In patients who are not catheterizing, post-void residual (PVR) urine volume should be assessed within 2 weeks post-treatment and periodically as medically appropriate up to 12 weeks, particularly in patients with multiple sclerosis or diabetes mellitus. Depending on patient symptoms, institute catheterization if PVR urine volume exceeds 200 mL and continue until PVR falls below 200 mL. Instruct patients to contact their physician if they experience difficulty in voiding as catheterization may be required.
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] .
Much like other fillers, Botox is slowly metabolized in the system, so for it to remain effective, patients have to get the procedure every three months or so (however, as Ravitz told me during a recent visit, you can't get it done too frequently or your body will develop antibodies). I've now had four additional rounds of Botox since my initial procedure and have learned a lot about how my body reacts to it. Read on for both Ravitz's insight and information about my experience with five rounds of Botox.
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.
Exactly how soon you'll need to return for more Botox injections is really up to you. Some patients prefer to return for a touch up of Botox cosmetic after just three months, or at the very first sign of fine lines and facial wrinkles returning. Others prefer to wait six months or more until the effects of the previous injection have completely faded away.
SkinMedica® TOTAL DEFENSE + REPAIR Broad Spectrum/PA++++ Sunscreens (SPF 34, SPF 34 Tinted, and SPF 50+) and Essential Defense Broad Spectrum/PA++++ Sunscreens (Everyday Clear SPF 47, Mineral Shield Tinted SPF 32, and Mineral Shield SPF 35) are over-the-counter drug products that are formulated and marketed pursuant to the FDA's governing regulations set forth at 21 CFR § 352.
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.
The potency Units of BOTOX® 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.
The most frequently reported adverse reactions following injection of BOTOX for adult lower limb spasticity appear in Table 17. Two hundred thirty one patients enrolled in a double-blind placebo controlled study (Study 6) received 300 Units to 400 Units of BOTOX, and were compared with 233 patients who received placebo. Patients were followed for an average of 91 days after injection.
"I have treated people with profound migraine headaches and it turns them right off," says Dr. Matarasso. "If you feel it coming on, it stops it, reducing the severity as well as the duration. I had a patient [who was] in college who had unremitting migraine headaches. She changed her diet, she changed her birth-control pill, she had acupuncture. I finally said to the mother, 'We need to try Botox,' and it has been a complete life-changing event for this woman."
Children do very well after having this procedure in our clinic and are not upset when they leave. We rarely use sedation. We use distraction and a quick injection method instead. In rare cases, localization of a muscle may be needed using an electromyograph (EMG) machine or electric stimulator. If this is needed we will discuss this before scheduling the injections.
Remember that the skill of the injector is extremely important when considering Botox injections. Because Botox can have some very obvious and embarrassing side effects like drooping eyelids, blurry vision, and excessive bruising around the injection site, it's important to consult with an experienced injector. Unlike dermal fillers which can be melted away with a follow-up injection of hyaluronidase, there's not much you can do about a bad Botox experience other than wait it out.
Botulinum toxin is one of the most poisonous substances known to man. Scientists have estimated that a single gram could kill as many as 1 million people and a couple of kilograms could kill every human on earth. In high concentrations, botulinum toxin can result in botulism, a severe, life-threatening illness. Botulism, left untreated, may result in respiratory failure and death. Despite botulinum toxin being so toxic, Botox is in huge demand.
Medicine to help the patient relax may be given in cases where the patient has not handled shots well in the past. If the patient has another procedure coming up, these shots can often be done at this time. Let the Rehabilitation Medicine office (513-636-7480) know if a procedure or surgery will be done in the future or if sedation is being discussed for injections in the clinic setting.
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.
Botulinum toxin produced by Clostridium botulinum is the cause of botulism. Humans most commonly ingest the toxin from eating improperly-canned foods in which C. botulinum has grown. However, the toxin can also be introduced through an infected wound. In infants, the bacteria can sometimes grow in the intestines and produce botulinum toxin within the intestine and can cause a condition known as floppy baby syndrome. In all cases, the toxin can then spread, blocking nerves and muscle function. In severe cases, the toxin can block nerves controlling the respiratory system or heart, resulting in death. Botulism can be difficult to diagnose, as it may appear similar to diseases such as Guillain–Barré syndrome, myasthenia gravis, and stroke. Other tests, such as brain scan and spinal fluid examination, may help to rule out other causes. If the symptoms of botulism are diagnosed early, various treatments can be administered. In an effort to remove contaminated food which remains in the gut, enemas or induced vomiting may be used. For wound infections, infected material may be removed surgically. Botulinum antitoxin is available and may be used to prevent the worsening of symptoms, though it will not reverse existing nerve damage. In severe cases, mechanical respiration may be used to support patients suffering from respiratory failure. The nerve damage heals over time, generally over weeks to months. With proper treatment, the case fatality rate for botulinum poisoning can be greatly reduced.
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.
Postmarketing safety data from BOTOX and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized 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 difficulti es can be life threatening and there have been reports of death related to spread of toxin effects. 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, and partic ularly 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, symptoms consistent with spread of toxin effect have been reported at do ses comparable to or lower than doses used to treat cervical dystonia and spasticity. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders occur.
Currently, there are several anti-CGRP treatments undergoing clinical trials. Some of these treatments involve monoclonal antibodies, which reduce the activity of CGRP, potentially leading to fewer migraine attacks. One of these anti-CGRP monoclonal antibodies, erenumab (Aimovig™), has been approved by the Federal Drug Administration (FDA) and is now available for patients. A second agent, fremanezumab (Ajovy™), was approved in September 2018. A week later, the FDA approved galcanezumab (Emgality™), making it the third anti-CGRP treatment currently on the market. Results from the clinical trials involving anti-CGRP antibodies have shown that about 50 percent of patients will have at least a 50 percent reduction in migraine days. “If you think about someone who has 20 migraine days per month, they have a 50 percent chance of having 10 or less migraine days,” Dr. Starling says. “We think that there are even these super-responders who have a 75 percent response rate, as well as super-super-responders who actually go into remission.” The results from these clinical trials are very promising, Dr. Starling adds. “The adverse events have been very minimal and the efficacy has been very good. It’s all looking up.” Dr. Starling says that although these medications are available, what really needs to be looked at is how to make them truly accessible for patients. Erenumab can cost about $7,000 per year without insurance coverage. “Insurance coverage is very, very key for the majority of our patient population,” she says. “Because the medications just came out on the market, there are still a lot of unknowns about insurance coverage.”
The 3rd Annual Migraine Moment Film Contest received a record-breaking number of film submissions this year. Each film delivered a unique message on living with migraine and how people cope with the symptoms that accompany this debilitating disease. At the 60th Annual Scientific Meeting in San Francisco earlier this year, Maria Galli was announced as the contest’s winner. Her powerful film, Invisible Hero, spoke to her strength and superhero-like qualities in fighting a disease that oftentimes makes her feel isolated and alone. In a recent Facebook Live hosted by the American Foundation, Maria Galli spoke with Dr. Bert Vargas, a Neurologist at UT Southwestern, about her experience living with chronic migraine and her outstanding work. [embed]https://www.facebook.com/americanmigrainefoundation/videos/1616373701807260/[/embed]
Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX® for their blepharospasm, especially in people with certain nerve disorders. BOTOX® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.