METHYLPHENIDATE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lannett Company, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Spec

Product summary:

Methylphenidate Hydrochloride Tablets, USP are available as follows: 5 mg: Round, yellow, uncoated, unscored, debossed "531 MD".       NDC 0527-2531-37      Bottle of 100's 10 mg: Round, pale blue/green, uncoated, scored, debossed "530 MD".       NDC 0527-2530-37      Bottle of 100's 20 mg: Round, orange, uncoated, scored, debossed "532 MD".       NDC 0527-2532-37      Bottle of 100's Store at 20° - 25°C (68°-77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Protect from light. 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. L6828 Rev. 05/18

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
Lannett Company, Inc.
----------
MEDICATION GUIDE
methylphenidate hydrochloride (METH-il-FEN-i-date HYE-droe-KLOR-ide)
tablets, USP CII
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 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 new o

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
LANNETT COMPANY, INC.
----------
METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP CII
Rx Only
DESCRIPTION
Methylphenidate hydrochloride is a mild central nervous system (CNS)
stimulant. Methylphenidate
hydrochloride is available as 5, 10, and 20 mg 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: Lactose, magnesium stearate, microcrystalline
cellulose, sodium starch glycolate;
5 mg contains D&C Yellow #10; 10 mg contains FD&C Green #3, and 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) 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%