methylphenidate hydrochloride- Methylphenidate Hydrochloride tablet methylphenidate hydrochloride- Methylphenidate Hydrochlorid

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

methylphenidate hydrochloride (UNII: 4B3SC438HI) (methylphenidate - UNII:207ZZ9QZ49)

Beschikbaar vanaf:

UCB Pharma, Inc.

INN (Algemene Internationale Benaming):

Methylphenidate Hydrochloride

farmaceutische vorm:

TABLET

Samenstelling:

5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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. Spec

Product samenvatting:

Methylphenidate Hydrochloride Tablets, USP are supplied as follows: 5 mg: round, yellow, uncoated, unscored, (debossed 531 and MD ). bottles of 100      NDC 0781-8840-01 10 mg: round, pale blue/green, uncoated, scored, (debossed 530 and MD ). bottles of 100      NDC 0781-8841-01 20 mg: round, orange, uncoated, scored, (debossed 532 and MD ). bottles of 100      NDC 0781-8842-01 Extended-Release, 20 mg: round, white, uncoated, unscored, (debossed 562 and MD ). bottles of 100      NDC 0781-8843-01 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.

Productkenmerken

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED
RELEASE
UCB PHARMA, INC.
----------
METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP
METHYLPHENIDATE HYDROCHLORIDE
EXTENDED-RELEASE TABLETS, USP
CII
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 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 extended-release tablets is more
slowly but as extensively absorbed
as in the regular tablets. Bioavailability of the UCB methylphenidate
hydrochloride extended