Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
methylphenidate hydrochloride (UNII: 4B3SC438HI) (methylphenidate - UNII:207ZZ9QZ49)
Unither Manufacturing, LLC
methylphenidate hydrochloride
methylphenidate hydrochloride 20 mg
ORAL
PRESCRIPTION DRUG
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. METADATE ER 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. Specific etiology of th
METADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are available as follows: 20 mg: Round, white, uncoated, unscored, debossed "562 MD". NDC 53014-594-07 Bottle of 100's NOTE: METADATE ER 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. Contact: Medical Affairs Department Phone: (866) 822-0068 Fax: (770) 970-8859 Manufactured for UCB, Inc. Smyrna, GA 30080 Rev. 9E 01/2014 METADATE is a registered trademark of the UCB Group of companies © 2014, UCB, Inc., Smyrna, GA 30080 All rights reserved. Printed in U.S.A.
Abbreviated New Drug Application
METADATE ER- METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE Unither Manufacturing, LLC ---------- MEDICATION GUIDE METADATE® ER (methylphenidate HCl extended-release tablets, USP) Tablets CII Read the Medication Guide that comes with METADATE ER 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 METADATE ER. What is the most important information I should know about METADATE ER? 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 METADATE ER. Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with METADATE ER. 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 METADATE ER. 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 while taking METADATE ER, especially seeing or hearing things that are not real, believing things that are not real, or are Đọc toàn bộ tài liệu
METADATE ER- METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE UNITHER MANUFACTURING, LLC ---------- METADATE ER TABLETS (METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP) CII Rx Only DESCRIPTION METADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are a mild central nervous system (CNS) stimulant. METADATE ER is available as 20 mg extended-release tablets for oral administration. 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: Cetyl alcohol, ethylcellulose, anhydrous lactose and magnesium stearate. CLINICAL PHARMACOLOGY PHARMACODYNAMICS METADATE ER 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. EFFECTS ON QT INTERVAL The effect of Focalin® XR (dexmethylphenidate, the pharmacologically active _d_-enantiomer of methylphenidate) on the QT interval was evaluated in a double-blind, placebo- and open label active (moxifloxacin)-controlled study following single doses of Focalin® XR 40mg in 75 healthy volunteers. ECGs were collected up to 12 h post-dose. 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% confidence interval wa Đọc toàn bộ tài liệu