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What is Autistic Disorder?
Autistic disorder is a developmental disability that affects a
person's ability to communicate, form relationships with others, and
respond appropriately to his or her environment. It begins in
childhood and is thought to be a lifelong disorder.
1
Some of the symptoms or deficits associated with autistic
disorder may vary among individuals; but generally, people with
autistic disorder tend to have social, communication, motor and
sensory impairments that affect their behavior. Patients with
autistic disorder may have subaverage IQ, lack language skills
completely or have language delays. Some individuals with autistic
disorder may seem closed off and unresponsive; others seem locked
into repetitive behaviors and rigid patterns of thinking. Patients
may exhibit repetitive body movements such as hand-flapping,
finger-flicking, rocking or swaying. Individuals with autistic
disorder also may demonstrate a range of behavioral symptoms
including aggression towards others, tantrums, self-injury and
quickly changing moods.
2
Autistic disorder is found in every country and every region of the
world. Autism is usually diagnosed by age 3 and may affect 1 in 250
children.
3
Autistic disorder is three to four times more common in
boys than in girls.
For more information on autistic disorder, please visit the
National
Institute of Mental Health Web site and
RisperdalAutism.com.
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What Are the Symptoms of Autistic Disorder?
People with autistic disorder demonstrate symptoms in three core
areas: social interaction, communication, and repetitive patterns of
behavior or restricted interests.
2
Social Interaction
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Impairment in the use of nonverbal behaviors such as eye contact,
facial expression, body postures and gestures
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Failure to develop peer relationships appropriate to developmental
level
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Lack of spontaneous social interaction, not sharing enjoyment,
interests or achievement with others; not showing, bringing, or
pointing out objects of interest to others
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Lack of social or emotional reciprocity
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Lack of varied, spontaneous, make-believe or imitative play
appropriate to developmental level
Communication
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Delay in or total lack of development of spoken language
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In individuals with speech impairment in the ability to initiate or
sustain a conversation with others
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Stereotype and repetitive use of language
Behavior Patterns
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Preoccupation with one or more repetitive and restricted patterns
of interest, abnormal in its intensity or focus
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Inflexible to routines or rituals
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Repetitive body movements (hand- or finger-flapping or twisting or
whole-body movements)
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Preoccupation with parts of objects
Individuals with autistic disorder also may have or develop symptoms
of various, co-occurring mental disorders including
attention-deficit/hyperactivity disorder (ADHD), psychoses,
depression, obsessive-compulsive disorder and other anxiety
disorders. About 25% of children and adolescents with autistic
disorder experience seizures.
2
Individuals with autistic disorder also may demonstrate
disruptive behaviors. They may be aggressive toward themselves or
others and have extreme temper tantrums.
2
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What Causes Autistic Disorder?
No one knows exactly what causes autistic disorder, but scientists
think that both genetic and environmental factors might play a role.
4
Recent research shows that autistic disorder is related to
abnormalities in brain structures or functions. Studies are ongoing
to examine whether autistic disorder affects specific areas of the
brain or if there are problems with the transmission of signals from
one part of the brain to another.
5
Some studies in identical twins suggest that autistic disorder can be
inherited. Currently, scientists are researching irregularities in
genetic codes and specific genes to determine the role that heredity
might play in autistic disorder.
5
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How Is Autistic Disorder Diagnosed?
Parents usually are the first to identify unusual behavior in their
child during infancy, such as unresponsiveness to sound or not making
eye contact. In other cases, parents may notice their child has
regressed or stopped meeting developmental milestones.
6
Diagnosis typically involves a developmental screening during a "well
child" check-up followed by a comprehensive evaluation by a
multidisciplinary team. A diagnosis requires a problem in at least
one area of either communication, socialization, or restricted
behavior before the age of 3 years.
6
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What Are the Treatment Options?
There is no single best treatment for individuals with autistic
disorder.
7
Experts agree that early identification and intervention are
important and that children with autistic disorder respond well to
participating in highly structured, specialized programs.
7
The child's parents or caregivers in collaboration with
his or her physician or other healthcare professional should
determine the best approach to treatment.
A number of treatment approaches have been identified. Some
approaches focus on developing skills and learning appropriate
behaviors. Other approaches are reward-based using positive
reinforcement to encourage children to practice certain skills.
RISPERDAL
®
(risperidone) is the first medication approved for the treatment of
irritability associated with autistic disorder in children and
adolescents ages 5-16 years. RISPERDAL is not used to treat the core
symptoms of autism. For more information, click here to review the
full
US Prescribing Information.
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What is RISPERDAL
®
(risperidone)?
RISPERDAL is a prescription medication indicated for the treatment of
irritability associated with autistic disorder in children and
adolescents aged 5-16 years, including symptoms of aggression towards
others, deliberate self-injuriousness, temper tantrums, and quickly
changing moods.
For more information on autistic disorder, please visit the
National
Institute of Mental Health Web site and
RisperdalAutism.com.
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What are the available doses of RISPERDAL?
RISPERDAL has convenient, flexible dosing allowing it to be
prescribed in different formulations to best meet personal
preferences and in different strengths to best manage individual
symptoms. The healthcare professional will determine which
formulation and strength is right.
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What is RISPERDAL M-TAB (risperidone)?
RISPERDAL M-TAB is a rapidly disintegrating tablet formulation of
RISPERDAL with added convenience:
* RISPERDAL M-TAB contains phenylalanine. It should not be taken by
people who have been diagnosed with PKU (phenylketonuria).
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How soon can the patient expect to see improvement?
In clinical trials significant improvement was observed in many
children and adolescents with irritability associated with autism at
eight (8) weeks. Irritability was measured using the Aberrant
Behavior Checklist (ABC)*
* Aberrant Behavior Checklist (ABC): a standardized checklist
designed to measure behavioral problems in children with
developmental disabilities. The checklist is made up of 5 subscales
(Irritability, Lethargy and Social Withdrawal, Stereotypic Behavior,
Hyperactivity/Noncompliance, and Inappropriate Speech); higher
subscale scores indicate increased symptom severity. The
ABC-Irritability (ABC-I)subscale was the primary outcome measure used
in the RISPERDAL clinical trials.
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What are the side effects of RISPERDAL?
RISPERDAL
®
(risperidone) has some possible side effects that you should know
about.
With any medication, some people have side effects and some don't. If
the individual taking RISPERDAL has any side effects with RISPERDAL,
or does not seem to be getting better, please talk to the healthcare
professional. The healthcare professional may adjust the dose to help
reduce or minimize your side effects.
Elderly patients with dementia-related psychosis
treated with atypical antipsychotic drugs are at an increased risk
of death compared to placebo. RISPERDAL
®
(risperidone) is not approved for the treatment of patients with
Dementia-Related Psychosis.
The most common side effects that may occur with RISPERDAL are:
somnolence, increased appetite, fatigue, rhinitis, upper respiratory
tract infection, vomiting, coughing, urinary incontinence, increased
saliva, constipation, fever, tremors, muscle stiffness, abdominal
pain, anxiety, nausea, dizziness, dry mouth, rash, restlessness, and
indigestion.
Studies suggest an increased risk of elevated blood sugar-related
side effects, and sometimes potentially fatal, in patients treated
with this class of medications, including RISPERDAL. Some people may
need regular blood sugar testing.
Some people taking RISPERDAL may feel faint or lightheaded when they
stand up or sit up too quickly. By standing up or sitting up slowly
and following your healthcare professional's dosing instructions,
this side effect may be reduced or it may go away over time.
You may have heard the term "extrapyramidal symptoms (EPS)." These
are usually reversible movement disorders or muscle disturbances,
such as restlessness, tremors, and muscle stiffness. Some people
taking RISPERDAL have these side effects. In clinical studies, these
side effects were uncommon at lower doses, but did increase with
higher doses. If an individual experiences these symptoms, talk to
your healthcare provider.
You may have heard the term "tardive dyskinesia." These are
potentially irreversible, uncontrollable, slow or jerky facial or
body movements that can be caused by all medications of this type
(antipsychotics). If an individual experiences these symptoms, talk
to your healthcare provider. Only your healthcare provider should
adjust the dose or stop the medication.
There are some medications that interact with RISPERDAL. Please
inform the doctor and pharmacist of all medications or supplements
that the individual is taking.
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How should RISPERDAL be stored?
RISPERDAL Tablets, RISPERDAL Oral Solution, and RISPERDAL M-TAB,
should be stored at controlled room temperature
(59-77°F/15-25°C)
, away from children, and should be protected from light and
moisture. RISPERDAL Oral Solution should be protected from light and
freezing temperatures.
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Should RISPERDAL be taken with or without food?
RISPERDAL may be taken conveniently with or without food.
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Can RISPERDAL Oral Solution be taken with all beverages?
No. RISPERDAL is compatible with water, orange juice, coffee, and low
fat milk. RISPERDAL Oral Solution should
not be taken with tea or cola because these
beverages will make the medication less effective.
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Does RISPERDAL contain latex?
No. RISPERDAL Oral Solution, Tablets and M-TAB do not contain latex.
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. cannot, however, discount any inadvertent exposure of our
products (for example, contact with latex gloves) during
manufacturing or processing operations.
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Does RISPERDAL contain gluten?
Patients who must adhere to a gluten-free diet must avoid products
that contain wheat, rye, oats, or barley. RISPERDAL Tablets and
RISPERDAL Oral Solution contain none of these ingredients. However,
gluten may be a component of the protein present in cornstarch (which
is approximately 0.3% protein), which is contained in RISPERDAL
Tablets. RISPERDAL M-TAB does contain bovine – animal source
gelatin, plus two synthetic carbohydrates but these components do not
have gluten content such as what is contained in wheat-based
ingredients.
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Are RISPERDAL Tablets kosher?
RISPERDAL Tablets contain no alcohol but do contain animal products
in the form of lactose (from cow's milk). They also contain
cornstarch. RISPERDAL M-TAB contains gelatin that is bovine-sourced
(i.e. from cattle) and is certified to be BSE-free.
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Does RISPERDAL contain aspartame?
Only RISPERDAL M-TAB contains aspartame.
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Does RISPERDAL contain phenylalanine?
Only RISPERDAL M-TAB contains phenylalanine.
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Are patient education materials available?
Yes. To obtain these materials call the Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Customer
Communications Center at 1 (800) 526-7736, Monday through Friday, 9AM
to 5 PM, EST.
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Is there a patient assistance program for RISPERDAL?
Yes, Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. provides assistance with RISPERDAL to patients who,
because of financial burden and lack of prescription drug coverage,
may have difficulty paying for their treatment.
The Patient Assistance Program is designed to make our products
available free of charge to persons who have a medical need and meet
specific financial criteria. It is important to note that our patient
assistance programs provide assistance when no source of prescription
drug coverage is available.
Please visit
access2wellness.com.