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In the case of Botox, doctors who experiment off-label say they do so because they're looking for better treatment options for their patients. "In my 30 years of medical practice, Botox is one of the most impactful treatments I had ever seen," says Dr. Linda Brubaker, dean and chief diversity officer of the Loyola University Chicago Stritch School of Medicine, who independently studied Botox for overactive bladder before the FDA approved it for that condition in 2013.
The safety and efficacy of onabotulinumtoxinA for CM was demonstrated in the pivotal phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) trial. In this trial, patients were treated every 12 weeks whether or not their headaches had returned to baseline levels and the primary outcome period was after two treatment cycles. At baseline, these patients had more than 19 headache days, and after two treatment cycles, their headaches had been reduced by 8 to 9 days per 28 days. The responder rate analysis of the study population shows that about 25% of patients improved by 75% in terms of a reduction of migraine days. In my practice, I usually do three cycles 12 weeks apart, and only if there is no change in headache frequency after this, do I change treatments. In the pivotal trials, the first statistical separation from placebo occurred in the first 4 weeks. There is a small subgroup of patients who fail to respond to the first two treatments and only start to respond after the third treatment.4-10
As part of the settlement, Allergan agreed to plead guilty to one criminal misdemeanor misbranding charge and pay $375 million. The company acknowledged that its marketing of Botox led to off-label uses of the drug. Allergan also agreed to pay $225 million to resolve civil charges alleging that the marketing of Botox had caused doctors to file false reimbursement claims, though Allergan denied wrongdoing. The company said in a statement that the settlement was in the best interest of its stockholders because it avoided litigation costs and "permits us to focus our time and resources on ... developing new treatments."
Postmarketing reports indicate that the effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, general ized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses. [See WARNINGS AND PRECAUTIONS]

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).
Botox is a brand name of a toxin produced by the bacterium Clostridium botulinum. There are other brand names for botulinum, such as Xeomin. In large amounts, this toxin can cause botulism, which you probably associate with food poisoning. Despite the fact that one of the most serious complications of botulism is paralysis, scientists have discovered a way to use it to human advantage. Small, diluted amounts can be directly injected into specific muscles causing controlled weakening of the muscles.
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.
What Other Factors Determine the Cost of Botox? The fixed cost of Botox or Dysport that the doctor pays for the drugs is relatively expensive and therefore that cost is obviously passed along to the patient. The cost of Botox or Dysport injections also depends upon the number of areas that are required to obtain the best results. The more areas that need treatment the greater the amount of injections that will be required to arrive at the most desirable result. Simply put -the more areas that need  treatment the higher the cost of treatment.

Galli’s winning film presents herself, and people with migraine, as superheroes, living with a secret identity: migraine. “Other than me laying down on my couch, and knowing what's going on inside my body, nobody sees what's happening,” she says. “It's all happening inside. It's like that same struggle that superheroes have.” The migraine symptoms are superpowers, albeit ones that you don’t want. When her migraine attacks first began, Galli recalls an increased sensitivity to sound, odors, light and “all these things that feel not normal.” Many people with migraine are fighting the disease on their own, because their peers can’t relate to what their feeling on a daily basis. “It's time that we create better awareness and we tell the world that no, we don't need to be alone,” she says. “We don't need to fight alone and hide in the dark.” The film, she hopes, will add to the conversation and bring this disease out of the shadows. For the more than 37 million Americans living with migraine, Galli says: “You’re all superheroes. I hear you, I feel you.”

The toxin itself is released from the bacterium as a single chain, then becomes activated when cleaved by its own proteases.[11] 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.[35] 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.[1][35] 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.[1] This blockage is slowly reversed as the toxin loses activity and the SNARE proteins are slowly regenerated by the affected cell.[1]
Potential Botox side effects include pain at the injection site, infection, inflammation, swelling, redness, bleeding and bruising. Some of these symptoms may indicate an allergic reaction; other allergy symptoms are itching, wheezing, asthma, a rash, red welts, dizziness and faintness. Tell your doctor immediately if you have any breathing issues or a faint or dizzy feeling.
Other side effects of BOTOX® and BOTOX® Cosmetic include: dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of eyelids, dry eyes, and drooping eyebrows. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.
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.
Getting Botox takes only a few minutes and no anesthesia is required. Botox is injected with a fine needle into specific muscles with only minor discomfort. It generally takes three to seven days to take full effect and it is best to avoid alcohol at least one week prior to treatment. Aspirin and anti-inflammatory medications should be stopped two weeks before treatment as well in order to reduce bruising.
Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscle for the treatment of cervical dystonia have been reported to be at greater risk for dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Injections into the levator scapulae may be associated wit h an increased risk of upper respiratory infection and dysphagia.

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.

Sarah of My Migraine Life is a mom living with chronic migraine and daily headaches who has tried a gamete of medications, alternative therapies and lifestyle changes. These experiences led her to write “My Migraine Life,” a website for people living with migraine and their caretakers devoted to telling stories, raising awareness, giving support, product reviews and more. My Migraine Life is a partner of the American Migraine Foundation.
Co-administration of BOTOX® or other agents interfering with neuromuscular transmission (eg, aminoglycosides, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX®.
Recently, there has been an emerging trend of “BOTOX® Cosmetic parties,” in which several people gather at a physician’s house or another location to have BOTOX® Cosmetic injections at a lower cost. While prices for treatment may be somewhat lower at a BOTOX® Cosmetic party than for treatment administered during a normal office visit, the situation may not be ideal. The American Academy of Dermatology and the American Society of Aesthetic Plastic Surgery have both issued warnings against such “parties,” as they have reservations about the ability of the physician to provide a safe and sterile environment outside of their office.

I’ve had migraine since I was 5 and have learned a lot over the years about how to manage it. I’m aware of the foods that trigger my migraine attacks, and I try to eat consistently and drink a lot of water. My children and I eat as healthy as possible throughout the day to keep energy up, knowing skipped meals are a trigger for both tantrums and migraine attacks. Staying on a schedule allows my body to stay stable and helps me identify triggers. The same goes for my children. Maintaining their energy and providing them with good food and water prevents them from getting “hangry” later. We all want to avoid a food meltdown. I know that I am triggered by weather, hormones, stress, diet, hydration, light, sound, heat, sleep and more. I try to be prepared for as many of these situations as I can, but some are easier to avoid than others. If you’re unaware of your triggers, keep a log. There are migraine apps that can help you track your symptoms and identify what’s causing your attacks. Finding patterns in how you react may help with identifying effective medications or alternative treatments.


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.

Severe side effects are very rare but can happen if the botulinum toxin unexpectedly spreads throughout the body from the site of the shots. This can cause muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids. The breathing and swallowing problems can be life-threatening. If this happens, seek medical attention right away.

Sharona Hoffman, professor of law and bioethics at Case Western Reserve University School of Law, says that step therapy is driven by a single motivator: saving costs. Hoffman, who’s written about the legal and ethical implications of step therapy, says that sometimes step therapy can have sensible outcomes, like pushing patients to take generics instead of brand-name drugs. But these policies can also keep doctors from prescribing the more expensive drugs of choice, forcing patients to take medications that are less effective or have worse side effects.
Safety and effectiveness of BOTOX® have not been established for the treatment of other upper or lower limb muscle groups or for the treatment of spasticity in pediatric patients under age 18 years. BOTOX® has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with BOTOX® is not intended to substitute for usual standard of care rehabilitation regimens.
Two double-blind, placebo-controlled, randomized, multi-center, 24-week clinical studies were conducted in patients with OAB with symptoms of urge urinary incontinence, urgency, and frequency (Studies OAB -1 and OAB-2). Patients needed to have at least 3 urinary urgency incontinence episodes and at least 24 micturitions in 3 days to enter the studies. A total of 1105 patients, whose symptoms had not been adequately managed with anticholinergic therapy (inadequate response or intolerable side effects), were randomized to receive either 100 Units of BOTOX (n=557), or placebo (n=548). Patients received 20 injections of study drug (5 units of BOTOX or placebo) spaced approximately 1 cm apart into the detrusor muscle.

In some practices, the cost of the actual product determines the price, but in others, "The cost of the treatment is based on the skill set, not the product," says Day. In other words, seeing a trained aesthetic physician, who has the time and technique to give you tailored, micro injections, might actually be more costly than larger, more formulaic doses.
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.

Since then, several randomized control trials have shown botulinum toxin type A to improve headache symptoms and quality of life when used prophylactically for patients with chronic migraine[88] who exhibit headache characteristics consistent with: pressure perceived from outside source, shorter total duration of chronic migraines (<30 years), "detoxification" of patients with coexisting chronic daily headache due to medication overuse, and no current history of other preventive headache medications.[89]


Just because not every cosmetic Botox procedure is FDA-approved doesn't mean it's not safe and effective, if done properly. Off-label procedures are still within the standard of care, and there are tons of them. “There are so many non-FDA-approved applications for Botox,” says dermatologist Dendy Engelman, MD. “It can be used to decrease scalp-sweating (which helps prolong blowouts), correct a droopy nasal tip (called nasal-tip ptosis), fix brow asymmetry, minimize bunny lines from wrinkling your nose, decrease skin oiliness, minimize the appearance of pores...” The list goes on and on.
Botox is an injectable drug made from a toxic bacterium called Clostridium botulinum. When you eat the toxin produced by this bacterium, it causes a life-threatening form of food poisoning, known as botulism. But when you inject it into your body, it causes different symptoms. It blocks certain chemical signals from your nerves, causing temporary paralysis of your muscles.
Keep in mind that the price is often reflective of experience and quality. Botox injections gone wrong can lead to a  "Botox face", a droopy eyelid, migraine headaches, and frozen facial expressions. Unskilled or inexperienced injectors may also cause excessive bruising and more asymmetric results. Experienced plastic surgeons and dermatologists who are good Botox injectors can be much more expensive than injectors with limited experience.
The efficacy and safety of BOTOX for the treatment of lower limb spasticity was evaluated in Study 6, a randomized, multi-center, double-blind, placebo-controlled study. Study 6 included 468 post-stroke patients (233 BOTOX and 235 placebo) with ankle spasticity (modified Ashworth Scale ankle score of at least 3) who were at least 3 months post-stroke. A total dose of 300 Units of BOTOX or placebo were injected intramuscularly and divided between the gastrocnemius, soleus, and tibialis posterior, with optional injection into the flexor hallucis longus, flexor digitorum longus, flexor digitorum brevis, extensor hallucis, and rectus femoris (see Table 33) with up to an additional 100 Units (400 Units total dose). The use of electromyographic guidance or nerve stimulation was required to assist in proper muscle localization for injections. Patients were followed for 12 weeks.

Dermal fillers, as we’ve discussed in our previous post, vary on what you’re looking for and how long you’d like to see those results. According to the Plastic Surgeons Portal, the minimum you’ll pay for dermal fillers, like Juvederm and Restylane, is going to $1500, while the maximum you’re looking at is $2,500. It’s a small price to pay for radiance and confidence!
BOTOX increases the incidence of urinary tract infection [see ADVERSE REACTIONS]. Clinical trials for overactive bladder excluded patients with more than 2 UTIs in the past 6 months and those taking antibiotics chronically due to recurrent UTIs. Use of BOTOX for the treatment of overactive bladder in such patients and in patients with multiple recurrent UTIs during t reatment should only be considered when the benefit is likely to outweigh the potential risk.
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Why Botox works isn’t completely clear. There’s some evidence that it may reduce the production of neurotransmitters related to pain in the areas where it’s injected. There’s also some evidence that it may have a broader effect on the brain’s pain centers, reducing the sensitivity that causes migraine sufferers to react to migraine triggers. While the exact mechanisms are poorly understood, the studies, as well as many of my patients’ experiences, do show a real benefit for many people.
Jump up ^ Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF (June 2010). "OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program". Headache. 50 (6): 921–36. doi:10.1111/j.1526-4610.2010.01678.x. PMID 20487038.
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BOTOX blocks neuromuscular transmission by binding to acceptor sites on motor or sympathetic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP -25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings. When injected intramuscularly at therapeutic doses, BOTOX produces partial chemical denervation of the muscle resulting in a localized reduction in muscle act ivity. In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop. There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by BOTOX.
In November, the FDA held a two-day hearing asking for expert comment on the agency's rules concerning off-label drug use and marketing. Some said the practice paves the way for scientific progress and gives doctors and their patients much needed alternatives for hard-to-treat medical conditions. Others said that off-label drug use is primarily financially motivated and that it poses a serious threat to public health, particularly when drugs are used experimentally on children.
Jump up ^ Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF (June 2010). "OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program". Headache. 50 (6): 921–36. doi:10.1111/j.1526-4610.2010.01678.x. PMID 20487038.

BOTOX® increases the incidence of urinary tract infection. Clinical trials for overactive bladder excluded patients with more than 2 UTIs in the past 6 months and those taking antibiotics chronically due to recurrent UTIs. Use of BOTOX® for the treatment of overactive bladder in such patients and in patients with multiple recurrent UTIs during treatment should only be considered when the benefit is likely to outweigh the potential risk.
It will not affect the nerves that cause sensation, or make you feel numb. When it is used correctly, it can lift the brow to give an appealing and sincere look. "But if too much is injected in the danger zone—the horizontal lines in the forehead—you can look Spocked, as in Spock from Star Trek," says Jean Carruthers, a Vancouver eye surgeon who, with her husband, Alastair, coauthored the first paper on the cosmetic benefits of Botox in 1989. That's why it's important to be treated by an experienced doctor who can judge the size of your muscles and how much Botox you will need.
Most doctors who provide cosmetic services such as BOTOX® treatments accept payment by various methods, including cash, personal check, major credit cards, or through arrangements made with an established lending institution. Some practices even offer their own financing plans. Don’t be afraid to inquire about BOTOX® treatment financing during your initial consultation.
Aesthetician Mary Schook is anti-Botox because she sees the long-term effects on her clients. “Everyone is always like, ‘Look how great this looks,’ and then there is the long-term and they are like, 'Fix me,'” she says. “Allergan [the company that owns Botox] says one in 100 patients gets eyelid-drop, so I always joke, ‘I must meet one in 100 patients, because everyone I see has that drop.'”
I love talking about migraines. I don't do it to be a downer; I do it because talking about dealing with my chronic migraines may lead to hearing tips from another fellow sufferer, and I've tried nearly everything at this point. I've dealt with migraines for almost two decades, and as anyone who deals with them knows, having a variety of remedies in your toolbox is crucial when the pain hits.

In November, the FDA held a two-day hearing asking for expert comment on the agency's rules concerning off-label drug use and marketing. Some said the practice paves the way for scientific progress and gives doctors and their patients much needed alternatives for hard-to-treat medical conditions. Others said that off-label drug use is primarily financially motivated and that it poses a serious threat to public health, particularly when drugs are used experimentally on children.
Allergan Plc engages in the research, development, and manufacture of pharmaceutical products. It operates through the following business segments: US Specialized Therapeutics; US General Medicine, and International. The US Specialized Therapeutics segment includes sales and expenses relating to branded products within the United States. The US General Medicine segment involves Central Nervous System; Gastrointestinal; Women's Health; Anti-Infectives; and Diversified brands. The International segment comprises of products sold outside the United States. The company was founded on in 1984 and is headquartered in Dublin, Ireland.
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.
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.

Bankrate.com is an independent, advertising-supported publisher and comparison service. Bankrate is compensated in exchange for featured placement of sponsored products and services, or your clicking on links posted on this website. This compensation may impact how, where and in what order products appear. Bankrate.com does not include all companies or all available products.
On July 7, 2015, the company acquired the rights to the late stage CGRP migraine portfolio of Merck & Co, as well as two experimental drugs (MK-1602 and MK-8031) for an upfront payment of $250 million.[12] On August 10, the company acquired Oculeve for $125 million.[13] On August 31, the company acquired Naurex for an upfront payment of $560 million.[14] On October 19, the company acquired AqueSys, developer of ocular implants that reduce intraocular pressure associated with glaucoma, for an initial payment of $300 million.[15] On October 1, the company acquired Kythera Biopharmaceuticals, a company focused on the medical aesthetics market, for $2.1 billion.[16] On November 4 the company announced the acquisition of Northwood Medical Innovation, developer of earFold, a medical device to correct protruding ears.[17] On November 25, 2015, the company announced it would partner with Rugen Therapeutic to develop new therapies for autism spectrum disorder, rabies and obsessive compulsive disorder.[18]
Allergan Plc engages in the research, development, and manufacture of pharmaceutical products. It operates through the following business segments: US Specialized Therapeutics; US General Medicine, and International. The US Specialized Therapeutics segment includes sales and expenses relating to branded products within the United States. The US General Medicine segment involves Central Nervous System; Gastrointestinal; Women's Health; Anti-Infectives; and Diversified brands. The International segment comprises of products sold outside the United States. The company was founded on in 1984 and is headquartered in Dublin, Ireland.

There’s a wide variety of factors that influence the total cost: the number of units required to effectively limit facial movement in the forehead, the areas in the upper face you wish to treat, the experience level of your injector, and finally, the location of the clinic where you undergo the procedure. Botox is usually charged per unit, with a unit priced from $10 to $20. The final price can also be determined per area treated, with the forehead and frown lines charged as two seperate areas.

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.'”
Other side effects of BOTOX® and BOTOX® Cosmetic include: dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of eyelids, dry eyes, and drooping eyebrows. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.
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