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A Definitive Look at BOTOX®
by Dr. George Wooming
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BOTOX® Yields Promising Results
by Dr. George Wooming
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BOTOX® as a Natural Defense Against the Signs of Aging
by Dr. George Wooming
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BOTOX® is a therapeutic muscle-relaxing agent that works at motor nerve
endings (nerves that lead to muscles). It is in a class of drugs called
neurotoxins. When considering neurotoxin therapy, it is important to understand
how the product works, the history of its use in patients, its protein content,
and possible side effects. This page is designed to help you understand more
about BOTOX®: what it is, how it works, and how it can help you. Refer to this
page in the future should you have further questions about BOTOX® treatment.
BOTOX® is indicated for the treatment of cervical dystonia in adults to
decrease the severity of abnormal head position and neck pain associated with
cervical dystonia.
BOTOX® is indicated for the treatment of strabismus
and blepharospasm associated with dystonia, including benign essential
blepharospasm or VII nerve disorders in patients 12 years of age and above.
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BOTOX® is a novel therapeutic agent derived from the bacterium,
Clostridium Botulinum. Also known as Botulinum Toxin Type A, the brand BOTOX® is
produced in controlled laboratory conditions and given in extremely small
therapeutic doses.
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Normally your brain sends electrical messages to your muscles so that
they can contract and move. The electrical message is transmitted to the muscle
by a substance called acetylcholine. BOTOX® works to block the release of
acetylcholine and, as a result, the muscle doesn't receive the message to
contract. This means that the muscle spasms stop or are greatly reduced after
using BOTOX®, providing reliable relief from symptoms.
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BOTOX® is not a cure. For many patients, however, its therapeutic
effects have been dramatic — symptoms usually begin to dissipate
within three to fourteen days and the effects can last for approximately
three months.
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At a normal neuromuscular junction, a nerve impulse
triggers the release of acetylcholine, which causes the muscle to contract.
Hyperactive muscle contraction, regardless of the underlying cause, is
characterized by excessive release of acetylcholine at the neuromuscular
junction. The use of BOTOX® can be effective in reducing this excessive
activity.
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BOTOX® is injected into the muscle. Your doctor will determine the
muscle(s) in need of treatment.
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A very fine needle is used for the injection. Some patients report minor and temporary discomfort from the
injection.
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For blepharospasm, the initial effect of the injection is seen within
three days and reaches a peak at one to two weeks post-treatment. When you are
being treated for cervical dystonia, clinical improvement generally begins
within the first two weeks after injection, with maximum clinical benefit at
approximately six weeks post-injection.
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The relief you will feel from a single treatment of BOTOX® will normally
be sustained for approximately three months. You will notice a gradual fading of
its effects. At this point you will return to your doctor for your next
treatment.
Usually, BOTOX® treatment is required only three or four
times a year. Symptoms may vary throughout the course of the condition, and so
the degree of relief and duration of effect varies from person to person.
Consult your doctor, who has special knowledge about how to achieve the best
possible results with BOTOX® for your individual case.
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Treatment with BOTOX® can typically be repeated as long as the patient
continues to respond and does not have a serious allergic reaction. BOTOX® has
been used for over ten years commercially worldwide. Acceptable safety in
long-term treatment has been well established. However, formal clinical
evaluations of long-term treatment have not been conducted.
There are a
number of factors that can impact the long-term usage of BOTOX®. These include:
- Setting appropriate expectations - Changes occurring with subsequent
BOTOX® injections may be less dramatic than the first injection.
- Appropriate muscle selection - Identifying and injecting the affected
muscle can be difficult, complicated by the changing pattern of muscle
involvement and progression of the disorder.
- Adequate dosing - Changes in response may require dose adjustment.
- Minimizing exposure to neurotoxin complex proteins1
- Botulinum toxins contain proteins. In certain circumstances,
when foreign proteins enter the body, the natural response is
to form antibodies to the protein. When antibodies are formed,
the effect may be that one is no longer able to respond to the
therapy. Formation of neutralizing antibodies to botulinum toxin
type A may reduce the effectiveness of BOTOX®. The rate of formation
of neutralizing antibodies in patients receiving BOTOX® has
not been well studied. The critical factors for neutralizing
antibody formation have not been well characterized. The results
from some studies suggest that BOTOX® injections at more frequent
intervals or at higher doses may lead to greater incidence of
antibody formation. The potential for antibody formation may
be minimized by injecting with the lowest effective dose given
at the longest feasible intervals between injections. Well-controlled
studies designed to determine the rate formation of neutralizing
antibodies in patients receiving BOTOX® have yet to be conducted.
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BOTOX® has been used commercially for over ten years in thousands of
patients worldwide. The American Academy of Neurology, American Academy of
Ophthalmology, and National Institutes of Health have endorsed BOTOX® (Botulinum
Toxin Type A) as a valuable treatment.
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Ask your doctor if BOTOX® is the right treatment for you. BOTOX® should
not be used during pregnancy, if you are nursing, or if you are taking certain
medications. Only your physician can determine the best course of therapy.
The effects of BOTOX® may be increased with the use of certain
antibiotics or other drugs that interfere with neuromuscular transmission.
Ensure that your doctor is aware of any current medications you are taking. If
you have any questions regarding the use of BOTOX® treatment, please consult
your doctor.
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Patients with neuromuscular disorders may be at increased risk of
clinically significant systemic effects including severe dysphagia
and respiratory compromise from typical doses of BOTOX®. The effects
of therapy may be increased with the use of aminoglycoside antibiotics
or with other drugs that interfere with neuromuscular transmission.
There have been rare reports of spontaneous death, sometimes associated
with dysphagia, pneumonia, and/or other significant debility, after
treatment with botulinum toxin.
There have
also been rare reports of adverse events involving the cardiovascular system,
including arrhythmia and myocardial infarction, some with fatal outcomes. Some
of these patients had risk factors including cardiovascular disease. The exact
relationship of these events to the botulinum toxin injection has not been
established.
In general, adverse events occur within the first week following
injection of BOTOX® and while generally transient, may have a duration
of several months. Localized pain, tenderness and/or bruising may
be associated with the injection. Local weakness of the injected
muscle(s) represents the expected pharmacological action of botulinum
toxin. However, weakness of adjacent muscles may also occur due
to spread of toxin.
Cervical
Dystonia
Dysphagia is a commonly reported adverse event following
treatment of cervical dystonia patients with all botulinum toxins. In these
patients, there are reports of rare cases of dysphagia severe enough to warrant
the insertion of a gastric feeding tube. There are also rare case reports where
subsequent to the finding of dysphagia a patient developed aspiration pneumonia
and died. Patients with smaller neck muscle mass and patients who require
bilateral injections into the sternocleidomastoid muscle have been reported to
be at greater risk for dysphagia. Limiting the dose injected into the
sternocleidomastoid muscle may reduce the occurrence of dysphagia. Injections
into the levator scapulae may be associated with an increased risk of upper
respiratory infection and dysphagia. The most frequently reported adverse
reactions in patients with cervical dystonia are dysphagia (19%), upper
respiratory infection (12%), neck pain (11%), and headache (11%).4
Blepharospasm
Reduced blinking from BOTOX® injection of the orbicularis muscle
can lead to corneal exposure, persistent epithelial defect and corneal
ulceration, especially in patients with VII nerve disorders. The
most frequently reported treatment-related adverse reactions in
patients with blepharospasm are ptosis (20.8%), superficial punctate
keratitis (6.3%) and eye dryness (6.3%).5 Other side
effects may include irritation, tearing, lagophthalmos, photophobia,
ectropion, keratitis, diplopia and entropion, diffuse skin rash
and local swelling of the eyelid skin lasting for several days following
eyelid injection.
Strabismus
During the administration of BOTOX® for the treatment of strabismus,
retrobulbar hemorrhages sufficient to compromise retinal circulation have
occurred from needle penetrations into the orbit. Extraocular muscles adjacent
to the injection site can be affected, causing ptosis (15.7%) or vertical
deviation (16.9%) in patients treated for horizontal strabismus, especially with
higher doses of BOTOX®.6 Inducing paralysis in one or more
extraocular muscles may produce spatial disorientation, double vision, or
past-pointing.
References:
1. Scott AB. Foreward.
In: Jankovic J, Hallett M, eds. Therapy with Botulinum Toxin. New York, NY:
Marcel Dekker, Inc; 1994:vii-ix.
2. Hatheway CL, Dang C. Immunogenicity of
the Neurotoxins of Clostridium botulinum in Jankovic J, Hallett M, eds. Therapy
with Botulinum Toxin. New York, NY: Marcel Dekker, Inc; 1994:93-107.
3. Data
on file, Allergan, 1999.
4. Data on file, Allergan, Inc. 1999.
5. Data
on file, Allergan, Inc. 1997.
6. Data on file, Allergan, Inc.
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