מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)
Physicians Total Care, 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. Ritalin 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 this
Tablets 5 mg - round, yellow (imprinted CIBA 7) Tablets 20 mg - round, pale yellow (imprinted CIBA 34) Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in tight, light -resistant container (USP).
New Drug Application
RITALIN - METHYLPHENIDATE HYDROCHLORIDE TABLET Physicians Total Care, Inc. ---------- MEDICATION GUIDE RITALIN® (methylphenidate hydrochloride tablets, USP) CII Read the Medication Guide that comes with RITALIN® 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 RITALIN®. What is the most important information I should know about RITALIN®? 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 RITALIN®. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with RITALIN®. 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 RITALIN®. 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 RITALIN®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. What Is RITALIN®? RITALIN® is קרא את המסמך השלם
RITALIN - METHYLPHENIDATE HYDROCHLORIDE TABLET PHYSICIANS TOTAL CARE, INC. ---------- RITALIN RITALIN HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLETS USP RITALIN-SR METHYLPHENIDATE HYDROCHLORIDE USP SUSTAINED-RELEASE TABLETS RX ONLY PRESCRIBING INFORMATION DESCRIPTION Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 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._ Ritalin tablets: D&C Yellow No. 10 (5-mg and 20-mg tablets), FD&C Green No. 3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets). Ritalin-SR tablets: Cellulose compounds, cetostearyl alcohol, lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Ritalin is a mild central nervous system stimulant. The mode of action in man is not completely understood, but Ritalin 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 Ritalin 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 Ritalin) on the QT interval was evaluated in a double-blind, placebo- and open label active (moxifloxacin)- cont קרא את המסמך השלם