METADATE ER- methylphenidate hydrochloride tablet, extended release

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Lannett Company, Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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. METADATE ER 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 th

Ürün özeti:

METADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are available as follows: 20 mg: Round, white, uncoated, unscored, debossed "562 MD".      NDC 0527-2562-37   Bottle of 100's NOTE: METADATE ER Tablets are color-additive free. Store at 20° - 25°C (68°-77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP with a child-resistant closure. Contact: Lannett Company, Inc. Phone: [phone] Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 All brand names are the trademarks of their respective owners. L6827 Rev. 04/18

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

METADATE ER- METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE
Lannett Company, Inc.
----------
MEDICATION GUIDE
METADATE® (MET-uh-date) ER
(methylphenidate HCl extended-release tablets, USP) Tablets CII
Read the Medication Guide that comes with METADATE ER 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
METADATE ER.
What is the most
important information
I should know about
METADATE ER?
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 METADATE
ER.
Your doctor should
check your or your
child's blood pressure
and heart rate
regularly during
treatment with
METADATE ER.
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
METADATE ER.
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
METADATE ER,
especially seeing or
hearing things that are
not real, believing
things that are not

Ürün özellikleri

METADATE ER- METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE
LANNETT COMPANY, INC.
----------
METADATE ER TABLETS
(METHYLPHENIDATE HYDROCHLORIDE
EXTENDED-RELEASE TABLETS, USP)
CII
Rx Only
DESCRIPTION
METADATE ER Tablets (methylphenidate hydrochloride extended-release
tablets, USP) are a mild
central nervous system (CNS) stimulant. METADATE ER is available as 20
mg extended-release
tablets for oral administration.
Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate
hydrochloride, and its structural
formula is:
Methylphenidate hydrochloride 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 chemical formula is C
H NO •HCl, and its molecular weight is
269.77.
Inactive Ingredients: Cetyl alcohol, ethylcellulose, anhydrous lactose
and magnesium stearate.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
METADATE ER 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) 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 postdose. Frederica's method for
heart rate correction was
employed to derive the corrected QT interval (QTcF). The maximum mean
prolongation of QTcF
intervals was <5 ms, and the upper limit of the 90% confidence
interval was b