METHYLPHENIDATE HYDROCHLORIDE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Trigen Laboratories, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [ see Clinical Studies (14)] . Methylphenidate hydrochloride extended-release tablets are contraindicated in patients: - with a known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions (6.2)] . - receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a MAOI, because of the risk of hypertensive crisis [see Drug Interactions (7.1)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, inclu

Product summary:

How Supplied Methylphenidate hydrochloride extended-release tablets are available as: Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from humidity.

Authorization status:

New Drug Application

Patient Information leaflet

Trigen Laboratories, LLC
----------
MEDICATION GUIDE
MEDICATION GUIDE
Methylphenidate hydrochloride extended-release tablets
(METH-il-FEN-i-date)
for oral use, CII
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 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 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 serio

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED RELEASE
TRIGEN LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS.
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 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
Dosage and Administration (2.1, 2.3) 10/2023
Warnings and Precautions (5.1, 5.2, 5.9, 5.10, 5.11) 10/2023
INDICATIONS AND USAGE
Methylphenidate hydrochloride extended-release tablets are a central
nervous system (CNS) stimulant
indicated for the treatment of Attention Deficit Hyperactivity
Disorder (ADHD) in adults (up to the age of
65 years) and pediatric patients 6 years of age and older (1).
DOSAGE AND ADMINISTRATION
Administer once daily in the morning with or without food. (2.2)
Swallow whole with liquid. Do not chew, divide, or crush. (2.2)
Recommended dosage for patients new to methylphenidate (2.3):
Pediatric patients 6 to 17 years
Starting dosage is 18 mg once