Patients experiencing adequate paralysis of the target muscle that require subsequent injections should receive a dose comparable to the initial dose.

Tell your health care provider if you are taking blood thinners or medicines that can interfere with the clotting of blood, such as aspirin or warfarin. These medicines might make it more likely that you will experience bruising or bleeding at the injection site.

Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy.

It is not known if onabotulinumtoxinA passes into breast milk. Talk to your healthcare provider about the best way to feed your baby.

Avoiding injection near the levator palpebrae superioris may reduce the complication of ptosis. Avoiding medial lower lid injections, and thereby reducing diffusion into the inferior oblique, may reduce the complication of diplopia. Ecchymosis occurs easily in the soft eyelid tissues. This can be prevented by applying pressure at the injection site immediately after the injection.

Each dose is injected to a depth of approximately 2 mm and at a 45° angle to the skin surface, with the bevel side up to minimize leakage and to ensure the injections remain intradermal.

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.

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.

Botox may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving the injection. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary retention than those without diabetes, as shown in Table 11.

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

Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water.

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 9).

The initial listed doses of the reconstituted BOTOX typically create paralysis of the injected muscles beginning one to two days after injection and increasing in intensity during sculptra the first week. The paralysis lasts for 2-6 weeks and gradually resolves over a similar time period.