Please see the Patient Information Guide available at for list of these events. Tell your health care provider about any side effects that bother you or do not go away.

Focal dystonias - involuntary muscle contractions in a specific body area (such as in the neck) in people over the age of 16

Volume of reconstituted BOTOX and Diluent* (mL) to draw into dosing syringe to achieve a final volume of 10 mL

Vigorous treatment of any epithelial defect should be employed. This may require protective drops, ointment, therapeutic soft contact lenses, or closure of the eye by patching or other means.

Muscle Strength and Mass: Individuals with stronger or larger facial muscles (often, but not always, correlating with male patients) will typically need more units to achieve the desired relaxation compared to those with weaker or smaller muscles.

However, there appears to be little benefit obtainable from injecting more than 5 Units per sitio. Some tolerance may be found when BOTOX is used in treating blepharospasm if treatments are given any more frequently than every three months, and is rare to have the effect be permanent.

After the injections are botox given, the saline used for bladder wall visualization should be drained. The patient should be observed for at least 30 minutes post-injection.

Adult Detrusor Overactivity associated with a Neurologic Condition In two double-blind, placebo-controlled trials in adult patients with detrusor overactivity associated with a neurologic condition (NDO-1 and NDO-2), the proportion of subjects who were not using clean intermittent catheterization (CIC) prior to injection and who subsequently required catheterization for urinary retention following treatment with BOTOX 200 Units or placebo is shown in Table 12.

treat neurogenic detrusor overactivity (NDO) in children 5 years of age and older when anticholinergics do not work well enough or cannot be taken

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for onabotulinumtoxinA.

In adult spasticity patients with reduced lung function, upper respiratory tract infections were also reported more frequently as adverse reactions in patients treated with BOTOX than in patients treated with placebo [see Warnings and Precautions (5.10)].

If patient’s body weight is greater than or equal to 34 kg, the recommended dosage is 200 Units of BOTOX per treatment administered as an intradetrusor injection after dilution:

To prepare the eye for BOTOX injection, it is recommended that several drops of a local anesthetic and an ocular decongestant be given several minutes prior to injection.

BOTOX is indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication.