Proper refrigeration at temperatures below 3 °C (38 °F) retards the growth of Clostridium botulinum. The organism is also susceptible to high salt, high oxygen, and low pH levels. The toxin itself is rapidly destroyed by heat, such as in thorough cooking. The spores that produce the toxin are heat-tolerant and will survive boiling water for an extended period of time.
Unlike some resurfacing or surgical procedures, after which there is possible pigmentation or scarring, when Botox is done correctly, it can be done on all skin tones. “This is a procedure [and] product that crosses all divides,” says Dr. Matarasso. “Men, women, Caucasian, African-American, Asian, Indian. I don’t think there is a demographic that has not enjoyed the benefit of this product.”
When BOTOX (4, 8, or 16 Units/kg) was administered intramuscularly to pregnant mice or rats two times during the period of organogenesis (on gestation days 5 and 13), reductions in fetal body weight and decreased fetal skeletal ossification were ob served at the two highest doses. The no-effect dose for developmental toxicity in these studies (4 Units/kg) is approximately equal to the human dose of 400 Units, on a body weight basis (Units/kg).
Study 3 compared 3 doses of BOTOX with placebo and enrolled 88 patients [BOTOX 360 Units (N=23), BOTOX 180 Units (N=23), BOTOX 90 Units (N=23), and placebo (N=19)] with upper limb spasticity (expanded Ashworth score of at least 2 for elbow flexor tone and at least 3 for wrist flexor tone and/or finger flexor tone) who were at least 6 weeks post -stroke. BOTOX and placebo were injected with EMG guidance into the flexor digitorum profundus, flexor digitorum sublimi s, flexor carpi radialis, flexor carpi ulnaris, and biceps brachii (see Table 27).
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%).
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
Side effects from therapeutic use can be much more varied depending on the location of injection and the dose of toxin injected. In general, side effects from therapeutic use can be more serious than those that arise during cosmetic use. These can arise from paralysis of critical muscle groups and can include arrhythmia, heart attack, and in some cases seizures, respiratory arrest, and death. Additionally, side effects which are common in cosmetic use are also common in therapeutic use, including trouble swallowing, muscle weakness, allergic reactions, and flu-like syndromes.
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 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).
Temporary bruising is the most common side effect of Botox. Headaches, which resolve in 24-48 hours, can occur, but this is rare. A small percentage of patients may develop eyelid drooping. This usually resolves in three weeks. This usually happens when the Botox moves around so you shouldn't rub the treated area for 12 hours after injection or lay down for three to four hours.
As the only Facial Plastic Surgeon in North Texas to have Diamond status with Allergan, we have found that in today's economic environment, patients want value as well as quality. Understand that when you go to a non-physician med-spa for injectible treatments, there are more hands in the "cookie jar" diluting the price for your treatment. For example, the med-spa that is owned by a non-physician, with a nurse injector, is the hardest model to stay competitive in today's world. In that scenario, the patient is paying for the cost of the Botox; PLUS the cost of the nurse to inject the product; PLUS the fee for the medical director to sign off on the nurse doing the injections; AND the profit for the medspa. By going to a physician, the patient can cut out 2 of the middle-people. The chances of getting more product for the same price is greater by going to a doctor's office for your treatment.
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.
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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.
During a recent therapy session, one of Dr. Norman Rosenthal's regulars said he was considering suicide. It wasn't the first time the patient had entertained the thought, and even though he was on antidepressants and always kept up with his appointments, Rosenthal, a licensed psychiatrist with a private practice in North Bethesda, Md., wanted to offer his patient something else.
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).