Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)
Bionpharma Inc.
METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE 5 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 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. Specif
Tablets 5 mg - Light Yellow to beige, round shaped, flat faced, uncoated tablets, debossed with "FM 1" on one side and plain on other side. Bottles of 100 tablets ……………………………………………………………...NDC 69452-165-20 Tablets 10 mg– Light blue to blue round shaped, flat faced, uncoated, tablets debossed with "FM" and “2” on either side of the score line on one side and plain on other side. Bottles of 100 tablets ……………………………………………………………...NDC 69452-166-20 Tablets 20 mg- White to off white round shaped flat faced, uncoated tablets debossed with "FM" and "3" on either side of the score line on one side and plain on other side. Bottles of 100 tablets ……………………………………………………………...NDC 69452-167-20 Store at 20° to 25°C (68° to 77°F) with excursion permitted between 15° to 30°C (59°to 86°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. June 2018
Abbreviated New Drug Application
METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET Bionpharma Inc. ---------- MEDICATION GUIDE Methylphenidate Hydrochloride Tablets, USP (meth" il fen' i date hye" droe klor' ide) Read the Medication Guide that comes with methylphenidate hydrochloride 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. What is the most important information I should know about methylphenidate hydrochloride? 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. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride. 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. 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 taki Прочитайте повний документ
METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET BIONPHARMA 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 mg, 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: Methylphenidate Hydrochloride Tablets, USP, 5 mg, 10 mg and 20 mg contain: lactose monohydrate, microcrystalline cellulose, stearic acid 50, FD& C Yellow No 6 Aluminum Lake (5 mg tablet), FD& C Blue No 1 Aluminum Lake (10 mg tablet). 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 Dexmethylphenidate Hydrochloride Tablets 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 Dexmethylphenidate Hydrochloride Tablets XR 40 mg in 75 healthy volunteers. ECGs were collected up to 12 hours postdose. Frederica’s method for heart rate correction was emp Прочитайте повний документ