METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Actavis Pharma, Inc.

INN (Nama Internasional):

METHYLPHENIDATE HYDROCHLORIDE

Komposisi:

METHYLPHENIDATE HYDROCHLORIDE 5 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 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. Speci

Ringkasan produk:

Methylphenidate Hydrochloride Tablets, USP are available as follows: Tablets 5 mg: round, purple, unscored, imprinted DAN 5 and 5882 supplied in bottles of 100. Tablets 10 mg: round, green, scored, imprinted DAN 10 and 5883 supplied in bottles of 100. Tablets 20 mg: round, peach, scored, imprinted DAN 20 and 5884 supplied in bottles of 100. Protect from light. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Do not store above 30°C (86°F). Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: October 2016

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
Actavis Pharma, Inc.
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MEDICATION GUIDE
Methylphenidate Hydrochloride Tablets, USP CII
(meth" il fen' i date hye" droe klor' ide)
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 has 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 has 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

Karakteristik produk

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
ACTAVIS PHARMA, INC.
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METHYLPHENIDATE HCL TABLETS USP CII
REVISED: OCTOBER 2016
RX ONLY
DESCRIPTION
Methylphenidate hydrochloride USP, is a mild central nervous system
(CNS) stimulant, available as
tablets of 5 mg, 10 mg, 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 formula is C
H NO •HCl, and its molecular weight is
269.77.
_Inactive Ingredients. _Methylphenidate hydrochloride tablets:
colloidal silicon dioxide, compressible
sugar, lactose monohydrate and magnesium stearate. Additionally, the 5
mg contains FD&C Blue #2 and
FD&C Red #40; the 10 mg contains FD&C Blue #2 and D&C Yellow #10; and
the 20 mg contains
FD&C Yellow #6.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Methylphenidate is a mild central nervous system stimulant.
The mode of action in man is not completely understood, but
methylphenidate 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
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 tablets) 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 hour post-dose.
Frederica’s method for heart rate
14
19
2
correction was em