METHYLPHENIDATE HYDROCHLORIDE capsule, extended release

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Amneal Pharmaceuticals of New York LLC

INN (আন্তর্জাতিক নাম):

METHYLPHENIDATE HYDROCHLORIDE

রচনা:

METHYLPHENIDATE HYDROCHLORIDE 10 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Methylphenidate hydrochloride extended-release capsules are contraindicated in patients with: - known hypersensitivity to methylphenidate or other component of methylphenidate hydrochloride extended-release capsules. Angioedema has been reported in patients treated with methylphenidate hydrochloride extended-release capsules. Anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions (6)] . - Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crisis [see Drug Interactions (7)] . - Methylphenidate hydrochloride extended-release capsules contain sucrose. Therefore, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorpti

পণ্য সারাংশ:

How Supplied Methylphenidate hydrochloride extended-release capsules are available in six strengths: Methylphenidate hydrochloride extended-release capsules, 10 mg are green cap and white body, opaque capsules, imprinted with ‘CP’ over ‘401’ on the cap and ‘10 mg’ on the body. They are available as: Bottles of 100:                        NDC 0115-1736-01 Methylphenidate hydrochloride extended-release capsules, 20 mg are blue cap and white body, opaque capsules, imprinted with ‘CP’ over ‘402’ on the cap and ‘20 mg’ on the body. They are available as: Bottles of 100:                        NDC 0115-1737-01 Methylphenidate hydrochloride extended-release capsules, 30 mg are brown cap and white body, opaque capsules, imprinted with ‘CP’ over ‘403’ on the cap and ‘30 mg’ on the body. They are available as: Bottles of 100:                        NDC 0115-1738-01 Methylphenidate hydrochloride extended-release capsules, 40 mg are yellow cap and white body, opaque capsules, imprinted with ‘CP’ over ‘404’ on the cap and ‘40 mg’ on the body. They are available as: Bottles of 100:                        NDC 0115-1739-01 Methylphenidate hydrochloride extended-release capsules, 50 mg are navy blue cap and white body, opaque capsules, imprinted with ‘CP’ over ‘405’ on the cap and ‘50 mg’ on the body. They are available as: Bottles of 100:                        NDC 0115-1740-01 Methylphenidate hydrochloride extended-release capsules, 60 mg are white opaque capsule imprinted with ‘CP’ over ‘406’ on the cap and ‘60 mg’ on the body. They are available as: Bottles of 100:                        NDC 0115-1741-01 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Amneal Pharmaceuticals of New York LLC
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MEDICATION GUIDE
Methylphenidate Hydrochloride (meth" il fen' i date hye" droe klor'
ide)
Extended-Release Capsules, CII
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, has 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 your child’s risk for abuse,
misuse, and addiction before
starting treatment with methylphenidate hydrochloride extended-release
capsules and will
monitor 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
is 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 your child has 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 dise

পণ্য বৈশিষ্ট্য

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE
HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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 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
METHYLPHENIDATE
HYDROCHLORIDE EXTENDED-RELEASE, CAN RESULT IN OVERDOSE AND DEATH (5.1,
9.2, 10):
BEFORE PRESCRIBING METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE,
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) 10/2023
Warnings and Precautions (5.1, 5.2, 5.8, 5.9, 5.10) 10/2023
INDICATIONS AND USAGE
Methylphenidate hydrochloride extended-release capsules are a central
nervous system (CNS) stimulant
indicated for the treatment of Attention Deficit Hyperactivity
Disorder (ADHD) in pediatric patients 6 to 15
years of age. (1)
DOSAGE AND ADMINISTRATION
Take orally once daily in the morning, before breakfast.
Swallow whole with the aid of liquids, or sprinkle contents onto a
small amount of applesauce and give
immediately.
Do not crush or chew the capsule or capsule contents. (2.1)
Recommended starting dose is 20 mg once daily. Dosage may be increased