METHYLPHENIDATE HYDROCHLORIDE tablet, chewable

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Novel Laboratories, Inc.

INN (mednarodno ime):

METHYLPHENIDATE HYDROCHLORIDE

Sestava:

METHYLPHENIDATE HYDROCHLORIDE 2.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 centra

Povzetek izdelek:

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 40032-570-01 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 40032-571-01 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 40032-572-01 Protect from moisture. Dispense in tight container with child-resistant closure. Storage: 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 PI5700000103 Rev. 09/2016

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

Novel Laboratories, Inc.
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MEDICATION GUIDE
Methylphenidate Hydrochloride Chewable Tablets
2.5 mg, 5 mg, and 10 mg
CII
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 doctor
about your or your child's treatment
with Methylphenidate Hydrochloride Chewable Tablets.
Revised: 12/2019
Document Id: 7620b57a-02e8-4fe6-9cd1-0e07a6152636
34391-3
Set id: 16508cc6-13c7-4088-927a-b7206eb7c633
Version: 5
Effective Time: 20191220
Novel Laboratories, Inc.

Lastnosti izdelka

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
CHEWABLE
NOVEL LABORATORIES, INC.
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METHYLPHENIDATE HCL CHEWABLE TABLETS CII
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 the d- and l-threo
enantiomers. The d-threo
enantiomer is more pharmacologically active than the l-threo
enantiomer.
Methylphenidate HCl is a central nervous system (CNS) stimulant.
The mode of therapeutic action in humans is not completely understood,
but methylphenidate presumably
activates the brain stem arousal system and cortex to produce its
stimulant effect. Methylphenidate is
thought to block the reuptake of norepinephrine and dopamine into the
presynaptic neuron and increase
the release of these monoamines into the extraneuronal space.
There is neither specific evidence which clearly establishes the
mechanism whereby Methylphenidate
Hydrochloride Chewable Tablets produces its mental and behavioral
effects in children, nor conclusive
evidence regarding how these effects relate to the condition of the
central nervous system.
PHARMACOKINETICS
ABS ORPTION
Methylphenidate Hydrochloride Chewable Tablets are readily absorbed.
Following oral administration
of Methylphenidate Hydrochloride Chewab