Commitment to a
Better You!
Cosmetic Specialties
BOTOX® Cosmetic Treatments
BOTOX® has fast become the cosmetic treatment of choice!

Description and Procedure

BOTOX® is the brand name for a chemical produced from Clostridium botulinum
bacterium.  In April 2002, the FDA has approved the use of BOTOX
® for
treatment of moderate to severe frown lines between the eyebrows.  BOTOX
®
has been used for other medical conditions since 1989.

A BOTOX
® cosmetic treatment is a non-surgical medical procedure.  Our
physician will inject the troublesome lines or wrinkle area with small amounts of
BOTOX
®.  These injections relax the muscles in the area of the injections and
prevent them from contracting.  The injected area then appears more relaxed
and smoother.

The procedure itself is rather quick and only takes about 10 minutes per
treatment.  There is very little discomfort and no anesthesia is necessary.  It will
take anywhere from three days to a week for you to notice the change.   

The best line areas that respond to treatment are the forehead, eyes and
frown.  Note: wrinkles from sun damage do not respond well to BOTOX
®
treatments.


Follow-up Treatments

BOTOX® cosmetic treatments can last anywhere from three to six months.  Each
person is different but when you notice the lines reappearing then it may be
time for another treatment.  Overtime, as your muscles learn how to relax,
fewer intense lines may appear.


Preparation

Bruising is a common side effect so taking aspirin or other anti-inflammatory
medications, two weeks before the treatments, can make it worst.  In addition,
it is advised that you do not drink alcohol at least one week prior to your
treatment.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

Indications

Glabellar Lines
BOTOX® Cosmetic (onabotulinumtoxinA) for injection is indicated for the temporary improvement in the appearance of
moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

Lateral Canthal Lines
BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe lateral
canthal lines associated with orbicularis oculi activity in adult patients.

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING


WARNING: DISTANT SPREAD OF TOXIN EFFECT

    Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may
    spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may
    include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary
    incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection.
    Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk
    of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults
    treated for spasticity and other conditions, particularly in those patients who have an underlying condition
    that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in
    approved indications, cases of spread of effect have been reported at doses comparable to those used to
    treat cervical dystonia and at lower doses.


CONTRAINDICATIONS
BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals
with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

WARNINGS AND PRECAUTIONS
Lack of Interchangeability between Botulinum Toxin Products

The potency Units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not
interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of
BOTOX®Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products
assessed with any other specific assay method.

Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.

No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of
BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 44 Units (for
simultaneous treatment of lateral canthal lines and glabellar lines) have been reported.

Injections In or Near Vulnerable Anatomic Structures
Care should be taken when injecting in or near vulnerable anatomic structures. Serious adverse events including fatal
outcomes have been reported in patients who had received BOTOX® injected directly into salivary glands, the oro-
lingual-pharyngeal region, esophagus and stomach. Safety and effectiveness have not been established for
indications pertaining to these injection sites. Some patients had pre-existing dysphagia or significant debility.
Pneumothorax associated with injection procedure has been reported following the administration of BOTOX® near
the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices.

Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum
sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic
should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has
been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably
determined.

Cardiovascular System
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system,
including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors
including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing
cardiovascular disease.

Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional
disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given
botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including
severe dysphagia and respiratory compromise from typical doses of BOTOX®Cosmetic.

Pre-existing Conditions at the Injection Site
Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed
injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product
manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for
transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral
diseases or CJD have ever been identified for albumin.

ADVERSE REACTIONS
The most frequently reported adverse event following injection of BOTOX®Cosmetic for glabellar lines was eyelid
ptosis (3%).

The most frequently reported adverse event following injection of BOTOX®Cosmetic for lateral canthal lines was eyelid
edema (1%).

DRUG INTERACTIONS
Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular
transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be
potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic
anticholinergic effects.

The effect of administering different botulinum neurotoxin products at the same time or within several months of each
other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum
toxin prior to the resolution of the effects of a previously administered botulinum toxin.

Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of
BOTOX® Cosmetic.

USE IN SPECIFIC POPULATIONS
BOTOX® Cosmetic is not recommended for use in children or pregnant women. It is not known whether BOTOX®
Cosmetic is excreted in human milk. Caution should be exercised when BOTOX® Cosmetic is administered to a nursing
woman.

Please see BOTOX® Cosmetic full
Prescribing Information including Boxed Warning and Medication Guide.
 
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Medical Disclaimer
The information on this web-site or by any links to or from this site is strictly presented for educational purposes only.  
This information is not a recommendation for a specific treatment plan, product, or course of action or medical or healthcare
provider.  In addition, this information may become out of date over time.  It is important that you see a healthcare professional
for detailed information about medical conditions and treatments.  This information is not intended to be a substitute for the advice
of a healthcare professional or a recommendation for any particular treatment plan.
___________________________________________________________________________________________________________________________

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