Over time, skin becomes less elastic; repeated frowning creates lines and wrinkles between the brows (also known as glabellar lines). BOTOX® Cosmetic is the only FDA-approved prescription treatment for moderate to severe frown lines between the brows in people ages 18 to 65. The American Society for Aesthetic Plastic Surgery ranked BOTOX® Cosmetic as the most popular physician-administered cosmetic procedure in the United States for the 4th year in a row; almost 3.3 million BOTOX® Cosmetic procedures were performed in 2005 alone.
BOTOX® Cosmetic is a purified protein that smooths the muscles by blocking nerve impulses. With a few tiny injections, BOTOX® Cosmetic blocks the release of acetylcholine, the chemical that causes muscles to contract. With less movement, the skin surface gradually smooths out and the lines begin to fade.
The BOTOX® Cosmetic procedure consists of a few tiny injections and takes only 10 minutes. No anesthesia is required; however Dr. Bernstein may numb the area with a cold pack or anesthetic cream prior to injecting. There may be minimal and brief discomfort, along with slight temporary bruising at the injection sight which can easily be covered up with make-up. There is no down-time.
Results are typically seen in days and may continue to improve during the first week after treatment. Results may vary. With proper unit dosing, the effects of BOTOX® Cosmetic can last up to four months. 89% of men and women surveyed rated the improvement in their appearance of brow frown lines as moderate to better after one month.
BOTOX® can be used for therapeutic and rehabilitative applications, such as a muscle relaxant to relieve pain associated with chronic clenching and grinding of teeth with TMJ Disorder. With TMJ, a BOTOX® injection is often required to relax the jaw muscles prior to surgery.
BOTOX® Cosmetic is a prescription-only medical product that contains tiny amounts of a highly purified botulinum toxin protein refined from a bacterium, Clostridium botulinum.1
Visible results have been shown to last up to 4 months in physician-reported response 25% (102/403) vs. 2% (2/128) for placebo (P<.001).1 Individual patient results may vary.
Within 24 to 48 hours1 patients may notice a softening in the appearance of the frown lines between the brows. The area may continue to improve for up to a month.
Since BOTOX® Cosmetic was first approved in 2002, the number of women considering talking to their doctor about BOTOX® Cosmetic treatment has more than quadrupled from 1.3 million2 to 5.8 million.4
Many patients today are open about their decision to be treated. About 61 percent of women report they are very willing to reveal to a friend that they have been treated with BOTOX® Cosmetic (n=312).5
BOTOX® Cosmetic is the brand name for a specific botulinum toxin type A product and is not a generic term for all botulinum toxins.
Botulinum toxins are not interchangeable. Approved doses, dilution, volume and formulations are unique to each product. The FDA emphasizes units/dosing are not interchangeable in labeling1. Dosing, solution and volume of BOTOX® Cosmetic are specific only to BOTOX® Cosmetic.
BOTOX® Cosmetic and dermal fillers are used for different things. BOTOX® Cosmetic is injected into the underlying muscles where the vertical frown lines appear between your brows. A dermal filler is used to restore volume in the lower part of the face where wrinkles appear that look like parenthesis around the mouth; marionette lines along the sides of the chin; and vertical lines around the lips. These wrinkles result from a loss of volume and they are referred to as static wrinkles because they appear even when the face is at rest.
Over the past decade, there have been approximately 11 million treatments in the United States and BOTOX® Cosmetic is the number-one prescribed physician administered minimally invasive aesthetic treatment.3
Treatment with BOTOX® Cosmetic is a technique-sensitive procedure and should only be performed by a licensed and trained physician. It is important to note that when administered by an experienced physician, patients should not lose the ability to show expression.
Those vertical lines that appear between the brows result from muscle contractions. When people concentrate, squint, or frown, the muscles between the brows contract, causing the skin to furrow and fold. After years of frequent contraction, those wrinkles can linger even after the muscles are at rest.
Although the results are visible, a treatment with BOTOX® Cosmetic will not radically change the facial appearance or make patients look as if they’ve “had work done.” The muscle activity that causes frown lines between the brows is temporarily reduced, so patients can still frown or look surprised without the wrinkles and creases between the brows.
The United States FDA has stated that all botulinum toxins carry a potential for developing antibodies which contributes to resistance. The critical factors for neutralizing antibody formation have not been well characterized and neutralizing antibody formation may occur with BOTOX® Cosmetic treatment.
Side effects associated with the injection include localized pain, infection, inflammation, tenderness, swelling, redness, and/or bleeding/bruising.
BOTOX® Cosmetic can cause serious side effects. Please see the full Medication Guide. Other side effects include dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems such as double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of the eyelids, and dry eyes may occur. Symptoms of allergic reaction to BOTOX® Cosmetic may include itching, rash, red itchy welts, wheezing, asthma symptoms, 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.
BOTOX® was first approved by the FDA more than 22 years ago for therapeutic use, making it the first botulinum toxin type A product approved in the world. Since its first approval in 1989, BOTOX® has been recognized by regulatory authorities worldwide as an effective treatment for 25 different indications in approximately 85 countries, benefiting millions of patients worldwide
In addition to its therapeutic uses, the same formulation of BOTOX® with dosing specific to moderate to severe glabellar lines was approved by the FDA in 2002 under the trade name BOTOX® Cosmetic (onabotulinumtoxinA). BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) associated with corrugator and/or procerus muscle activity in adult patients up to 65 years of age.
In addition to approximately 21 years of clinical experience, the safety and efficacy of BOTOX® have been well-established in approximately 65 randomized, placebo-controlled clinical trials and in approximately 15,000 patients treated with BOTOX® and BOTOX® Cosmetic in Allergan’s clinical trials.i Worldwide, approximately 30 million vials of BOTOX® and BOTOX® Cosmetic have been distributed and approximately 29 million treatment sessions have been performed over the past 20 years (1990-2010).ii With approximately 2,300 articles on BOTOX® and BOTOX® Cosmetic in scientific and medical journals,iii BOTOX® neurotoxin is one of the most widely researched medicines in the world.
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 people 18 to 65 years of age 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:
The dose of BOTOX® Cosmetic is not the same as, or comparable to, another 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.
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.
1. BOTOX® Cosmetic Prescribing Information, November 2012.
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).
Human albumin and spread of viral diseases. BOTOX® Cosmetic contains albumin, a protein component of human blood. The potential risk of spreading viral diseases [eg, Creutzfeldt-Jakob disease (CJD)] via human serum albumin is extremely rare. No cases of viral diseases or CJD have ever been reported in association with human serum albumin.
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; or take a sleep medicine.
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.
Full Product Information, including Boxed Warning and Medication Guide, has been provided to your doctor.
1. BOTOX® Cosmetic Prescribing Information, November 2012.