Study 1 included 126 patients (64 BOTOX and 62 placebo) with upper limb spasticity (Ashworth score of at least 3 for wrist flexor tone and at least 2 for finger flexor tone) who were at least 6 months post -stroke. BOTOX (a total dose of 200 Units to 240 Units) and placebo were injected intramuscularly (IM) into the flexor digitorum profundus, flexor digito rum sublimis, flexor carpi radialis, flexor carpi ulnaris, and if necessary into the adductor pollicis and flexor pollicis longus (see Table 25). Use of an EMG/nerve stimulator was recommended to assist in proper muscle localization for injection. Patients were followed for 12 weeks.
Many times, effects on spasticity are longer lasting. It is not clear if this is due to breaking down patterned movements (many muscles contracting together rather than singly) or from allowing weak muscles to get stronger over time (that were overpowered before by more spastic muscles pulling against them). It is vital to have close follow-up after the injections to figure out the best course of treatment.

The median duration of response in study NDO-3, based on patient qualification for re-treatment was 362 days (52 weeks) for the BOTOX 100 Units dose group compared to 88 days (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 with no more than 1 incontinence -free day.
Unremarkable. I mean, that’s a good thing in the MRI-reading world, but I’d like to say my brain is freakin’ remarkable sometimes. Maybe I’m biased. Anyways. Shortly after those tests, the Botox arrived at the office and I was scheduled for my injections. To say I was scared is putting it lightly. Like I mentioned before, I have a complete irrational fear of new medication. Also, I didn’t want my face to look different! So I documented my wrinkles just to see how many would last (if you want, be my guest to check out my embarrassing video). I didn’t have to wait long and before I knew it, I was in a room with my mom, my boyfriend, a neurologist and three needles.
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.

Not much. Results begin to show in a couple of days and develop gradually over the course of two weeks. "I tell anyone preparing for a big event to have shots two weeks ahead of time," says Kane. Some observers believe Dysport sets in faster than Botox, but that has not been proven in a study. Patients taking medications that contain aspirin or NSAIDs can develop pinpoint blue bruising. Patients can wear makeup immediately but should avoid heavy workouts for 24 hours, says Carruthers.

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 rare cases, Botox toxin can spread to areas beyond the injection site. If this happens, you may experience muscle weakness, vision changes, difficulty swallowing, and drooping eyelids. To reduce your risk of serious side effects and complications, always make sure Botox is prescribed and administered by a trained healthcare professional who has experience in using Botox.
On average, each BOTOX treatment requires 32 injections, though individual patients may require fewer or more. You’ll receive injections every twelve weeks, and each session only takes a few minutes. BOTOX begins to work as soon as it’s injected, and you should see full results within a week of your first injections. Most patients who benefit from BOTOX treatments receive five rounds of injections over 15 months. BOTOX is injected using a very fine needle. Most patients describe it as feeling like a tiny pinprick.
When pregnant rats received single intramuscular injections (1, 4, or 16 Units/kg) at three different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal develop ment were observed. The developmental no-effect level for a single maternal dose in rats (16 Units/kg) is approximately 2 times the human dose of 400 Units, based on Units/k g.
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions).
Jump up ^ van Ermengem E (1979). "Classics in infectious diseases. A new anaerobic bacillus and its relation to botulism. E. van Ermengem. Originally published as "Ueber einen neuen anaëroben Bacillus und seine Beziehungen zum Botulismus" in Zeitschrift für Hygiene und Infektionskrankheiten 26: 1–56, 1897". Reviews of Infectious Diseases (in German). 1 (4): 701–19. PMID 399378. Original doi:10.1007/BF02220526
After the injections, the patient will usually lay upright or semiupright on the exam table for about two to five minutes to make sure he or she feels good after the procedure, and then the patient should avoid lying down for two to four hours. If bruising is a concern, it will be important for the patient to avoid taking aspirin or related products, such as ibuprofen (Advil, Motrin) or naproxen (Aleve), if possible after the procedure to keep bruising to a minimum.
The results usually start to be noticed within three to 10 days or even sooner. They tend to last in most people for up to three or four months. As time passes, the muscle activity will gradually return to normal. Additionally, other areas may return to activity over time, depending on the amount injected. The interesting thing about Botox is that it tends to work fairly well even up to the third month, as a procedure that might last a very short time at full strength and then go away quickly (filler injections such as Restylane, Perlane, or Juvederm tend to last approximately six to 12 months, depending on the amount used).

Botulinum toxin injections are one approach to the treatment of muscle spasticity. These injections can be given with ease and have minimal side effects. They can also be used in very focal spasticity problems that involve a few muscle groups. This treatment may not be right for some patients, such as patients with severe, widespread muscle spasticity, and patients with permanent muscle contractures that have become rigid.
Sunburn alert: The AHA/BHA Exfoliating Cleanser and AHA/BHA Cream in the Lytera® 2.0 Advanced Pigment Correcting System contain an alpha-hydroxy acid (AHA) that may increase the skin’s sensitivity to the sun and particularly the possibility of sunburn. Patients should use a sunscreen, wear protective clothing, and limit sun exposure while using these products (or this system) and for a week following.
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.
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.
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.
Botox is considered as an elective procedure which means that the insurance does not cover the cost. But in case of treating medical conditions, an insurance can cover the cost of the treatment but make sure to consult your doctor regarding the coverage. Botox injections can also be used to treat conditions such as excessive perspiration (hyperhidrosis), migraine and muscle spasticity.
In a recent Facebook Live, our new director Nim Lalvani introduced herself to the migraine community. If you missed our Facebook Live, watch the recording below or read on to learn more about Lalvani’s personal connection to migraine and her plans for the Foundation. [embed]https://www.facebook.com/americanmigrainefoundation/videos/290329171553466/[/embed] In the short time that Lalvani has worked at AMF, she’s been impressed by the strong and vibrant community of doctors, patients and advocates. Lalvani’s background is in public health, and she has dedicated her career to patient engagement. She has worked in the nonprofit and patient advocacy spaces for more than 12 years, helping patients at both the national and international level. “I've specifically focused my career on designing and providing the rights tools and resources for patients at the times that they need it most,” she shared, adding that her goal is to amplify patients’ voices in research and therapeutic development.
Allergan PLC (AGN) is a large market cap ($65B) biopharmaceutical company with a pipeline of innovative and generic therapeutics for diseases affecting the eyes, bowel, lungs, skin, urogenital systems and brain. Through the acquisition of Tobira Pharmaceuticals and its assets including cenicriviroc (CVC), Allergan is one of the leaders in the clinical development of anti-NASH therapeutics (the focus of this article).
Exploratory analyses of this study suggested that the majority of patients who had shown a beneficial response by week 6 had returned to their baseline status by 3 months after treatment. Exploratory analyses of subsets by patient sex and age suggest that both sexes receive benefit, although female patients may receive somewhat greater amounts than male patients. There is a consistent trea tmentassociated effect between subsets greater than and less than age 65. There were too few non-Caucasian patients enrolled to draw any conclusions regarding relative efficacy in racial subsets.
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.

The co-primary endpoints were the average of the change from baseline in modified Ashworth Scale (MAS) ankle score at Week 4 and Week 6, and the average of the Physician Global Assessment of Response (CGI) at Week 4 and Week 6. The CGI evaluated the response to treatment in terms of how the patient was doing in his/her life using a 9-point scale from -4=very marked worsening to +4=very marked improvement).
Most SkinMedica® products are intended to meet the FDA's definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA, and the statements have not been evaluated by the FDA.
In both studies, significant improvements compared to placebo in the primary efficacy variable of change from baseline in wee kly frequency of incontinence episodes were observed for BOTOX (200 Units) at the primary efficacy time point at week 6. Increases in maximum cystometric capacity and reductions in maximum detrusor pressure during the first involuntary detrusor contraction we re also observed. These primary and secondary endpoints are shown in Tables 21 and 22, and Figures 7 and 8.
Patients should shave underarms and abstain from use of over-the-counter deodorants or antiperspirants for 24 hours prior to the test. Patient should be resting comfortably without exercise, hot drinks for approximately 30 minutes prior to the test. Dry the underarm area and then immediately paint it with iodine solution. Allow the area to dry, then lightly sprinkle the area with starch powder. Gently blow off any excess starch powder. The hyperhidrotic area will develop a deep blue-black color over approximately 10 minutes.
The following adverse reactions with BOTOX 200 Units were reported at any time following initial injection and prior to re -injection or study exit (median duration of exposure was 44 weeks): urinary tract infections (49%), urinary retention (17%), constipation (4%), muscular weakness (4%), dysuria (4%), fall (3%), gait disturbance (3%), and muscle spasm (2%).
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Above all, I try to be gentle with myself and my children. It’s easier said than done.  Mom guilt and migraine guilt weigh heavy on my heart, and I continue to remind myself that I’m doing my best. I give myself a break as I do with my children when they’re having a bad day. I’m patient with them and try to give myself the same respect.  As a mom, it seems like my job is never done and that I can always do better. The reality is, no one is perfect, and we all have our flaws. We don’t expect our children to be perfect, and we should not expect ourselves to be. We do what we can when we can and take each day as it comes. I find joy in the smallest things and find that being grateful and mindful remind me off all the blessings I have, despite my unpredictable and chronic migraine attacks.
Botulinum toxin injections are one approach to the treatment of muscle spasticity. These injections can be given with ease and have minimal side effects. They can also be used in very focal spasticity problems that involve a few muscle groups. This treatment may not be right for some patients, such as patients with severe, widespread muscle spasticity, and patients with permanent muscle contractures that have become rigid.

After the injections, the patient will usually lay upright or semiupright on the exam table for about two to five minutes to make sure he or she feels good after the procedure, and then the patient should avoid lying down for two to four hours. If bruising is a concern, it will be important for the patient to avoid taking aspirin or related products, such as ibuprofen (Advil, Motrin) or naproxen (Aleve), if possible after the procedure to keep bruising to a minimum.
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.
It’s not just about Botox, though. Last month, the FDA approved the first migraine-specific drug to prevent the severe headaches. Called Aimovig, the injectable med will cost $6,900 a year, according to The New York Times, plus injection fees. Because of the high costs, experts expect the new drug to be subject to step therapy policies. Stephen Silberstein, the director of the headache center at Jefferson University, told me in 2016 that he wouldn’t be surprised if insurance companies required patients to even try and fail Botox before covering the new meds (there are a few of them under development).

Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery.
It's also not approved by the U.S. Food and Drug Administration (FDA) for depression, not that that stops doctors from prescribing it that way. Such off-label use of Botox, like that of any FDA-approved drug, is legal in the U.S. That's because once a drug has been approved by the FDA for a condition, licensed physicians are legally allowed to prescribe it for any medical issue they think it could benefit, regardless of whether it's been proved to work for that condition.

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Jump up ^ Arnon SS, Schechter R, Inglesby TV, Henderson DA, Bartlett JG, Ascher MS, Eitzen E, Fine AD, Hauer J, Layton M, Lillibridge S, Osterholm MT, O'Toole T, Parker G, Perl TM, Russell PK, Swerdlow DL, Tonat K (February 2001). "Botulinum toxin as a biological weapon: medical and public health management". JAMA. 285 (8): 1059–70. doi:10.1001/jama.285.8.1059. PMID 11209178.

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.
Each vial of BOTOX contains either 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride; 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride; or 200 Units of Clostridium botulinum type A neurotoxin complex, 1 mg of Albumin Human, and 1.8 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.
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).
Please note, there are no guaranteed results with BOTOX and results may vary from patients to patient. Though BOTOX is not effective for all types of headaches, about 90% of MRC’s patients report that their migraines are less frequent and not as severe after BOTOX treatment. In clinical trials, patients reported seven to nine fewer headaches per month. In a study by A. H. Elkind, P. O’Carroll, A. Blumenfeld, R. DeGryse, and R. Dimitrova, a standard course of treatment brought patients these results:
The FDA now requires black box labeling on Botox and similar products such as Dysport and Xeomin to warn of rare but potentially life-threatening swallowing and breathing complications if the toxin spreads beyond the injection site. None of these complications have occurred in people using Botox for cosmetic reasons and the FDA states that cosmetic use of Botox appears to be safe.

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.

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

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.
Since Botox made its first appearance in the med-spa world, a number of similar treatments have also become available. These include Dysport, another Botulinum toxin type A injectable, as well as dermal fillers (which use hyaluronic acid to plump skin) such as Juvéderm, Restylane, and Perlane. The decision to choose between Botox vs Dysport depends largely on the results you're hoping to achieve. For more information, check out the following guides:
Formation of neutralizing antibodies to botulinum toxin type A may reduce the effectiveness of BOTOX treatment by inactivating the biological activity of the toxin. The critical factors for neutralizing antibody formation have not been well characterized. The results from some studies suggest that BOTOX injections at more frequent intervals or at higher doses may lead to greater incidence of antibody formation. The potential for antibody formation may be minimized by injecting with the lowest effective dose given at the longest feasible intervals between injections.
There are no limits on therapy or activity after the session. For patients that don’t normally use a device to help them walk, at first it may seem like their walking has gotten worse. They need some time to get used to the feeling of the sudden change in the way their muscle contracts when they walk. This most often improves quickly over one to two weeks. Some very young children may have discomfort in their heel cord from rapid stretching. The child may limp or refuse to put weight on it. Again, this most often resolves quickly in the first week.
Botox has also been shown to prevent chronic migraines, but there, it's unclear exactly why Botox works. (For doctors, reaching a firm understanding of how Botox prevents migraines will be tricky, since they don't know for certain what causes the severe headaches in the first place.) "There were multiple clinical trials for migraines, and most of them failed," says Dr. Mitchell Brin, senior vice president of drug development at Allergan and chief scientific officer for Botox. "It took a long time to figure out where to inject and how much." Today people who receive Botox for migraine prevention get 31 injections in different spots on their head and neck. The effects of Botox can last about three to six months depending on the condition.
The FDA approved such usage in the late 1980s when it was discovered that BOTOX® could stop ailments such as blepharospasm (uncontrolled blinking) and strabismus (lazy eye). Cosmetic physicians have been using BOTOX® for years to successfully treat wrinkles and facial creases. BOTOX® is approved for treatment of frown lines on the forehead, crow’s feet (lines around the eye), and axillary hyperhidrosis (increased sweating of the armpits). Within the past few years, new products that have similar preparations have been introduced into the U.S. market and have been well-received by patients.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.
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