METHYLPHENIDATE HYDROCHLORIDE tablet, chewable

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)

Доступна з:

Camber Pharmaceuticals Inc.

ІПН (Міжнародна Ім'я):

METHYLPHENIDATE HYDROCHLORIDE

Склад:

METHYLPHENIDATE HYDROCHLORIDE 2.5 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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

Огляд продуктів:

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

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

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

Характеристики продукта

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