METHYLPHENIDATE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novel Laboratories, Inc.

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Composition:

METHYLPHENIDATE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 is 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 dysfun

Product summary:

Methylphenidate hydrochloride tablets, USP are available as follows. Tablets 5 mg  -round, light yellow (imprinted n above 573) Bottles of 30 ……………………………......NDC 40032-573-03 Bottles of 100………………………………...NDC 40032-573-01 Bottles of 500 ……………………………......NDC 40032-573-05 Tablets 10 mg  -round, white, scored (imprinted n above 574) Bottles of 30 ……………………………......NDC 40032-574-03 Bottles of 100………………………………...NDC 40032-574-01 Bottles of 500 ……………………………......NDC 40032-574-05 Tablets 20 mg  -round, light yellow, scored (imprinted n above 575) Bottles of 30 ……………………………......NDC 40032-575-03 Bottles of 100………………………………...NDC 40032-575-01 Bottles of 500 ……………………………......NDC 40032-575-05 . Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in tight, light-resistant container (USP). Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 PI5750000102 Rev. 05/2015

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Novel Laboratories, Inc.
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MEDICATION GUIDE
Methylphenidate Hydrochloride (METH-il-FEN-i-date HYE-droe-KLOR-ide)
Tablets, USP CII
Read the Medication Guide that comes with Methylphenidate
Hydrochloride 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 Tablets.
Revised: 1/2016
Document Id: 07e58ef7-4278-4994-a6f3-ac37d27c3655
Set id: e5e705f5-e4f2-46c0-a157-1b4f7413807e
Version: 4
Effective Time: 20160105
Novel Laboratories, Inc.

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
NOVEL LABORATORIES, INC.
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METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP CII
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Methylphenidate hydrochloride USP, is a mild central nervous system
(CNS) stimulant, available as
tablets of 5, 10, and 20 mg 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. Its molecular weight is
269.77.
_Inactive Ingredients._ Methylphenidate hydrochloride tablets, USP:
D&C Yellow No. 10 (5-mg and 20-
mg tablets), lactose monohydrate, microcrystalline cellulose, sodium
starch glycolate (Potato),
magnesium stearate, and talc.
USP Dissolution Testing pending.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Methylphenidate hydrochloride is a mild central nervous system
stimulant.
The mode of action in man is not completely understood, but
methylphenidate hydrochloride presumably
activates the brain stem arousal system and cortex to produce its
stimulant effect.
There is neither specific evidence which clearly establishes the
mechanism whereby methylphenidate
hydrochloride produces its mental and behavioral effects in children,
nor conclusive evidence
regarding how these effects relate to the condition of the central
nervous system.
EFFECTS ON QT INTERVAL
The effect of Focalin® XR (dexmethylphenidate, the pharmacologically
active _d-_enantiomer of
methylphenidate hydrochloride) on the QT interval was evaluated in a
double-blind, placebo- and open
label active (moxifloxacin)-controlled study following single doses of
Focalin XR 40 mg in 75 healthy
volunteers. ECGs were collected up to 12 hours postdose. Frederica's
method for heart rate correction
was employed to derive the corrected QT interval (QTcF). The maximum
mean prolongation of QTcF
intervals was <5 ms, and the upper limit of the 90% co