Approved Drug Label (PDF)
4
Contraindications
Additions and/or revisions
underlined:
CONCERTA
is contraindicated in patients:
Known to be hypersensitive to methylphenidate or other
components of CONCERTA. Hypersensitivity reactions, such as angioedema and
anaphylactic reactions, have been reported in patients treated with CONCERTA. [see Adverse Reactions (6)].
Receiving concomitant
monoamine oxidase inhibitors (MAOIs), and within 14 days following
discontinuation of treatment with a MAO inhibitor because of the risk
of a hypertensive crisis
5
Warnings and Precautions
5.4 Psychiatric
Adverse Reactions
Additions and/or
revisions underlined:
Exacerbation of Psychosis in Patients with a
Psychotic Disorder
CNS stimulants, including CONCERTA, may exacerbate
behavior disturbance and thought disorder in patients with a pre-existing
psychotic disorder.
. . .
Induction of a Manic Episode in Patients with
Bipolar Disorder
CNS stimulants, including CONCERTA, may induce a
manic or mixed episode in patients with bipolar disorder. Prior to
initiating CONCERTA treatment, screen patients for risk factors for developing
a manic episode (e.g., history of depressive symptoms or a family history of
suicide, bipolar disorder, or depression).
New Psychotic or Manic Symptoms in Patients without a History of a
Bipolar or Psychotic Disorder
CNS stimulants (including CONCERTA), at the
recommended dosage, may cause psychotic or manic symptoms (e.g.,
hallucinations, delusional thinking, or mania) in patients without a prior
history of psychotic illness or mania.
. . .
5.5 Priapism
Additions and/or
revisions underlined:
Prolonged
and painful erections, sometimes requiring surgical intervention, have been
reported with methylphenidate use in adult and pediatric male patients [see Adverse Reactions (6)]. Although
priapism was not reported with methylphenidate initiation, priapism occurred
in patients treated with methylphenidate after some time, often subsequent
to an increase in dosage. Priapism also occurred during methylphenidate
withdrawal (drug holidays or during discontinuation).
.
. .
5.6 Peripheral
Vasculopathy, including Raynaud’s Phenomenon
Additions and/or
revisions underlined:
CNS
stimulants, including CONCERTA, used to treat ADHD are associated with
peripheral vasculopathy, including Raynaud’s phenomenon [see Adverse Reactions (6.2)]. Signs and symptoms of these cases
of peripheral vasculopathy were usually intermittent and mild; however,
sequelae have included digital ulceration and/or soft tissue breakdown. Effects
of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in
post-marketing reports and at the therapeutic dosages of CNS stimulants in all
age groups throughout the course of treatment. Signs and symptoms of
peripheral vasculopathy generally improved after CNS stimulant
dosage reduction or discontinuation.
During
CONCERTA treatment, carefully assess for digital changes. Further
clinical evaluation (e.g., rheumatology referral) may be appropriate for
CONCERTA-treated patients who develop signs or symptoms of peripheral
vasculopathy.
5.7 Long-Term
Suppression of Growth in Pediatric Patients
Additions and/or
revisions underlined:
.
. .
Pediatric
patients 7 to 13 years of age who received methylphenidate for 7 days
per week for over 14 months to over 36 months had a temporary slowing in
growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg
less growth in weight over 3 years), without evidence of growth rebound during
this development period.
.
. .
5.8 Risk of
Gastrointestinal Obstruction in Patients with Gastrointestinal Narrowing
Additions and/or
revisions underlined:
.
. .
CONCERTA
should be used only in patients who are able to swallow the extended-release
tablets whole [see Dosage and
Administration (2.2)].
5.11 Motor and
Verbal Tics, and Worsening of Tourette’s Syndrome
Additions and/or
revisions underlined:
.
. .
Before
initiating CONCERTA, assess the family history for tics or Tourette’
syndrome and clinically evaluate patients for tics or Tourette’s syndrome.
Regularly monitor CONCERTA-treated patients for the emergence or worsening of
tics or Tourette’s syndrome, and discontinue CONCERTA treatment if clinically
appropriate.
6
Adverse Reactions
Additions and/or
revisions underlined:
. . .
- Risks of Gastrointestinal Obstruction in Patients with Gastrointestinal
Narrowing [see Warnings and Precautions (5.8)]
. . .
6.1 Clinical
Trials Experience
Extensive changes;
please refer to label for complete information
7
Drug Interactions
Extensive changes;
please refer to label for complete information
8
Use in Specific Populations
8.1 Pregnancy
PLLR conversion
Pregnancy
Exposure Registry
There
is a pregnancy exposure registry that monitors pregnancy outcomes in women
exposed to ADHD drugs, including CONCERTA, during pregnancy. Healthcare
providers are encouraged to advise patients to register by calling the National
Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/.
Risk
Summary
Published
studies and post-marketing reports on methylphenidate use during pregnancy have
inconsistent findings about a drug-associated risk of major birth defects,
miscarriage, or adverse maternal or fetal outcomes. There are risks to the
fetus associated with the use of central nervous system (CNS) stimulants during
pregnancy (see Clinical Considerations).
No
effects on morphological development were observed in embryo-fetal development
studies with oral administration of methylphenidate to pregnant rats and
rabbits throughout organogenesis at doses up to 4 and 16 times, respectively,
the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a
mg/m2 basis. However, spina bifida was observed in rabbits at a dose
54 times the MRHD given to adults. A slight decrease in body weight was
observed in pregnant rats at the highest dose of 30 mg/kg/day (4 times the MRHD
given to adults).
In
a pre- and postnatal development study in which rats were treated with oral
administration of methylphenidate throughout pregnancy and lactation, a
decrease in pup body weight, alterations in sensory and neuromotor performance,
and deficits in learning and memory were observed in both sexes at the highest
dose (4 times the MRHD given to adults on a mg/m2 basis) (see Data).
The
background risk of major birth defects and miscarriage in those with ADHD is
unknown. All pregnancies have a background risk of birth defects, loss, or
other adverse outcomes. In the U.S. general population, the estimated
background risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical
Considerations
Fetal/Neonatal
Adverse Reactions: CNS
stimulants, such as CONCERTA, can cause vasoconstriction and thereby decrease
placental perfusion. No fetal and/or neonatal adverse reactions have been
reported with the use of a therapeutic dosage of methylphenidate during
pregnancy; however, premature delivery and low birth weight infants have been
reported in amphetamine dependent mothers.
Data
Animal Data: In embryo-fetal
development studies conducted in rats and rabbits, methylphenidate was
administered orally at doses up to 30 and 200 mg/kg/day, respectively, during
the period of organogenesis.
Malformations
(increased incidence of fetal spina bifida) were observed in rabbits at the
highest dose, which is approximately 54 times the maximum recommended human
dose (MRHD) of 72 mg/day given to adults on a mg/m2 basis. The no
effect level for embryo-fetal development in rabbits was 60 mg/kg/day (16 times
the MRHD given to adults on a mg/m2 basis).
There
was no evidence of changes in morphological development in rats, although a
reduction in maternal body weight was observed at the highest dose of 30
mg/kg/day (4 times the MRHD of 72 mg/day given to adults (on a mg/m2
basis). The no effect level for maternal body weight in rats is 5 mg/day (equal
to the MRHD for adults on a mg/m2 basis); and the no effect level
for embryo-fetal development is 30 mg/kg/day (4 times the MRHD for adults on a
mg/m2 basis).
When
methylphenidate was administered to rats throughout pregnancy and lactation at
doses of up to 30 mg/kg/day, decreases in offspring body weight, alterations in
sensory and neuromotor performance, and deficits in learning and memory were
observed in both sexes at the highest dose (4 times the MRHD of 72 mg/day,
given to adults on a mg/m2 basis). The no effect level for pre-and
post-natal development in rats was 12.5 mg/kg/day (2 times the MRHD given to
adults on a mg/m2 basis).
8.2 Lactation
PLLR conversion
Risk
Summary
Limited
published literature, based on breast milk sampling from a small number of methylphenidate-treated
lactating women, reports that methylphenidate is present in human milk, which
resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted
methylphenidate 15 dosage and a milk/plasma ratio ranging between 1.1 and 2.7.
There are no reports of adverse effects on the breastfed infant or effects on
milk production. Long-term neurodevelopmental effects on infants from CNS
stimulant exposure are unknown.
The
developmental and health benefits of breastfeeding should be considered along
with the mother’s clinical need for CONCERTA and any potential adverse effects
on the breastfed child from CONCERTA or from the underlying maternal condition.
Clinical
Considerations
Monitor
breastfeeding infants of CONCERTA-treated lactating women 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 CONCERTA for the
treatment of ADHD have been established in pediatric patients 6 years of age
and older. The safety and effectiveness of CONCERTA have not
been established in pediatric patients below the age of 6 years.
In studies evaluating extended-release
methylphenidate products, patients 4 to less than 6 years of age had higher
systemic methylphenidate exposures than those observed in older pediatric patients
at the same dosage. Pediatric patients 4 to less than 6 years of age also had a
higher incidence of adverse reactions, including weight loss.
CNS stimulants have been associated with weight loss
and slowing of growth rate in pediatric patients. Growth (weight and height)
should be monitored in pediatric patients during treatment with CNS stimulants,
including CONCERTA. Pediatric patients who are not growing or gaining weight as
expected may need to have their CONCERTA treatment interrupted [see Warnings and Precautions (5.7)].
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 54 mg/day given to
pediatric patients 6 to 12 years of age on a mg/m squared 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 54 mg/day given to pediatric patients 6 to
12 years of age 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 (9 times the MRHD given to pediatric patients 6 to 12 years of age
on a mg/m2 basis). The no effect level for juvenile neurobehavioral
development in rats was 5 mg/kg/day (approximately 0.4 times the MRHD given to
pediatric patients 6 to 12 years of age on a mg/m squared basis). The clinical
significance of the long-term behavioral effects observed in rats is unknown.
8.5 Geriatric Use
Additions and/or
revisions underlined:
CONCERTA is not indicated for use in patients
greater than 65 years of age.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or
revisions underlined:
.
. .
Increased
Blood Pressure and Heart Rate
Advise
patients and their caregivers that CONCERTA can cause elevations in
blood pressure and heart rate [see
Warnings and Precautions (5.3)].
Psychiatric Risks
Advise
patients and their caregivers that CONCERTA, at recommended doses, can
cause psychotic or manic symptoms, even in patients without a prior history of
psychotic symptoms or mania [see Warnings
and Precautions (5.4)].
Priapism
Advise
patients, caregivers, and family members of CONCERTA-treated males of the
possibility of priapism. Instruct the patient to seek immediate medical
attention in the event of priapism [see
Warnings and Precautions (5.5)].
Peripheral
Vasculopathy, including Raynaud’s Phenomenon
Instruct
patients about the risk of peripheral vasculopathy, including Raynaud’s
phenomenon, and associated signs and symptoms; to report to their health
care provider any new numbness, pain, skin color change, or sensitivity to
temperature in fingers or toes; to call their health care provider immediately
with any signs of unexplained wounds appearing on fingers or toes while taking
CONCERTA [see Warnings and Precautions
(5.6)].
.
. .
Long-term
Suppression of Growth in Pediatric Patients
Advise
patients, caregivers, and family members that CONCERTA may cause slowing of
growth and weight loss in pediatric patients [see Warnings and Precautions (5.7)].
Glaucoma and
Increased Intraocular Pressure
Advise
patients that increased intraocular pressure and glaucoma may occur during
CONCERTA treatment [see Warnings and
Precautions (5.10)].
.
. .
Administration
Instructions
Instruct
patients to swallow
CONCERTA whole with liquids, and not to split, crush, or chew, the
extended-release tablets. Advise patients not to be concerned if
they occasionally notice a tablet-appearing substance in their stool.
.
. .
Pregnancy
Advise
patients that there is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to CONCERTA during pregnancy [see Use in Specific Populations (8.1)].
Lactation
Advise
CONCERTA-treated breastfeeding women to monitor their infants for agitation,
poor sleeping patterns, changes in feeding, and reduced weight gain [see Use in Specific Populations (8.2)].
MEDICATION GUIDE
Additions and/or
revisions underlined:
.
. .
Before taking
CONCERTA, tell your healthcare provider about all of your or your child’s
medical conditions, including if you or your child:
.
. .
are
pregnant or plan to become pregnant. It is not known if CONCERTA will harm the
unborn baby.
There is a
pregnancy exposure registry for women are exposed to CONCERTA during pregnancy.
The purpose of the registry is to collect information about the health of women
exposed to CONCERTA and their baby. If you or your child becomes pregnant
during treatment with CONCERTA, talk to your healthcare provider about
registering with the National Pregnancy Registry for ADHD Medications at
1-866-961-2388 or visit online at
https://womensmentalhealth.org/adhd-medications/.
are
breastfeeding or plan to breastfeed. CONCERTA passes into the breast milk. Talk
to your healthcare provider about the best way to feed the baby during
treatment with CONCERTA. If you breastfeed during treatment with CONCERTA,
monitor your baby for agitation, poor sleeping patterns, changes in feeding,
and reduced weight gain.
. . .
. .
.
Risk of intestinal blockage in people with narrowed
digestive tract (gastrointestinal narrowing). Because the CONCERTA tablet does not change in shape in the intestines
(GI tract), CONCERTA should not be taken by people with severe intestinal
problems (pre-existing severe gastrointestinal narrowing).
. .
.
The most common side effect of CONCERTA in
children 6 to 17 years of age is upper
stomach-area (abdominal) pain.
. .
.
The most common side effects of CONCERTA
in adults up to 65 years of age include:
. .
.
.
. .
Approved Drug Label (PDF)
4
Contraindications
Additions and/or revisions
underlined:
CONCERTA
is contraindicated in patients:
Known to be hypersensitive to methylphenidate or other
components of CONCERTA. Hypersensitivity reactions, such as angioedema and
anaphylactic reactions, have been reported in patients treated with CONCERTA. [see Adverse Reactions (6)].
Receiving concomitant
monoamine oxidase inhibitors (MAOIs), and within 14 days following
discontinuation of treatment with a MAO inhibitor because of the risk
of a hypertensive crisis
5
Warnings and Precautions
5.4 Psychiatric
Adverse Reactions
Additions and/or
revisions underlined:
Exacerbation of Psychosis in Patients with a
Psychotic Disorder
CNS stimulants, including CONCERTA, may exacerbate
behavior disturbance and thought disorder in patients with a pre-existing
psychotic disorder.
. . .
Induction of a Manic Episode in Patients with
Bipolar Disorder
CNS stimulants, including CONCERTA, may induce a
manic or mixed episode in patients with bipolar disorder. Prior to
initiating CONCERTA treatment, screen patients for risk factors for developing
a manic episode (e.g., history of depressive symptoms or a family history of
suicide, bipolar disorder, or depression).
New Psychotic or Manic Symptoms in Patients without a History of a
Bipolar or Psychotic Disorder
CNS stimulants (including CONCERTA), at the
recommended dosage, may cause psychotic or manic symptoms (e.g.,
hallucinations, delusional thinking, or mania) in patients without a prior
history of psychotic illness or mania.
. . .
5.5 Priapism
Additions and/or
revisions underlined:
Prolonged
and painful erections, sometimes requiring surgical intervention, have been
reported with methylphenidate use in adult and pediatric male patients [see Adverse Reactions (6)]. Although
priapism was not reported with methylphenidate initiation, priapism occurred
in patients treated with methylphenidate after some time, often subsequent
to an increase in dosage. Priapism also occurred during methylphenidate
withdrawal (drug holidays or during discontinuation).
.
. .
5.6 Peripheral
Vasculopathy, including Raynaud’s Phenomenon
Additions and/or
revisions underlined:
CNS
stimulants, including CONCERTA, used to treat ADHD are associated with
peripheral vasculopathy, including Raynaud’s phenomenon [see Adverse Reactions (6.2)]. Signs and symptoms of these cases
of peripheral vasculopathy were usually intermittent and mild; however,
sequelae have included digital ulceration and/or soft tissue breakdown. Effects
of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in
post-marketing reports and at the therapeutic dosages of CNS stimulants in all
age groups throughout the course of treatment. Signs and symptoms of
peripheral vasculopathy generally improved after CNS stimulant
dosage reduction or discontinuation.
During
CONCERTA treatment, carefully assess for digital changes. Further
clinical evaluation (e.g., rheumatology referral) may be appropriate for
CONCERTA-treated patients who develop signs or symptoms of peripheral
vasculopathy.
5.7 Long-Term
Suppression of Growth in Pediatric Patients
Additions and/or
revisions underlined:
.
. .
Pediatric
patients 7 to 13 years of age who received methylphenidate for 7 days
per week for over 14 months to over 36 months had a temporary slowing in
growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg
less growth in weight over 3 years), without evidence of growth rebound during
this development period.
.
. .
5.8 Risk of
Gastrointestinal Obstruction in Patients with Gastrointestinal Narrowing
Additions and/or
revisions underlined:
.
. .
CONCERTA
should be used only in patients who are able to swallow the extended-release
tablets whole [see Dosage and
Administration (2.2)].
5.11 Motor and
Verbal Tics, and Worsening of Tourette’s Syndrome
Additions and/or
revisions underlined:
.
. .
Before
initiating CONCERTA, assess the family history for tics or Tourette’
syndrome and clinically evaluate patients for tics or Tourette’s syndrome.
Regularly monitor CONCERTA-treated patients for the emergence or worsening of
tics or Tourette’s syndrome, and discontinue CONCERTA treatment if clinically
appropriate.
6
Adverse Reactions
Additions and/or
revisions underlined:
. . .
- Risks of Gastrointestinal Obstruction in Patients with Gastrointestinal
Narrowing [see Warnings and Precautions (5.8)]
. . .
6.1 Clinical
Trials Experience
Extensive changes; please
refer to label for complete information
7
Drug Interactions
Extensive changes;
please refer to label for complete information
8
Use in Specific Populations
8.1 Pregnancy
PLLR conversion
Pregnancy
Exposure Registry
There
is a pregnancy exposure registry that monitors pregnancy outcomes in women
exposed to ADHD drugs, including CONCERTA, during pregnancy. Healthcare
providers are encouraged to advise patients to register by calling the National
Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/.
Risk
Summary
Published
studies and post-marketing reports on methylphenidate use during pregnancy have
inconsistent findings about a drug-associated risk of major birth defects,
miscarriage, or adverse maternal or fetal outcomes. There are risks to the
fetus associated with the use of central nervous system (CNS) stimulants during
pregnancy (see Clinical Considerations).
No
effects on morphological development were observed in embryo-fetal development
studies with oral administration of methylphenidate to pregnant rats and
rabbits throughout organogenesis at doses up to 4 and 16 times, respectively,
the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a
mg/m2 basis. However, spina bifida was observed in rabbits at a dose
54 times the MRHD given to adults. A slight decrease in body weight was
observed in pregnant rats at the highest dose of 30 mg/kg/day (4 times the MRHD
given to adults).
In
a pre- and postnatal development study in which rats were treated with oral
administration of methylphenidate throughout pregnancy and lactation, a
decrease in pup body weight, alterations in sensory and neuromotor performance,
and deficits in learning and memory were observed in both sexes at the highest
dose (4 times the MRHD given to adults on a mg/m2 basis) (see Data).
The
background risk of major birth defects and miscarriage in those with ADHD is
unknown. All pregnancies have a background risk of birth defects, loss, or
other adverse outcomes. In the U.S. general population, the estimated
background risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical
Considerations
Fetal/Neonatal
Adverse Reactions: CNS
stimulants, such as CONCERTA, can cause vasoconstriction and thereby decrease
placental perfusion. No fetal and/or neonatal adverse reactions have been
reported with the use of a therapeutic dosage of methylphenidate during
pregnancy; however, premature delivery and low birth weight infants have been
reported in amphetamine dependent mothers.
Data
Animal Data: In embryo-fetal
development studies conducted in rats and rabbits, methylphenidate was
administered orally at doses up to 30 and 200 mg/kg/day, respectively, during
the period of organogenesis.
Malformations
(increased incidence of fetal spina bifida) were observed in rabbits at the
highest dose, which is approximately 54 times the maximum recommended human
dose (MRHD) of 72 mg/day given to adults on a mg/m2 basis. The no
effect level for embryo-fetal development in rabbits was 60 mg/kg/day (16 times
the MRHD given to adults on a mg/m2 basis).
There
was no evidence of changes in morphological development in rats, although a
reduction in maternal body weight was observed at the highest dose of 30
mg/kg/day (4 times the MRHD of 72 mg/day given to adults (on a mg/m2
basis). The no effect level for maternal body weight in rats is 5 mg/day (equal
to the MRHD for adults on a mg/m2 basis); and the no effect level
for embryo-fetal development is 30 mg/kg/day (4 times the MRHD for adults on a
mg/m2 basis).
When
methylphenidate was administered to rats throughout pregnancy and lactation at
doses of up to 30 mg/kg/day, decreases in offspring body weight, alterations in
sensory and neuromotor performance, and deficits in learning and memory were
observed in both sexes at the highest dose (4 times the MRHD of 72 mg/day,
given to adults on a mg/m2 basis). The no effect level for pre-and
post-natal development in rats was 12.5 mg/kg/day (2 times the MRHD given to
adults on a mg/m2 basis).
8.2 Lactation
PLLR conversion
Risk
Summary
Limited
published literature, based on breast milk sampling from a small number of methylphenidate-treated
lactating women, reports that methylphenidate is present in human milk, which
resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted
methylphenidate 15 dosage and a milk/plasma ratio ranging between 1.1 and 2.7.
There are no reports of adverse effects on the breastfed infant or effects on
milk production. Long-term neurodevelopmental effects on infants from CNS
stimulant exposure are unknown.
The
developmental and health benefits of breastfeeding should be considered along
with the mother’s clinical need for CONCERTA and any potential adverse effects
on the breastfed child from CONCERTA or from the underlying maternal condition.
Clinical
Considerations
Monitor
breastfeeding infants of CONCERTA-treated lactating women 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 CONCERTA for the
treatment of ADHD have been established in pediatric patients 6 years of age
and older. The safety and effectiveness of CONCERTA have not
been established in pediatric patients below the age of 6 years.
In studies evaluating extended-release
methylphenidate products, patients 4 to less than 6 years of age had higher
systemic methylphenidate exposures than those observed in older pediatric patients
at the same dosage. Pediatric patients 4 to less than 6 years of age also had a
higher incidence of adverse reactions, including weight loss.
CNS stimulants have been associated with weight loss
and slowing of growth rate in pediatric patients. Growth (weight and height)
should be monitored in pediatric patients during treatment with CNS stimulants,
including CONCERTA. Pediatric patients who are not growing or gaining weight as
expected may need to have their CONCERTA treatment interrupted [see Warnings and Precautions (5.7)].
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 54 mg/day given to
pediatric patients 6 to 12 years of age on a mg/m squared 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 54 mg/day given to pediatric patients 6 to
12 years of age 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 (9 times the MRHD given to pediatric patients 6 to 12 years of age
on a mg/m2 basis). The no effect level for juvenile neurobehavioral
development in rats was 5 mg/kg/day (approximately 0.4 times the MRHD given to
pediatric patients 6 to 12 years of age on a mg/m squared basis). The clinical
significance of the long-term behavioral effects observed in rats is unknown.
8.5 Geriatric Use
Additions and/or
revisions underlined:
CONCERTA is not indicated for use in patients
greater than 65 years of age.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or
revisions underlined:
.
. .
Increased
Blood Pressure and Heart Rate
Advise
patients and their caregivers that CONCERTA can cause elevations in
blood pressure and heart rate [see
Warnings and Precautions (5.3)].
Psychiatric Risks
Advise
patients and their caregivers that CONCERTA, at recommended doses, can
cause psychotic or manic symptoms, even in patients without a prior history of
psychotic symptoms or mania [see Warnings
and Precautions (5.4)].
Priapism
Advise
patients, caregivers, and family members of CONCERTA-treated males of the
possibility of priapism. Instruct the patient to seek immediate medical
attention in the event of priapism [see
Warnings and Precautions (5.5)].
Peripheral
Vasculopathy, including Raynaud’s Phenomenon
Instruct
patients about the risk of peripheral vasculopathy, including Raynaud’s
phenomenon, and associated signs and symptoms; to report to their health
care provider any new numbness, pain, skin color change, or sensitivity to
temperature in fingers or toes; to call their health care provider immediately
with any signs of unexplained wounds appearing on fingers or toes while taking
CONCERTA [see Warnings and Precautions
(5.6)].
.
. .
Long-term
Suppression of Growth in Pediatric Patients
Advise
patients, caregivers, and family members that CONCERTA may cause slowing of
growth and weight loss in pediatric patients [see Warnings and Precautions (5.7)].
Glaucoma and
Increased Intraocular Pressure
Advise
patients that increased intraocular pressure and glaucoma may occur during
CONCERTA treatment [see Warnings and
Precautions (5.10)].
.
. .
Administration
Instructions
Instruct
patients to swallow
CONCERTA whole with liquids, and not to split, crush, or chew, the
extended-release tablets. Advise patients not to be concerned if
they occasionally notice a tablet-appearing substance in their stool.
.
. .
Pregnancy
Advise
patients that there is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to CONCERTA during pregnancy [see Use in Specific Populations (8.1)].
Lactation
Advise
CONCERTA-treated breastfeeding women to monitor their infants for agitation,
poor sleeping patterns, changes in feeding, and reduced weight gain [see Use in Specific Populations (8.2)].
MEDICATION GUIDE
Additions and/or
revisions underlined:
.
. .
Before taking
CONCERTA, tell your healthcare provider about all of your or your child’s
medical conditions, including if you or your child:
.
. .
are
pregnant or plan to become pregnant. It is not known if CONCERTA will harm the
unborn baby.
There is a
pregnancy exposure registry for women are exposed to CONCERTA during pregnancy.
The purpose of the registry is to collect information about the health of women
exposed to CONCERTA and their baby. If you or your child becomes pregnant
during treatment with CONCERTA, talk to your healthcare provider about
registering with the National Pregnancy Registry for ADHD Medications at
1-866-961-2388 or visit online at
https://womensmentalhealth.org/adhd-medications/.
are
breastfeeding or plan to breastfeed. CONCERTA passes into the breast milk. Talk
to your healthcare provider about the best way to feed the baby during
treatment with CONCERTA. If you breastfeed during treatment with CONCERTA,
monitor your baby for agitation, poor sleeping patterns, changes in feeding,
and reduced weight gain.
. . .
Risk of intestinal blockage in people with narrowed
digestive tract (gastrointestinal narrowing). Because the CONCERTA tablet does not change in shape in the intestines
(GI tract), CONCERTA should not be taken by people with severe intestinal
problems (pre-existing severe gastrointestinal narrowing).
. .
.
The most common side effect of CONCERTA in
children 6 to 17 years of age is upper
stomach-area (abdominal) pain.
. .
.
The most common side effects of CONCERTA
in adults up to 65 years of age include:
. .
.
.
. .
Approved Drug Label (PDF)
4
Contraindications
Additions and/or revisions
underlined:
CONCERTA
is contraindicated in patients:
Known to be hypersensitive to methylphenidate or other
components of CONCERTA. Hypersensitivity reactions, such as angioedema and
anaphylactic reactions, have been reported in patients treated with CONCERTA. [see Adverse Reactions (6)].
Receiving concomitant
monoamine oxidase inhibitors (MAOIs), and within 14 days following
discontinuation of treatment with a MAO inhibitor because of the risk
of a hypertensive crisis
5
Warnings and Precautions
5.4 Psychiatric
Adverse Reactions
Additions and/or
revisions underlined:
Exacerbation of Psychosis in Patients with a
Psychotic Disorder
CNS stimulants, including CONCERTA, may exacerbate
behavior disturbance and thought disorder in patients with a pre-existing
psychotic disorder.
. . .
Induction of a Manic Episode in Patients with
Bipolar Disorder
CNS stimulants, including CONCERTA, may induce a
manic or mixed episode in patients with bipolar disorder. Prior to
initiating CONCERTA treatment, screen patients for risk factors for developing
a manic episode (e.g., history of depressive symptoms or a family history of
suicide, bipolar disorder, or depression).
New Psychotic or Manic Symptoms in Patients without a History of a
Bipolar or Psychotic Disorder
CNS stimulants (including CONCERTA), at the
recommended dosage, may cause psychotic or manic symptoms (e.g.,
hallucinations, delusional thinking, or mania) in patients without a prior
history of psychotic illness or mania.
. . .
5.5 Priapism
Additions and/or
revisions underlined:
Prolonged
and painful erections, sometimes requiring surgical intervention, have been
reported with methylphenidate use in adult and pediatric male patients [see Adverse Reactions (6)]. Although
priapism was not reported with methylphenidate initiation, priapism occurred
in patients treated with methylphenidate after some time, often subsequent
to an increase in dosage. Priapism also occurred during methylphenidate
withdrawal (drug holidays or during discontinuation).
.
. .
5.6 Peripheral
Vasculopathy, including Raynaud’s Phenomenon
Additions and/or
revisions underlined:
CNS
stimulants, including CONCERTA, used to treat ADHD are associated with
peripheral vasculopathy, including Raynaud’s phenomenon [see Adverse Reactions (6.2)]. Signs and symptoms of these cases
of peripheral vasculopathy were usually intermittent and mild; however,
sequelae have included digital ulceration and/or soft tissue breakdown. Effects
of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in
post-marketing reports and at the therapeutic dosages of CNS stimulants in all
age groups throughout the course of treatment. Signs and symptoms of
peripheral vasculopathy generally improved after CNS stimulant
dosage reduction or discontinuation.
During
CONCERTA treatment, carefully assess for digital changes. Further
clinical evaluation (e.g., rheumatology referral) may be appropriate for
CONCERTA-treated patients who develop signs or symptoms of peripheral
vasculopathy.
5.7 Long-Term
Suppression of Growth in Pediatric Patients
Additions and/or
revisions underlined:
.
. .
Pediatric
patients 7 to 13 years of age who received methylphenidate for 7 days
per week for over 14 months to over 36 months had a temporary slowing in
growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg
less growth in weight over 3 years), without evidence of growth rebound during
this development period.
.
. .
5.8 Risk of
Gastrointestinal Obstruction in Patients with Gastrointestinal Narrowing
Additions and/or
revisions underlined:
.
. .
CONCERTA
should be used only in patients who are able to swallow the extended-release
tablets whole [see Dosage and
Administration (2.2)].
5.11 Motor and
Verbal Tics, and Worsening of Tourette’s Syndrome
Additions and/or
revisions underlined:
.
. .
Before
initiating CONCERTA, assess the family history for tics or Tourette’
syndrome and clinically evaluate patients for tics or Tourette’s syndrome.
Regularly monitor CONCERTA-treated patients for the emergence or worsening of
tics or Tourette’s syndrome, and discontinue CONCERTA treatment if clinically
appropriate.
6
Adverse Reactions
Additions and/or
revisions underlined:
. . .
- Risks of Gastrointestinal Obstruction in Patients with Gastrointestinal
Narrowing [see Warnings and Precautions (5.8)]
. . .
7
Drug Interactions
DRUG INTERACTIONS
Extensive changes;
please refer to label for complete information
8
Use in Specific Populations
8.1 Pregnancy
PLLR conversion
Pregnancy
Exposure Registry
There
is a pregnancy exposure registry that monitors pregnancy outcomes in women
exposed to ADHD drugs, including CONCERTA, during pregnancy. Healthcare
providers are encouraged to advise patients to register by calling the National
Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/.
Risk
Summary
Published
studies and post-marketing reports on methylphenidate use during pregnancy have
inconsistent findings about a drug-associated risk of major birth defects,
miscarriage, or adverse maternal or fetal outcomes. There are risks to the
fetus associated with the use of central nervous system (CNS) stimulants during
pregnancy (see Clinical Considerations).
No
effects on morphological development were observed in embryo-fetal development
studies with oral administration of methylphenidate to pregnant rats and
rabbits throughout organogenesis at doses up to 4 and 16 times, respectively,
the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a
mg/m2 basis. However, spina bifida was observed in rabbits at a dose
54 times the MRHD given to adults. A slight decrease in body weight was
observed in pregnant rats at the highest dose of 30 mg/kg/day (4 times the MRHD
given to adults).
In
a pre- and postnatal development study in which rats were treated with oral
administration of methylphenidate throughout pregnancy and lactation, a
decrease in pup body weight, alterations in sensory and neuromotor performance,
and deficits in learning and memory were observed in both sexes at the highest
dose (4 times the MRHD given to adults on a mg/m2 basis) (see Data).
The
background risk of major birth defects and miscarriage in those with ADHD is
unknown. All pregnancies have a background risk of birth defects, loss, or
other adverse outcomes. In the U.S. general population, the estimated
background risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical
Considerations
Fetal/Neonatal
Adverse Reactions: CNS
stimulants, such as CONCERTA, can cause vasoconstriction and thereby decrease
placental perfusion. No fetal and/or neonatal adverse reactions have been
reported with the use of a therapeutic dosage of methylphenidate during
pregnancy; however, premature delivery and low birth weight infants have been
reported in amphetamine dependent mothers.
Data
Animal Data: In embryo-fetal
development studies conducted in rats and rabbits, methylphenidate was
administered orally at doses up to 30 and 200 mg/kg/day, respectively, during
the period of organogenesis.
Malformations
(increased incidence of fetal spina bifida) were observed in rabbits at the
highest dose, which is approximately 54 times the maximum recommended human
dose (MRHD) of 72 mg/day given to adults on a mg/m2 basis. The no
effect level for embryo-fetal development in rabbits was 60 mg/kg/day (16 times
the MRHD given to adults on a mg/m2 basis).
There
was no evidence of changes in morphological development in rats, although a
reduction in maternal body weight was observed at the highest dose of 30
mg/kg/day (4 times the MRHD of 72 mg/day given to adults (on a mg/m2
basis). The no effect level for maternal body weight in rats is 5 mg/day (equal
to the MRHD for adults on a mg/m2 basis); and the no effect level
for embryo-fetal development is 30 mg/kg/day (4 times the MRHD for adults on a
mg/m2 basis).
When
methylphenidate was administered to rats throughout pregnancy and lactation at
doses of up to 30 mg/kg/day, decreases in offspring body weight, alterations in
sensory and neuromotor performance, and deficits in learning and memory were
observed in both sexes at the highest dose (4 times the MRHD of 72 mg/day,
given to adults on a mg/m2 basis). The no effect level for pre-and
post-natal development in rats was 12.5 mg/kg/day (2 times the MRHD given to
adults on a mg/m2 basis).
8.2 Lactation
PLLR conversion
Risk
Summary
Limited
published literature, based on breast milk sampling from a small number of methylphenidate-treated
lactating women, reports that methylphenidate is present in human milk, which
resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted
methylphenidate 15 dosage and a milk/plasma ratio ranging between 1.1 and 2.7.
There are no reports of adverse effects on the breastfed infant or effects on
milk production. Long-term neurodevelopmental effects on infants from CNS
stimulant exposure are unknown.
The
developmental and health benefits of breastfeeding should be considered along
with the mother’s clinical need for CONCERTA and any potential adverse effects
on the breastfed child from CONCERTA or from the underlying maternal condition.
Clinical
Considerations
Monitor
breastfeeding infants of CONCERTA-treated lactating women 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 CONCERTA for the
treatment of ADHD have been established in pediatric patients 6 years of age
and older. The safety and effectiveness of CONCERTA have not
been established in pediatric patients below the age of 6 years.
In studies evaluating extended-release
methylphenidate products, patients 4 to less than 6 years of age had higher
systemic methylphenidate exposures than those observed in older pediatric patients
at the same dosage. Pediatric patients 4 to less than 6 years of age also had a
higher incidence of adverse reactions, including weight loss.
CNS stimulants have been associated with weight loss
and slowing of growth rate in pediatric patients. Growth (weight and height)
should be monitored in pediatric patients during treatment with CNS stimulants,
including CONCERTA. Pediatric patients who are not growing or gaining weight as
expected may need to have their CONCERTA treatment interrupted [see Warnings and Precautions (5.7)].
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 54 mg/day given to
pediatric patients 6 to 12 years of age on a mg/m squared 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 54 mg/day given to pediatric patients 6 to
12 years of age 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 (9 times the MRHD given to pediatric patients 6 to 12 years of age
on a mg/m2 basis). The no effect level for juvenile neurobehavioral
development in rats was 5 mg/kg/day (approximately 0.4 times the MRHD given to
pediatric patients 6 to 12 years of age on a mg/m squared basis). The clinical
significance of the long-term behavioral effects observed in rats is unknown.
8.5 Geriatric Use
Additions and/or
revisions underlined:
CONCERTA is not indicated for use in patients
greater than 65 years of age.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or
revisions underlined:
.
. .
Increased
Blood Pressure and Heart Rate
Advise
patients and their caregivers that CONCERTA can cause elevations in
blood pressure and heart rate [see
Warnings and Precautions (5.3)].
Psychiatric Risks
Advise
patients and their caregivers that CONCERTA, at recommended doses, can
cause psychotic or manic symptoms, even in patients without a prior history of
psychotic symptoms or mania [see Warnings
and Precautions (5.4)].
Priapism
Advise
patients, caregivers, and family members of CONCERTA-treated males of the
possibility of priapism. Instruct the patient to seek immediate medical
attention in the event of priapism [see
Warnings and Precautions (5.5)].
Peripheral
Vasculopathy, including Raynaud’s Phenomenon
Instruct
patients about the risk of peripheral vasculopathy, including Raynaud’s
phenomenon, and associated signs and symptoms; to report to their health
care provider any new numbness, pain, skin color change, or sensitivity to
temperature in fingers or toes; to call their health care provider immediately
with any signs of unexplained wounds appearing on fingers or toes while taking
CONCERTA [see Warnings and Precautions
(5.6)].
.
. .
Long-term
Suppression of Growth in Pediatric Patients
Advise
patients, caregivers, and family members that CONCERTA may cause slowing of
growth and weight loss in pediatric patients [see Warnings and Precautions (5.7)].
Glaucoma and
Increased Intraocular Pressure
Advise
patients that increased intraocular pressure and glaucoma may occur during
CONCERTA treatment [see Warnings and
Precautions (5.10)].
.
. .
Administration
Instructions
Instruct
patients to swallow
CONCERTA whole with liquids, and not to split, crush, or chew, the
extended-release tablets. Advise patients not to be concerned if
they occasionally notice a tablet-appearing substance in their stool.
.
. .
Pregnancy
Advise
patients that there is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to CONCERTA during pregnancy [see Use in Specific Populations (8.1)].
Lactation
Advise
CONCERTA-treated breastfeeding women to monitor their infants for agitation,
poor sleeping patterns, changes in feeding, and reduced weight gain [see Use in Specific Populations (8.2)].
MEDICATION GUIDE
Additions and/or
revisions underlined:
.
. .
Before taking
CONCERTA, tell your healthcare provider about all of your or your child’s
medical conditions, including if you or your child:
.
. .
are
pregnant or plan to become pregnant. It is not known if CONCERTA will harm the
unborn baby.
There is a
pregnancy exposure registry for women are exposed to CONCERTA during pregnancy.
The purpose of the registry is to collect information about the health of women
exposed to CONCERTA and their baby. If you or your child becomes pregnant
during treatment with CONCERTA, talk to your healthcare provider about
registering with the National Pregnancy Registry for ADHD Medications at
1-866-961-2388 or visit online at
https://womensmentalhealth.org/adhd-medications/.
are
breastfeeding or plan to breastfeed. CONCERTA passes into the breast milk. Talk
to your healthcare provider about the best way to feed the baby during
treatment with CONCERTA. If you breastfeed during treatment with CONCERTA,
monitor your baby for agitation, poor sleeping patterns, changes in feeding,
and reduced weight gain.
. . .
Risk of intestinal blockage in people with narrowed
digestive tract (gastrointestinal narrowing). Because the CONCERTA tablet does not change in shape in the intestines
(GI tract), CONCERTA should not be taken by people with severe intestinal
problems (pre-existing severe gastrointestinal narrowing).
. .
.
The most common side effect of CONCERTA in
children 6 to 17 years of age is upper
stomach-area (abdominal) pain.
. .
.
The most common side effects of CONCERTA
in adults up to 65 years of age include:
. .
.
.
. .
Approved Drug Label (PDF)
Boxed Warning
Additions and/or
revisions underlined:
WARNING: ABUSE,
MISUSE, AND ADDICTION
CONCERTA 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 CONCERTA, 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
CONCERTA, 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 CONCERTA 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
New subsection
added:
CONCERTA has a high potential for abuse and misuse.
The use of CONCERTA exposes individuals to the risks of abuse and misuse, which
can lead to the development of a substance use disorder, including addiction.
CONCERTA 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 CONCERTA, 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 CONCERTA, 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 CONCERTA in a safe place, preferably locked, and instruct patients to not
give CONCERTA to ![]()
anyone else.
Throughout CONCERTA treatment, reassess each patient’s risk of abuse, misuse,
and ![]()
addiction and
frequently monitor for signs and symptoms of abuse, misuse, and addiction.
5.11 Acute Angle Closure Glaucoma
New subsection
added
There have been rare reports of angle closure
glaucoma associated with methylphenidate treatment.
![]()
Although the
mechanism is not clear, CONCERTA-treated patients considered at risk for acute
angle closure glaucoma (e.g., patients with significant hyperopia) should be
evaluated by an ophthalmologist.
5.12 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 (6.5)].
Prescribe CONCERTA to patients with open-angle
glaucoma or abnormally increased IOP only if the benefit of treatment is
considered to outweigh the risk. Closely monitor CONCERTA-treated patients with
a history of abnormally increased IOP or open angle glaucoma.
5.13 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 [see
Adverse Reactions (6.2, 6.5)]. Worsening of Tourette’s syndrome has also
been reported.
Before initiating CONCERTA, assess the family
history and clinically evaluate patients for tics or Tourette’s syndrome.
Regularly monitor CONCERTA-treated patients for the emergence or worsening of
tics or Tourette’s syndrome, and discontinue treatment if clinically
appropriate.
6
Adverse Reactions
Additions and/or
revisions underlined:
The following are discussed in more detail in other
sections of the labeling:
…
…
Acute Angle Closure Glaucoma [see Warnings and Precautions (5.11)]
Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.12)]
Motor and Verbal Tics, and Worsening of Tourette’s
Syndrome [see Warnings and Precautions
(5.13)]
…
6.5 Postmarketing
Experience
Additions and/or revisions underlined:
…
Eye Disorders: Diplopia, Increased intraocular
pressure, Mydriasis, Visual impairment
…
Nervous
System Disorders: Convulsion, Grand mal convulsion, Dyskinesia, Serotonin
syndrome in combination with serotonergic drugs, Motor and Verbal Tics
…
7
Drug Interactions
7.4 Halogenated Anesthetics
New
subsection added:
Concomitant
use of halogenated anesthetics and CONCERTA may increase the risk of sudden
blood pressure and heart rate increase during surgery. Monitor blood pressure
and avoid use of CONCERTA in patients being treated with anesthetics on the day
of surgery.
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 CONCERTA, 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 CONCERTA in a safe place,
preferably locked, and instruct patients to not give CONCERTA 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 CONCERTA
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 and Precautions (5.2)].
Increased Blood Pressure and Heart Rate
Advise patients that CONCERTA can cause elevations
in blood pressure and heart rate [see
Warnings and Precautions (5.3)].
Psychiatric Risks
Advise patients that CONCERTA, at recommended doses,
can cause psychotic or manic symptoms, even in patients without a prior history
of psychotic symptoms or mania [see
Warnings and Precautions (5.4)].
…
Suppression of Growth
Advise patients, caregivers, and family members that
CONCERTA may cause slowing of growth and weight loss [see Warnings and Precautions (5.8)].
Increased Intraocular Pressure (IOP) and Glaucoma
Advise patients that IOP and glaucoma may occur
during treatment with CONCERTA [see
Warnings and Precautions (5.12)].
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 CONCERTA.
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 (5.13)].
…
MEDICATION GUIDE
Medication Guide has undergone extensive changes;
please refer to label.
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