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).
Good question. botox can be used to help elevate the eyebrows, which contribute to the heavy lid look. You want the "depressor muscles" of the brow weakened leaving the "elevator muscles" still functional. It will give some lift. It may not be enough depending on the severity of the heaviness to your eyelids. A board certified plastic surgeons should be able to advise you... READ MORE
A double-blind, placebo-controlled study enrolled patients who had extended histories of receiving and tolerating BOTOX injections, with prior individualized adjustment of dose. The mean BOTOX dose administered to patients in this study was 236 Units (25th to 75th percentile range of 198 Units to 300 Units). The BOTOX dose was divided among the affected muscles [see Clinical Studies].
There have been spontaneous reports of death, sometimes associated with dysphagia, pneumonia, and/or other significant debility or anaphylaxis, after treatment with botulinum toxin. There have also been reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including cardiovascular disease. The exact relationship of these events to the botulinum toxin injection has not been established.
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.
When asked how often he turns people away, Dr. Matarasso says: “I turned someone away today. I had a gentleman come in, he was an appropriate candidate anatomically, he had some deep lines in his forehead, but his expectations were unrealistic. He wanted every line erased, and I said, ‘No, you are going to look a little mask-like.’ I gave him a brochure and said, 'Go home and think about it.'”
Over the next three decades, 1895-1925, as food canning was approaching a billion-dollar-a-year industry, botulism was becoming a public health hazard. Karl Friedrich Meyer, a prodigiously productive Swiss-American veterinary scientist created a center at the Hooper Foundation in San Francisco, where he developed techniques for growing the organism and extracting the toxin, and conversely, for preventing organism growth and toxin production, and inactivating the toxin by heating. The California canning industry was thereby preserved.
Still, there have been enough concerns that the FDA instituted a REMS (Risk Evaluation and Mitigation Strategy) requirement for all botulinum toxin preparations that specifically addresses the issues of distant spread of the toxin and the risk of problems, leading to death, from swallowing or breathing issues in certain patients who may be susceptible after botulinum toxin treatment. All products, including Dysport, Myobloc, Xeomin, and Botox, are monitored via this strategy. This is specifically aimed at a certain population of patients receiving more than the usual doses of botulinum toxin and not aimed at the casual user of Botox, per se.
As anyone who’s tried Botox for Migraine (or wrinkle reduction) will tell you, your forehead feels heavier after the injections are done, where the nerve endings are in essence frozen. As in ‘Frozen Face.’ Little to no movement, depending on how many units you receive and where they are injected. In my case, my usually expressive face didn’t track with my emotions: no raised eyebrows of surprise or delight or shock.
Some doctors, however, say their experience with their own patients indicates Botox — which was approved by the FDA in 2010 to treat migraines — is quite effective for this purpose. Lawrence Newman, MD, a neurologist and director of the headache division at NYU Langone Medical Center in New York City, says many of his patients have experienced a significant decline in the number of headaches per month after receiving Botox. In many cases, he says, it has cut down that number by 50% and frequently more than that.
If going back for additional treatments three or four times a year sounds like a lot of treatments, the good news is that the more Botox treatments you get, the fewer Botox units you'll need. With each repeat Botox session, the frontalis muscle and other facial muscles surrounding Botox injection sites get a little weaker and become "trained" to not contract.
Botox was introduced to the world in the late 1980s by ophthalmologists, who began using it to treat optic muscle disorders. It was approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe frown lines between the eyebrows (glabellar lines) in 2002, and its popularity has soared ever since. Botox is consistently one of the top five nonsurgical cosmetic procedures performed each year.
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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.
Firstly, that is one of the most popular combination of areas for Botox treatment in my office. Like others on this panel, I happen to think the fairest method for charging for Botox is by the unit. Botox can only be purchased through Allergan here in the United States and comes in a 100 unit bottle typically. The only common denominator between offices is how many units of Botox are you... READ MORE
Unopened vials of BOTOX should be stored in a refrigerator (2° to 8°C) for up to 36 months. Do not use after the expiration d ate on the vial. Administer BOTOX within 24 hours of reconstitution; during this period reconstituted BOTOX should be stored in a refrigerator (2° to 8°C). Reconstituted BOTOX should be clear, colorless, and free of particulate matter.
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.
Investors have been unhappy with Allergan's stock performance over the last year, and some have expressed interest in seeing the pharma company explore splitting up. On Wednesday, Allergan announced it plans to sell its women's health and infectious disease businesses. The news sent Allergan's stock down 2%, suggesting the move didn't go as far as some would like.
Contrary to popular belief, the bacteria that causes botulism, clostridium botulinum, is not part of the treatment, nor are six of the seven neurotoxins it secretes. The only substance used in Botox injections, botulinum toxin A, is carefully extracted, purified, and standardized into FDA-approved doses. Plus, the dosage is so small, it can't get beyond the muscle tissue it's injected into, meaning there's little if any chance for Botox to reach the bloodstream.
Most physicians pay roughly the same amount of money to purchase a vial of Botox. However, the cost of a Botox treatment is not the same among all providers. Botox is not an ordinary commodity such as wheat or sugar or flour. Botox is a medical procedure that requires nuance, experience and expertise. All Botox providers are not equal in education or skill and some are actually quite poor. Most Botox providers charge either by the amount of Botox used or by the region of the face treated. I feel that charging by the amount of Botox used is the most equitable.
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.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported.
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.
The primary release procedure for BOTOX uses a cell-based potency assay to determine the potency relative to a reference standard. The assay is specific to Allergan's products BOTOX and BOTOX Cosmetic. One Unit of BOTOX corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. Due to specific details of this assay such as the vehicle, dilution scheme, and laboratory protocols, Units of biological activity of BOTOX cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. The specific activity of BOTOX is approximately 20 Units/nanogram of neurotoxin protein complex.
There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, strabismus, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.