METHYLIN- methylphenidate hydrochloride solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

SHIONOGI INC.

INN (International namn):

METHYLPHENIDATE HYDROCHLORIDE

Sammansättning:

METHYLPHENIDATE HYDROCHLORIDE 5 mg in 5 mL

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Methylin is indicated for the treatment of: - Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older - Narcolepsy Methylin is contraindicated in patients: - with known hypersensitivity to methylphenidate or other components of Methylin. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions (6)] . - receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions (7)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Methylin, 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

Produktsammanfattning:

How Supplied Methylin oral solution is a colorless, grape flavored liquid available in the following strengths: Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container with child-resistant closure.

Bemyndigande status:

New Drug Application

Bipacksedel

SHIONOGI INC.
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MEDICATION GUIDE
MEDICATION GUIDE
METHYLIN® (METH il in)
(methylphenidate hydrochloride)
oral solution, CII
What is the most important information I should know about METHYLIN?
METHYLIN may cause serious side effects, including:
•
Abuse, misuse, and addiction. METHYLIN has a high chance for abuse and
misuse and may lead
to substance use problems, including addiction. Misuse and abuse of
METHYLIN, 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
METHYLIN 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 METHYLIN and will monitor you
or your child
during treatment.
•
METHYLIN may lead to physical dependence after prolonged use, even if
taken as
directed by your healthcare provider.
•
Do not give METHYLIN to anyone else. See “What is METHYLIN?” for
more
information.
•
Keep METHYLIN in a safe place and properly dispose of any unused
medicine. See
“How should I store METHYLIN?” 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 treatment with METHYLIN. Tell your healthcare provider if you
or your child have any
heart problems, heart disease, or heart defects.
Call your healthcare provider 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, or fainting
during treatment with METHYLIN.
Your healthcare provider should check you or your child caref

Produktens egenskaper

METHYLIN- METHYLPHENIDATE HYDROCHLORIDE SOLUTION
SHIONOGI INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METHYLIN .
METHYLIN (METHYLPHENIDATE HYDROCHLORIDE) ORAL SOLUTION, CII
INITIAL U.S. APPROVAL: 1955
WARNING: ABUSE, MISUSE, AND ADDICTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
METHYLIN 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 METHYLIN, CAN RESULT IN OVERDOSE AND DEATH
(5.1, 9.2, 10):
BEFORE PRESCRIBING METHYLIN, 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)
10/2023
Warnings and Precautions (5.1, 5.2, 5.8, 5.9, 5.10)10/2023
INDICATIONS AND USAGE
Methylin is a central nervous system (CNS) stimulant indicated for the
treatment of:
Attention Deficit Hyperactivity Disorder (ADHD) in adults and
pediatric patients 6 years of age and older
(1)
Narcolepsy (1)
DOSAGE AND ADMINISTRATION
_Pediatric patients 6 years and older:_ Starting dose is 5 mg twice
daily (before breakfast and lunch);
increase the dose 5 mg to 10 mg weekly; daily dosage above 60 mg is
not recommended. (2.2)
_Adults:_ Administer in divided doses 2 or 3 times daily, preferably
30 to 45 minutes before meals.
Average dosage is 20 to 30 mg daily. Maximum recommended daily dosage
is 60 mg. (2)
DOSAGE FORMS AND STRENGTHS
_Oral solution:_ 5 mg per 5 mL and 10 mg per 5 mL. (3)
CONTRAINDICATIONS
Known hypersensitivity to methylphenidate or other components of
Methylin (4)
Concurrent treatment with a monoamine oxidase