BOTOX Information for Consumers

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What Is BOTOX®?

The existence of botulinum toxin has been known for centuries; however, its positive effects have only been appreciated in recent decades. In 1895 Professor Emile Pierre van Ermengem of Ellezelles, Belgium, identified the bacterium Bacillus botulinus. The agent, later renamed Clostridium botulinum, was the precursor to what is now known as botulinum toxin type A (BOTOX®).

BOTOX, which has been used to treat a variety of medical conditions for nearly 15 years, is also FDA-approved as BOTOX® Cosmetic.  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 brows in people 18 to 65 years of age for a short period of time (temporary). Source: Botox Cosmetic

Botox Cosmetic is used to treat moderate to severe wrinkles between the brows.

BOTOX Cosmetic or Botulinum toxic type A has been used in lower doses of BOTOX® Cosmetic to treat moderate to severe glabellar lines.

BOTOX Cosmetic is a simple, non-surgical procedure that smooths the deep persistent lines between the brows. BOTOX® Cosmetic is a purified protein complex derived from the bacterium Clostridium botulinum.

How does BOTOX work?

BOTOX Cosmetic is administered by a healthcare professional as a simple, nonsurgical treatment that is injected directly into the muscles between the brows. It works by blocking nerve impulses to the injected muscles. This reduces muscle activity that causes moderate to severe lines to form between the brows. 

(Source:  http://www.botoxcosmetic.com/What_Is_Botox.aspx)

When injected in very low doses into the overactive muscles that cause lines to form, BOTOX® Cosmetic blocks the transmission of acetylcholine impulses that trigger hyperactive muscle contractions.

Before BOTOX Cosmetic is administered, motor nerve terminals rest on facial muscle, activating the release of acetylcholine. When BOTOX Cosmetic is introduced, it binds with high affinity to the motor neuron and is then internalized via receptor-mediated endocytosis where the plasma membrane of the nerve cell envelopes the toxin receptor, forming a toxin-containing vesicle within the nerve terminal.

Botox Injections:  Where does Botox Cosmetic Work?

The Facial Muscles

The superficial muscles of the face, which include the corrugator muscles and the procerus muscle, are responsible for controlling facial movement and giving the face expression.
The glabella is a smooth elevation of the frontal bone just above the bridge of the nose. The procerus draws the medial angle of the eyebrows down and produces transverse wrinkles over the bridge of the nose. The corrugator supercilii muscles run at an angle along and above the eyebrows. These intertwined muscles usually work together and so are collectively called the “glabellar complex.”

Glabellar Lines

Glabellar lines, or “frown lines,” are the vertical creases between the eyebrows. These are often the first wrinkles of concern to the middle-aged patient.  The formation of glabellar wrinkles is multifactorial but is often made worse by hypertrophy of the underlying muscles.

(Source:  Courtesy of Allergan, Inc. and Caruthers J, Fagien S, Matarasso SL. Consensus Recommendations on the use of Botulinum toxin type. A in Facial Aesthetics. Plast Reconstr Surg 2004;114:1S-22S.)

Botox Cosmetic Costs

According to the American Society of Plastic Surgeons, the average cost of BOTOX Cosmetic is approximately $400. 

 However, other sources indicate that botox treatments can range in cost between $150 and $500. 

Injection intervals should be no more frequent than every 3 months.

Botox Side Effects and Considerations

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.

(Souce:  http://www.botoxcosmetic.com/What_Is_Botox.aspx)

Patients with neurological disorders such as amyotrophic lateral sclerosis (ALS), myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects.

Coadministration of BOTOX Cosmetic with aminoglycosides or other agents that can interfere with neuromuscular transmission should be performed with caution.

It is not advised to administer BOTOX Cosmetic to pregnant women.

The most common side effects associated with the use of BOTOX Cosmetic include headache, respiratory infection, flu syndrome, temporary eyelid droop, and nausea.

Other side effects include pain and redness where the medicine was injected, pain in the face, and muscle weakness.

Botox vs. Dysport 

The consensus regarding the differences between Botox Cosmetic and Dysport® include:

  • The manufacturing process is slightly different, which leads to some potential, subtle differences in clinical practice.
  • Some people feel that Dysport® may provide a slightly faster onset of action (24 hours versus 72 hours for Botox®).
  • It is important to know that the unit size of Dysport® is smaller than the unit size of Botox®.   According to the FDA, it takes a minimum of two times more units of Dysport® to get the same effect as Botox®. So, if the patient has opted for Botox® and received 20 units, the same patient will need 40 units of Dysport® for an equivalent treatment.  However among physicians, it has been debated, yet somewhat accepted, that 1 unit of Botox is “similar” to 2.5 or 3 units of Dysport.
  • Initially, doctors were annecdotally saying that “one Botox unit should equal 2.5 Dysport units”.  However, most seasoned physicians now believe that “a 3:1 ratio is a more accurate dosage in the quest for equipotent treatment between the two drugs.”
  • Dysport® has been shown to “drift” or diffuse more than Botox®, increasing the chances of an accidental droopy eyelid or unintentional relaxation of a neighboring muscle due to diffusion of the product.

Botox®: Botox has been manufactured and studied in the US since 1985, and was officially approved by the FDA for cosmetic use in April 2002. Botox Cosmetic from Allergan uses a form of the botulinum toxin so that when it is injected into facial lines, those muscles are paralyzed, making the wrinkles invisible. Results last for three to eight months and are visible within a few days after treatment. 

For specific product information from Allergan, go to http://www.allergan.com/assets/pdf/botox_cosmetic_pi.pdf.

Dysport (TM):  Dysport, from Medicis, has been studied in Europe since 1988, has been available for use outside the US since 1991, and was recently approved for cosmetic use in the US in May 2009.  Dysport is an injection used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years. The dose of Dysport is not the same as or interchangeable with the dose of any other botulinum toxin product, e.g Botox Cosmetic.
For specific product information from Medicis, go to http://www.medicis.com/products/pi/pi_dysport.pdf
 
Botox for Migraines

In late 2010, Botox was approved by the FDA to treat chronic migraine headaches in adults.

The FDA says Botox injections have been shown to be effective in the prevention of migraines, which are debilitating headaches that cause intense pulsing or throbbing pain and affect about 12% of Americans. “Chronic migraine is one of the most disabling forms of headache,” Russell Katz, MD, of the FDA, says in a news release. “Patients with chronic migraine experience a headache more than 14 days of the month. This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available.”

(Source:  http://www.webmd.com/migraines-headaches/news/20101018/fda-approves-botox-to-treat-chronic-migraines)

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