IMPORTANT SAFETY INFORMATION about Botox
IMPORTANT SAFETY INFORMATION
BOTOX may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are preexisting before injection. Swallowing problems may last for several months.
- Spread of toxin results. The effect of botulinum toxin might influence areas far from the shot site and trigger severe signs and symptoms, including loss of toughness and all-over muscular tissue weak point; dual vision; blurred vision; drooping eyelids; hoarseness or adjustment or loss of voice; trouble saying words plainly; loss of bladder control; trouble breathing; and problem ingesting.
BOTOX may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving BOTOX. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Do not receive BOTOX if you are allergic to any of the ingredients in BOTOX (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Do not receive BOTOX for the treatment of urinary incontinence if you have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing. Due to the risk of urinary retention (difficulty fully emptying the bladder), only patients who are willing and able to initiate catheterization posttreatment, if required, should be considered for treatment.
Patients treated for overactive bladder: In clinical trials, 36 of the 552 patients had to self- catheterize for urinary retention following treatment with BOTOX compared to 2 of the 542 treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days), as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary retention than nondiabetics.
Adult patients treated for overactive bladder due to a neurologic disease: In clinical trials, 30.6% of adult 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 postinjection 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).
Among adult patients not using CIC at baseline, those with multiple sclerosis were more likely to require CIC postinjection than those with spinal cord injury.
The dose of BOTOX is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported, including itching; rash; red, itchy welts; wheezing; asthma symptoms; dizziness; or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX should be discontinued.
Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing from typical doses of BOTOX.
Autonomic dysreflexia in patients treated for overactive bladder due to a neurologic disease. 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 adult patients treated with BOTOX 200 Units compared with placebo (1.5% versus 0.4%, respectively).
Tell your doctor about all your medical conditions, including if you have or have had bleeding problems; have plans to have surgery; had surgery on your face; have weakness of forehead muscles, trouble raising your eyebrows, drooping eyelids, and any other abnormal facial change; have symptoms of a UTI and are being treated for urinary incontinence (symptoms of a UTI may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX in the past.
Tell your doctor if you 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 by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.
Opposite side impacts of BOTOX consist of completely dry mouth; discomfort or discomfort at the shot website; exhaustion; headache; neck discomfort; eye problems such as dual vision, blurred vision, lowered eyesight, drooping eyelids, swelling of your eyelids, and completely dry eyes; sagging brows; and upper respiratory system infection. In grownups being dealt with for urinary system incontinence, opposite results consist of UTI and painful peeing. In kids being dealt with for urinary system incontinence, opposite side impacts include UTI; microorganisms, white blood cells, and blood in the urine. In clients being dealt with for urinary system incontinence, one more negative effects includes the lack of ability to clear your bladder on your own. If you have difficulty fully emptying your bladder on your own after receiving BOTOX, you may require to use disposable self-catheters to empty your bladder as much as a few times every day up until your bladder has the ability to start emptying again.
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