METHYLPHENIDATE HYDROCHLORIDE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Par Pharmaceutical

INN (Mezinárodní Name):

METHYLPHENIDATE HYDROCHLORIDE

Složení:

METHYLPHENIDATE HYDROCHLORIDE 5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 tablets USP 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 nervous system dysfunction may or may not be war

Přehled produktů:

Methylphenidate Hydrochloride Tablets USP are available as follows: 5 mg – light-yellow, round, convex tablets debossed “4576” on one side and debossed “V” on the reverse side in bottles of 100 (NDC: 0603-4576-21). 10 mg – green, round, convex, scored tablets debossed “4577” on one side and debossed “V” on the reverse side in bottles of 100 (NDC: 0603-4577-21). 20 mg – light-yellow, round, convex, scored tablets debossed “4578” on one side and debossed “V” on the reverse side in bottles of 100 (NDC: 0603-4578-21). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in tight, light-resistant container (USP).

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
Par Pharmaceutical
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MEDICATION GUIDE
Read the Medication Guide that comes with methylphenidate
hydrochloride 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 doctor about your or your
child’s treatment with
methylphenidate hydrochloride tablets.
What is the most important information I should know about
methylphenidate hydrochloride tablets?
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
methylphenidate hydrochloride tablets.
Your doctor should check your or your child’s blood pressure and
heart rate regularly during
treatment with methylphenidate hydrochloride tablets.
Call your doctor right away if you or your child have any signs of
heart problems such as chest pain,
shortness of breath, or fainting while taking methylphenidate
hydrochloride tablets.
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 methylphenidate hydrochloride t

Charakteristika produktu

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
PAR PHARMACEUTICAL
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METHYLPHENIDATE HYDROCHLORIDE TABLETS USP CLL
5 MG, 10 MG, AND 20 MG
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Methylphenidate hydrochloride USP, is a mild central nervous system
(CNS) stimulant, available as
tablets of 5, 10, and 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._ Methylphenidate Hydrochloride Tablets USP:
colloidal silicon dioxide,
compressible sugar, D&C Yellow #10, lactose monohydrate, magnesium
stearate, and microcrystalline
cellulose. The 10 mg tablets also contain FD&C Blue #1.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Methylphenidate hydrochloride is a mild central nervous system
stimulant.
The mode of action in man is not completely understood, but
methylphenidate hydrochloride 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 methylphenidate
hydrochloride 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
methylphenidate hydrochloride) on the QT interval was evaluated in a
double-blind, placebo- and open
label active (moxifloxacin)-controlled study following single doses of
Focalin XR 40 mg in 75
healthy volunteers. ECGs were collected up to 12 hours post-dose.
Frederica’s method for heart rate
correction was employed to derive the corrected QT interval (QTcF).
T