Approved Drug Label (PDF)
5
Warnings and Precautions
5.7 Long-Term Suppression of Growth in Pediatric Patients
Additions and/or revisions underlined:
Ritalin LA is not
approved for use and is not recommended in pediatric patients below 6 years of
age [see Use in Specific Populations (8.4)].
![]()
…
8
Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
The safety and effectiveness of Ritalin LA have not
been established in pediatric patients below the age of 6 years.
In studies evaluating extended-release
methylphenidate products, patients 4 to <6 years of age had higher systemic
methylphenidate exposures than those observed in older pediatric patients at
the same dosage. Pediatric patients 4 to <6 years of age also had a higher
incidence of adverse reactions, including weight loss.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions
and/or revisions underlined:
…
What is RITALIN
LA?
RITALIN
LA is a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention
Deficit Hyperactivity Disorder (ADHD). RITALIN LA may help increase
attention and decrease impulsiveness and hyperactivity in patients with ADHD.
RITALIN
LA should be used as a part of a total treatment program for ADHD that may
include counseling or other therapies.
Ritalin
LA is not recommended for use in children under 6 years of age with ADHD.
…
Approved Drug Label (PDF)
Boxed Warning
Additions and/or
revisions underlined:
WARNING: ABUSE,
MISUSE, AND ADDICTION
Ritalin LA 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 LA, 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 LA, 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 LA 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), Drug Abuse and
Dependence (9.2)].
5
Warnings and Precautions
5.1 Abuse, Misuse, and Addiction
Additions and/or
revisions underlined:
Ritalin LA has a high
potential for abuse and misuse. The use of Ritalin LA exposes
individuals to the risks of abuse and misuse, which can lead to the
development of a substance use disorder, including addiction. Ritalin LA 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 LA, 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 LA, 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 LA in a safe
place, preferably locked, and instruct patients to not give Ritalin LA to
anyone else. Throughout Ritalin LA 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 LA, assess the family history and clinically evaluate
patients for tics or Tourette’s syndrome. Regularly monitor Ritalin LA-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 LA-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 LA 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 LA-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)]
6.1 Clinical
Trials Experience
Additions and/or
revisions underlined:
…
Nervous
System Disorders: migraine, motor and verbal tics
Eye
Disorders: diplopia, increased intraocular pressure,
mydriasis
…
6.2 Postmarketing
Experience
Additions
and/or revisions underlined:
…
Adverse
Reactions Reported with Ritalin and Ritalin LA
…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
…
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
LA, 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 LA in a safe place, preferably locked, and
instruct patients to not give Ritalin LA to anyone else.
…
Increased Intraocular Pressure (IOP) and Glaucoma
Advise patients that IOP and glaucoma may occur
during treatment with Ritalin LA [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 LA.
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.
MEDICATION GUIDE
(Additions
and/or revisions underlined)
- There is a pregnancy registry for females
who are exposed
to ADHD medications, including RITALIN LA during pregnancy. The purpose of the
registry is to collect information about the health of females exposed to
RITALIN LA and their baby. If you or your child becomes pregnant during
treatment with RITALIN LA, talk to your healthcare provider about registering
with the National Pregnancy Registry
of ADHD medications at 1-866-961-2388 or visit online
at https://womensmentalhealth.org/adhd-medications/.
Approved Drug Label (PDF)
Boxed Warning
(newly
created by PLR conversion as below)
WARNING: ABUSE
AND DEPENDENCE
CNS stimulants,
including Ritalin LA, 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
6
Adverse Reactions
6.1 Clinical
Trials Experience
(new
subsection added, please refer to label)
6.2
Postmarketing Experience
(new
subsection added, please refer to label)
7
Drug Interactions
7.1 Clinically Important Interactions with Ritalin LA
(new
subsection added, additions underlined)
Table
3 presents clinically important drug interactions with Ritalin LA
Table
3: Drugs Having Clinically Important Drug Interactions with Ritalin LA
(please
refer to label to view Table 3)
8
Use in Specific Populations
8.4 Pediatric Use
(additions
underlined)
The
safety and effectiveness of Ritalin LA for the treatment of ADHD have been
established in pediatric patients 6 to 12 years.
The
safety and effectiveness of Ritalin LA in pediatric patients less than 6 years
have not been established. The long- term efficacy of Ritalin LA in
pediatric patients has not been established.
Long-Term
Suppression of Growth
Growth
should be monitored during treatment with stimulants, including Ritalin LA.
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)
Get Email Alerts |
Guide
