Two double-blind, placebo-controlled, randomized, multi-center clinical studies were conducted in patients with urinary incontinence due to detrusor overactivity associated with a neurologic condition who were either spontaneously voiding or using catheterization (Studies NDO-1 and NDO-2). A total of 691 spinal cord injury (T1 or below) or multiple sclerosis patients, who had an inadequate response to or were intolerant of at least one anticholinergic medication, were enrolled. These patients were randomized to receive either 200 Units of BOTOX (n=227), 300 Units of BOTOX (n=223), or placebo (n=241).
The trapezius muscle is a large, triangular, superficial muscle. It attaches proximally in the medial third of the superior nuchal line, external occipital protuberance, nuchal ligament, and spinous processes of the C7-T12 vertebrae. Distal attachment of the trapezius occurs at the lateral third of the clavicle and acromion and spine of the scapula. The action of the muscle includes neck extension and stabilization of the scapula and support for the arm. The muscle fibers proximal to the inflection point of the neck (ie, necklace line) run vertically and are involved with neck extension. According to the PREEMPT injection paradigm, one injection of 5 units of onabotulinumtoxinA to each of three sites on either side of the trapezius, for a total of 30 units divided across six sites, is given. The first injection site can be identified by visually dividing the upper portion of the trapezius muscle in half, from the inflection point of the neck (ie the necklace line) to the acromion (acromio-clavicular joint); the midpoint of this location is where the injection should be administered. The second injection is located at the midpoint of the first injection site and the acromion. The third injection should be administered at the midpoint between the first injection site and the necklace line. Injections should occur in the supraclavicular portion of the muscle, lateral to the neckline, and medial to the deltoid and the acromio-clavicular joint. The injections into the trapezius should be administered horizontally and superficially to avoid injecting too deep.
The safe and effective use of BOTOX depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques. An understanding of standard electromyographic techniques is also required for treatment of strabismus, upper or lower limb spasticity, and may be useful for the treatment of cervical dystonia. Physicians administering BOTOX must understand the relevant neuromuscular and structural anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures and disease, especially when injecting near the lungs.
A concern of both parents and children is whether these injections will be painful. There is no pain linked to the action of the toxin itself, only with the needle injections. To lessen this problem, the skin where the injections will be done is coated with EMLA cream before the procedure . A topical coolant spray is also used right before the needle is put in. This numbs the skin. The child may still feel pressure from the needle and a dull feeling in the muscle. The fact that a child is having a procedure done and is being held in place can upset a child more than the needle going in, even more so for preschool-aged children.
Both Aetna and HealthPartners tell The Verge in an email that they don’t require patients to try verapamil specifically. “Verapamil is just one of many options available to treat migraines. Some are FDA-approved, others are not,” says Becca Johnson, a spokesperson for HealthPartners. Patients are required to try other oral medications because they’re either cheaper or not as invasive as getting Botox injections. “The rationale is that these medications are generally effective and safe,” says Ethan Slavin, a spokesperson for Aetna.
After an exam by a therapist and doctor, botulinum toxin for focal relief of muscle spasticity can be advised as the best way to address a child's functional problems. The problem muscle groups are identified, and goals for that child are discussed. Then the injection of botulinum toxin can be done if there are no permanent contractures of the muscle groups.
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. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX 200 Units compared with placebo (1.5% versus 0.4%, respectively).
BOTOX blocks neuromuscular transmission by binding to acceptor sites on motor or sympathetic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP -25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings. When injected intramuscularly at therapeutic doses, BOTOX produces partial chemical denervation of the muscle resulting in a localized reduction in muscle act ivity. In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop. There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by BOTOX.

In my experience, this, like all other treatments we use in medicine, doesn’t benefit every patient. I find that it helps a majority of appropriate patients, that is, those patients with a diagnosis of chronic migraine who have failed not just abortive but also preventative migraine treatments. Is there sufficient benefit, however, to outweigh the cost and pain of this treatment? In the case of most of my patients, the answer is yes.
My patients who do respond say that it is absolutely worth it. For people who can’t get their headaches under control with the usual medications, or who suffer from problematic side effects from those drugs, Botox can be a great option. For many of my patients, it has reduced their medication needs and restored their ability to function in their jobs and families.
Botulinum toxin exerts its effect by cleaving key proteins required for nerve activation. First, the toxin binds specifically to nerves which use the neurotransmitter acetylcholine. Once bound to the nerve terminal, the neuron takes up the toxin into a vesicle. As the vesicle moves farther into the cell, it acidifies, activating a portion of the toxin which triggers it to push across the vesicle membrane and into the cell cytoplasm.[1] Once inside the cytoplasm, the toxin cleaves SNARE proteins preventing the cell from releasing vesicles of neurotransmitter. This stops nerve signaling, leading to paralysis.[1]

Botox comes as a crystalline substance from the manufacturer, which then has to be reconstituted with saline or another liquid. Practitioners add varying amounts of liquid when reconstituting it. Although there is no right or wrong amount of liquid to add, most physicians add about 2 mL-3 mL (about a half a teaspoon) of liquid to each vial. Some add quite a bit more, which can lead patients to think they are getting more Botox when, in reality, they are getting the same or less amount of Botox than samples reconstituted in a stronger way. It is the total dose of medication, not the volume of liquid, that leads to the desired effect.
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Headache is a universal experience. At present, there are more than 100 different types of headache and one of the most recurring ones is migraine, which affects approximately 10-12% of the population, being three times more common in women than in men. When migraine becomes chronic -occurring more than 15 days a month-, it can disrupt patients' daily life in a great degree.


Jump up ^ Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF (June 2010). "OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program". Headache. 50 (6): 921–36. doi:10.1111/j.1526-4610.2010.01678.x. PMID 20487038.
These injection sites have been carefully chosen to treat specific nerve endings that are sending pain signals. BOTOX for migraines has proven to be a highly-effective treatment for people who are living with the painful, debilitating symptoms of chronic migraines. BOTOX will be carefully and correctly injected into muscles just beneath the skin. The procedure is not particularly painful, with a sensation of pinpricks.
What is Botox? | How much does Botox cost? | Where can I find Botox deals near me? | How does Botox work? | How long does it take for Botox to work? | How long does Botox last? | Is Botox a treatment for migraines? What about sweating? | Am I eligible for Botox? | Dysport vs. Botox | What are the Botox injection sites? | What are the side effects of Botox?
Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® passes into breast milk).
Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist f or several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.
Each vial of BOTOX contains either 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride; 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride; or 200 Units of Clostridium botulinum type A neurotoxin complex, 1 mg of Albumin Human, and 1.8 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.
Botox essentially paralyzes the muscles and stops them from contracting. Results are visible within one week after treatment and remain for a minimum of three months. Some surgeons suggest that Zytaze, a new prescription zinc supplement, can extend these results if taken in the days leading up to your Botox injections. Ask your doctor about Zytaze before your next Botox injection.
Wrinkles, whether they be fine line or deep furrows, typically appear on areas of the body that receive a high amount of exposure to the sun. Smoking, light skin type, hairstyle, the way you dress, your occupational and recreational habits, and heredity are all factors that promote wrinkling. Medical treatments for wrinkles include antioxidants, moisturizers, alpha-hydroxy acids, and vitamin A acid. Cosmetic procedures that treat wrinkles include dermabrasion, microdermabrasion, glycolic acid peels, laser resurfacing, Botox, and fillers.
Allergan has a deep commitment to the health and well-being of patients who use our products and the global communities where we operate. We are focused on access to our medicines, as well as environmental, health and sustainability initiatives. In 2016, Allergan introduced Our Social Contract with Patients, focused on four areas – Invest & Innovate, Access & Pricing, Quality & Safety, and Education -- where Allergan is committed to doing what is right for patients and society
Exploratory analyses of this study suggested that the majority of patients who had shown a beneficial response by week 6 had returned to their baseline status by 3 months after treatment. Exploratory analyses of subsets by patient sex and age suggest that both sexes receive benefit, although female patients may receive somewhat greater amounts than male patients. There is a consistent trea tmentassociated effect between subsets greater than and less than age 65. There were too few non-Caucasian patients enrolled to draw any conclusions regarding relative efficacy in racial subsets.
Postmarketing reports indicate that the effects of BOTOX® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat Cervical Dystonia and spasticity and at lower doses.
The safety and effectiveness for the treatment of anatomic regions other than the mid-face with JUVÉDERM VOLUMA® XC; facial wrinkles and folds with JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLLURE™ XC; and the lips and perioral area with JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® XC have not been established in controlled clinical studies

Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.
“I see a lot of patients who come in from sun damage, or who have creases in their foreheads, more lines around the sides of their mouths, crow's feet, and wrinkles on the side of their nose,” Shah says. “At this age, a dermatologist can inject Botox in the right places to help train a person’s face to no longer fall into that habit, which can help decrease the odds that they’ll develop permanent wrinkles in those spots later on.”
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The number of headache days determines whether the patient has episodic migraine (EM) (14 or fewer headache days a month) or CM (more than 15 days of headache a month). The best method of determining the actual number of headache days is to subtract this from the number of completely headache-free days in a month. If headache is present on more than half the days in the month, and there are migraine features on at least 8 days a month, the condition is termed CM. The migraine features only have to be present on 8 days out of the month and not on every headache day. The other headache days in this condition are considered to be milder forms of migraine, and they do not have all the typical migraine features. If headache is present on fewer than 15 days a month, this is referred to as EM. EM can transform to CM over time. If analgesics are used on 10 or more days per month, this can lead to a transformation to CM. The patient’s headache pattern over a 12-month period should be determined, and during this time, there should be at least 3 months with 15 headache days; 8 of these days should meet migraine criteria.1-3
My patients who do respond say that it is absolutely worth it. For people who can’t get their headaches under control with the usual medications, or who suffer from problematic side effects from those drugs, Botox can be a great option. For many of my patients, it has reduced their medication needs and restored their ability to function in their jobs and families.
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