METHYLPHENIDATE HYDROCHLORIDE tablet, chewable

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Lupin Pharmaceuticals,Inc.

INN (nemzetközi neve):

METHYLPHENIDATE HYDROCHLORIDE

Összetétel:

METHYLPHENIDATE HYDROCHLORIDE 2.5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Attention Deficit Disorders , Narcolepsy Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride chewable tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. Methylphenidate hydrochloride chewable tablet is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the drug. Methylphenidate hydrochloride chewable tablets are contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

Termék összefoglaló:

Each methylphenidate hydrochloride chewable tablet 2.5 mg is available as a white colored, grape flavored round, flat faced, beveled edge tablet debossed with "NL" above and "570" below on the one side and plain on the other side. Bottles of 100 .........NDC 43386-570-01 Each methylphenidate hydrochloride chewable tablet 5 mg is available as a white colored, grape flavored round, flat faced, beveled edge tablet debossed with "NL" above and "571" below on the one side and plain on the other side. Bottles of 100 .........NDC 43386-571-01 Each methylphenidate hydrochloride chewable tablet 10 mg is available as a white colored, grape flavored round, flat faced, beveled edge tablet debossed with "NL" above the bisect and "572" below the bisect on one side and plain on the other side. Bottles of 100 .........NDC 43386-572-01 Protect from moisture. Dispense in tight container with child-resistant closure. Store at 20º to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Ritalin is a registered trademark of Novartis Corporation. Manufactured by: Novel Laboratories Inc. 400 Campus Drive Somerset, NJ 08873 USA Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 SAP Code: 274932 Rev. 11/2023

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

METHYLPHENIDATE HYDROCHLORIDE - METHYLPHENIDATE HYDROCHLORIDE TABLET,
CHEWABLE
Lupin Pharmaceuticals,Inc.
----------
MEDICATION GUIDE
Methylphenidate Hydrochloride Chewable Tablets CII
2.5 mg, 5 mg, and 10 mg
Read the Medication Guide that comes with methylphenidate
hydrochloride chewable tablets before you
or your child starts taking it and each time you get a refill. There
may be new information. This
Medication Guide does not take the place of talking to your healthcare
provider about your or your child's
treatment with methylphenidate hydrochloride chewable tablets.
What is the most important information I should know about
methylphenidate hydrochloride chewable
tablets?
Methylphenidate hydrochloride chewable tablets may cause serious side
effects, including:
•
Abuse, misuse, and addiction. Methylphenidate hydrochloride chewable
tablets have a high
chance for abuse and misuse and may lead to substance use problems,
including addiction. Misuse
and abuse of methylphenidate hydrochloride chewable 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 chewable
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
chewable tablets
and will monitor you or your child during treatment.
•
Methylphenidate hydrochloride chewable tablets may lead to physical
dependence after
prolonged use, even if taken as directed by your healthcare provider.
•
Do not give methylphenidate hydrochloride chewable tablets to anyone
else. See "What
Are methylphenidate hydrochloride chewable tablets?" for more
information.
•
Keep methylphenidate hydrochloride chewable tablets in a safe place
and properly dispose
of any unused medicine. See "How should I store methylphenidate
hydroc

Termékjellemzők

METHYLPHENIDATE HYDROCHLORIDE - METHYLPHENIDATE HYDROCHLORIDE TABLET,
CHEWABLE
LUPIN PHARMACEUTICALS,INC.
----------
METHYLPHENIDATE HCL CHEWABLE TABLETS CII
RX ONLY
WARNING: ABUSE, MISUSE, AND ADDICTION
METHYLPHENIDATE HYDROCHLORIDE CHEWABLE TABLETS 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 CHEWABLE TABLETS, CAN RESULT
IN
OVERDOSE AND DEATH (_SEE _OVERDOSAGE), AND THIS RISK IS INCREASED WITH
HIGHER DOSES OR UNAPPROVED METHODS OF ADMINISTRATION, SUCH AS SNORTING
OR INJECTION.
BEFORE PRESCRIBING METHYLPHENIDATE HYDROCHLORIDE CHEWABLE 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
METHYLPHENIDATE HYDROCHLORIDE CHEWABLE TABLETS TREATMENT, REASSESS
EACH PATIENT'S RISK OF ABUSE, MISUSE, AND ADDICTION AND FREQUENTLY
MONITOR FOR SIGNS AND SYMPTOMS OF ABUSE, MISUSE, AND ADDICTION (_SEE_
WARNINGS AND PRECAUTIONS AND DRUG ABUSE AND DEPENDENCE).
DESCRIPTION
Methylphenidate hydrochloride is a mild central nervous system (CNS)
stimulant,
available as 2.5 mg, 5 mg and 10 mg chewable tablets for oral
administration.
Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate
hydrochloride, and
its structural formula is
Methylphenidate hydrochloride USP is a white to off-white powder. Its
solutions are acid
to litmus. It is soluble in water, alcohol, and chloroform.
Each methylphenidate hydrochloride chewable tablet, for oral
administration, contains
2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In
addition,
methylphenidate hydrochloride chewable tablets also contain the
following inactive
ingredients: aspartame, maltose, microcrystalline cellulose, grape
flavor, pregelatinized
starch, phosphoric acid, and stearic acid.
CLINICAL PHARMACOLOGY
Methylphenidate is a racemic mixture comprised of th