METHYLPHENIDATE HYDROCHLORIDE tablet, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Amneal Pharmaceuticals LLC

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Sammensetning:

METHYLPHENIDATE HYDROCHLORIDE 18 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Methylphenidate hydrochloride (HCl) extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents and adults up to the age of 65 [see Clinical Studies (14)] . Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate HCl extended-release tablets. Therefore, methylphenidate HCl extended-release tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see Adverse Reactions (6.5)] . Methylphenidate HCl extended-release tablets are contraindicated during treatment with monoamine oxidase (MAO) inhibitors, and also within a minimum of 14 days following discontinuation of a MAO inhibitor (hypertensive crises may result) [see Drug Interactions (7.1)] . Pregnancy Category C Methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively. A reproduction study in rats revealed no evidence of harm to the fetus at oral doses up to 30 mg/kg/day, approximately 15-fold and 3-fold the maximum recommended human dose of methylphenidate HCl extended-release tablets on a mg/kg and mg/m2 basis, respectively. The approximate plasma exposure to methylphenidate plus its main metabolite PPAA in pregnant rats was 1 to 2 times that seen in trials in volunteers and patients with the maximum recommended dose of methylphenidate HCl extended-release tablets based on the AUC. The safety of methylphenidate for use during human pregnancy has not been established. There are no adequate and well-controlled studies in pregnant women. Methylphenidate HCl extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effect of methylphenidate HCl extended-release tablets on labor and delivery in humans is unknown. It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if methylphenidate HCl extended-release tablets are administered to a nursing woman. In lactating female rats treated with a single oral dose of 5 mg/kg radiolabeled methylphenidate, radioactivity (representing methylphenidate and/or its metabolites) was observed in milk and levels were generally similar to those in plasma. Methylphenidate HCl extended-release tablets should not be used in children under six years, since safety and efficacy in this age group have not been established. Long-term effects of methylphenidate in children have not been well established. Methylphenidate HCl extended-release tablets have not been studied in patients greater than 65 years of age. Methylphenidate hydrochloride extended-release tablets contain methylphenidate a Schedule II controlled substance. Methylphenidate HCl extended-release tablets 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 HCl extended-release tablets 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 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 HCl extended-release tablets, 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. In two placebo-controlled human abuse potential studies, single oral doses of methylphenidate HCl extended-release tablets were compared to single oral doses of immediate-release methylphenidate (IR MPH) and placebo in subjects with a history of recreational stimulant use to assess relative abuse potential. For the purpose of this assessment, the response for each of the subjective measures was defined as the maximum effect within the first 8 hours after dose administration. In one study (n=40), both methylphenidate HCl extended-release tablets (108 mg) and 60 mg IR MPH compared to placebo produced statistically significantly greater responses on the five subjective measures suggestive of abuse potential. In comparisons between the two active treatments, however, methylphenidate HCl extended-release tablets (108 mg) produced variable responses on positive subjective measures that were either statistically indistinguishable from (Abuse Potential, Drug Liking, Amphetamine and Morphine Benzedrine Group [Euphoria]) or statistically less than (Stimulation – Euphoria) responses produced by 60 mg IR MPH. In another study (n=49), both doses of methylphenidate HCl extended-release tablets (54 mg and 108 mg) and both doses of IR MPH (50 mg and 90 mg) produced statistically significantly greater responses compared to placebo on the two primary scales used in the study (Drug Liking, Euphoria). When doses of methylphenidate HCl extended-release tablets (54 mg and 108 mg) were compared to IR MPH (50 mg and 90 mg), respectively, methylphenidate HCl extended-release tablets produced statistically significantly lower subjective responses on these two scales than IR MPH. Methylphenidate HCl extended-release tablets (108 mg) produced responses that were statistically indistinguishable from the responses on these two scales produced by IR MPH (50 mg). Differences in subjective responses to the respective doses should be considered in the context that only 22% of the total amount of methylphenidate in methylphenidate extended-release tablets are available for immediate release from the drug overcoat [see System Components and Performance (11.1)] . Although these findings reveal a relatively lower response to methylphenidate HCl extended-release tablets on subjective measures suggestive of abuse potential compared to IR MPH at roughly equivalent total MPH doses, the relevance of these findings to the abuse potential of methylphenidate HCl extended-release tablets in the community is unknown. Physical Dependence Methylphenidate HCl extended-release tablets 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 HCl extended-release tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. Tolerance Methylphenidate HCl extended-release tablets 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).

Produkt oppsummering:

Methylphenidate HCl extended-release tablets, USP, 18 mg, are supplied as yellow, round, film-coated biconvex tablets, debossed “18” on one side and plain on the other side. They are available as follows: Bottles of 30:                          NDC 65162-231-03 Bottles of 90:                          NDC 65162-231-09 Methylphenidate HCl extended-release tablets, USP, 27 mg, are supplied as gray, round, film-coated biconvex tablets, debossed “27” on one side and plain on the other side. They are available as follows: Bottles of 30:                          NDC 65162-233-03 Bottles of 90:                          NDC 65162-233-09 Methylphenidate HCl extended-release tablets, USP, 36 mg, are supplied as white, round, film-coated biconvex tablets, debossed “36” on one side and plain on the other side. They are available as follows: Bottles of 30:                          NDC 65162-235-03 Bottles of 90:                          NDC 65162-235-09 Methylphenidate HCl extended-release tablets, USP, 54 mg, are supplied as red, round, film-coated biconvex tablets, debossed “54” on one side and plain on the other side. They are supplied as follows: Bottles of 30:                          NDC 65162-237-03 Bottles of 90:                          NDC 65162-237-09 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from humidity.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Amneal Pharmaceuticals LLC
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MEDICATION GUIDE
MEDICATION GUIDE
Methylphenidate (meth” il fen’ i date) HCl Extended-Release
Tablets, USP CII
What is the most important information I should know about
methylphenidate HCl extended-release
tablets?
Methylphenidate HCl extended-release tablets may cause serious side
effects, including:
•
Abuse, misuse, and addiction. Methylphenidate HCl extended-release
tablets have a high chance
for abuse and misuse and may lead to substance use problems, including
addiction. Misuse and
abuse of methylphenidate HCl extended-release tablets, 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
HCl extended-release
tablets or when it is used in ways that are not approved, such as
snorting or injection.
•
Your healthcare provider should check you or your child’s risk for
abuse, misuse, and addiction
before starting treatment with methylphenidate HCl extended-release
tablets and will monitor you
or your child during treatment.
•
Methylphenidate HCl extended-release tablets may lead to physical
dependence after prolonged
use, even if taken as directed by your healthcare provider.
•
Do not give methylphenidate HCl extended-release tablets to anyone
else. See “What are
methylphenidate HCl extended-release tablets?” for more information.
•
Keep methylphenidate HCl extended-release tablets in a safe place and
properly dispose of any
unused medicine. See “How should I store methylphenidate HCl
extended-release tablets?” for
more information.
•
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 healthcare provider should check you or your child carefully for
heart problems before starting
tre

Preparatomtale

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED RELEASE
AMNEAL PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE HCL
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
METHYLPHENIDATE HCL EXTENDED-RELEASE TABLETS.
METHYLPHENIDATE HCL EXTENDED-RELEASE TABLETS, FOR ORAL ADMINISTRATION
CII
INITIAL U.S. APPROVAL: 2000
WARNING: ABUSE, MISUSE, AND ADDICTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
METHYLPHENIDATE HCL EXTENDED-RELEASE TABLETS HAVE 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 HCL
EXTENDED-RELEASE TABLETS, CAN RESULT IN OVERDOSE AND DEATH (5.1, 9.2,
10):
BEFORE PRESCRIBING METHYLPHENIDATE HCL EXTENDED-RELEASE TABLETS,
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.
RECENT MAJOR CHANGES
Boxed Warning 10/2023
Indications and Usage (1) 10/2023
Dosage and Administration (2.1, 2.6) 10/2023
Dosage and Administration, Maintenance/Extended
Treatment (2.5) Removed 10/2023
Contraindications (4) 10/2023
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.6, 5.7,
5.8, 5.11, 5.12, 5.13) 10/2023
Warnings and Precautions (5.7) Removed 10/2023
INDICATIONS AND USAGE
Methylphenidate HCl extended-release tablets are a CNS stimulant
indicated for the treatment of
Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of
age and older, adolescents and
adults up to the age of 65. (1)
DOSAGE AND ADMINISTRATION
Methylphenidate HCl extended-release tablets should be taken once
daily in the morning and swallowed
whole with the aid of l