METHYLPHENIDATE- methylphenidate hydrochloride tablet METHYLPHENIDATE- methylphenidate hydrochloride tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Physicians Total Care, Inc.

INN (nemzetközi neve):

METHYLPHENIDATE HYDROCHLORIDE

Összetétel:

METHYLPHENIDATE HYDROCHLORIDE 5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

Methylphenidate Hydrochloride Tablets USP are available as follows: 5 mg: Round, purple, unscored, imprinted DAN 5 and 5882 supplied in: 10 mg: Round, green, scored, imprinted DAN 10 and 5883 supplied in: 20 mg: Round, peach, scored, imprinted DAN 20 and 5884 supplied in: Protect from light. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Do not store above 30°C (86°F). Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Revised: January 2009 0109B Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

METHYLPHENIDATE - METHYLPHENIDATE HYDROCHLORIDE TABLET
Physicians Total Care, Inc.
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MEDICATION GUIDE
Methylphenidate Hydrochloride 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.
What is the most important information I should know about
methylphenidate hydrochloride tablets? The following have been
reported with use of methylphenidate hydrochloride 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 has 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 or problems whil

Termékjellemzők

METHYLPHENIDATE - METHYLPHENIDATE HYDROCHLORIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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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, 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 molecular formula is C
H NO •HCl, and its molecular weight is
269.77.
_Inactive Ingredients._ Methylphenidate hydrochloride tablets:
colloidal silicon dioxide, compressible
sugar, lactose monohydrate 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 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.
Methylphenidate hydrochloride in the extended-release tablets is more
slowly but as extensively
absorbed as in the regular tablets. Relative bioavailability of the
extended-release tablet compared to
the methylphenidate hydrochloride tablet, measured by the urinary
excretion of methylphenidate
hydrochloride major metabolite (α-phenyl-2-piperidine acetic acid)
was 105% (49%-168%) in children
and 101% (85%-152%) in adults. The time to peak rate in children was
4.7 hours (1.3-8.2 hours) for the
extended-release tablets and 1.9 hours (0.3-4.4 hours) for the
tablets. An average of 67% of extended-
release tablet dose was excreted in children as compared to 86% in
adults.
In a clinical study i