A double-blind, placebo-controlled study enrolled patients who had extended histories of receiving and tolerating BOTOX injections, with prior individualized adjustment of dose. The mean BOTOX dose administered to patients in this study was 236 Units (25th to 75th percentile range of 198 Units to 300 Units). The BOTOX dose was divided among the affected muscles [see Clinical Studies (14.7)]. Dosing in initial and sequential treatment sessions should be tailored to the individual patient based on the patient’s head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history. The initial dose for a patient without prior use of BOTOX should be at a lower dose, with subsequent dosing adjusted based on individual response.

Its generally lower cost also provides a more accessible option for many patients seeking neurotoxin treatments.

Neurogenic detrusor overactivity (an overactive bladder disorder caused by a dysfunction in the nerves that supply the bladder) in pediatric patients 5 years of age and older who do not respond to, or are intolerant of, anticholinergic medication.

Subsequent injections should not be administered until the effects of the previous dose have dissipated as evidenced by substantial function in the injected and adjacent muscles.

Do not use in people who are hypersensitive to any botulinum toxin product or any components of the vial. There should be no infection at the proposed injection site.

Cervical Dystonia: Base dosing on the patient’s head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history; use lower initial dose in botulinum toxin naïve patients.

Note that this list is not all-inclusive and includes only common medications that may interact with Botox. You should refer to the prescribing information for Botox for a complete list of interactions.

Blepharospasm and strabismus (eye misalignment [one eye faces a different way to the other]) associated with dystonia in people aged 12 years and older

If injection sites are marked in ink, do not inject BOTOX directly through the ink mark to avoid a permanent tattoo effect.

Subsequent doses for patients experiencing incomplete paralysis of the target muscle may be increased up to two-fold compared to the previously administered dose.

In patients 12 years of age or older: Consider botox an intravesical instillation of diluted local anesthetic with or without sedation, or general anesthesia prior to injection, per local sitio practice.

Botox Cosmetic is the brand used to smooth wrinkles. Botox is injected into specific muscles or glands every 3 months or more, depending on the condition. 

In a double-blind, placebo-controlled, parallel group study in adult patients with detrusor overactivity associated with a neurologic condition and restrictive lung disease of neuromuscular etiology [defined as FVC 50-80% of predicted value in patients with spinal cord injury between C5 and C8, or MS] the event rate in change of Forced Vital Capacity ≥15% or ≥20% was generally greater in patients treated with BOTOX than in patients treated with placebo (see Table nove).

BOTOX is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.