Overall, with the exception of Overactive Bladder (see below), clinical studies of BOTOX did not include sufficient numbers o f subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. There were too few patients over the age of 75 to enable any comparisons. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease o r other drug therapy.
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.
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As a plastic surgeon, it will never be a major source of income for me, so I choose to make it easy and affordable. We charge $13 per Botox unit. Having said that, though, we have a monthly day of beauty when Botox, facials, and peels are discounted - in the case of Botox, usually to $10 per unit. Currently, because we are welcoming a Nurse Practitioner to our Aesthetic Surgery Center, we are even offering Botox for $7 per unit!
Botulinum toxin exerts its effect by cleaving key proteins required for nerve activation. First, the toxin binds specifically to nerves which use the neurotransmitter acetylcholine. Once bound to the nerve terminal, the neuron takes up the toxin into a vesicle. As the vesicle moves farther into the cell, it acidifies, activating a portion of the toxin which triggers it to push across the vesicle membrane and into the cell cytoplasm. Once inside the cytoplasm, the toxin cleaves SNARE proteins preventing the cell from releasing vesicles of neurotransmitter. This stops nerve signaling, leading to paralysis.
It may be the most well known, but Botox is just one type of neurotoxin on the market. Other, next-level neurotoxins are Dysport, FDA-approved in 2009, and Xeomin, FDA-approved in 2011. “They all originate from the same strain of bacteria, therefore they work essentially in the same way,” explains Z. Paul Lorenc, MD, a board certified aesthetic plastic surgeon in Manhattan. “There are some nuanced differences between the three,” he adds. Xeomin is a purified neurotoxin, also called a “naked molecule,” because it doesn’t contain any extra surface proteins, the way Botox and Dysport do. This “pure” neurotoxin migrates deeper into skin, works faster, and poses less risk of an allergic reaction. “Theoretically, decreasing the protein load also lessens the chance of becoming a non-responder, meaning it lessens the chance that the patient will become immune to the neuromodulator being injected,” Dr. Lorenc says. Dysport tends to spread a little more than Botox, so it’s good for areas that would otherwise need multiple injections. It also kicks in faster than the other two, typically showing effects after two to three days opposed to seven to ten days with Botox, and five to six days with Xeomin. Once you try the different neurotoxins, you might decide you like one brand better than the others.
Strabismus is caused by imbalances in the actions of muscles that rotate the eyes, and can sometimes be relieved by weakening a muscle that pulls too strongly, or pulls against one that has been weakened by disease or trauma. Muscles weakened by toxin injection recover from paralysis after several months, so it might seem that injection would then need to be repeated. However, muscles adapt to the lengths at which they are chronically held, so that if a paralyzed muscle is stretched by its antagonist, it grows longer, while the antagonist shortens, yielding a permanent effect. If there is good binocular vision, the brain mechanism of motor fusion, which aligns the eyes on a target visible to both, can stabilize the corrected alignment.
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.
Botox stays only where injected, it does not roam through the body. "If I inject it in your face, it's not going to work [or show up in] your toe," says Rowe. "It does not have a systemic effect." However, it may migrate up to 3 cm from where it was injected. But even if some molecules were to go into the bloodstream and travel to distant sites in the body, the cosmetic doses (typically less than 100 units) used are significantly lower than the toxic dose that would be harmful systemically (2,500-3,000 units).
An injection of BOTOX is prepared by drawing into an appropriately sized sterile syringe an amount of the properly reconstituted toxin slightly greater than the intended dose. Air bubbles in the syringe barrel are expelled and the syringe is attached to an appropriate injection needle. Patency of the needle should be confirmed. A new, sterile needle and syringe should be used to enter the vial on each occasion for removal of BOTOX.
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Sedation is not often used because the injection time is so short. A local numbing cream (anesthetic) is used instead. Young children often behave as if no numbing cream was used. This may be due to not fully understanding what is being done and having a fear of "shots." In these cases, gentle holding (restraint) is done to keep the area of the shot still. Two staff members sometimes give the injections at the same time to decrease the time of the session.
I’ve been getting injections for migraine and cervical dystonia for a couple of years. Thank GAWD for Medicaid to cover it. I went 2 days ago for my 12 week appt. The relief was instantaneous. I’ve been under an immense amount of stress due to losing my only child 5 months ago. I’m still alive and virtually headache free. Botulism…who knew?! But…THANK YOU♡
Most doctors suggest focusing on the quality of the skin with a proper regimen that includes daily exfoliation and SPF protection, as well regular chemical peels or specialized treatments such as Clear and Brilliant laser resurfacing during this decade. Still, there are exceptions. If constant eyebrow furrowing has resulted in the first signs of an angry crease or premature crow’s feet due to naturally thin skin are a persistent cause of frustration, injectibles can help. But as any good dermatologist will note, there is a caveat: When it comes to Botox and filler, there's a fine line between targeted tweaks and doing too much too soon. Here, in-demand experts share their guidelines for women in their 20s.
The incidence of UTI increased in patients who experienced a maximum post-void residual (PVR) urine volume ≥200 mL following BOTOX injection compared to those with a maximum PVR <200 mL following BOTOX injection, 44% versus 23%, respectively. No change was observed in the overall safety profile with repeat dosing during an open-label, uncontrolled extension trial.
Some doctors, however, say their experience with their own patients indicates Botox — which was approved by the FDA in 2010 to treat migraines — is quite effective for this purpose. Lawrence Newman, MD, a neurologist and director of the headache division at NYU Langone Medical Center in New York City, says many of his patients have experienced a significant decline in the number of headaches per month after receiving Botox. In many cases, he says, it has cut down that number by 50% and frequently more than that.
In a double-blind, placebo-controlled, parallel group study in adult patients with detrusor overactivity associated with a neurologic condition and restrictive lung disease of neuromuscular etiology [defined as FVC 50-80% of predicted value in patients with spinal cord injury between C5 and C8, or MS] the event rate in change of Forced Vital Capacity ≥15% or ≥20% was generally greater in patients treated with BOTOX than in patients treated with placebo (see Table 6).
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.
Patients with compromised respiratory status treated with BOTOX for spasticity should be monitored closely. In a double-blind, placebo-controlled, parallel group study in patients treated for upper limb spasticity with stable reduced pulmonary function (defined as FEV1 40-80% of predicted value and FEV1/FVC ≤0.75), the event rate in change of Forced Vital Capacity (FVC) ≥15% or ≥20% was generally greater in patients treated with BOTOX than in patients treated with placebo (see Table 5).
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.
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Prior to injection, reconstitute each vacuum-dried vial of BOTOX with only sterile, preservative-free 0.9% Sodium Chloride Injection USP. Draw up the proper amount of diluent in the appropriate size syringe (see Table 1, or for specific instructions for detr usor overactivity associated with a neurologic condition see Section 2.3), and slowly inject the diluent into the vial. Discard the vial if a vacuum does not pull the diluent into the vial. Gently mix BOTOX with the saline by rotating the vial. Record the date and time of reconstitution on the space on the label. BOTOX should be administered within 24 hours after reconstitution. During this time period, reconstituted BOTOX should be stored in a refrigerator (2° to 8°C).
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.
Treatment with BOTOX and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a conseq uence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing [see Spread Of Toxin Effect].
Currently, to participate in ARMR, you must be a patient at one of the study’s enrolling medical centers. You can see a full list of the participating centers here. “The number of centers participating in the ARMR is growing rapidly,” Dr. Schwedt says. “There will be eight or nine centers by the end of this year, and ARMR will continue to grow in 2019.” Patients at any of the participating centers who are interested in ARMR can visit ARMR.org to learn more and can contact their clinician’s office to find out how to enroll. Once enrolled, participants answer online questionnaires, provide a blood sample, and maintain a daily headache diary. Visit the ARMR website for more information and to learn about how you can get involved in the study.
How Was the Botox Mixed? A factor that many patients are unaware of is that Botox and Dysport come in a powder form that must be mixed with sterile saline to reconstitute the vial. The amount of water that is mixed with the Botox or Dysport can vary and will determine the concentration of the medicine. Some doctors and nurses dilute the powder too much so that the final concentration of Botox or Dysport is weak. So if you go to a provider who advertises a cheap price (for instance below the wholesale price) the injections you may be getting may be very dilute and may not be as effective as a more concentrated (more expensive) injection.
This is where Botox comes into play. When you get consistent Botox injections, you prevent potential wrinkle formations from getting deeper or worse. Botox limits the range of facial muscle movement (when done skillfully, your face will not get that frozen look) so that wrinkles don't worsen over time. If you have a bad habit of frowning or lifting your brows for no reason, consistent Botox injections can also help your face kick these bad habits and therefore prevent any potential lines from getting etched in your skin. Getting frequent Botox injections may also help relax your facial muscles so that you don't need as a high a dose or as frequent as an injection to maintain your results.
Sometimes, because of these policies, patients are put on meds that are not approved by the FDA for the treatment of migraines, like the antidepressant amitriptyline and the high blood pressure drug verapamil. “In my experience, [verapamil is] not very effective,” says Elizabeth Loder, chief of the headache division at Brigham and Women’s Hospital in Boston and the former president of the American Headache Society. For the insurance companies, that doesn’t seem to matter. “It’s frustrating to patients, especially when it seems like some of the treatments that they’re required to try have a lot of side effects and haven’t really been tested that carefully for migraines.”
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, 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 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.
Each patient has their own goals for treatment of muscle spasticity made in our clinic. These goals can include decreasing pain from muscle spasms. This can be done by reducing both how often and how intense the spasms are. It can also be done by increasing the range of motion of joints to allow improved function. Improvement of range of motion can help to:
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It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.