JORNAY PM EXTENDED-RELEASE- methylphenidate hydrochloride capsule

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

Methylphenidate Hydrochloride (UNII: 4B3SC438HI) (Methylphenidate - UNII:207ZZ9QZ49)

Доступно од:

Ironshore Pharmaceuticals Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

JORNAY PM is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)] . JORNAY PM is contraindicated in patients: - With a history of hypersensitivity to methylphenidate or other components of JORNAY PM. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products [see Adverse Reactions (6)]. - Receiving concomitant treatment with monoamine oxidase (MAO) inhibitors, or within 14 days following discontinuation of a monoamine oxidase inhibitor, 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 JORNAY PM during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388. Risk Summary Published studies and postmarketing repo

Резиме производа:

JORNAY PM (methylphenidate hydrochloride) extended-release capsules are available as follows: 20 mg Capsules – ivory opaque body and light green opaque cap (imprinted with “20 mg” in black on the body and “IRONSHORE” in black on the cap) Bottles of 100................................................……………………………………………NDC 71376-201-03 40 mg Capsules – ivory opaque body and blue-green opaque cap (imprinted with “40 mg” in black on the body and “IRONSHORE” in black on the cap) Bottles of 100................................................……………………………………………NDC 71376-202-03 60 mg Capsules – white opaque body and powder blue opaque cap (imprinted with “60 mg” in black on the body and “IRONSHORE” in black on the cap) Bottles of 100................................................……………………………………………NDC 71376-203-03 80 mg Capsules – white opaque body and light blue opaque cap (imprinted with “80 mg” in black on the body and “IRONSHORE” in black on the cap) Bottles of 100.......................................................................................................……… NDC 71376-204-03 100 mg Capsules – white opaque body and dark blue opaque cap (imprinted with “100 mg” in black on the body and “IRONSHORE” in white on the cap) Bottles of 100...............................................……………………………………….……NDC 71376-205-03 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.

Статус ауторизације:

New Drug Application

Информативни летак

Ironshore Pharmaceuticals Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 10/2023
MEDICATION GUIDE
JORNAY PM (JOR-nay)
(methylphenidate hydrochloride) extended-release capsules, CII
What is the most important information I should know about JORNAY PM?
JORNAY PM may cause serious side effects, including:
Abuse, misuse, and addiction. JORNAY PM has a high chance for abuse
and misuse and may lead to
substance use problems, including addiction. Misuse and abuse of
JORNAY PM, 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 JORNAY PM 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 JORNAY PM and will monitor you or your
child during treatment.
•
JORNAY PM may lead to physical dependence after prolonged use, even if
taken as directed by
your healthcare provider.
•
Do not give JORNAY PM to anyone else. See “What is JORNAY PM?” for
more information.
•
Keep JORNAY PM in a safe place and properly dispose of unused
medicine. See “How should I
store JORNAY PM?” 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 JORNAY PM. Tell your healthcare provider if you or your child
have any heart
problems, heart disease, or heart defects.
Call your healthcare provider right away or go to the nearest hospital
emergency room right away
if you or your child have any signs of heart problems such as chest
pain, shortness of breath, o

Карактеристике производа

JORNAY PM EXTENDED-RELEASE - METHYLPHENIDATE HYDROCHLORIDE CAPSULE
IRONSHORE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JORNAY PM® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR JORNAY PM.
JORNAY PM (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._
JORNAY PM 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 JORNAY PM, CAN RESULT IN OVERDOSE AND DEATH
(5.1, 9.2, 10):
BEFORE PRESCRIBING JORNAY PM, 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, 2.2, 2.3, 2.5)
10/2023
Warnings and Precautions (5.1, 5.2, 5.8, 5.9, 5.10)
10/2023
INDICATIONS AND USAGE
JORNAY PM is a central nervous system (CNS) stimulant indicated for
the treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in patients 6 years and older. (1)
DOSAGE AND ADMINISTRATION
JORNAY PM should be taken only in the evening. (2.2)
Recommended starting dose for patients 6 years and above is 20 mg
daily in the evening. (2.2)
Adjust the timing of administration between 6:30 p.m. and 9:30 p.m. to
optimize the tolerability and the
efficacy the next morning and throughout the day.
Dosage may be increased weekly in increments of 20 mg per day up to a
maximum daily dose of 100
mg. (2.2)
Patients are advised to take JORNAY PM consistently either with food
or without food. (2.2)
Capsules may be swallowed whole or opened and the entire contents
sprinkled