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).
For blepharospasm, reconstituted BOTOX is injected using a sterile, 27-30 gauge needle without electromyographic guidance. The initial recommended dose is 1.25 Units-2.5 Units (0.05 mL to 0.1 mL volume at each site) injected into the medial and lateral pre tarsal orbicularis oculi of the upper lid and into the lateral pre-tarsal orbicularis oculi of the lower lid. Avoiding injection near the levator palpebrae superioris may reduce the complication of ptosis. Avoiding medial lower lid injections, and thereby reducin g diffusion into the inferior oblique, may reduce the complication of diplopia. Ecchymosis occurs easily in the soft eyelid tissues. This can be prevented by applying pressure at the injection site immediately after the injection.
Chronic migraines are what were formerly known as “transformed” migraines. These are near daily headaches, sometimes with migraine features but otherwise with frequent features of tension headaches. This may sound trivial but the treatment for tension headaches, typically with analgesics, would only make this syndrome worse. We learned that treating these with migraine preventive medications proved mostly effective. The current International Classification of Headache Disorders defines chronic migraine as a recurrent headache that has been ongoing for the past 3 months, occurs on at least 15 days per month, lasts at least 4 hours per day, and has 8 or more days per month when the headache has features of a migraine or responds to a typical migraine medication.
Botox prevents migraine headaches before they start, but takes time to work. “I look to the second and third treatments to maximize effects,” says Dr. Andrew Blumenfeld. “Patients see increasing benefit with an increase in the number of treatment cycles.” One treatment lasts for 10-12 weeks, and patients reported that two Botox treatments reduced the number of headache days by approximately 50%.
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.
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.
Botox is mostly performed in a medical setting and is known to be a quick and painless medical procedure.The skin is cleansed with alcohol or another antiseptic and a topical anesthetic ointment is applied to the skin. After ten minutes the physician or nurse injects Botox or disport with a very fine needle. The procedure should be almost painless and takes only takes about 15 minutes to perform. You can easily walk out of the office and resume your daily activities.The effect of Botox or Dysport will usually take 48 to72 hours before you see the results.
Still, Botox's use for depression raises a question that confounds some researchers. In some cases, how Botox works is evident: the toxin can block the signals between nerves and muscles, which is why it can help calm an overactive bladder, say, or a twitching eye, or the facial muscles that make wrinkles more apparent. In other cases, however (with migraines as well as with depression), scientists are flummoxed. They may have noticed that the drug works for a given condition, but they aren't always sure why--in sciencespeak, they don't know what the mechanism is.
It takes a village to raise a child. My family members are well aware of how I cope with migraine. They make themselves available to help my children and me often. I rely on people to drive me to doctor’s appointments as well as take my children to sports practices. I arrange carpools and am honest with the people in our lives about how a migraine attack can be unpredictable and suddenly change plans. Every year, I alert my children’s teachers of my chronic migraine and ask them to watch and listen for signs of migraine or stress in my children. I worry about them physically and emotionally and so far, they have handled my disease as they would any other illness. By being honest about the help I need, I find that the people in my life are better equipped to follow through. Many people would like to help but don’t know how. I have given up pride and allowed others to help, which inevitably takes stress away from us all.
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Botulinum toxin produced by Clostridium botulinum is the cause of botulism. Humans most commonly ingest the toxin from eating improperly-canned foods in which C. botulinum has grown. However, the toxin can also be introduced through an infected wound. In infants, the bacteria can sometimes grow in the intestines and produce botulinum toxin within the intestine and can cause a condition known as floppy baby syndrome. In all cases, the toxin can then spread, blocking nerves and muscle function. In severe cases, the toxin can block nerves controlling the respiratory system or heart, resulting in death. Botulism can be difficult to diagnose, as it may appear similar to diseases such as Guillain–Barré syndrome, myasthenia gravis, and stroke. Other tests, such as brain scan and spinal fluid examination, may help to rule out other causes. If the symptoms of botulism are diagnosed early, various treatments can be administered. In an effort to remove contaminated food which remains in the gut, enemas or induced vomiting may be used. For wound infections, infected material may be removed surgically. Botulinum antitoxin is available and may be used to prevent the worsening of symptoms, though it will not reverse existing nerve damage. In severe cases, mechanical respiration may be used to support patients suffering from respiratory failure. The nerve damage heals over time, generally over weeks to months. With proper treatment, the case fatality rate for botulinum poisoning can be greatly reduced.
BOTOX may be an effective treatment for those who suffer from chronic migraines. Many patients have struggled to find a treatment that truly provides relief from this debilitating condition. While there are migraine medications and a host of natural remedies, for many people, none of these methods bring real relief. BOTOX may be the option that brings the relief from pain that patients have been seeking for so long.
If, however, you are on a budget, you might want to wait until the end of the year to get your Botox injections. Botox promotions, whether from the Brilliant Distinctions program or from individual doctor's offices, are more common towards the end of the year when people want to get touch ups and look their best for the holidays. However, if someone is offering Botox for a ridiculously cheap price (like you sometimes see on deal websites like Groupon.com), that should raise some red flags. You tend to get what you pay for and in my experience with my mom's Botox treatments, it is better to overpay than underpay. Don't get Botox from a shady place just because it's cheap. Remember, you are not only paying for the units of Botox per treatment, you are also paying for the skill and expertise of the doctor. So make sure you get Botox from a well-trained, reputable physician!
Side effects from therapeutic use can be much more varied depending on the location of injection and the dose of toxin injected. In general, side effects from therapeutic use can be more serious than those that arise during cosmetic use. These can arise from paralysis of critical muscle groups and can include arrhythmia, heart attack, and in some cases seizures, respiratory arrest, and death. Additionally, side effects which are common in cosmetic use are also common in therapeutic use, including trouble swallowing, muscle weakness, allergic reactions, and flu-like syndromes.
According to the PREEMPT injection paradigm, one injection of 5 units of onabotulinumtoxinA is administered to one site in the procerus muscle. The procerus injection site is approximately midway between the two corrugator injections. In order to confirm the location of the procerus muscle, the patient is asked to furrow the brow, which will activate the belly of the muscle causing the medial furrowing to occur. Once identified, 5 units of onabotulinumtoxinA is injected superficially into the belly of the muscle at a 90° angle to ensure the injection is administered into the procerus rather than the frontalis. Injections placed too superiorly may inadvertently lead to penetration of the frontalis muscle.
Some skin care centers advertise low prices for Botox on a "cost per area" basis, advertising prices of $200-$300 for one area. The doctor we spoke to recommends getting price quotes on a "cost per unit" basis, because some places might be quoting lower prices but giving you smaller treatments, which may be less effective and require more frequent visits.
The drug has come a long way since its ability to smooth facial wrinkles was first discovered, by accident. In the 1970s, ophthalmologist Dr. Alan B. Scott started studying the toxin as a therapy for people with a medical condition that rendered them cross-eyed. "Some of these patients that would come would kind of joke and say, 'Oh, Doctor, I've come to get the lines out.' And I would laugh, but I really wasn't tuned in to the practical, and valuable, aspect of that," Scott told CBS in 2012. Scott named the drug Oculinum and formed a company of the same name in 1978. In 1989 he received FDA approval for the treatment of strabismus (the crossed-eye disorder) and abnormal eyelid spasms.
In clinical trials, 6.5% of patients (36/552) initiated clean intermittent catheterization for urinary retention following treatment with BOTOX® 100 Units as compared to 0.4% of patients (2/542) treated with placebo. The median duration of catheterization for patients treated with BOTOX® 100 Units was 63 days (minimum 1 day to maximum 214 days) as compared to a median duration 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo.
Reduced blinking from BOTOX injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders. Vigorous treatment of any epithelial defect should be employed. This may require protective drops, ointment, therapeutic soft contact lenses, or closure of the eye by patching or other me ans.
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
Extraocular muscles adjacent to the injection site can be affected, causing vertical deviation, especially with higher do ses of BOTOX. The incidence rates of these adverse effects in 2058 adults who received a total of 3650 injections for horizontal strabismus was 17%. The incidence of ptosis has been reported to be dependent on the location of the injected muscles, 1% after inferior rectus injections, 16% after horizontal rectus injections and 38% after superior rectus injections.
Food-borne botulism results, indirectly, from ingestion of food contaminated with Clostridium spores, where exposure to an anaerobic environment allows the spores to germinate, after which the bacteria can multiply and produce toxin. Critically, it is ingestion of toxin rather than spores or vegetative bacteria that causes botulism. Botulism is nevertheless known to be transmitted through canned foods not cooked correctly before canning or after can opening, and so is preventable. Infant botulism cases arise chiefly as a result of environmental exposure and are therefore more difficult to prevent. Infant botulism arising from consumption of honey can be prevented by eliminating honey from diets of children less than 12 months old.
During a recent therapy session, one of Dr. Norman Rosenthal's regulars said he was considering suicide. It wasn't the first time the patient had entertained the thought, and even though he was on antidepressants and always kept up with his appointments, Rosenthal, a licensed psychiatrist with a private practice in North Bethesda, Md., wanted to offer his patient something else.
Dr. Engelman says preventative is legit. “Most certainly! I do micro-injections on patients who are just starting to show the finest expression lines in order to prevent them from ever making the wrinkle." NYC-based board-certified plastic surgeon Norman Rowe, MD, is also a fan. "While Botox has a fundamental use in treating wrinkles that are already formed, it has a role in the prophylactic, or prevention, of wrinkles. So, don't think that you don't need Botox because you don't have wrinkles. If you want to keep that smooth skin, start with Botox before they form."
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX® should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent, and consequently the causal agent cannot be reliably determined.
Finding an experienced practitioner is particularly important if you’ve never had Botox treatments before as he or she will devise an optimal treatment plan to address your forehead wrinkles. Furthermore, with an experienced, board-certified plastic surgeon you’ll be far less likely to experience any side effects like pain, bruising around the injection site, droopy eyelids, or mistakenly be administered too much Botox, leaving your face looking frozen for the next several months.
Injections: They're a popular topic and yet still shrouded in mystery and a veritable amount of secrecy. Most of us venture to a consultation or decide against them without actually knowing much information—how much they cost, what to expect during an appointment, or what the results will be. Because we're not willing to openly and freely discuss it (or have been taught not to), more often than not these conversations occur through a series of unanswered questions. Like sexual education, relying on abstinence is never going to be enough. We want to feel confident, look good, and make our own choices, and as such, that often leads to investing in modern skincare techniques.
A placebo-controlled, double-blind randomized post-approval 52 week study (Study NDO-3) was conducted in MS patients with urinary incontinence due to neurogenic detrusor overactivity who were not adequately managed with at least one anticholinergic agent and not catheterizing at baseline. These patients were randomized to receive either 100 Units of BOTOX (n=66) or placebo (n=78).
Other treatment areas that have been proven to be useful include the scalp (for migraine headaches), neck, facial and peripheral muscles (for spasms), arm pits (to inhibit sweating), the bladder and numerous other areas. The way that Botox and Dysport work is that they temporarily inhibit muscle contraction beneath the skin. When underlying muscles are relaxed the overlying folds and wrinkles are smoothed out. These injections work only by weakening underlying muscle contraction are not facial fillers like Restylane or Juvederm. Fillers and Botox or Dysport injections are not interchangeable. These injections work only by weakening underlying muscle contraction are not facial fillers like Restylane or Juvederm. Fillers are not interchangeable with Botox or Dysport injections. Fillers replace or “fill-in” lost facial volume whereas Botox or Dysport only inhibit muscle contraction.Both treatments are in fact complimentary aesthetic injections that will relax wrinkles and folds and help you regain your youthful appearance and enhance your face.
Of 1242 overactive bladder patients in placebo-controlled clinical studies of BOTOX, 41.4% (n=514) were 65 years of age or older, and 14.7% (n=182) were 75 years of age or older. Adverse reactions of UTI and urinary retention were more common in patients 65 years of age or older in both placebo and BOTOX groups compared to younger patients (see Table 18). Otherwise, there were no overall differences in the safety profile following BOTOX treatment between patients aged 65 years and older compared to youn ger patients in these studies.
“Your doctor still has to be willing to do the work of filing a waiver and they don’t get reimbursed for that work, so they don’t like to do it,” Hoffman says. Plus, there’s a federal law called ERISA that exempts certain types of employer-provided health plans, called self-funded plans, from the requirements of state laws. So, for roughly a quarter of Americans who have these health plans, the state limitations to step therapy don’t apply.
The toxin itself is released from the bacterium as a single chain, then becomes activated when cleaved by its own proteases. The active form consists of a two-chain protein composed of a 100-kDa heavy chain polypeptide joined via disulfide bond to a 50-kDa light chain polypeptide. The heavy chain contains domains with several functions: it has the domain responsible for binding specifically to presynaptic nerve terminals, as well as the domain responsible for mediating translocation of the light chain into the cell cytoplasm as the vacuole acidifies. The light chain is a zinc metalloprotease and is the active part of the toxin. It is translocated into the host cell cytoplasm where it cleaves the host protein SNAP-25, a member of the SNARE protein family which is responsible for fusion. The cleaved SNAP-25 is unable to mediate fusion of vesicles with the host cell membrane, thus preventing the release of the neurotransmitter acetylcholine from axon endings. This blockage is slowly reversed as the toxin loses activity and the SNARE proteins are slowly regenerated by the affected cell.
The cost for Botox may range from $125 to $400 per treatment area. Multiple areas may be treated at one time, and repeat treatments are needed every three to four months, on average. When it comes to Botox and other injectables, you get what you pay for. Buyer beware: bargain Botox may increase your risk of complications, including poor cosmetic results. If the cost is prohibitive, ask your doctor about payment plans.
Botox should definitely last longer than a few weeks, but how much longer varies. First time Botox users, for example, might experience Botox wearing off in less than 3 months. However, as facial muscles get conditioned to Botox, results should lengthen. Botox injections around the eyes can also last shorter than 3 months. Men, on the other hand, tend to need more Botox than women. Whatever the case, Botox results should generally last around 3 months, give or take a few days.
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.
In a long term, open-label study evaluating 326 cervical dystonia patients treated for an average of 9 treatment sessions with the current formulation of BOTOX, 4 (1.2%) patients had positive antibody tests. All 4 of these patients responded to BOTOX therapy at the time of the positive antibody test. However, 3 of these patients developed clinical resistance after subsequent treatment , while the fourth patient continued to respond to BOTOX therapy for the remainder of the study.
In response to the occurrence of these side effects, in 2008 the U.S. Food and Drug Administration notified the public of the potential dangers of the botulinum toxin as a therapeutic. Namely, they warned that the toxin can spread to areas distant from the site of injection and paralyze unintended muscle groups, especially when used for treating muscle spasticity in children treated for cerebral palsy. In 2009, the FDA announced that boxed warnings would be added to available botulinum toxin products, warning of their ability to spread from the injection site. Additionally, the FDA announced name changes to several botulinum toxin products, meant to emphasize that the products are not interchangeable and require different doses for proper use. Botox and Botox Cosmetic were renamed onabotulinumtoxinA, Myobloc was renamed rimabotulinumtoxinB, and Dysport name renamed abobotulinumtoxinA. In conjunction with this, the FDA issued a communication to health care professionals reiterating the new drug names and the approved uses for each. A similar warning was issued by Health Canada in 2009, warning that botulinum toxin products can spread to other parts of the body.