
irritation, lacrimation, photophobia, keratitis, diplopia
, neuromuscular blocking agents
may potentiate neuromuscular blockade; chloroquine
may antagonize blocking effects.
Assessment & Drug Effects
- Evaluate for therapeutic effectiveness, maximal at about 12 wk (lasting 34 mo).
Patient & Family Education
- Inform physician about all prescription, nonprescription, and herbal drugs being taken.
- Report immediately any of the following: difficulty breathing or swallowing, problem with speech; unusual bleeding, bruising,
or swelling around injection site.
- Note: Effects of the injection generally last 34 mo and then repeat treatments may be given.