METHYLPHENIDATE capsule, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)

Dostupné z:

Sandoz Inc

INN (Medzinárodný Name):

METHYLPHENIDATE HYDROCHLORIDE

Zloženie:

METHYLPHENIDATE HYDROCHLORIDE 20 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride extended-release capsules during pregnancy. Healthcare providers are encouraged to register patients 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 postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use 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 during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m2 basis. However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, 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 methylphenidate hydrochloride extended-release capsules, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses 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 of up to 75 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 52 times the MRHD of 60 mg/day given to adolescents on a mg/m2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15 times the MRHD given to adolescents on a mg/m2 basis). There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m2 basis), but no other effects on postnatal development were observed. The no effect level for pre- and post-natal development in rats was 15 mg/kg/day (approximately 2 times the MRHD given to adolescents on a mg/m2 basis). 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 methylphenidate hydrochloride extended-release capsules and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride extended-release capsules or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. The safety and effectiveness of methylphenidate hydrochloride extended-release capsules for the treatment of ADHD have been established in pediatric patients aged 6 to 12 years. The safety and effectiveness of methylphenidate hydrochloride extended-release capsules in pediatric patients aged less than 6 years have not been established. The long-term efficacy of methylphenidate hydrochloride extended-release capsules in pediatric patients has not been established. Long-Term Suppression of Growth Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride extended-release capsules. Pediatric patients who are not growing or gaining weight as expected may need to have their 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 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. Methylphenidate hydrochloride extended-release capsules have not been studied in the geriatric population. Methylphenidate hydrochloride extended-release capsules are Schedule II controlled substance. Methylphenidate hydrochloride extended-release capsules have a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1)] . Methylphenidate hydrochloride extended-release capsules can be diverted for non-medical use into illicit channels or distribution. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of methylphenidate hydrochloride extended-release capsules may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release capsules, 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. Physical Dependence Methylphenidate hydrochloride extended-release capsules may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including methylphenidate hydrochloride extended-release capsules include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. Tolerance Methylphenidate hydrochloride extended-release capsules may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

Prehľad produktov:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP controlled room temperature]. Dispense in tight container (USP).

Stav Autorizácia:

New Drug Application Authorized Generic

Príbalový leták

Sandoz Inc
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MEDICATION GUIDE
Methylphenidate (meth-ill-FEN-ih-date) Hydrochloride
Extended-Release Capsules for Oral Use, CII
What is the most important information I should know about
methylphenidate hydrochloride extended-
release capsules?
Methylphenidate hydrochloride extended-release capsules may cause
serious side effects, including:
•
Abuse, misuse, and addiction. Methylphenidate hydrochloride
extended-release capsuleshave a
high chance for abuse and misuse and may lead to substance use
problems, including addiction.
Misuse and abuse of methylphenidate hydrochloride extended-release
capsules, other
methylphenidate containing medicines, and amphetamine containing
medicines, can lead to
overdose and death. The risk of overdose and death is increased with
higher doses of
methylphenidate hydrochloride extended-release capsules or when it is
used in ways that are not
approved, such as snorting or injection.
o Your healthcare provider should check you or your child’s risk for
abuse, misuse, and addiction before
starting
treatment with methylphenidate hydrochloride extended-release capsules
and will monitor you or your
child during treatment.
o Methylphenidate hydrochloride extended-release capsules may lead to
physical dependence after
prolonged use, even if taken as directed by your healthcare provider.
o Do not give methylphenidate hydrochloride extended-release capsules
to anyone else. See “What are
methylphenidate hydrochloride extended-release capsules?” for more
information.
o Keep methylphenidate hydrochloride extended-release capsules in a
safe place and properly dispose of
any unused medicine. See “How should I store methylphenidate
hydrochloride extended-release
capsules?” for more information.
o Tell your healthcare provider if you or your child have ever abused
or been dependent on alcohol,
prescription
medicines, or street drugs.
•
Risks for people with serious heart disease. Sudden death has happened
in people who have heart
defects or other serious heart disease.
Your healt

Súhrn charakteristických

METHYLPHENIDATE- METHYLPHENIDATE CAPSULE, EXTENDED RELEASE
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
HYDROCHLORIDE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE
CAPSULES.
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES FOR ORAL USE,
CII
INITIAL U.S. APPROVAL: 1955
WARNING: ABUSE, MISUSE, AND ADDICTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULESHAVE 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
METHYLPHENIDATE
HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, CAN RESULT IN OVERDOSE AND
DEATH (5.1, 9.2,
10).
•
•
•
RECENT MAJOR CHANGES
Boxed Warning 10/2023
Dosage and Administration (2.1) 10/2023
Warnings and Precautions (5.1, 5.2, 5.8, 5.9, 5.10) 10/2023
INDICATIONS AND USAGE
Methylphenidate hydrochloride extended-release capsules are a central
nervous system (CNS) stimulant
indicated for the treatment of Attention Deficit Hyperactivity
Disorder (ADHD) in pediatric patients 6 to 12
years of age (1).
DOSAGE AND ADMINISTRATION
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•
•
•
•
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DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 10 mg, 20 mg, 30 mg, and 40 mg (3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
•
•
•
BEFORE PRESCRIBING METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE
CAPSULES,
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 TREATMENT, REASSESS EACH PATIENT’S RISK AND FREQUENTLY
MONITOR FOR
SIGNS AND SYMPTOMS OF ABUSE, MISUSE, AND ADDICTION.
Administer orally once daily in the morning (2.2).
Capsules may be swallowed whole or opened and the entire contents
sprinkled on applesauce (2.2).
S