METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE- methylphenidate hydrochloride tablet, extended release

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

SpecGx LLC

INN (আন্তর্জাতিক নাম):

METHYLPHENIDATE HYDROCHLORIDE

রচনা:

METHYLPHENIDATE HYDROCHLORIDE 27 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Methylphenidate hydrochloride 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 hydrochloride extended-release tablets. Therefore, methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effect of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 healthcare 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets (54 mg and 108 mg) were compared to IR MPH (50 mg and 90 mg), respectively, methylphenidate hydrochloride extended-release tablets produced statistically significantly lower subjective responses on these two scales than IR MPH. Methylphenidate hydrochloride 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 hydrochloride extended-release tablets is 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 hydrochloride 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 hydrochloride extended-release tablets in the community is unknown. Physical Dependence Methylphenidate hydrochloride 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 hydrochloride extended-release tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. Tolerance Methylphenidate hydrochloride 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).

পণ্য সারাংশ:

Strength Color Tablet Description Bottle Count NDC 27 mg Gray capsule shaped, imprinted with “M” in a box and “27” on one side in black ink 100 0406-0127-01 36 mg White capsule shaped, imprinted with “M” in a box and “36” on one side in black ink 100 0406-0136-01 54 mg Red capsule shaped, imprinted with “M” in a box and “54” on one side in black ink 100 0406-0154-01 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from humidity. Dispense in tight, light-resistant container with child-resistant closure.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

HYDROCHLORIDE TABLET, EXTENDED RELEASE
SpecGx LLC
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MEDICATION GUIDE
Methylphenidate Hydrochloride Extended-Release Tablets USP, CII
(METH il FEN i date)
What is the most important information I should know about
methylphenidate hydrochloride extended-
release tablets?
Methylphenidate hydrochloride extended-release tablets may cause
serious side effects, including:
•
Abuse, misuse, and addiction. Methylphenidate hydrochloride
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 hydrochloride 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 hydrochloride extended-release tablets or when they
are 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 hydrochloride
extended-release
tablets and will monitor you or your child during treatment.
•
methylphenidate hydrochloride extended-release tablets may lead to
physical dependence
after prolonged use, even if taken as directed by your healthcare
provider.
•
Do not give methylphenidate hydrochloride extended-release tablets to
anyone else. See
“What are methylphenidate hydrochloride extended-release tablets?”
for more
information.
•
Keep methylphenidate hydrochloride extended-release tablets in a safe
place and
properly dispose of any unused medicine. See “How should I store
methylphenidate
hydrochloride 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 ser

পণ্য বৈশিষ্ট্য

METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE- METHYLPHENIDATE
HYDROCHLORIDE TABLET, EXTENDED RELEASE
SPECGX LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP SAFELY AND EFFECTIVELY. SEE
FULL
PRESCRIBING INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE
EXTENDED-RELEASE
TABLETS.
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, FOR ORAL
USE, CII
INITIAL U.S. APPROVAL: 2000
WARNING: ABUSE, MISUSE, AND ADDICTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
METHYLPHENIDATE HYDROCHLORIDE 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
HYDROCHLORIDE EXTENDED-RELEASE TABLETS, CAN RESULT IN OVERDOSE AND
DEATH (5.1, 9.2,
10):
BEFORE PRESCRIBING METHYLPHENIDATE HYDROCHLORIDE 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
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
INDICATIONS AND USAGE
Methylphenidate hydrochloride extended-release tablets USP 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 hydrochloride extended-release tablets should be taken
once daily in the morning and
swallowed whole with the aid of liquids. Methylphenidate hydrochloride
extend