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:

Unither Manufacturing, LLC

INN (International Name):

methylphenidate hydrochloride

Composition:

methylphenidate hydrochloride 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 dysfunction may or may not be warranted. Speci

Product summary:

Methylphenidate Hydrochloride Tablets, USP are available as follows: 5 mg: Round, yellow, uncoated, unscored, debossed "531 MD".       NDC 53014-531-07      Bottle of 100's 10 mg: Round, pale blue/green, uncoated, scored, debossed "530 MD".       NDC 53014-530-07      Bottle of 100's 20 mg: Round, orange, uncoated, scored, debossed "532 MD".       NDC 53014-532-07      Bottle of 100's Dispense in a tight container as defined in the USP with a child-resistant closure. Store at 20° - 25°C (68°-77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Contact: Medical Affairs Department Phone: [phone] Fax: [phone] Manufactured for UCB, Inc. Smyrna, GA 30080 Rev. 8E 01/2014 © 2014, UCB, Inc., Smyrna, GA 30080 All rights reserved. Printed in U.S.A.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
Unither Manufacturing, LLC
----------
MEDICATION GUIDE
(methylphenidate hydrochloride tablets , USP) Tablets 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.
What is the most important information I should know about
methylphenidate hydrochloride tablets?
The following have been reported with use of methylphenidate HCl, USP
and other stimulant medicines.
1. Heart-related problems:
•
sudden death in patients who have heart problems or heart defects
•
stroke and heart attack in adults
•
increased blood pressure and heart rate
Tell your doctor if you or your child have any heart problems, heart
defects, high blood pressure, or a
family history of these problems.
Your doctor should check you or your child carefully for heart
problems before starting methylphenidate
hydrochloride tablets.
Your doctor should check your or your child's blood pressure and heart
rate regularly during treatment
with methylphenidate hydrochloride tablets.
Call your doctor right away if you or your child has any signs of
heart problems such as chest pain,
shortness of breath, or fainting while taking methylphenidate
hydrochloride tablets.
2. Mental (Psychiatric) problems:
All Patients
•
new or worse behavior and thought problems
•
new or worse bipolar illness
•
new or worse aggressive behavior or hostility
Children and Teenagers
•
new psychotic symptoms (such as hearing voices, believing things that
are not true, are
suspicious) or new manic symptoms
Tell your doctor about any mental problems you or your child have, or
about a family history of suicide,
bipolar illness, or depression.
Call your doctor right away if you or your child have any new or
worsening mental symptoms

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
UNITHER MANUFACTURING, LLC
----------
METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP CII
Rx Only
DESCRIPTION
Methylphenidate hydrochloride is a mild central nervous system (CNS)
stimulant. Methylphenidate
hydrochloride is available as 5, 10, and 20 mg tablets for oral
administration.
Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate
hydrochloride, and its structural
formula is:
Methylphenidate hydrochloride is a white, odorless, fine crystalline
powder. Its solutions are acid to
litmus. It is freely soluble in water and in methanol, soluble in
alcohol, and slightly soluble in
chloroform and in acetone. Its chemical formula is C
H NO •HCl, and its molecular weight is
269.77.
Inactive Ingredients: Lactose, magnesium stearate, microcrystalline
cellulose, sodium starch glycolate;
5 mg contains D&C Yellow #10; 10 mg contains FD&C Green #3, and 20 mg
contains FD&C Yellow
#6.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Methylphenidate is a mild central nervous system stimulant.
The mode of action in man is not completely understood, but
methylphenidate 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
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) on the QT interval was evaluated in a double-blind,
placebo- and open label active
(moxifloxacin)-controlled study following single doses of Focalin® XR
40mg in 75 healthy
volunteers. ECGs were collected up to 12 h post-dose. 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 th