Properly trained, board-certified dermatologists and plastic surgeons separate the "forehead" area into the upper/main forehead, and the glabella, the area between the eyebrows that has the frown lines. Depending on your exact anatomy and types of lines and facial movement, you may need only 3 to 5 units total in the upper forehead area, or up to 40 units for the combined glabella... READ MORE
Safety and effectiveness of BOTOX have not been established for the treatment of other upper or lower limb muscle groups. Safety and effectiveness of BOTOX have not been established for the treatment of spasticity in pediatric patients under age 18 years. BOTOX has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with BOTOX is not intended to substitute for usual standard of care rehabilitation regimens.
As part of the settlement, Allergan agreed to plead guilty to one criminal misdemeanor misbranding charge and pay $375 million. The company acknowledged that its marketing of Botox led to off-label uses of the drug. Allergan also agreed to pay $225 million to resolve civil charges alleging that the marketing of Botox had caused doctors to file false reimbursement claims, though Allergan denied wrongdoing. The company said in a statement that the settlement was in the best interest of its stockholders because it avoided litigation costs and "permits us to focus our time and resources on ... developing new treatments."
Sharona Hoffman, professor of law and bioethics at Case Western Reserve University School of Law, says that step therapy is driven by a single motivator: saving costs. Hoffman, who’s written about the legal and ethical implications of step therapy, says that sometimes step therapy can have sensible outcomes, like pushing patients to take generics instead of brand-name drugs. But these policies can also keep doctors from prescribing the more expensive drugs of choice, forcing patients to take medications that are less effective or have worse side effects.
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According to the PREEMPT paradigm, one injection of 5 units of onabotulinumtoxinA into four sites (total 20 units) into the frontalis muscle is done. The injection points are located by visually drawing a line up from the medial edge of the supraorbital rim. Patients will be injected into the muscle in the upper third of the forehead at least 1 to 2 fingerbreadths above the corrugator injection site. The lateral muscle injection areas are parallel and approximately 1 fingerbreadth lateral to the medial injection site, which is roughly in line with either the midpupillary line or the lateral edge of the cornea, which is the limbus line. In cases in which I am worried about ptosis, I inject the frontalis close to the hairline. In order to reduce the risk of these unwanted effects, injections should be administered in the upper third of the forehead only. The needle should be inserted at a 45° angle superiorly. Because the frontalis is an elevator muscle, weakening can cause brow ptosis or exacerbate preexisting brow ptosis.
When pregnant rats received single intramuscular injections (1, 4, or 16 Units/kg) at three different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal develop ment were observed. The developmental no-effect level for a single maternal dose in rats (16 Units/kg) is approximately 2 times the human dose of 400 Units, based on Units/k g.
Safety and effectiveness of BOTOX® have not been established for the treatment of other upper or lower limb muscle groups or for the treatment of spasticity in pediatric patients under age 18 years. BOTOX® has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with BOTOX® is not intended to substitute for usual standard of care rehabilitation regimens.
The efficacy and safety of BOTOX for the treatment of primary axillary hyperhidrosis were evaluated in two randomized, multi center, double-blind, placebo-controlled studies. Study 1 included adult patients with persistent primary axillary hyperhidrosis who scored 3 or 4 on a Hyperhidrosis Disease Severity Scale (HDSS) and who produced at least 50 mg of sweat in each axilla at res t over 5 minutes. HDSS is a 4-point scale with 1 = “underarm sweating is never noticeable and never interferes with my daily activities”; to 4 = “underarm sweating is intolerable and always interferes with my daily activities”. A total of 322 patients were randomized in a 1:1:1 ratio to treatment in both axillae with either 50 Units of BOTOX, 75 Units of BOTOX, or placebo. Patients were evaluated at 4-week intervals. Patients who responded to the first injection were re-injected when they reported a re-increase in HDSS score to 3 or 4 and produced at least 50 mg sweat in each axilla by gravimetric measurement, but no sooner than 8 we eks after the initial injection.
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. Once inside the cytoplasm, the toxin cleaves SNARE proteins preventing the cell from releasing vesicles of neurotransmitter. This stops nerve signaling, leading to paralysis.
A placebo-controlled, double-blind post-approval 52 week study with BOTOX 100 Units (Study NDO-3) was conducted in non-catheterizing MS patients with urinary incontinence due to detrusor overactivity associated with a neurologic condition. Catheterization for urinary retention was initiated in 15.2% (10/66) of patients following treatment with BOTOX 100 Units versus 2.6% (2/78) on placebo at any time during the complete treatment cycle. The median duration of post-injection catheterization for those who developed urinary retention was 64 days for BOTOX 100 Units and 2 days for placebo.
Botox injections like other goods and services in New York City are typically more expensive then in the suburbs where the rent and salaries are also less expensive. So it is true that in general Botox cost more in NYC. In one vial of Botox there is 100 units of medicine and each unit costs on average $20. Most patients require between 20 to 60 units.That translates into an average between $400 and $1200.
Study 3 compared 3 doses of BOTOX with placebo and enrolled 88 patients [BOTOX 360 Units (N=23), BOTOX 180 Units (N=23), BOTOX 90 Units (N=23), and placebo (N=19)] with upper limb spasticity (expanded Ashworth score of at least 2 for elbow flexor tone and at least 3 for wrist flexor tone and/or finger flexor tone) who were at least 6 weeks post -stroke. BOTOX and placebo were injected with EMG guidance into the flexor digitorum profundus, flexor digitorum sublimi s, flexor carpi radialis, flexor carpi ulnaris, and biceps brachii (see Table 27).
Most insurance providers now recognize BOTOX as treatment for migraines. Some have specific criteria that patients must meet, or require documentation that you have gone through other treatment protocols before trying BOTOX. It can take several weeks to receive authorization to begin treatment. Check with your insurance provider to make sure you fulfill their requirements, and to begin the approval process.
I asked this question as Ravitz was putting the first needles in my face, which was probably a mistake as I get anxious easily. However, she assured me that the side effects of Botox typically don't happen at the doses prescribed for migraines, and even if the scary-sounding side effects you read about online do occur (such as one-side paralysis and eye droops), they aren't particularly dangerous and last four to six weeks.
Lastly, a Botox treatment does not offer permanent results. Botox is most effective when treatments are carried out at regular intervals before the results fully wear off. On average, the results last for three to four months, although Botox metabolizes at different rates in different individuals. The first ever Botox treatment you receive may not last as long as subsequent treatments, plus you may require touch-ups two weeks after the procedure as your injector determines the right dosage for you. Over time, however, many patients notice that they can wait longer intervals between treatments as their treated facial muscles weaken.
The correct way to inject Botox is to always customize the treatment plan to solve the aesthetic issues that bother the person. Some patients need only limited areas injected such as the vertical lines between their brows, their “crow’s feet” at the outer aspects of their eyelids, the “bunny” lines that radiate on the sides of their nose, vertical and horizontal lip lines and rarely patients request a correction of their “gummy” smile where their upper gums show when a person smile. Yes, you usually can pay for specific areas of treatment or by the number of units injected. But if you only want single line or area of your forehead injected you may not be satisfied with the results in the end. Why? -because when Botox or Dysport is injected it will weaken only the muscles that are treated, there may be muscles that were not treated that are pulling in an opposite direction that will produce undesirable results(an example of an undesirable effect occurs when treating just the glabella “11” lines between your eyebrows that may produce an overarched brow contour that resembles Mr. Spock.) Therefore, a complete treatment plan that includes all muscle groups should be treated to balance the pull and counter-pull of facial muscles.In addition, injections around the mouth must be performed by an experienced injector because there is the potential for the mouth to droop afterwards which can cause you to drool or may impact your ability to eat, pucker and smile. These adverse effect may last several weeks.
Two double-blind, placebo-controlled, randomized, multi-center, 24-week clinical studies were conducted in patients with OAB with symptoms of urge urinary incontinence, urgency, and frequency (Studies OAB -1 and OAB-2). Patients needed to have at least 3 urinary urgency incontinence episodes and at least 24 micturitions in 3 days to enter the studies. A total of 1105 patients, whose symptoms had not been adequately managed with anticholinergic therapy (inadequate response or intolerable side effects), were randomized to receive either 100 Units of BOTOX (n=557), or placebo (n=548). Patients received 20 injections of study drug (5 units of BOTOX or placebo) spaced approximately 1 cm apart into the detrusor muscle.
In recent years, a number of high-profile lawsuits have been brought against Allergan in which plaintiffs claimed that off-label uses--for ailments including a child's cerebral-palsy symptoms, for instance, or an adult's hand tremors--resulted in lasting deleterious side effects. Still, the drug's acceptance in a growing number of doctors' offices worldwide, and its revenue growth, show no signs of slowing.
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When BOTOX (4, 8, or 16 Units/kg) was administered intramuscularly to pregnant mice or rats two times during the period of organogenesis (on gestation days 5 and 13), reductions in fetal body weight and decreased fetal skeletal ossification were ob served at the two highest doses. The no-effect dose for developmental toxicity in these studies (4 Units/kg) is approximately equal to the human dose of 400 Units, on a body weight basis (Units/kg).
Children do very well after having this procedure in our clinic and are not upset when they leave. We rarely use sedation. We use distraction and a quick injection method instead. In rare cases, localization of a muscle may be needed using an electromyograph (EMG) machine or electric stimulator. If this is needed we will discuss this before scheduling the injections.
Receiving Botox injections for migraines is a straightforward outpatient procedure. The skin in the area to be injected is cleaned. Most injections are administered in the forehead area, usually above the eyes or where “worry lines” might occur. Because this area may be sensitive or patients may be experiencing hypersensitivity to pain, a topical anesthetic may be applied before the injection.
According to the PREEMPT injection paradigm, 5 units of onabotulinumtoxinA is to be administered to two sites on each side for a total dose of 20 units across four sites in the cervical paraspinal muscle group near the midline. The first injection site is approximately 1 cm left of the midline of the cervical spine and approximately 3 cm (2 fingerbreadths) inferior to the occipital protuberance. The second site is measured approximately 1 fingerbreadth diagonally up at a 45° angle from the first injection. The injections should be administered in the most superficial aspect of the muscle, angling the needle 45° and superiorly. To aid in the placement of the injections, the patient should be positioned upright with the head in a neutral position. If the neck is flexed too far forward, injections may be too deep. Injections that are too low or too deep in this muscle group can lead to muscle weakness and neck pain. Injectors should use a suboccipital approach to ensure that the injection sites are not too low. In addition, a horizontal line can be visualized across the neck, approximately 2 fingerbreadths down from the occipital protuberance, to make certain the injections remain above the line and are not administered too low in the neck. The higher these injections are, the more likely that they will be in the muscle fascial condensation, which will minimize the potential for neck weakness. These injections should not be done below the hairline. Patients who have trigger points in the neck should not be injected at these sites as these are generally areas where muscles may be weakened and injections of onabotulinumtoxinA at these sites might worsen their neck issues.
In the mid-1990s, people who received BOTOX for other conditions reported improvement in their chronic migraine pain. A two-phase study was conducted, treating patients who averaged 20 headache days a month. They received BOTOX injections every twelve weeks for 56 weeks. At the end of that period, 70% of the patients had fewer than half the number of headaches they had before treatment. The FDA officially approved BOTOX to treat chronic migraine in October of 2010. Since then, more than 100,000 patients have been treated.
The seven toxin types (A-G) have different tertiary structures and sequence differences. While the different toxin types all target members of the SNARE family, different toxin types target different SNARE family members. The A, B, and E serotypes cause human botulism, with the activities of types A and B enduring longest in vivo (from several weeks to months).
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.
The recommended dilution is 200 Units/2 mL, 200 Units/4 mL, 100 Units/1 mL, or 100 Units/2 mL with preservative-free 0.9% Sodium Chloride Injection, USP, depending on volume and number of injection sites desired to achieve treatment objectives (see Table 1). In general, no more than 50 Units per site should be administered using a sterile needle (e.g., 25-30 gauge) of an appropriate length. Localization of the involved muscles with electromyographic guidance may be useful.
In 1820, Justinus Kerner, a small-town German medical officer and romantic poet, gave the first complete description of clinical botulism based on extensive clinical observations of so-called “sausage poisoning”. Following experiments on animals and on himself, he concluded that the toxin acts by interrupting signal transmission in the somatic and autonomic motor systems, without affecting sensory signals or mental functions. He observed that the toxin develops under anaerobic conditions, and can be lethal in minute doses. His prescience in suggesting that the toxin might be used therapeutically earned him recognition as the pioneer of modern botulinum toxin therapy.
Currently, there are several anti-CGRP treatments undergoing clinical trials. Some of these treatments involve monoclonal antibodies, which reduce the activity of CGRP, potentially leading to fewer migraine attacks. One of these anti-CGRP monoclonal antibodies, erenumab (Aimovig™), has been approved by the Federal Drug Administration (FDA) and is now available for patients. A second agent, fremanezumab (Ajovy™), was approved in September 2018. A week later, the FDA approved galcanezumab (Emgality™), making it the third anti-CGRP treatment currently on the market. Results from the clinical trials involving anti-CGRP antibodies have shown that about 50 percent of patients will have at least a 50 percent reduction in migraine days. “If you think about someone who has 20 migraine days per month, they have a 50 percent chance of having 10 or less migraine days,” Dr. Starling says. “We think that there are even these super-responders who have a 75 percent response rate, as well as super-super-responders who actually go into remission.” The results from these clinical trials are very promising, Dr. Starling adds. “The adverse events have been very minimal and the efficacy has been very good. It’s all looking up.” Dr. Starling says that although these medications are available, what really needs to be looked at is how to make them truly accessible for patients. Erenumab can cost about $7,000 per year without insurance coverage. “Insurance coverage is very, very key for the majority of our patient population,” she says. “Because the medications just came out on the market, there are still a lot of unknowns about insurance coverage.”
Allergan Plc engages in the research, development, and manufacture of pharmaceutical products. The firm offers products under the following brands: BOTOX, Juvederm, Linzess, Namenda, Restasis, Latisse, Teflaro, Lo Loestrin Fe, Bystolic, DORYX, Saphris, Fetzima, Namenda XR, Namzaric, Viberzi, Viibryd, Alphagan, LUMIGAN, ESTRACE Cream, Rapaflo, Asacol, DELZICOL, Zenpep, Avycaz, and Dalvance. Its brand portfolio delivers treatments that address unmet medical needs in therapeutic categories such as dermatology and aesthetics;Read More
BOTOX® can be used on the forehead lines, frown lines, crow’s feet, bunny lines (lines in the nose), chin (for dimpling), skin bands on the neck, and around the mouth (for smoker’s lines and down-turned corners of the mouth). Wrinkles caused by sun damage and gravity often will not respond to BOTOX®. It is important to re-emphasize that BOTOX® is NOT a facial filler (that is, it does not fill existing wrinkles) – it merely relaxes the muscles that are creating those wrinkles.
Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include Micromedex® (updated Oct 1st, 2018), Cerner Multum™ (updated Oct 2nd, 2018), Wolters Kluwer™ (updated Oct 2nd, 2018) and others. To view content sources and attributions, please refer to our editorial policy.
It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.