The efficacy and safety of BOTOX for the treatment of lower limb spasticity was evaluated in Study 6, a randomized, multi-center, double-blind, placebo-controlled study. Study 6 included 468 post-stroke patients (233 BOTOX and 235 placebo) with ankle spasticity (modified Ashworth Scale ankle score of at least 3) who were at least 3 months post-stroke. A total dose of 300 Units of BOTOX or placebo were injected intramuscularly and divided between the gastrocnemius, soleus, and tibialis posterior, with optional injection into the flexor hallucis longus, flexor digitorum longus, flexor digitorum brevis, extensor hallucis, and rectus femoris (see Table 33) with up to an additional 100 Units (400 Units total dose). The use of electromyographic guidance or nerve stimulation was required to assist in proper muscle localization for injections. Patients were followed for 12 weeks.
Prevention of contractures begins with finding out what is limiting a child from either actively (moving oneself) or passively (being moved by someone else) moving the joints through a full range of motion. In some cases, this can be due to destruction or abnormality of the bones around a joint. It can also be due to problems with the ligaments and tissue around that joint.
Even though the procedure seems easy, it is still a medical procedure and requires a trained professional to administer the Botox solution. The credentials and experience of the doctors are critical regardless how much does Botox cost in their shop. Remember that a legit procedure is much safer and guarantees the end result which directly protects your investment.
In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Preventio n (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration. In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local o r state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 1-770-488-7100. More information can be obtained at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5232a8.htm.
Risks are very minor with this procedure. The main risks consist of headache, pain, and flu-like illness. In rare cases, there may be a drooping lid or eyebrow area. It is important for the cosmetic surgeon to assess the patient's lids before injecting because the patient may not be a good candidate if he or she has an extremely droopy lid to begin with or one that is held up by constantly arching the lids. Ptosis (a severe drooping of the eyelid) can occur in up to 5% of patients but is very rare if the cosmetic surgeon does this procedure often. These complications are typically very minor occurrences and resolve with time.
Not much. Results begin to show in a couple of days and develop gradually over the course of two weeks. "I tell anyone preparing for a big event to have shots two weeks ahead of time," says Kane. Some observers believe Dysport sets in faster than Botox, but that has not been proven in a study. Patients taking medications that contain aspirin or NSAIDs can develop pinpoint blue bruising. Patients can wear makeup immediately but should avoid heavy workouts for 24 hours, says Carruthers.
The potency Units of BOTOX® are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of BOTOX® cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method.
Still, there have been enough concerns that the FDA instituted a REMS (Risk Evaluation and Mitigation Strategy) requirement for all botulinum toxin preparations that specifically addresses the issues of distant spread of the toxin and the risk of problems, leading to death, from swallowing or breathing issues in certain patients who may be susceptible after botulinum toxin treatment. All products, including Dysport, Myobloc, Xeomin, and Botox, are monitored via this strategy. This is specifically aimed at a certain population of patients receiving more than the usual doses of botulinum toxin and not aimed at the casual user of Botox, per se.
Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.