País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)
SpecGx LLC
METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE 5 mg in 5 mL
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 HCl Oral Solution 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 dy
Methylphenidate HCl Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL NDC 0406-3005-50 Methylphenidate HCl Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL NDC 0406-3010-50 Dispense in tight container with child-resistant closure. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Ritalin is a registered trademark of Novartis Corporation. Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt. Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA L20M56 Rev 08/2017 Mallinckrodt TM Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M57.pdf or by calling 1-800-778-7898 for alternate delivery options.
New Drug Application Authorized Generic
METHYLPHENIDATE HCL- METHYLPHENIDATE HYDROCHLORIDE SOLUTION SpecGx LLC ---------- MEDICATION GUIDE Methylphenidate HCl Oral Solution (methylphenidate HCl oral solution) 5 mg/5 mL and 10 mg/5 mL CII Read the Medication Guide that comes with Methylphenidate HCl Oral Solution 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 HCl Oral Solution. What is the most important information I should know about Methylphenidate HCl Oral Solution? The following have been reported with use of methylphenidate HCl oral solution 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 HCl Oral Solution. Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with Methylphenidate HCl Oral Solution. 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 HCl Oral Solution. 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 3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. • Tell your doctor Leer el documento completo
METHYLPHENIDATE HCL- METHYLPHENIDATE HYDROCHLORIDE SOLUTION SPECGX LLC ---------- METHYLPHENIDATE HCL ORAL SOLUTION METHYLPHENIDATE HCL ORAL SOLUTION, 5 MG/5 ML METHYLPHENIDATE HCL ORAL SOLUTION, 10 MG/5 ML CII RX ONLY DESCRIPTION Methylphenidate HCl Oral Solution is a mild central nervous system (CNS) stimulant available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α- phenyl-2-piperidineacetate hydrochloride, and its structural formula is METHYLPHENIDATE HYDROCHLORIDE C H NO • HCL MW = 269.77 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. Each mL of Methylphenidate HCl Oral Solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of Methylphenidate HCl Oral Solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. In addition, Methylphenidate HCl Oral Solution also contains the following inactive ingredients: citric acid anhydrous, glycerin, N&A grape flavor, PEG 1450, and purified water. CLINICAL PHARMACOLOGY Methylphenidate is a racemic mixture comprised of the _d-_ and _l-threo_ enantiomers. The _d-threo_ enantiomer is more pharmacologically active than the _l-threo_ enantiomer. 14 19 2 Methylphenidate HCl is a central nervous system (CNS) stimulant. The mode of therapeutic action in humans is not completely understood, but methylphenidate presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. There is neither specific evidence which clearly establishes the mechanism whereby Methylphenidate HCl Oral Solution produces its mental and behavioral effects in children, nor conclusive evidence regarding how these e Leer el documento completo