METHYLPHENIDATE HYDROCHLORIDE tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Bionpharma Inc.

INN:

METHYLPHENIDATE HYDROCHLORIDE

composition:

METHYLPHENIDATE HYDROCHLORIDE 5 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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. Specif

leaflet_short:

Tablets 5 mg - Light Yellow to beige, round shaped, flat faced, uncoated tablets, debossed with "FM 1" on one side and plain on other side. Bottles of 100 tablets ……………………………………………………………...NDC 69452-165-20 Tablets 10 mg– Light blue to blue round shaped, flat faced, uncoated, tablets debossed with "FM" and “2” on either side of the score line on one side and plain on other side. Bottles of 100 tablets ……………………………………………………………...NDC 69452-166-20 Tablets 20 mg- White to off white round shaped flat faced, uncoated tablets debossed with "FM" and "3" on either side of the score line on one side and plain on other side. Bottles of 100 tablets ……………………………………………………………...NDC 69452-167-20 Store at 20° to 25°C (68° to 77°F) with excursion permitted between 15° to 30°C (59°to 86°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. June 2018

authorization_status:

Abbreviated New Drug Application

PIL

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

SPC

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
BIONPHARMA INC.
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METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP CII
RX ONLY
PRESCRIBING INFORMATION
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 weight is 269.77.
Inactive Ingredients: Methylphenidate Hydrochloride Tablets, USP, 5
mg, 10 mg and 20 mg contain:
lactose monohydrate, microcrystalline cellulose, stearic acid 50, FD&
C Yellow No 6 Aluminum Lake
(5 mg tablet), FD& C Blue No 1 Aluminum Lake (10 mg tablet).
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 Dexmethylphenidate Hydrochloride Tablets 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 Dexmethylphenidate Hydrochloride Tablets XR 40 mg in
75 healthy volunteers. ECGs
were collected up to 12 hours postdose. Frederica’s method for heart
rate correction was emp