New section added:
WARNING: ABUSE,
MISUSE, AND ADDICTION
Methylin has a
high potential for abuse and misuse, which can lead to the development of a
substance use disorder, including addiction. Misuse and abuse of CNS
stimulants, including Methylin, can result in overdose and death (see OVERDOSAGE), and this risk is
increased with higher doses or unapproved methods of administration, such as
snorting or injection.
Before prescribing
Methylin, assess each patient’s risk for abuse, misuse, and addiction. Educate
patients and their families about these risks, proper storage of the drug, and
proper disposal of any unused drug. Throughout Methylin treatment, reassess
each patient’s risk of abuse, misuse, and addiction and frequently monitor for
signs and symptoms of abuse, misuse, and addiction (see WARNINGS, PRECAUTIONS, and
DRUG ABUSE AND DEPENDENCE).
WARNINGS
Additions and/or
revisions underlined:
Abuse, Misuse, and Addiction
Methylin has a high potential for abuse and misuse.
The use of Methylin exposes individuals to the risks of abuse and misuse, which
can lead to the development of a substance use disorder, including addiction.
Methylin can be diverted for non-medical use into illicit channels or
distribution (see DRUG ABUSE AND
DEPENDENCE). Misuse and abuse of CNS stimulants, including Methylin, can
result in overdose and death (see OVERDOSAGE),
and this risk is increased with higher doses or unapproved methods of
administration, such as snorting or injection.
Before prescribing Methylin, assess each patient’s
risk for abuse, misuse, and addiction. Educate patients and their families
about these risks and proper disposal of any unused drug. Advise patients to
store methylphenidate in a safe place, preferably locked, and instruct patients
to not give Methylin to anyone else. Throughout Methylin treatment, reassess
each patient’s risk of abuse, misuse, and addiction and frequently monitor for
signs and symptoms of abuse, misuse, and addiction.
…
Long-Term Suppression of Growth in Pediatric
Patients
CNS stimulants have been associated with weight
loss and slowing of growth rate in pediatric patients.
…
Acute Angle Closure Glaucoma
There have been reports
of angle closure glaucoma associated with methylphenidate treatment.
Although the mechanism is not clear,
Methylin-treated patients considered at risk for acute angle closure glaucoma
(e.g., patients with significant hyperopia) should be evaluated by an
ophthalmologist.
Increased Intraocular Pressure and Glaucoma
There have been reports of an elevation of
intraocular pressure (IOP) associated with methylphenidate treatment (see ADVERSE REACTIONS).
Prescribe Methylin to patients with open-angle
glaucoma or abnormally increased IOP only if the benefit of treatment is
considered to outweigh the risk. Closely monitor Methylin-treated patients with
a history of abnormally increased IOP or open angle glaucoma.
Motor and Verbal Tics, and Worsening of Tourette’s
Syndrome
CNS stimulants, including methylphenidate, have
been associated with the onset or exacerbation of motor and verbal tics.
Worsening of Tourette’s syndrome has also been reported. Before initiating
Methylin, assess the family history and clinically evaluate patients for tics
or Tourette’s syndrome. Regularly monitor patients for the emergence or
worsening of tics or Tourette’s syndrome with Methylin, and discontinue
treatment if clinically appropriate.
PRECAUTIONS
Additions and/or
revisions underlined:
Information for Patients
Advise the patient to read the FDA-approved patient
labeling (Medication Guide).
Abuse, Misuse, and Addiction
Educate patients and their families about the risks
of abuse, misuse, and addiction of Methylin, which can lead to overdose and
death, and proper disposal of any unused drug (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE, OVERDOSAGE).
Advise patients to store
Methylin in a safe place, preferably locked, and
instruct patients to not give Methylin to anyone else.
Risks to Patients with Serious Cardiac Disease
Advise patients that there are potential risks to
patients with serious cardiac disease, including sudden death, with Methylin
use. Instruct patients to contact a healthcare provider immediately if they
develop symptoms such as exertional chest pain, unexplained syncope, or other
symptoms suggestive of cardiac disease (see WARNINGS).
Increased Blood Pressure and Heart Rate
Advise patients that Methylin can elevate blood
pressure and heart rate (see WARNINGS).
Psychiatric Adverse Reactions
Advise patients that Methylin, at recommended
doses, can cause psychotic or manic symptoms, even in patients without a prior
history of psychotic symptoms or mania (see WARNINGS).
…
Suppression of Growth in Pediatric Patients
Advise patients, caregivers, and family members
that Methylin can cause slowing of growth and weight loss (see WARNINGS).
Increased Intraocular Pressure and Glaucoma
Advise patients that IOP and glaucoma may occur
during treatment with Methylin (see WARNINGS).
Motor and Verbal Tics, and Worsening of Tourette’s
Syndrome
Advise patients that motor and verbal tics and
worsening of Tourette’s syndrome may occur during treatment with Methylin. Instruct
the patients to notify their healthcare provider if emergence or worsening of
tics or Tourette’s syndrome occurs (see WARNINGS).
Choking – Taking this product without
adequate fluid may cause it to swell and block your throat or esophagus and may
cause choking. Do not take this product if you have difficulty in swallowing.
If you experience chest pain, vomiting, or difficulty
in swallowing or breathing after taking this product, seek immediate medical
attention.
Directions – Take this
product (child or adult dose) with at least 8 ounces (a full glass) of water or
other fluid. Taking this product without enough liquid may cause choking. See
choking warning.
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