국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)
Camber Pharmaceuticals Inc.
METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE 2.5 mg
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 hydrochloride chewable 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
Each methylphenidate hydrochloride chewable tablet 2.5 mg is available as a white to off-white round beveled edge chewable tablets debossed with '260' on one side and 'AT' on the other side. Bottles of 100 NDC 31722-926-01 Each methylphenidate hydrochloride chewable tablet 5 mg is available as a white to off-white round beveled edge chewable tablets debossed with '261' on one side and 'AT' on the other side. Bottles of 100 NDC 31722-927-01 Each methylphenidate hydrochloride chewable tablet 10 mg is available as a white to off-white flat round chewable tablets debossed with 'AT' on left side and '262' on the right side of the bisect line and other side plain. Bottles of 100 NDC 31722-928-01 Protect from moisture. Dispense in tight container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Ritalin® is a registered trademark of Novartis Corporation. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev: 09/23
Abbreviated New Drug Application
Camber Pharmaceuticals Inc. ---------- MEDICATION GUIDE METHYLPHENIDATE HCL CHEWABLE TABLET, CII (METH'' IL FEN' I DATE HYE'' DROE KLOR' IDE) Read the Medication Guide that comes with methylphenidate hydrochloride chewable 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 healthcare provider about your or your child’s treatment with methylphenidate hydrochloride chewable tablets. What is the most important information I should know about methylphenidate hydrochloride chewable tablets? Methylphenidate hydrochloride chewable tablets may cause serious side effects, including: • Abuse, misuse, and addiction. Methylphenidate hydrochloride chewable tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methylphenidate hydrochloride chewable tablets, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of methylphenidate hydrochloride chewable tablets or when it is used in ways that are not approved, such as snorting or injection. • Heart-related problems: • Mental (Psychiatric) problems: • 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. What Are methylphenidate hydrochloride chewable tablets? Methylphenidate hydrochloride chewable tablets are a central nervous system stimulant prescription medicine. Methylphenidate hydrochloride chewable tablets are tablets that are made to be chewed and swallowed. They are used for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD). Methylphenidate hydrochloride chewable tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Methylphenidate h 전체 문서 읽기
METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE CAMBER PHARMACEUTICALS INC. ---------- METHYLPHENIDATE HCL CHEWABLE TABLET, CII RX ONLY WARNING: ABUSE, MISUSE, AND ADDICTION METHYLPHENIDATE HYDROCHLORIDE CHEWABLE TABLETS HAS A HIGH POTENTIAL FOR ABUSE AND MISUSE, WHICH CAN LEAD TO THE DEVELOPMENT OF A SUBSTANCE USE DISORDER, INCLUDING ADDICTION. MISUSE AND ABUSE OF CNS STIMULANTS, INCLUDING METHYLPHENIDATE HYDROCHLORIDE CHEWABLE TABLETS, CAN RESULT IN OVERDOSE AND DEATH _([SEE OVERDOSAGE]), _AND THIS RISK IS INCREASED WITH HIGHER DOSES OR UNAPPROVED METHODS OF ADMINISTRATION, SUCH AS SNORTING OR INJECTION. BEFORE PRESCRIBING METHYLPHENIDATE HYDROCHLORIDE CHEWABLE TABLETS, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION. EDUCATE PATIENTS AND THEIR FAMILIES ABOUT THESE RISKS, PROPER STORAGE OF THE DRUG, AND PROPER DISPOSAL OF ANY UNUSED DRUG. THROUGHOUT METHYLPHENIDATE HYDROCHLORIDE CHEWABLE TABLETS TREATMENT, REASSESS EACH PATIENT’S RISK OF ABUSE, MISUSE, AND ADDICTION AND FREQUENTLY MONITOR FOR SIGNS AND SYMPTOMS OF ABUSE, MISUSE, AND ADDICTION _(SEE_ _WARNINGS AND PRECAUTIONS AND DRUG ABUSE AND DEPENDENCE)._ DESCRIPTION Methylphenidate hydrochloride chewable tablets are a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg 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 methylphenidate hydrochloride chewable tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, 14 19 2 methylphenidate hydrochloride chewable tablets also contain the following inactive ingredients: aspartame, lactose anhydrous, microc 전체 문서 읽기