Methylphenidate Hydrochloride Extended-Release Tablets USP, CII                          

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

methylphenidate hydrochloride (UNII: 4B3SC438HI) (methylphenidate - UNII:207ZZ9QZ49)

Available from:

Alvogen Inc.

INN (International Name):

methylphenidate hydrochloride

Composition:

methylphenidate hydrochloride 20 mg

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 Extended-Release Tablets 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 m

Product summary:

Methylphenidate Hydrochloride Extended-Release Tablets USP 10 mg: Round, white, uncoated, unscored, debossed "τ 2371". NDC 47781- 540- 01 Bottle of 100's 20 mg: Round, white, uncoated, unscored, debossed "τ 2372". NDC 47781- 541- 01 Bottle of 100's Note : Methylphenidate Hydrochloride Extended-Release Tablets are color-additive free. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container (USP) with a child-resistant closure. For Medical Information Contact:  Alvogen, Inc. Phone: [phone] Made in USA Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA PI540-00 Rev. 01/2017

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED
RELEASE
Alvogen Inc.
----------
MEDICATION GUIDE
Methylphenidate Hydrochloride Extended-Release Tablets USP, CII
(meth" il fen' i date hye" droe klor' ide)
Read the Medication Guide that comes with Methylphenidate
Hydrochloride Extended-Release 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 Extended-Release Tablets.
What is the most important information I should know about
Methylphenidate Hydrochloride Extended-Release 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 Extended-
Release Tablets.
Your doctor should check your or your child's blood pressure and heart
rate regularly during treatment with Methylphenidate
Hydrochloride Extended-Release 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 Extended-Release 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,

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED
RELEASE
ALVOGEN INC.
----------
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, CII
RX ONLY
DESCRIPTION
Methylphenidate hydrochloride USP is a mild central nervous system
(CNS) stimulant. Methylphenidate
Hydrochloride Extended-Release Tablets are available as
extended-release tablets of 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 weight is 269.77.
_Inactive Ingredients_: hypromellose, microcrystalline cellulose,
magnesium stearate and talc.
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) 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