Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
methylphenidate hydrochloride (UNII: 4B3SC438HI) (methylphenidate - UNII:207ZZ9QZ49)
Alvogen Inc.
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. Methylphenidate Hydrochloride Extended-Release 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 central nervous system dysfunction may or m
Methylphenidate Hydrochloride Extended-Release Tablets USP 10 mg: Round, white, uncoated, unscored, debossed "τ 2371". NDC 47781- 540- 01 Bottle of 100's 20 mg: Round, white, uncoated, unscored, debossed "τ 2372". NDC 47781- 541- 01 Bottle of 100's Note : Methylphenidate Hydrochloride Extended-Release Tablets are color-additive free. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container (USP) with a child-resistant closure. For Medical Information Contact: Alvogen, Inc. Phone: 1-866-770-3024 Made in USA Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA PI540-00 Rev. 01/2017
Abbreviated New Drug Application
METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE Alvogen Inc. ---------- MEDICATION GUIDE Methylphenidate Hydrochloride Extended-Release Tablets USP, CII (meth" il fen' i date hye" droe klor' ide) Read the Medication Guide that comes with Methylphenidate Hydrochloride Extended-Release 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 Extended-Release Tablets. What is the most important information I should know about Methylphenidate Hydrochloride Extended-Release 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 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 Methylphenidate Hydrochloride Extended- Release Tablets. Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with Methylphenidate Hydrochloride Extended-Release 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 Extended-Release 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, Přečtěte si celý dokument
METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE ALVOGEN INC. ---------- METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, CII RX ONLY DESCRIPTION Methylphenidate hydrochloride USP is a mild central nervous system (CNS) stimulant. Methylphenidate Hydrochloride Extended-Release Tablets are available as extended-release tablets of 10 mg 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 weight is 269.77. _Inactive Ingredients_: hypromellose, microcrystalline cellulose, magnesium stearate and talc. 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) 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% confidence interval was b Přečtěte si celý dokument