METHYLPHENIDATE HYDROCHLORIDE capsule, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Granules Pharmaceuticals Inc.

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)] . - Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions (6.1)]. - 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 (7.1)]. 8.1 Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride extended-release capsules during pregnancy. Healthcare providers are encouraged to register patients by calling t

Prehľad produktov:

Methylphenidate hydrochloride extended-release capsules are supplied as: 10 mg: Hard gelatin capsules, yellow opaque cap printed with “G 10mg” and white opaque body printed with “012” contains white to off-white pellets. Bottles of 100 NDC 70010-012-01 20 mg: Hard gelatin capsules, white opaque cap printed with “G 20mg” and white opaque body printed with “013” contains white to off-white pellets. Bottles of 100 NDC 70010-013-01 30 mg: Hard gelatin capsules, yellow opaque cap printed with “G 30mg” and yellow opaque body printed with “014” contains white to off-white pellets. Bottles of 100 NDC 70010-014-01 40 mg: Hard gelatin capsules, yellow opaque cap printed with “G 40mg” and yellow opaque body printed with “015” contains white to off-white pellets. Bottles of 100 NDC 70010-015-01 60 mg: Hard gelatin capsules, yellow opaque cap printed with “G 60mg” and yellow opaque body printed with “016” contains white to off-white pellets. Bottles of 30 NDC 70010-016-03 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] Dispense in a tight container as defined in the USP with a child-resistant closure.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Granules Pharmaceuticals Inc.
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SPL MEDGUIDE SECTION
Dispense with medication guide available at:
https://granulespharma.com/product/methylphenidate-er-
cap/
MEDICATION GUIDE
Methylphenidate Hydrochloride Extended-Release Capsules for oral
use,CII
(METH-il-FEN-i-date HYE-droe-KLOR-ide)
What is the most important information I should know about
methylphenidate hydrochloride
extended-release
capsules?
Methylphenidate hydrochloride extended-release capsules may cause
serious side effects, including:
•
Abuse, misuse, and addiction. Methylphenidate hydrochloride
extended-release capsules 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 capsules,
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 capsules 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 capsules and will
monitor
you
or
your
child
during
treatment.
• Methylphenidate hydrochloride extended-release capsules may lead
to physical dependence after
prolonged
use,
even
if
taken
as
directed
by
your
healthcare
provider.
• Do not give methylphenidate hydrochloride extended-release
capsules to anyone else. See “What are
methylphenidate
hydrochloride
extended-release
capsules?”
for
more
information.
• Keep methylphenidate hydrochloride extended-release capsules in a
safe place and properly dispose
of any unused medicine. See “How should I store methylphenidate
hydrochloride extended-release
capsules?”
for
more
information.
• Tell your healthcare provider if you or your child have ever
abused or been dependent on alcohol,
prescription medicine

Súhrn charakteristických

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE
HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
GRANULES PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES.
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
HYDROCHLORIDE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE
CAPSULES.
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._
​
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES 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 CAPSULES, CAN RESULT IN OVERDOSE AND
DEATH ( 5.1, 9.2,
10).
BEFORE PRESCRIBING METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE
CAPSULES,
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) 10/2023
Warnings and Precautions ( 5.1, 5.2, 5.8, 5.9, 5.10) 10/2023
INDICATIONS AND USAGE
Methylphenidate hydrochloride extended-release capsule is a central
nervous system (CNS) stimulant
indicated for the treatment of Attention Deficit Hyperactivity
Disorder (ADHD) in pediatric patients 6 to 12
years of age ( 1).
DOSAGE AND ADMINISTRATION
Administer orally once daily in the morning (2.2).
Capsules may be swallowed whole or opened and the entire contents
sprinkled on applesauce (2.2).
Should not be crushed, chewed, or divided ( 2.2).
Patients new to methylphe