Dosing in initial and sequential treatment sessions should be tailored to the individual patient based on the patientâ€™s head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history. The initial dose for a patie nt without prior use of BOTOX should be at a lower dose, with subsequent dosing adjusted based on individual response. Limiting the total dose injected into the sternocleidomastoid muscle to 100 Units or less may decrease the occurrence of dysphagia [see WARNINGS AND PRECAUTIONS].
A migraine requires only two of the following headache features: a unilateral distribution (one-sided), pulsatile quality (throbbing), moderate or severe pain (more than 5 out of 10), and aggravation by physical activity (such as bending over). In addition, to diagnose migraine, only one of the following is required: nausea or vomiting or sensitivity to light and noise.
Botox stays only where injected, it does not roam through the body. "If I inject it in your face, it's not going to work [or show up in] your toe," says Rowe. "It does not have a systemic effect." However, it may migrate up to 3 cm from where it was injected. But even if some molecules were to go into the bloodstream and travel to distant sites in the body, the cosmetic doses (typically less than 100 units) used are significantly lower than the toxic dose that would be harmful systemically (2,500-3,000 units).
Besides the three primary U.S. manufacturers, there are numerous other botulinum toxin producers. Xeomin, manufactured in Germany by Merz, is also available for both therapeutic and cosmetic use in the U.S. Lanzhou Institute of Biological Products in China manufactures a BTX-A product; as of 2014 it was the only BTX-A approved in China. BTX-A is also sold as Lantox and Prosigne on the global market. Neuronox, a BTX-A product, was introduced by Medy-Tox Inc. of South Korea in 2009;
In cosmetic applications, botulinum toxin is considered safe and effective for reduction of facial wrinkles, especially in the uppermost third of the face. Injection of botulinum toxin into the muscles under facial wrinkles causes relaxation of those muscles, resulting in the smoothing of the overlying skin. Smoothing of wrinkles is usually visible three days after treatment and is maximally visible two weeks following injection. The treated muscles gradually regain function, and generally return to their former appearance three to four months after treatment. Muscles can be treated repeatedly to maintain the smoothed appearance.
Results can vary depending on who is performing the injection on the patient. It is very important to go to a physician who is experienced at this procedure, does it him- or herself (rather than having a nurse, physician's assistant [PA], or other nonphysician do it), and has a good reputation for performing this type of procedure. The manufacturers of Botox recommend physicians inject the medication themselves. As with most procedures, the skill of the practitioner is related to how often he or she performs the procedure.
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.
But today it's the medical uses of the drug that are the great moneymaker, in part because doctors are getting a better handle on how to use it. Botulinum toxin type A is one of seven neurotoxins produced from Clostridium botulinum. Contracting botulism is bad news: it can cause blurred vision, persistent trouble swallowing and worse. In one recent case, close to 30 people were hospitalized in Ohio in 2015 after attending a church potluck. One person died. The outbreak was ultimately attributed to a potato salad made from improperly home-canned potatoes that were harboring the bacteria. Given its level of toxicity, some countries have even explored its potential use as a bioweapon.
Most insurance companies require patients to try at least two oral medications first. Botox is expensive, so if you respond well to oral medications, it makes sense to stick with the more-affordable option. If you don’t respond to medications or if the side effects are intolerable, however, your insurer may cover Botox. You’ll need to check with your plan for your specific coverage requirements.
Botox injections work by weakening or paralyzing certain muscles or by blocking certain nerves. The effects last about three to twelve months, depending on what you are treating. The most common side effects are pain, swelling, or bruising at the injection site. You could also have flu-like symptoms, headache, and upset stomach. Injections in the face may also cause temporary drooping eyelids. You should not use Botox if you are pregnant or breastfeeding.
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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.
Robert Anolik, a board-certified, cosmetic dermatologist explains, "The cost for these types of treatments is widely variable, as every patient needs different amounts and in different areas. It could be a few hundred dollars to a few thousand. For example, a patient may have deepened nasolabial folds (smile lines) requiring multiple syringes of Restylane Defyne. Or a patient could need a subtle lift with a small amount of Restylane-Lyft in the cheeks and mid-face. I find many of my patients will come in consistently for Dysport (Dysport spreads out a bit more, so you're able to get a better global balancing, whereas Botox has a little more of an isolated effect) every three to four months on average, and then we will review what might be needed among the fillers. Often more syringes of filler may be needed at first and then we can maintain over time."
The studies using Botox for depression, like other research into Botox's off-label potential, were so encouraging that they caught the attention of Allergan. In Rosenthal and Finzi's research, 74 people with major depressive disorder were randomly assigned to receive Botox injections or a placebo. Six weeks later, 52% of the people who received Botox experienced a drop in reported symptoms, compared with 15% of the people given a placebo. "Over 50% of people responding is a high number," says Finzi. "These are people who have already tried other treatments, and they are significantly depressed."
That said, there are a few things I'd make sure everyone knows before trying it. For one thing, it can be pretty painful. I have a pretty high pain tolerance, but getting 30 to 40 shots every three months is pretty rough — it feels a bit like getting tattooed with a bee's stinger, but once the needle is out of your skin, the pain goes away, and if it works for you, it's worth it. It's also important to know that it can take some time to work. The first treatment barely worked at all for me, and the second round took a few weeks. If you're going to try it out, be patient.
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.
In this study the median total BOTOX dose in patients randomized to receive BOTOX (N=88) was 236 Units, with 25th to 75th percentile ranges of 198 Units to 300 Units. Of these 88 patients, most received injections to 3 or 4 muscles; 38 received in jections to 3 muscles, 28 to 4 muscles, 5 to 5 muscles, and 5 to 2 muscles. The dose was divided amongst the affected muscles in quantities shown in Table 36. The total dose and muscles selected were tailored to meet individual patient needs.
There are no data on the presence of BOTOX in human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BOTOX and any potential adverse effects on the breastfed infant from BOTOX or from the underlying maternal conditions.
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).
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.
Richard Clark, a plastic surgeon from Sacramento (CA), was the first to document a cosmetic use for botulinum toxin. He treated forehead asymmetry caused by left sided forehead nerve paralysis that occurred during a cosmetic facelift. Since the injured nerve could possibly regenerate by 24 months, a two-year waiting period was necessary before definitive surgical treatment could be done. Clark realized that botulinum toxin, which had been previously used only for cross eyed babies and facial tics, could also be injected to smooth the wrinkles of the right forehead to match her paralyzed left. He received FDA approval for this cosmetic application of the toxin and successfully treated the person and published the case study in 1989.
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.
Make sure your practitioner is very experienced at Botox injections and is a respected medical professional. A salon stylist, for example, is not an appropriate person to administer Botox, because he or she would not have emergency equipment or sufficient medical knowledge if something went wrong. Some disreputable people have reportedly administered injections that were over- or under-diluted with saline, as well as counterfeit solutions that didn't contain Botox at all.
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Though there's still more research to be done on Botox for migraines and doctors aren't yet completely sure why the procedure is effective, they have some ideas. Ravitz tells me, "What [Botox] does is paralyze nerve terminals. Essentially, nerve terminals transmit pain, but they also produce pain substances while they’re doing that, and it completely paralyzes that process." She says that it stops the process of pain patterning and it also relaxes the muscles.
The needle should be inserted approximately 2 mm into the detrusor, and 20 injections of 0.5 mL each (total volume of 10 mL) should be spaced approximately 1 cm apart (see Figure 1). For the final injection, approximately 1 mL of sterile normal saline should be injected so that the remaining BOTOX in the needle is delivered to the bladder. After the injections are given, patients shou ld demonstrate their ability to void prior to leaving the clinic. The patient should be obser ved for at least 30 minutes post-injection and until a spontaneous void has occurred.
On November 23, 2015, Allergan and Pfizer announced their intention to merge in a $160 billion transaction, the largest pharmaceutical deal and the third largest merger in history. On April 5, 2016, after the Obama administration announced its plan to ban tax inversions, Pfizer terminated the acquisition and paid Allergan a $150 million breakup fee.
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
After working out techniques for freeze-drying, buffering with albumin, and assuring sterility, potency, and safety, Scott applied to the FDA for investigational drug use, and began manufacturing botulinum type A neurotoxin in his San Francisco lab. He injected the first strabismus patients in 1977, reported its clinical utility in 1980, and had soon trained hundreds of ophthalmologists in EMG-guided injection of the drug he named Oculinum ("eye aligner").
The median duration of response in Study OAB-1 and OAB-2, based on patient qualification for re-treatment, was 19-24 weeks for the BOTOX 100 Unit dose group compared to 13 weeks for placebo. To qualify for re -treatment, at least 12 weeks must have passed since the prior treatment, post-void residual urine volume must have been less than 200 mL and patients must have reported at least 2 urinary incontinence episodes over 3 days.
According to the PREEMPT injection paradigm, a total of 5 units of onabotulinumtoxinA is injected into each corrugator muscle. To confirm the location of the muscle, the patient is asked to furrow the brow in order to activate the corrugator. Once the muscle has been located, the muscle should be palpated and pinched by holding it between the thumb and index finger. Five units of onabotulinumtoxinA is injected at an approximate 90° angle with the bevel of the needle pointing upward into the medial belly of the muscle. As the needle is inserted, there is skin resistance, which lessens when the muscle is penetrated. This decrease in resistance is termed a muscle pop. Once the muscle pop occurs, inject into the superficial muscle. If the injection is too far superior or above the corrugator muscle, brow ptosis can occur due to depression of the medial brow as the frontalis elevating function is lost and the corrugator depressing function remains unopposed. Whereas weakening the corrugator muscle will cause elevation of the medial eyebrow, alternatively, if the corrugator injection is done too low, then diffusion to the levator palpebral muscle could lead to lid ptosis.
"Botox inactivates the muscle," Rowe tells SELF, "and therefore the muscle doesn't fire and pull on skin, thus reducing animation." However, when I asked Sobel what was happening during the exact incubation, he told SELF that "I'm not sure if anyone can give you an answer&we've noticed that when we inject it, it just takes three of four days for you to see the muscle contract."
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.
Yes. The number of men receiving cosmetic treatments overall has risen by 325% over the last 20 years. And the number of men specifically choosing treatments like BOTOX® Cosmetic has also risen fast– in the past three years alone, men have received over one million botulinum toxin treatments. When surveyed, the majority of men say they want to look good and they’re bothered by the changes they see in the mirror. 80% would choose to treat their crow’s feet first, while 74% would prioritize their forehead lines, and 60% would most like to treat their frown lines.†
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.
Besides the volume of product used, Baby Botox is about the technique, says Doris Day, a board-certified dermatologist in New York City and author of Beyond Beautiful. "If you're very precise in where you put the product, you can use lower doses," she tells Allure. These super targeted micro injections deliver the more natural, tailored look Baby Botox is so coveted for.
"I had 25 units of Botox done by Dr. Goldberg on my forehead and frown lines. Few days later I could see the result with which I was very happy! [...] I have done Botox few times before with other specialists, after which my face would resemble a doll [...] However, after procedure with Dr. Goldberg, I am still able to lift my eyebrows and frown without forming any wrinkles." – from Dinara D.'s review of Alexander Golberg Physician PC in New York.
Botulinum toxin has been investigated for use in patients with blepharospasm in several studies. In an open label, historical ly controlled study, 27 patients with essential blepharospasm were injected with 2 Units of BOTOX at each of six sites on each side. Twenty-five of the 27 patients treated with botulinum toxin reported improvement within 48 hours. One patient was controlled with a higher dosage at 13 weeks post initial injection and one patient reported mild improvement but remained functionally impaired.
Galli has been living with migraine for most of her adult life, but recently, her attacks became more severe and frequent. “My whole life went upside down and nothing was the same,” Galli says, upon being diagnosed with chronic migraine. “The person I used to be wasn't there anymore. I didn't even recognize myself.” To cope with the symptoms that often accompany chronic migraine, Galli found herself retreating to a dark room, waiting for the pain to pass, but it never did. In response, Galli says, she asked herself what she could do to feel better but also share her story. “Everyone around me that knew how high energy, and how much of a go-getter I am, asked what was happening? Where was that person?” When she came across the announcement of the Migraine Moment Film Contest, she saw it as her opportunity to bring awareness about what it is like to live with migraine and bust the misconceptions surrounding this invisible disease. Enter: “Invisible Hero.”
The frontalis muscle attaches to the skin of the lower forehead and ascends to join the fronto-occipital aponeurosis. The action of the frontalis muscle involves elevation of the eyebrows to produce expressions such as surprise, and can cause deep transverse wrinkles on the forehead. The antagonists for brow depression are the corrugators, procerus, and orbicularis oculi muscles.
Botox only lasts three to six months—and yet what's less commonly discussed is this: Facial muscles naturally weaken over time and going overboard in a certain area could have unwanted consequences. "If you do too much Botox on your forehead for many, many years, the muscles will get weaker and flatter," cautions Wexler, adding that the skin can also appear thinner and looser. Moreover, as your muscles become weaker, they can start to recruit surrounding muscles when you make facial expressions. "If one stops using their forehead muscles, they may start squinting using their nose and have wrinkles along the side of their nose," she explains. Translation: You need even more Botox for the newly recruited muscles, says Wexler. To avoid these kind of missteps, researching a doctor diligently is essential, as is approaching injectables conservatively, and asking questions about how the treatment will be tailored to your needs.
In study 2, 320 adults with bilateral axillary primary hyperhidrosis were randomized to receive either 50 Units of BOTOX (n=2 42) or placebo (n=78). Treatment responders were defined as subjects showing at least a 50% reduction from baseline in axillary sweating measured by gravimetric measurement at 4 weeks. At week 4 post-injection, the percentages of responders were 91% (219/242) in the BOTOX group and 36% (28/78) in the placebo group, p<0.001. The difference in percentage of responders between BOTOX and placebo was 55% (95% CI=43.3, 65.9).
I always tell my patients that you get what you pay for. However, you need to advocate for yourself and understand what you are getting for your dollars. Ensure that your injector is experienced and properly trained; that you are getting FDA approved Botox Cosmetic from Allergan; and know how many units you receive. As well, a physician's office should maintain a medical record of your treatments so you can optimize and customize your Botox to achieve the best effect and value. Good Luck!
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Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX® for their blepharospasm, especially in people with certain nerve disorders. BOTOX® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.