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.
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.
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
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In overactive bladder patients with analyzed specimens from the two phase 3 studies and the open-label extension study, neutralizing antibodies developed in 0 of 954 patients (0.0%) while receiving BOTOX 100 Unit doses and 3 of 260 patients (1.2%) after subsequently receiving at least one 150 Unit dose. Response to subsequent BOTOX treatment was not different following seroconversion in these three patients.
In general, adverse reactions occur within the first week follo wing injection of BOTOX and while generally transient, may have a duration of several months or longer. Localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising may be associated with the injection. Needle-related pain and/or anxiety may result in vasovagal responses (including e.g., syncope, hypotension), which may require appropriate medical therapy.
In the mid- to late-1990’s dermatologists were the first to report headache relief to migraineurs who were receiving BOTOX injections to reduce facial (forehead) wrinkles. Initially there was significant controversy about whether BOTOX really did help migraine patients. The use of BOTOX for treatment of tension headaches was studied and found to be no more effective than placebo. With migraines, it was more complex. In 2009 the data showed that BOTOX injected in particular areas of the head and neck in patients who met the International Classification of Headache Disorders criteria for chronic migraine provided sufficient benefit to recommend the treatment modality. In 2010, the FDA approved BOTOX for chronic migraine and recommended the protocol of injections and treatment frequency that had been successful in the studies.
Some industry insiders say it's not unusual, if still legally murky, for drug-company representatives and doctors to share information with one another about the different ways an approved drug may be used. If a doctor notices that, say, a treatment for crossed eyes also "takes the lines out," he may mention it to the representative from whom he buys the drugs. That rep may share that with another of his clients, and so on.
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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.


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.
University-based ophthalmologists in the USA and Canada further refined the use of botulinum toxin as a therapeutic agent. By 1985, a scientific protocol of injection sites and dosage had been empirically determined for treatment of blepharospasm and strabismus.[76] Side effects in treatment of this condition were deemed to be rare, mild and treatable.[77] The beneficial effects of the injection lasted only 4–6 months. Thus, blepharospasm patients required re-injection two or three times a year.
BOTOX was evaluated in two randomized, multi-center, 24-week, 2 injection cycle, placebo-controlled double-blind studies. Study 1 and Study 2 included chronic migraine adults who were not using any concurrent headache prophylaxis, and during a 28 -day baseline period had ≥15 headache days lasting 4 hours or more, with ≥50% being migraine/probable migraine. In both studies, patients were randomized to receive placebo or 155 Units to 195 Units BOTOX injections every 12 weeks for the 2-cycle, double-blind phase. Patients were allowed to use acute headache treatments during the study. BOTOX treatment demonstrated statistically significa nt and clinically meaningful improvements from baseline compared to placebo for key efficacy variables (see Table 24).
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.
Most practices have a flat cost for each injection of BOTOX® Cosmetic, though some will break it down by “units” used per treatment. Flat rates are usually somewhere between $300 and $1000, while per-unit rates are usually around $10-15 per unit. Though the BOTOX® Cosmetic price paid by physicians is normally about $400 for each vial (each vial contains 100 units, or enough for about 4 or 5 treatments), the vial must be used within a few hours of opening, so if the entire vial is not used, the physician will often have to throw the rest out.
If the musculature of the oropharynx and esophagus are affected, aspiration may occur which may lead to development of aspira tion pneumonia. If the respiratory muscles become paralyzed or sufficiently weakened, intubation and assisted respiration may be necessary until recovery takes place. Supportive care could involve the need for a tracheostomy and/or prolonged mechanical ventilation, in addition to other general supportive care.
Allergan says Botox is well established as a drug and that the benefits and risks of toxins are well understood. "With more than 25 years of real-world clinical experience ... approximately 3,200 articles in scientific and medical journals, marketing authorizations in more than 90 markets and many different indications, Botox and Botox Cosmetic are [among] the most widely researched medicines in the world," an Allergan rep wrote in an emailed statement.

Botox costs can vary anywhere from $200 to $400 or more depending on the physician, location, units purchased, desired profit margin, ongoing promotions, etc. Many doctor's offices price Botox based on cost per unit, but others price Botox injections based on the area of the injection. Whether Botox is charged by the unit or by the area might not matter that much if the Botox treatment is effective, but if you want to know exactly how much you are paying for your treatment, you need to know the number of units of Botox per treatment and the cost per unit. (An honest practice will not hesitate to give you this information if you ask.)
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.
Ophthalmologists specializing in eye muscle disorders (strabismus) had developed the method of EMG-guided injection (using the electromyogram, the electrical signal from an activated muscle, to guide injection) of local anesthetics as a diagnostic technique for evaluating an individual muscle’s contribution to an eye movement.[44] Because strabismus surgery frequently needed repeating, a search was undertaken for non-surgical, injection treatments using various anesthetics, alcohols, enzymes, enzyme blockers, and snake neurotoxins. Finally, inspired by Daniel Drachman’s work with chicks at Johns Hopkins,[45] Alan B Scott and colleagues injected botulinum toxin into monkey extraocular muscles.[46] The result was remarkable: a few picograms induced paralysis that was confined to the target muscle, long in duration, and without side-effects.
"There is a difference in pricing based on the duration of the results," says L.A.-based injection specialist Lisa Goodman. (FYI: She's incredible, and I emphatically recommend seeing her if you're in L.A. or Dara Liotta, MD, if you're in NYC.) "The longer-lasting formulas cost more upfront. Shorter-term fillers can last from six to 11 months based on the patient's rate of aging (i.e., smoking, drinking, sun exposure, genetics), while the longer-term fillers last about one to two years."

They affect 39 million folks in the U.S., 4 million of whom deal with daily pain. Chronic migraines can severely inhibit daily life, and when I started to feel like my bad days were outnumbering my good, I knew I needed to find a solution. Botox had been suggested to me multiple times before by friends, family, and doctors, and though it took quite a while to get it approved by insurance and find a provider I trusted, my migraines were making it hard to live a normal life, so I decided to try it out.
Migraine is not a synonym for just a really bad headache, Galli says, which is one of the biggest misconceptions of this disease. It’s a full-body experience that affects your daily life. Being able to break that stigma and, instead, making migraine a synonym of the “this huge debilitating monster of a disease” is one way to change that. Knowledge is a powerful tool for migraine management. The American Migraine Foundation maintains a comprehensive resource library full of fact sheets, toolkits and advice sourced directly from the nation’s leading migraine specialists. Visit AMF’s website to learn more and to find a headache doctor near you.

Exactly how soon you'll need to return for more Botox injections is really up to you. Some patients prefer to return for a touch up of Botox cosmetic after just three months, or at the very first sign of fine lines and facial wrinkles returning. Others prefer to wait six months or more until the effects of the previous injection have completely faded away.


BOTOX is administered about every three months, and must be injected at the site of each nerve trigger, relaxing the surrounding muscles so that they won’t compress the nerve and trigger a migraine. It is a potent drug, and we only recommend using it if other preventative treatment options haven’t helped you. It is generally only administered to patients who have at least 14 headaches a month, or don’t respond to other treatments.
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”.[37] 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.[38] His prescience in suggesting that the toxin might be used therapeutically earned him recognition as the pioneer of modern botulinum toxin therapy.[39]
The primary efficacy variable was wrist flexors muscle tone at week 6, as measured by the Ashworth score. The Ashworth Scale is a 5-point scale with grades of 0 [no increase in muscle tone] to 4 [limb rigid in flexion or extension]. It is a clinical measure of the force required to move an extremity around a joint, with a reduction in score clinically representing a reduction in the force need ed to move a joint (i.e., improvement in spasticity).
Injection description is very important. It is best to describe the injections as a pinch rather than a bee sting, and to explain that the injections are shallow, with only a half-inch needle. As a result of the superficial technique used with the injections, deep anticoagulation can be continued. The procedure is short, and talking to the patient during the procedure about something other than the injections can help alleviate the patient’s anxiety. It is important to describe onabotulinumtoxinA as a purified protein rather than a toxin or a poison. In addition, stating that it relaxes muscles rather than causing paralysis will be reassuring to the patient. In a very anxious patient, the areas to be injected can be iced first or a local anesthetic cream can be applied. Starting with the trapezius muscle can also help, as these injections are the least painful, and the patient cannot see the needle. Finally, it is important to make sure the injections are performed with a sharp needle, and blunt needles are discarded. Thirty-gauge needles only remain sharp for six to eight needle sticks each.
Kybella helps patients lose their dreaded double chin and regain the taut, sculpted profile of their youth. The ingredients in Kybella are naturally made by the body, which means that you’re very likely to be satisfied with the results. It works by destroying the fat cells under the chin, making them unable to store fat any longer. Each treatment only requires 15-20 minutes, which leaves enough time to grab some sushi before you head back to the office. You’ll pay out somewhere between $1200 and $1800, but a chin tuck can cost anywhere from $1500 to $4000. Plus, Kybella doesn’t require the healing time that traditional skin liposuction does.
Patients with compromised respiratory status treated with BOTOX for spasticity should be monitored closely. In a double-blind, placebo-controlled, parallel group study in patients treated for upper limb spasticity with stable reduced pulmonary function (defined as FEV1 40-80% of predicted value and FEV1/FVC ≤0.75), the event rate in change of Forced Vital Capacity (FVC) ≥15% or ≥20% was generally greater in patients treated with BOTOX than in patients treated with placebo (see Table 5).
In addition to glabellar lines, Botox is used to eradicate crow’s feet, frown lines, and lines and furrows in the forehead. Whereas treating crow's feet and forehead lines with Botox was for many years an off-label use, the toxin has since received FDA approval for both uses. Botox is also approved to treat a variety of medical conditions, including ocular muscle spasms, problems with eye coordination, severe armpit perspiration, migraine headaches, overactive bladder, urinary incontinence related to nerve damage from conditions such as multiple sclerosis and spine injury. Botox is being studied to determine if it might be useful in treating conditions such as knee and hip osteoarthritis, temporomandibular joint disorder (TMJ) and benign prostatic hyperplasia (BPH).
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.
In May, hedge fund Appaloosa Management, run by David Tepper, received antitrust clearance from the Federal Trade Commission to potentially increase its stake in the Botox-maker. This means that Appaloosa now has more flexibility to push for further changes at Allergan. It remains to be seen if that happens, but if so, it could mean more changes are ahead for the drugmaker.

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During treatment, very low doses of Botox® Cosmetic are administered via a few tiny injections directly into the muscles responsible for frown lines between the brows. By blocking the release of a chemical that causes them to contract, Botox® Cosmetic enables them to relax. The effects are very localized and, when administered by an experienced injector, do not affect your ability to smile, laugh, or otherwise show expression. Botox® Cosmetic is the only product of its kind that has been approved for use in this area.
It may be the most well known, but Botox is just one type of neurotoxin on the market. Other, next-level neurotoxins are Dysport, FDA-approved in 2009, and Xeomin, FDA-approved in 2011. “They all originate from the same strain of bacteria, therefore they work essentially in the same way,” explains Z. Paul Lorenc, MD, a board certified aesthetic plastic surgeon in Manhattan. “There are some nuanced differences between the three,” he adds. Xeomin is a purified neurotoxin, also called a “naked molecule,” because it doesn’t contain any extra surface proteins, the way Botox and Dysport do. This “pure” neurotoxin migrates deeper into skin, works faster, and poses less risk of an allergic reaction. “Theoretically, decreasing the protein load also lessens the chance of becoming a non-responder, meaning it lessens the chance that the patient will become immune to the neuromodulator being injected,” Dr. Lorenc says. Dysport tends to spread a little more than Botox, so it’s good for areas that would otherwise need multiple injections. It also kicks in faster than the other two, typically showing effects after two to three days opposed to seven to ten days with Botox, and five to six days with Xeomin. Once you try the different neurotoxins, you might decide you like one brand better than the others.
Sarah of My Migraine Life is a mom living with chronic migraine and daily headaches who has tried a gamete of medications, alternative therapies and lifestyle changes. These experiences led her to write “My Migraine Life,” a website for people living with migraine and their caretakers devoted to telling stories, raising awareness, giving support, product reviews and more. My Migraine Life is a partner of the American Migraine Foundation.
As you noted in your question, the effects of Botox don't last forever. For some patients the short term effects of Botox are a ‘good thing,’ as it means that trying Botox is a relatively low risk/low commitment procedure. If you don't like your Botox results, there's not much to worry about: They will fade on their own in a few months. Generally speaking, the results last between three to five months -- but the duration of the Botox effect depends on the individual and on how many Botox units were used.
In the United States, botulinum toxin products are manufactured by a variety of companies, for both therapeutic and cosmetic use. A U.S. supplier reported in its company materials in 2011 that it could "supply the world's requirements for 25 indications approved by Government agencies around the world" with less than one gram of raw botulinum toxin.[66] Myobloc or Neurobloc, a botulinum toxin type B product, is produced by Solstice Neurosciences, a subsidiary of US WorldMeds. AbobotulinumtoxinA), a therapeutic formulation of the type A toxin manufactured by Galderma in the United Kingdom, is licensed for the treatment of focal dystonias and certain cosmetic uses in the U.S. and other countries.[30]
Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscle for the treatment of cervical dystonia have been reported to be at greater risk for dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Injections into the levator scapulae may be associated wit h an increased risk of upper respiratory infection and dysphagia.
In double-blind, placebo-controlled chronic migraine efficacy trials (Study 1 and Study 2), the discontinuation rate was 12% in the BOTOX treated group and 10% in the placebo-treated group. Discontinuations due to an adverse event were 4% in the BOTOX group and 1% in the placebo group. The most frequent adverse events leading to discontinuation in the BOTOX group were neck pain, headache, worsening migraine, muscular weakness and eyelid ptosis.
Botox is injected in and around the head on an average of every three months. It blocks signals from nerves and paralyzes the muscles, ultimately preventing migraines. It is known to relax the muscles that usually contract during migraines. It’s also the only FDA-approved medication to prevent migraines before they even start! It’s known to prevent about nine migraines per month.
Charges can vary from $8 to $20 a unit depending on where you are in the country and the level of dilution, meaning that the price may actually be higher than the quoted price if a clinic dilutes it out instead of preparing full-strength Botox. The cost of the procedure varies as it depends upon the total number of units injected and the number of sites treated.

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.
Botox is administered by injection and dosing depends on the condition that it is used for. Administration of botulinum toxin with other agents (for example, aminoglycosides, curare) that affect neuromuscular function may increase the effect of botulinum toxin. There are no adequate studies of Botox in pregnant women and it has not been evaluated in nursing mothers.

The most frequently reported adverse reactions following injection of BOTOX® for Chronic Migraine vs placebo include, respectively: neck pain (9% vs 3%), headache (5% vs 3%), eyelid ptosis (4% vs < 1%), migraine (4% vs 3%), muscular weakness (4% vs < 1%), musculoskeletal stiffness (4% vs 1%), bronchitis (3% vs 2%), injection-site pain (3% vs 2%), musculoskeletal pain (3% vs 1%), myalgia (3% vs 1%), facial paresis (2% vs 0%), hypertension (2% vs 1%), and muscle spasms (2% vs 1%).

The incidence of UTI increased in patients who experienced a maximum post-void residual (PVR) urine volume ≥200 mL following BOTOX injection compared to those with a maximum PVR <200 mL following BOTOX injection, 44% versus 23%, respectively. No change was observed in the overall safety profile with repeat dosing during an open-label, uncontrolled extension trial.
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.
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).

BOTOX® Cosmetic targets one of the underlying causes of frown lines, crow’s feet and forehead lines — the repeated muscle contractions from frowning, squinting, smiling and raising the eyebrows over the years. Your specialist will inject these muscles with BOTOX® Cosmetic to temporarily reduce muscle activity. You will begin to notice a visible smoothing of the frown lines between your brows, your crow’s feet lines and your forehead lines.
Botox costs can vary anywhere from $200 to $400 or more depending on the physician, location, units purchased, desired profit margin, ongoing promotions, etc. Many doctor's offices price Botox based on cost per unit, but others price Botox injections based on the area of the injection. Whether Botox is charged by the unit or by the area might not matter that much if the Botox treatment is effective, but if you want to know exactly how much you are paying for your treatment, you need to know the number of units of Botox per treatment and the cost per unit. (An honest practice will not hesitate to give you this information if you ask.)
Focal Spasticity is a condition in which certain muscles in your body become stiff or tight. It is caused by damage to parts of the central nervous system that control voluntary movements. When this happens, your nerves send continuous messages to your muscles telling them to contract, or tighten. If you or someone you care for has stiffness in the muscles of the elbow, wrist, fingers, thumb, ankle, or toes, it could be Focal Spasticity.1
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