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BOTOX® belongs
to a class of drugs called botulinum toxins. BOTOX®,
a focal agent intended to reduce muscle contraction,
is the brand of botulinum toxin type A made by Allergan.
BOTOX® is the most studied brand of botulinum toxins
and has been used to treat over 1 million patients worldwide
for more than 11 years.
What is Botox
cosmetic?
BOTOX®
Cosmetic is a unique aesthetic treatment 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 65
years of age or less. It is also used by doctors to
treat crow's feet, lip lines, forehead lines.
The most common side effects are
headache, respiratory infection, flu syndrome, temporary
eyelid droop, and nausea.
BOTOX® Cosmetic is contraindicated
in the presence of infection at the proposed injection
site(s) and in individuals with known hypersensitivity
to any ingredient in the formulation.
BOTOX® Cosmetic is minimally
invasive and no recuperation time is required
What is Botox?
BOTOX® is a formulation of botulinum toxin type
A. It is derived from the bacterium Clostridium botulinum.
This bacterium produces a protein that blocks the release
of acetylcholine and relaxes muscles. Type A is just
one of seven different types of botulinum toxin (A,
B, C1, D, E, F, and G), and each has different properties
and actions. No two of these botulinum toxins are alike.
More than 100 years of research
have expanded our knowledge of botulinum toxin type
A from the identification of the bacterium Clostridium
botulinum to the commercialization of botulinum toxin
type A as BOTOX®.
In the 1960s, the muscle-relaxing
properties of botulinum toxin type A were tapped for
investigational use in realigning crossed eyes. These
early studies paved the way for treating other conditions
caused by overactive muscles with botulinum toxin type
A.
Today, BOTOX® is produced in
controlled laboratory conditions and given in extremely
small therapeutic doses. It has helped over 1 million
patients worldwide with conditions caused by overactive
muscles.
The most requently reported adverse
reactions in patients with cervical dystonia are dysphagia
(19%), upper respiratory infection (12%), neck pain
(11%), and headache (11%). The most frequently reported
adverse reactions in patients with blepharospasm are
drooping of the eyelid (21%), superficial punctate keratitis
(6%), and eye dryness (6%). 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®. BOTOX®
is contraindicated in the presence of infection at the
proposed injection site(s). The effects of BOTOX®
therapy may be increased with the use of aminoglycoside
antibiotics or with other drugs that interfere with
neuromuscular transmission.
Is Botox a new treatment?
BOTOX® has been used for more than 11 years to treat
over 1 million patients worldwide, and it is approved
by the health ministries of at least 70 countries. BOTOX®
has also been endorsed by the American Academy of Neurology
and the National Institutes of Health since 1990
How is Botox different from
other Botulinum toxin treatments?
BOTOX® is Allergan's brand of botulinum toxin type
A. A brand of botulinum toxin type B is also now available.
The two toxins are different in several ways:
They are different serotypes
They have different manufacturing processes
They work differently
They require different doses
How does Botox work?
Normally, your brain sends electrochemical messages
to your muscles to make them contract and move. These
messages are transmitted from a nerve to the muscle
by a substance called acetylcholine. When too much acetylcholine
is released, muscles become overly active and spasm
or tense up.
BOTOX® blocks the nerve from
releasing acetylcholine. As a result, the muscle spasms
stop or are greatly reduced, providing relief from symptoms.
Your health care provider will know how much BOTOX®
is needed to treat you effectively.
It's important to remember that
botulinum toxin treatment is not a cure. For many people,
however, its effects have been dramatic. With BOTOX®,
the nerve will take about 3 months to recover and begin
to release acetylcholine, and the muscles may become
overactive again. At that point, another injection will
be needed to provide relief, as long as no allergic
reactions or other significant side effects occurred
and clinical response was obtained.
How long can I be treated
with Botox?
Each treatment typically lasts up to 3 months and can
be repeated as long as your condition responds to BOTOX®
and you do not have any serious allergic reactions or
other significant side effects. BOTOX® has been
used for more than 11 years to treat more than 1 million
patients worldwide, and although formal, long-term clinical
evaluations have not been conducted, its safety in long-term
use has been well established.
Although most people continue to
respond to BOTOX® injections, some people have experienced
a diminished response over time. There may be several
explanations for this:
Changes in your condition-
If the pattern of your muscle activity changes, your
health care provider may need to inject new muscles
and/or change your dose. Identifying and injecting the
affected muscle can be difficult, complicated by the
changing pattern of muscle involvement and progression
of the disorder.
Setting appropriate expectations - You may believe
your first BOTOX® injection was more helpful than
subsequent injections. That's because your condition
was perhaps quite severe when you had your first injection.
Subsequent injections are usually given before your
condition becomes that severe again. Therefore, the
relief you experienced with subsequent injections may
not have been as dramatic as the first time.
Antibody formation - When foreign proteins, like
botulinum toxins, enter your body, antibodies may form.
If antibodies to botulinum toxin develop, you may no
longer respond to treatment.
Because botulinum toxins are usually
used to treat chronic conditions, it's important to
preserve responsiveness to therapy.
How can I help maintain my
responsiveness to therapy?
While the critical factors for neutralizing antibody
formation have not been well characterized, you may
be able to help maintain your response to BOTOX®
by minimizing your total exposure. The potential for
antibody formation may be minimized by injecting with
the lowest effective dose given at the longest feasible
intervals between injections.
How is Botox given?
BOTOX® is injected into the affected muscle(s).
Your doctor will determine which muscles need to be
treated.
Does the injection work?
Some people report minor, temporary discomfort from
the injection. BOTOX® is reconstituted with sterile,
preservative-free, normal saline for injection. The
neutral pH of the injected solution, in combination
with the fine-gauge needle your doctor will use, can
help to minimize any injection-related pain.
When will Botox start to
work?
BOTOX® offers sustained relief, dose after dose.
The relief you'll feel from one treatment of BOTOX®
will normally last for up to 3 months. Treatments can
be continued as long as your condition responds to BOTOX®,
and you do not have any serious allergic reactions or
other significant side effects. When the relief begins
to fade, you'll return to your doctor for your next
treatment.
Usually, BOTOX® treatment is
required approximately four times per year. Because
symptoms can change over time, the amount and duration
of relief you'll experience can vary. Consult your doctor,
who can determine how to achieve the best possible results
with BOTOX®.
What side effects will be
seen with Botox?
The most frequently reported adverse reactions in patients
receiving BOTOX® for the treatment of cervical dystonia
are dysphagia (difficulty swallowing, 19%), upper respiratory
infection (such as a cold or flu,12%), neck pain (11%),
and headache (11%). Dysphagia is a commonly reported
adverse event following treatment of cervical dystonia
patients. In these patients, there are reports of rare
cases of dysphagia serious enough to require the insertion
of a gastric feeding tube (a tube for introducing nutritious,
high-calorie fluids into the stomach.)
The most frequently reported treatment-related
adverse reactions in patients receiving BOTOX® for
the treatment of blepharospasm are ptosis (droopy eyelids,
21%), superficial punctuate keratitis (inflammation
of the cornea characterized by small erosions of the
tissue covering the cornea, 6%), and eye dryness (6%).
Reduced blinking from BOTOX® injection of the orbicularis
muscle can lead to corneal exposure, persistent epithelial
defect (a defect in the corneal covering) and corneal
ulceration (a hollowed-out cavity in the cornea), especially
in patients with VII nerve disorders.
In general, adverse reactions occur
within the first week following injection of BOTOX®
and, while generally transient, may last 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.
Is Botox right for me?
Your health care provider can help you decide if BOTOX®
is right for you. In order to make the right treatment
decision, you should discuss the following with your
health care provider before choosing treatment:
Clinical experience with
the drug
Effectiveness and side effects
Make sure your health care provider
knows if you are pregnant, nursing, or taking any medications
before receiving BOTOX® injections. Additionally,
you should not receive BOTOX® if you have an infection
at the injection site.
BOTOX® should be used
with caution if you have other neurological diseases
or disorders, or if you are taking aminoglycoside antibiotics
or other drugs that interfere with neuromuscular transmission.
Be sure to tell your health care provider about any
prescription or over-the-counter medications you are
taking before receiving BOTOX®.
text courtesty of botox.com
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