Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)
Novel Laboratories, Inc.
METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE 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 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 dysfun
Methylphenidate hydrochloride tablets, USP are available as follows. Tablets 5 mg -round, light yellow (imprinted n above 573) Bottles of 30 ……………………………......NDC 40032-573-03 Bottles of 100………………………………...NDC 40032-573-01 Bottles of 500 ……………………………......NDC 40032-573-05 Tablets 10 mg -round, white, scored (imprinted n above 574) Bottles of 30 ……………………………......NDC 40032-574-03 Bottles of 100………………………………...NDC 40032-574-01 Bottles of 500 ……………………………......NDC 40032-574-05 Tablets 20 mg -round, light yellow, scored (imprinted n above 575) Bottles of 30 ……………………………......NDC 40032-575-03 Bottles of 100………………………………...NDC 40032-575-01 Bottles of 500 ……………………………......NDC 40032-575-05 . Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in tight, light-resistant container (USP). Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 PI5750000102 Rev. 05/2015
Abbreviated New Drug Application
Novel Laboratories, Inc. ---------- MEDICATION GUIDE Methylphenidate Hydrochloride (METH-il-FEN-i-date HYE-droe-KLOR-ide) 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. Revised: 1/2016 Document Id: 07e58ef7-4278-4994-a6f3-ac37d27c3655 Set id: e5e705f5-e4f2-46c0-a157-1b4f7413807e Version: 4 Effective Time: 20160105 Novel Laboratories, Inc. সম্পূর্ণ নথি পড়ুন
METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET NOVEL LABORATORIES, INC. ---------- METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP CII RX ONLY PRESCRIBING INFORMATION 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 to off-white powder. Its solutions are acid to litmus. It is soluble in water, alcohol, and chloroform. Its molecular weight is 269.77. _Inactive Ingredients._ Methylphenidate hydrochloride tablets, USP: D&C Yellow No. 10 (5-mg and 20- mg tablets), lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Potato), magnesium stearate, and talc. USP Dissolution Testing pending. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Methylphenidate hydrochloride is a mild central nervous system stimulant. The mode of action in man is not completely understood, but methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride) on the QT interval was evaluated in a double-blind, placebo- and open label active (moxifloxacin)-controlled study following single doses of Focalin XR 40 mg in 75 healthy volunteers. ECGs were collected up to 12 hours postdose. 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 the 90% co সম্পূর্ণ নথি পড়ুন