RITALIN- methylphenidate hydrochloride tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Physicians Total Care, Inc.

INN (mednarodno ime):

METHYLPHENIDATE HYDROCHLORIDE

Sestava:

METHYLPHENIDATE HYDROCHLORIDE 5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

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).

Status dovoljenje:

New Drug Application

Navodilo za uporabo

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

Lastnosti izdelka

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