METHYLPHENIDATE HYDROCHLORIDE tablet, extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Physicians Total Care, Inc.

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Sammensætning:

METHYLPHENIDATE 20 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 war

Produkt oversigt:

Methylphenidate Hydrochloride Tablets, USP are supplied as follows: bottles of 10       NDC 54868-3454-5 bottles of 20       NDC 54868-3454-2 bottles of 30       NDC 54868-3454-4 bottles of 50       NDC 54868-3454-0 bottles of 60       NDC 54868-3454-1 bottles of 90       NDC 54868-3454-6 bottles of 100     NDC 54868-3454-3 NOTE: Extended-release tablets are color-additive free. 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. Manufactured by UCB Manufacturing, Inc. Rochester, NY 14623 for Sandoz Inc. Broomfield, CO 80020 Rev. 3E 06/2006 4000391 © 2006, UCB, Inc., Smyrna, GA 30080 All rights reserved. Printed in U.S.A. Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

METHYLPHENIDATE HYDROCHLORIDE - METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED
RELEASE
Physicians Total Care, Inc.
----------
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
wo

Produktets egenskaber

METHYLPHENIDATE HYDROCHLORIDE - METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED
RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
CII
Drug Dependence
Methylphenidate should be given cautiously to patients with a history
of drug dependence or
alcoholism.
Chronic abusive use can lead to marked tolerance and psychological
dependence with varying
degrees of abnormal behavior. Frank psychotic episodes can occur,
especially with parenteral
abuse. Careful supervision is required during drug withdrawal from
abusive use since severe
depression may occur. Withdrawal following chronic therapeutic use may
unmask symptoms of
the underlying disorder that may require follow-up.
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. A 20 mg Extended-
Release tablet for oral administration is also available.
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: Methylphenidate hydrochloride tablets: 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.
Methylphenidate hydrochloride extended-release tablets: cetyl alcohol,
ethylcellulose, anhydrous
lactose and magnesium stearate.
CLINICAL PHARMACOLOGY
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 w