Approved Drug Label (PDF)
6
Adverse Reactions
Additions and/or
revisions underlined:
…
The following adverse reactions associated with the
use of Ritalin and other methylphenidate products were identified in clinical
trials, spontaneous reports, and literature. Because these reactions were
reported voluntarily from a population of uncertain size, it is not always
possible to estimate their frequency reliably or to establish a causal
relationship to drug exposure.
Adverse Reactions Reported with Ritalin
…
Psychiatric Disorders: insomnia,
anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile
hallucinations), depressed mood, depression
…
Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis, trismus
…
Approved Drug Label (PDF)
Boxed Warning
Additions and/or
revisions underlined:
WARNING: ABUSE,
MISUSE, AND ADDICTION
Ritalin 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 Ritalin, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher
doses or unapproved methods of administration, such as snorting or injection.
Before prescribing
Ritalin, 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 Ritalin 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 and Precautions (5.1) and Drug Abuse
and Dependence (9.2)].
5
Warnings and Precautions
5.1 Abuse, Misuse, and Addiction
Additions and revisions underlined:
Ritalin have a high
potential for abuse and misuse. The use of Ritalin exposes
individuals to the risks of abuse and misuse, which can lead to
the development of a substance use disorder, including addiction. Ritalin can
be diverted for non- medical use into illicit channels or distribution [see
Drug Abuse and Dependence (9.2
)]. Misuse and abuse
of CNS stimulants, including Ritalin, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or
unapproved methods of administration, such as snorting or injection.
Before prescribing Ritalin, 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 Ritalin in a safe place, preferably locked, and
instruct patients to not give Ritalin to anyone else. Throughout Ritalin
treatment, reassess each patient’s risk of abuse, misuse, and addiction and
frequently monitor for signs and symptoms of abuse, misuse, and addiction.
5.10 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome
New
subsection added:
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 [see Adverse Reactions
(6.2)].
Before
initiating Ritalin, assess the family history and clinically evaluate patients
for tics or Tourette’s syndrome. Regularly monitor Ritalin-treated patients for
the emergence or worsening of tics or Tourette’s syndrome, and discontinue
treatment if clinically appropriate.
5.8 Acute Angle Closure Glaucoma
New
subsection added:
There
have been reports of angle closure glaucoma associated with methylphenidate
treatment.
Although
the mechanism is not clear, Ritalin -treated patients considered at risk for
acute angle closure glaucoma (e.g., patients with significant hyperopia) should
be evaluated by an ophthalmologist.
5.9 Increased Intraocular Pressure and Glaucoma
New
subsection added:
There
have been reports of an elevation of intraocular pressure (IOP) associated with
methylphenidate treatment [see Adverse
Reactions (6.2)].
Prescribe
Ritalin and Ritalin-SR to patients with open-angle glaucoma or abnormally
increased IOP only if the benefit of treatment is considered to outweigh the
risk. Closely monitor Ritalin-treated patients with a history of abnormally
increased IOP or open angle glaucoma.
6
Adverse Reactions
Additions and/or
revisions underlined:
The following are discussed in more detail in other
sections of the labeling:
Abuse, Misuse, and Addiction [see
Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2,
9.3)]
…
Acute Angle Closure Glaucoma [see Warnings and Precautions (5.8)]
Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.9)]
Motor and Verbal Tics, and Worsening of Tourette’s
Syndrome [see Warnings and Precautions
(5.10)]
The following adverse reactions associated with the
use of Ritalin and other methylphenidate products were identified in clinical
trials, spontaneous reports, and literature. Because these reactions were
reported voluntarily from a population of uncertain size, it is not always
possible to estimate their frequency reliably or to establish a causal
relationship to drug exposure.
Adverse Reactions Reported with Ritalin
…
Nervous
System Disorders: migraine, motor and verbal tics
Eye
Disorders: diplopia, increased intraocular pressure,
mydriasis
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or revisions underlined:
Abuse, Misuse, and Addiction
Educate patients and their
families about the risks of abuse, misuse, and addiction of Ritalin,
which can lead to overdose and death, and proper disposal of
any unused drug [see Warnings and
Precautions (5.1), Drug Abuse and Dependence (9.2), Overdosage (10)]. Advise patients to store Ritalin in a safe place,
preferably locked, and instruct patients to not give Ritalin to anyone else.
…
Increased Intraocular Pressure (IOP) and Glaucoma
Advise patients that IOP and glaucoma may occur
during treatment with Ritalin [see
Warnings and Precautions (5.9)].
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 Ritalin.
Instruct patients to notify their healthcare provider if emergence of new tics
or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.10)].
…
MEDICATION GUIDE
Medication Guide has undergone extensive changes;
please refer to label.
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
(Pregnancy and Lactation Labeling
Rule (PLLR) Conversion; Extensive changes: please refer to labeling)
8.2 Lactation
(Pregnancy and
Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions underlined)
Risk Summary
Limited published literature,
based on milk sampling from seven mothers reports that methylphenidate is
present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal
weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7.
There are no reports of adverse effects on the breastfed infant and no effects
on milk production. Long-term neurodevelopmental effects on infants from
stimulant exposure are unknown. The developmental and health benefits of
breastfeeding should be considered along with the mother’s clinical need for
RITALIN or RITALIN-SR and any potential adverse effects on the breastfed infant
from RITALIN or RITALIN-SR or from the underlying maternal condition.
Clinical Considerations
Monitor breastfeeding infants
for adverse reactions, such as agitation, insomnia, anorexia, and reduced
weight gain.
8.4 Pediatric Use
(Additions
and/or revisions underlined)
The safety and effectiveness of
Ritalin and Ritalin-SR for the treatment of ADHD have been established in
pediatric patients 6 to 17 years.
The safety and
effectiveness of Ritalin and Ritalin-SR in pediatric patients less than 6 years
have not been established. The long-term efficacy of Ritalin and Ritalin-SR in
pediatric patients has not been established.
Long-Term Suppression of Growth
Growth should be monitored during
treatment with stimulants, including Ritalin and Ritalin-SR. Pediatric patients
who are not growing or gaining weight as expected may need to have their treatment
interrupted.
Juvenile Animal Toxicity Data
Rats treated with
methylphenidate early in the postnatal period through sexual maturation
demonstrated a decrease in spontaneous locomotor activity in adulthood. A
deficit in acquisition of a specific learning task was observed in females
only. The doses at which these findings were observed are at least 4 times the
MRHD of 60 mg/day given to children on a mg/m2 basis.
In a study conducted
in young rats, methylphenidate was administered orally at doses of up to 100
mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7)
and continuing through sexual maturity (postnatal Week 10). When these animals
were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous
locomotor activity was observed in males and females previously treated with 50
mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to
children on a mg/m2 basis)
or greater, and a deficit in the acquisition of a specific learning task was
seen in females exposed to the highest dose (8 times the MRHD given to children
on a mg/m2 basis). The no
effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (
approximately 0.5 times the MRHD given to children on a mg/m2 basis). The clinical significance of
the long-term behavioral effects observed in rats is unknown.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions underlined)
Pregnancy Registry
Advise
patients that there is a pregnancy exposure registry that monitors pregnancy
outcomes in patients exposed to ADHD medications, including RITALIN and
RITALIN-SR, during pregnancy.
Approved Drug Label (PDF)
Boxed Warning
(newly
created by PLR conversion as below)
WARNING: ABUSE
AND DEPENDENCE
CNS stimulants,
including Ritalin and Ritalin-SR, other methylphenidate-containing products,
and amphetamines, have a high potential
for abuse and dependence. Assess the risk of abuse prior to prescribing, and
monitor for signs of abuse and dependence while on therapy.
4
Contraindications
5
Warnings and Precautions
(the following subsections created by PLR conversion, please refer to
label for more information)
5.1 Potential for Abuse and Dependence
5.2 Serious Cardiovascular Reactions
5.3 Blood Pressure and Heart Rate
Increases
5.4 Psychiatric Adverse Reactions
5.5 Priapism
5.6 Peripheral Vasculopathy, Including
Raynaud’s Phenomenon
5.7 Long-Term Suppression of Growth
7
Drug Interactions
7.1 Clinically Important Interactions with Ritalin and Ritalin
(subsection
created, additions underlined)
Table
1 presents clinically important drug interactions with Ritalin and Ritalin SR
(please refer to label to view Table 1)
8
Use in Specific Populations
8.4 Pediatric Use
(additions
underlined)
The
safety and effectiveness of Ritalin and Ritalin-SR for the treatment of ADHD
have been established in pediatric patients 6 to 17 years.
The
safety and effectiveness of Ritalin and Ritalin-SR in pediatric patients less
than 6 years have not been established. The long-term efficacy of Ritalin
and Ritalin-SR in pediatric patients has not been established
Long-Term
Suppression of Growth
Growth
should be monitored during treatment with stimulants, including Ritalin and
Ritalin-SR. Pediatric patients who are not growing or gaining weight as
expected may need to have their treatment interrupted.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(reformatted,
minor additions and revisions. Please refer to label)
PATIENT COUNSELING INFORMATION
(new
section added per PLR conversion)
Other
Get Email Alerts |
Guide
