The potency Units of BOTOX (onabotulinumtoxinA) for injection 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 [see WARNINGS AND PRECAUTIONS and DESCRIPTION] .

Headache is a universal experience. At present, there are more than 100 different types of headache and one of the most recurring ones is migraine, which affects approximately 10-12% of the population, being three times more common in women than in men. When migraine becomes chronic -occurring more than 15 days a month-, it can disrupt patients' daily life in a great degree.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
The cosmetic effect of BTX-A on wrinkles was originally documented by a plastic surgeon from Sacramento, California, Richard Clark, and published in the journal Plastic and Reconstructive Surgery in 1989.[51] Canadian husband and wife ophthalmologist and dermatologist physicians, JD and JA Carruthers, were the first to publish a study on BTX-A for the treatment of glabellar frown lines in 1992.[52] Similar effects had reportedly been observed by a number of independent groups (Brin, and the Columbia University group under Monte Keen.[53]) After formal trials, on April 12, 2002, the FDA announced regulatory approval of botulinum toxin type A (Botox Cosmetic) to temporarily improve the appearance of moderate-to-severe frown lines between the eyebrows (glabellar lines).[54] Subsequently, cosmetic use of botulinum toxin type A has become widespread.[78] The results of Botox Cosmetic can last up to four months and may vary with each patient.[79] The US Food and Drug Administration approved an alternative product-safety testing method in response to increasing public concern that LD50 testing was required for each batch sold in the market.[55][56]
There are numerous areas where Botox may be used, including the forehead, crow's feet, gummy smile, chin, neck, and other areas of the body. Many of these are under investigation at this time for approval by the FDA. Additionally, topical forms of botulinum toxin (Revance) are under study at present. With time, these will likely come to market and be absorbed into the body of treatments for which Botox is used.
Botox is best known for smoothing out wrinkles, but since 2010 it’s also been used to prevent migraines. (Scientists aren’t 100 percent sure why Botox works, though it may interfere with the transmission of pain signals to the brain.) Though the 36 injections I get every three months in my forehead, skull, neck, and shoulders are painful, they’ve been a game changer. I went from 16 to 18 migraines a month to about eight. The intensity of the pain has gone down, too. The results are so good that I find myself frustrated that I spent so many years in unnecessary misery.
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The Company provides warranty programs for breast implant sales primarily in the United States, Europe and certain other countries. The United States programs include the ConfidencePlus program, which is limited to saline breast implants that provide lifetime product replacement and contralateral implant replacement. It also include ConfidencePlus Premier warranty programs, which are standard for silicone gel implants and require a low enrollment fee for saline breast implants, and generally provide lifetime product replacement along with financial assistance for both saline and silicone gel breast implants for surgical procedures within 10 years of implantation and contralateral implant replacement.
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.[citation needed] Critically, it is ingestion of toxin rather than spores or vegetative bacteria that causes botulism.[citation needed] Botulism is nevertheless known to be transmitted through canned foods not cooked correctly before canning or after can opening, and so is preventable.[citation needed] Infant botulism cases arise chiefly as a result of environmental exposure and are therefore more difficult to prevent.[citation needed] Infant botulism arising from consumption of honey can be prevented by eliminating honey from diets of children less than 12 months old.[71]
The American Migraine Foundation recently launched the American Registry for Migraine Research, or ARMR. ARMR collects information and biospecimens from patients living with migraine and other disorders that cause head pain. ARMR will be used to help health care providers and scientists better understand the causes, characteristics, and management of migraine and other headache types. Anonymized ARMR data will be made available to researchers who apply for access, enhancing the efficiency by which headache research can be conducted. Dr. Todd Schwedt, Professor of Neurology at the Mayo Clinic in Scottsdale, Arizona, and co-principal investigator of ARMR, expands on the registry.

A recent encounter with one of my headache patients got me thinking. I am treating this young woman for chronic migraine with BOTOX injections. She told me that one of her other physicians had been surprised to hear about this use for onabotulinumtoxin A. According to my patient, the gastroenterologist’s words were, “BOTOX for migraines? I’ve never heard of that.” 
These injection sites have been carefully chosen to treat specific nerve endings that are sending pain signals. BOTOX for migraines has proven to be a highly-effective treatment for people who are living with the painful, debilitating symptoms of chronic migraines. BOTOX will be carefully and correctly injected into muscles just beneath the skin. The procedure is not particularly painful, with a sensation of pinpricks.

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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).
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).
Bronchitis was reported more frequently as an adverse reaction in patients treated for upper limb spasticity with BOTOX® (3% at 251 Units to 360 Units total dose) compared to placebo (1%). In patients with reduced lung function treated for upper limb spasticity, upper respiratory tract infections were also reported more frequently as adverse reactions in patients treated with BOTOX® (11% at 360 Units total dose; 8% at 240 Units total dose) compared to placebo (6%). In adult patients treated for lower limb spasticity, upper respiratory tract infections were reported more frequently as an adverse event in patients treated with BOTOX® (2% at 300 Units to 400 Units total dose), compared to placebo (1%).
Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).
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.

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“A younger face has a heart shape, and an older face is a little more bottom-heavy and square,” says Dr. Matarasso. “But if you put toxin in both sides, you are not reducing the movement of the muscle, you are thinning the muscle out a bit. You can restore a youthful look. It’s not as dramatic or quick-acting as other areas, but it can be a nice way to improve the contour of the face.”
BOTOX (onabotulinumtoxinA) for injection is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular, intradetrusor and intradermal use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.
In 1986, Scott's micromanufacturer and distributor of Botox was no longer able to supply the drug because of an inability to obtain product liability insurance. Patients became desperate, as supplies of Botox were gradually consumed, forcing him to abandon patients who would have been due for their next injection. For a period of four months, American blepharospasm patients had to arrange to have their injections performed by participating doctors at Canadian eye centers until the liability issues could be resolved.[48]
Vials of BOTOX have a holographic film on the vial label that contains the name “Allergan” within horizontal lines of rainbow color. In order to see the hologram, rotate the vial back and forth between your fin gers under a desk lamp or fluorescent light source. (Note: the holographic film on the label is absent in the date/lot area.) If you do not see the lines of rainbow color or the name “Allergan”, do not use the product and contact Allergan for additional information at 1-800-890-4345 from 7:00 AM to 3:00 PM Pacific Time.

Dr. Matarasso says hardly a week goes by when he doesn’t see a patient with a botched Botox job. Why? People are getting it done by unexperienced, often unlicensed, practitioners who don’t know the shape of the face and how to correctly administer the toxin. “I just had a patient come in the other day who went to an ER doctor, and one that went to a psychiatrist,” he says. “They [also] have these Botox parties and I have seen scarring, significant bruising, not only functional, but aesthetic complications.”
The safety and effectiveness of BOTOX® for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive BOTOX® for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (eg, hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.
There were 214 subjects evaluated for the open label period, of which 170 progressed into the randomized, blinded treatment p eriod (88 in the BOTOX group, 82 in the placebo group). Patient evaluations continued for at least 10 weeks post-injection. The primary outcome for the study was a dual endpoint, requiring evidence of both a change in the Cervical Dystonia Severity Scale (CDSS) and an increase in the percentage of patients showing any improvement on the Physician Global Assessment Scale at 6 weeks after the injection session. The CDSS quantifies the severity of abnormal head positioning and was newly devised for this study. CDSS a llots 1 point for each 5 degrees (or part thereof) of head deviation in each of the three planes of head movement (range of scores up to theoretical maximum of 54). The Physician Global Assessment Scale is a 9 category scale scoring the physician's evaluation of the patients' status compared to baseline, ranging from 4 to +4 (very marked worsening to complete improvement), with 0 indicating no change from baseline and +1 slight improvement. Pain is also an important symptom of cervical dystonia and was evaluated by separate assessments of pain frequency and severity on scales of 0 (no pain) to 4 (constant in frequency or extremely severe in intensity). Study results on the primary endpoints and the pain-related secondary endpoints are shown in Table 35.
"The cost for a procedure depends on two main factors," explains Joshua Zeichner, MD, a board-certified dermatologist. "First, different products cost different amounts because of the technology that goes into their manufacturing. In addition, the cost depends on the fee of the injector. If you are seeing a sought-after, skilled injector, you may be paying a premium for that treatment. Especially when getting injectable fillers, your treatment is dependent on the skill and aesthetic of your injector. I do not recommend compromising here or purchasing a deal on websites like Groupon."

Absolutely. Botox (and competitors like Dysport and Xeomin, which will be widely available next January) are highly purified toxins that can temporarily erase or reduce horizontal forehead lines, vertical frown lines, and crow's-feet. "The injections slow muscles that contract hundreds of times a day, eventually etching lines in the skin," says New York City plastic surgeon Michael Kane, author of The Botox Book (St. Martin's Press). Botox can also lift the corners of the mouth that sag with age, smooth out the "pin cushion" look in some chins, soften smoker's lines around the mouth, and soften vertical neck cords.
The Company is developing a number of products, some of which utilize drug delivery systems, through a combination of internal and collaborative programs, such as Esmya, Sarecycline, Ubrogepant, Abicipar, Bimatoprost SR, Relamorelin, Rapastinel, Cenicriviroc and Atogepant. The Company's portfolio of branded pharmaceutical products within the US Specialized Therapeutics, US General Medicine and International segments includes Alphagan/Combigan, which is used for the treatment of selective alpha2 agonist; Armour Thyroid, which is used for the treatment of Underactive thyroid; Asacol/Delzicol, which is used for the treatment of ulcerative colitis; Botox, which is used for the treatment of acetylcholine release inhibitor; Bystolic, which is used for the treatment of hypertension; Carafate/Sulcrate, which is used for the treatment of ulcerative colitis, and Dalvance, which is used for the treatment of acute bacterial skin infections. It also offers Estrace Cream, which is used for the treatment of hormone therapy; Linzess/Constella, which is used for the treatment of irritable bowel syndrome; Lo Loestrin which is an oral contraceptive; Lumigan/Ganfort, which is used for the treatment of prostaglandin analogue; Minastrin 24, which is an oral contraceptive; Namenda IR, Namenda XR and Namzaric, which are used for the treatment of Dementia; Restasis, which is used for the treatment of topical immunomodulator; Saphris, which is used for the treatment of schizophrenia, bipolar mania; Teflaro, which is used for the treatment of acute bacterial skin infections, community-acquired bacterial pneumonia; Viberzi, which is used for the treatment of irritable bowel syndrome; Viibryd/Fetzima, which is used for the treatment of depressive disorders, and Zenpep, which is used for the treatment of exocrine pancreatic insufficiency. The Company also offers CoolSculpting, which is a controlled-cooling fat reducing system.

Younger patients have been increasingly hopping on the Botox bandwagon as a preventative measure—even before the wrinkles appear or deepen. That’s why dermatologists can’t recommend the best age to start or try Botox, since it depends on your goals, your facial expressions, and your preference. If all you see when you look at a photo of yourself is that forehead wrinkle instead of your bright eyes or smile, it might make you happier to get the wrinkle taken care of. “Each time we raise our eyebrows, or scowl by bringing our eyebrows together, the wrinkles in these locations get deeper and more numerous. It happens slowly over a long period of time, so you don’t notice it on a daily basis,” Dr. Tutela says. “But if you look at the horizontal wrinkles in your forehead when you are not raising your eyebrows, you will see an increase in these wrinkles when you do raise your brows. If you then hold that raised brow position for 10 seconds, you will notice when you relax, your forehead wrinkles look deeper and more numerous. Botox prevents this from happening.” It’s almost never too early to start a good anti-aging regimen. Learn the most in-demand cosmetic treatments across the US.
If you have eyelid drooping after a Botox procedure, it is a good idea to let the cosmetic surgeon know because there is a medicine available to help this condition. Any other difficulties, such as difficulty breathing or rashes, should be reported to the surgeon immediately. Bruises are generally gone within one to two weeks, there are other medications available for the treatment of these, such as vitamin K topical treatments (Dr. Holmquist Healthcare CytoActive Post-Procedural Bruise Relief, Revision Skincare Vitamin K Serum, Clinicians Complex Bruise Cream, Glymed Plus Arnica+ Healing Cream).
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

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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.
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]
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.
As compared to standard-size injections, Baby Botox lowers the risk of your features appearing to be frozen. Take the forehead, for example: "The risk is that you weaken your frontalis muscle, which causes your eyebrows to drop," Darren Smith, a board-certified plastic surgeon in New York City, tells Allure. "If you're getting micro doses of Botox, that's a lot less likely to happen."
The overall cost of  the injection is charged either at a flat rate or per unit. In terms of per unit, the overall cost of the treatment will depend on the total volume or a total number of units used in the procedure. But service charged at a flat rate depends on the area to be treated. The most expensive area is around the underarm for treating hyperhidrosis.
Some critics say Botox makes you lose all the personality from your face, leaving you with a significantly less range of motion when you laugh, or get angry or upset. While it’s true that your movement will be restricted, a moderate amount of Botox will still allow you to react and communicate in a lively way. “Botox relaxes the wrinkle-forming facial muscles at the sight of injection, such as crow’s feet, glabella (the ‘furrows’ in between the brows), and frontalis (forehead lines),” Dr. Waibel says. “Botox does not affect other facial muscles that are used for overall facial expressions.”
There are eight types of botulinum toxin, named type A–H. Types A and B are capable of causing disease in humans, and are also used commercially and medically.[3] Types C–G are less common; types E and F can cause disease in humans, while the other types cause disease in other animals.[4] Type H is considered the deadliest substance in the world – an injection of only 2 ng can cause death to an adult.[5] Botulinum toxin types A and B are used in medicine to treat various muscle spasms and diseases characterized by overactive muscle. Commercial forms are marketed under the brand names Botox and Dysport, among others.[6][7]
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