INVEGA® (paliperidone) extended-release tablets are used for the
treatment of schizophrenia.
RISPERDAL® (risperidone) is used for the treatment of irritability
associated with autistic disorder; the treatment of schizophrenia; and
the treatment of acute manic or mixed episodes associated with Bipolar
I Disorder.
RISPERDAL® CONSTA® (risperidone) is indicated for the treatment
of schizophrenia.
IMPORTANT SAFETY INFORMATION FOR INVEGA, RISPERDAL,
AND RISPERDAL CONSTA
Elderly Patients with dementia-related psychosis
treated with atypical antipsychotic drugs are at an increased risk of
death compared to placebo. INVEGA (paliperidone), RISPERDAL
(risperidone), and RISPERDAL CONSTA (risperidone) are not approved for
the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal
side effect reported with INVEGA, RISPERDAL, RISPERDAL CONSTA, and
similar medicines. Call your doctor immediately if the person being
treated develops symptoms such as high fever; stiff muscles; shaking;
confusion; sweating; changes in pulse, heart rate, or blood pressure;
or muscle pain and weakness. Treatment should be stopped if the person
being treated has NMS.
One risk of INVEGA is that it may change your heart rhythm. This effect
is potentially serious, and you should talk to your doctor about any
current or past heart problems. Some medications interact with INVEGA.
Please inform your healthcare professional of any medications or
supplements that you are taking.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect
reported with INVEGA, RISPERDAL, RISPERDAL CONSTA, and similar
medications. TD includes uncontrollable movements of the face, tongue,
and other parts of the body. The risk of developing TD and the chance
that it will become permanent is thought to increase with the length of
therapy and the overall dose taken by the patient. This condition can
develop after a brief period of therapy at low doses, although this is
much less common. There is no known treatment for TD, but it may go
away partially or completely if therapy is stopped.
High blood sugar and diabetes have been reported with INVEGA,
RISPERDAL, RISPERDAL CONSTA, and similar medications. If the person
being treated has diabetes or risk factors such as being overweight or
a family history of diabetes, blood sugar testing should be performed
at the beginning and throughout treatment. Complications of diabetes
can be serious and even life threatening. If signs of high blood sugar
or diabetes develop, such as being thirsty all the time, going to the
bathroom a lot, or feeling weak or hungry, contact your doctor.
INVEGA, RISPERDAL, RISPERDAL CONSTA, and similar medications can raise
blood levels of a hormone known as prolactin, causing a condition known
as hyperprolactinemia. Blood levels of prolactin remain elevated with
continued use. Some side effects seen with these medications include
the absence of a menstrual period; breasts producing milk; the
development of breasts by males; and the inability to achieve an
erection. The connection between prolactin levels and side effects is
unknown.
People with narrowing or blockage of the gastrointestinal tract
(esophagus, stomach or small or large intestine) should talk to their
healthcare professional before taking INVEGA.
Some people taking INVEGA, RISPERDAL, or RISPERDAL CONSTA 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.
INVEGA, RISPERDAL, and RISPERDAL CONSTA may affect your driving
ability; therefore, do not drive or operate machinery before talking to
your healthcare professional.
INVEGA, RISPERDAL, and RISPERDAL CONSTA should be used cautiously in
people with a seizure disorder, who have had seizures in the past, or
who have conditions that increase their risk for seizures.
Extrapyramidal Symptoms (EPS) are usually persistent movement disorders
or muscle disturbances, such as restlessness, tremors, and muscle
stiffness. If you observe any of these symptoms, talk to your
healthcare professional.
Inform your healthcare professional if you are pregnant or if you are
planning to get pregnant while taking INVEGA, RISPERDAL, or RISPERDAL
CONSTA. Caution should be exercised when administering to a nursing
woman.
INVEGA, RISPERDAL, and RISPERDAL CONSTA may affect alertness and motor
skills; use caution until this effect is known.
INVEGA may make you more sensitive to heat. You may have trouble
cooling off, or be more likely to become dehydrated, so take care when
exercising or when doing things that make you warm.
INVEGA should be swallowed whole. Tablets should not be chewed,
divided, or crushed. Do not be worried if you see something that looks
like a tablet in your stool. This is what is left of the tablet after
all the medicine has been released.
Some medications interact with INVEGA, RISPERDAL, or RISPERDAL CONSTA.
Please inform your healthcare professional of any medications or
supplements that you are taking. Avoid alcohol while on INVEGA,
RISPERDAL, or RISPERDAL CONSTA.
The most common side effects that occurred with INVEGA were
restlessness and extra pyramidal disorder (for example, involuntary
movements, tremors and muscle stiffness).
The most common adverse reactions observed in all clinical trials with
RISPERDAL occurring at a rate of at least 10% were 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.
The most common side effects that occurred with RISPERDAL CONSTA were
anxiety, sleepiness, restlessness, tremors, muscle stiffness,
dizziness, constipation, nausea, stomach upset, runny nose, dry mouth,
rash, weight increase, and rapid heartbeat.
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