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BOTOX has been used therapeutically for more than 17 years to treat a variety of medical conditions. It is approved in more than 75 countries and remains the most-studied botulinum toxin and one of the most widely researched medicines in the world. In 2002, the same formulation-under the label BOTOX Cosmetic was approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe frown lines between the brows in people ages 18 to 65.
What is BOTOX Cosmetic?
During treatment, very low doses of BOTOX Cosmetic are administered via a few tiny injections directly into the muscles responsible for frown lines between the brows. By blocking the release of a chemical that causes these muscles to contract, BOTOX Cosmetic enables them to relax. The effects are localized and when, administered by an experienced physician like Dr. Reiter, do not affect your ability to smile, laugh, or otherwise show expression.
How does BOTOX Cosmetic work?
The lines that appear between your brows actually result from muscle movement and the passage of time. When powerful muscles between the brows contract, they draw the brows together, causing the skin to fold or furrow. As skin becomes less elastic with age, those folds or furrows result in stubborn lines.
Because frown lines are dynamic lines caused by overactive muscles, they can usually be treated with tiny injections of BOTOX Cosmetic.
Static lines, on the other hand, are lines that are visible even when the muscles are at rest. These lines are usually treated with a filler, such as JUVEDERM injectable gel.
What causes frown lines between the brows?
The most common side effects following injection include temporary eyelid droop and nausea, and in some cases, localized pain, infection, inflammation, tenderness, swelling, redness, and/or bleeding/bruising may be associated with the injection. Patients with certain neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects.
What are the common side effects?
Serious heart problems and serious allergic reactions have been reported rarely. If you think you're having an allergic reaction or other unusual symptoms, such as difficulty swallowing, speaking, or breathing, call your doctor immediately.
Is there any chance of serious side effects?
BOTOX Cosmetic is a quick and minimally invasive procedure consisting of a few tiny injections. Dr. Dennis Reiter will determine exactly where to administer these injections to achieve the best results for you. No anesthesia is required, though you may choose to numb the area with a cold pack or anesthetic cream prior to injecting.
The entire procedure takes approximately 10 minutes, and there is no downtime afterward. Discomfort is minimal and brief. Localized pain, infection, inflammation, tenderness, swelling, redness, and/or bleeding/bruising may be associated with the injection.
What is the treatment like?
Men and women of varying ethnicities have been treated with BOTOX Cosmetic. Because it works only on the underlying muscles, it is not expected to affect skin color. Take a look at the results of the American Society for Aesthetic Plastic Surgery (ASAPS) 2006 statistics report:
• BOTOX Cosmetic was the most popular physician administered cosmetic procedure in the United States for the fifth year in a row (surgical and nonsurgical combined) with nearly 3.2 million treatments in 2006
• Racial and ethnic minorities accounted for 22% of all physician-administered cosmetic procedures
• Men accounted for nearly 1 million physician-administered cosmetic procedures
• Patients ages 19 to 34 accounted for 22% of all physician-aministered cosmetic procedures
Who is being treated with BOTOX Cosmetic?
A 2005 survey (n=1048) by the Aesthetic Surgery Education & Research Foundation (ASERF) reported that 97% of the patients were satisfied with the results of their BOTOX Cosmetic Treatment.
Have patients been happy with their results?
Although you may see a marked improvement, a treatment with BOTOX Cosmetic does not make you look like you've "had work done." The muscle activity that causes frown lines is simply reduced, so you can still frown or look surprised without the wrinkles and creases between your brows.
Will I still be able to make facial expressions?
You can expect to see results within days after your treatment, and the appearance of the area between your brows may continue to improve for up to a week.
By day 30 in a phase 3 clinical study, 89% of patients judged the severity of their frown lines between their brows as moderate or better. Visible results have been shown to last up to 4 months. After that, many patients are ready to return for a follow-up treatment.
Your own results may vary- be sure to talk to your doctor about what you can expect.
How soon will I see the difference?
If you are between the ages of 18 and 65 with moderate to severe frown lines between your brows, you may be a candidate for BOTOX Cosmetic. Ask your doctor in BOTOX Cosmetic is right for you.
How do I know if BOTOX Cosmetic is right for me?
Actually, it's quite affordable. Although many people think BOTOX Cosmetic as a luxuty treatment for the "rich and famous," recent statistics show otherwise. According to the 2005 ASERF BOTOX Cosmetic Use Survey, people just like you make up two thirds of the patient base:
• Those with annual household incomes of less than $100,000 (44%) were more likely to be treated with BOTOX Cosmetic the those with annual incomes greater than $150,000 (36%)
• Working mothers between the ages of 40 and 55 are the most common users of BOTOX Cosmetic
Is BOTOX Cosmetic expensive?
Only licensed and trained healthcare professionals have the experience necessary to administer BOTOX Cosmetic. Allergan, Inc., the marker of BOTOX Cosmetic, is the only source for health care professionals to purchase the product, and each US FDA-approved vial label has the "Allergan" hologram.
How can I be sure I'm getting real BOTOX Cosmetic?
Talk to your doctor today to find out if BOTOX Cosmetic is right for you. If you still have questions, the comprehensive source of information is available at www.BotoxCosmetic.com There you can learn more about the procedure, see before-and-after photographs, and hear more stories about patients' experiences with this treatment.
Express your interest! Ask your physician about BOTOX Cosmetic!
Please visit www.BotoxCosmetic.com for more information or call 1-800-BOTOXMD
BOTOX® Cosmetic Consumer Important Information
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary).
BOTOX® Cosmetic is a prescription medicine that is injected into the area around the side of the eyes to improve the look of moderate to severe crow’s feet lines in adults for a short period of time (temporary).
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
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 pre-existing before injection. Swallowing problems may last for several months
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities
The dose of BOTOX® Cosmetic is not the same as, or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines or both at the same time.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (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.
Tell your doctor about all your muscle or nerve conditions, such as amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to breast-feed (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® Cosmetic 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® Cosmetic in the past.
Especially tell your doctor if you: have 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 (be sure your doctor knows 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 anti-platelets (aspirin-like products) or anti-coagulants (blood thinners).
Other side effects of BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.