Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)
Novel Laboratories, Inc.
METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE 2.5 mg
ORAL
PRESCRIPTION DRUG
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 Chewable Tablets are 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 centra
Each Methylphenidate Hydrochloride Chewable Tablet 2.5 mg is available as a white colored, grape flavored round, flat faced, beveled edge tablet debossed with "NL" above and "570" below on the one side and plain on the other side. Bottles of 100 .........NDC 40032-570-01 Each Methylphenidate Hydrochloride Chewable Tablet 5 mg is available as a white colored, grape flavored round, flat faced, beveled edge tablet debossed with "NL" above and "571" below on the one side and plain on the other side. Bottles of 100 .........NDC 40032-571-01 Each Methylphenidate Hydrochloride Chewable Tablet 10 mg is available as a white colored, grape flavored round, flat faced, beveled edge tablet debossed with "NL" above the bisect and "572" below the bisect on one side and plain on the other side. Bottles of 100 .........NDC 40032-572-01 Protect from moisture. Dispense in tight container with child-resistant closure. Storage: Store at 20º to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Ritalin is a registered trademark of Novartis Corporation. Manufactured by: Novel Laboratories Inc. 400 Campus Drive Somerset, NJ 08873 USA PI5700000103 Rev. 09/2016
Abbreviated New Drug Application
Novel Laboratories, Inc. ---------- MEDICATION GUIDE Methylphenidate Hydrochloride Chewable Tablets 2.5 mg, 5 mg, and 10 mg CII Read the Medication Guide that comes with Methylphenidate Hydrochloride Chewable 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 Chewable Tablets. Revised: 12/2019 Document Id: 7620b57a-02e8-4fe6-9cd1-0e07a6152636 34391-3 Set id: 16508cc6-13c7-4088-927a-b7206eb7c633 Version: 5 Effective Time: 20191220 Novel Laboratories, Inc. Izlasiet visu dokumentu
METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE NOVEL LABORATORIES, INC. ---------- METHYLPHENIDATE HCL CHEWABLE TABLETS CII DESCRIPTION Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg chewable tablets 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. Each Methylphenidate Hydrochloride Chewable Tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, Methylphenidate Hydrochloride Chewable Tablets also contain the following inactive ingredients: aspartame, maltose, microcrystalline cellulose, grape flavor, pregelatinized starch, phosphoric acid, and stearic acid. CLINICAL PHARMACOLOGY Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer. Methylphenidate HCl is a central nervous system (CNS) stimulant. The mode of therapeutic action in humans is not completely understood, but methylphenidate presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. There is neither specific evidence which clearly establishes the mechanism whereby Methylphenidate Hydrochloride Chewable Tablets produces its mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system. PHARMACOKINETICS ABS ORPTION Methylphenidate Hydrochloride Chewable Tablets are readily absorbed. Following oral administration of Methylphenidate Hydrochloride Chewab Izlasiet visu dokumentu