METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride tablet

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

CorePharma, LLC

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

রচনা:

METHYLPHENIDATE HYDROCHLORIDE 5 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 tablets, USP 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 may not be wa

পণ্য সারাংশ:

Methylphenidate hydrochloride tablets USP, 5 mg are Light Orange to Orange, Round Compressed Tablets. Debossed cor on one side and 237 on the other side. They are supplied as follows: Bottles of 100.........................................NDC 64720-237-10 Methylphenidate hydrochloride tablets USP, 10 mg are Light Orange to Orange, Round Compressed Tablets. Debossed cor over 238 on one side and bisect on the other side. They are supplied as follows: Bottles of 100........................................ NDC 64720-238-10 Methylphenidate hydrochloride tablets USP, 20 mg are Light Orange to Orange, Round Compressed Tablets. Debossed cor over 239 on one side and bisect on the other side. They are supplied as follows: Bottles of 100.........................................NDC 64720-239-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in tight, light-resistant container as defined in the USP. LB # 691-05 Rev. January, 2017 Dist. by: CorePharma, LLC Middlesex, NJ 08846 For additional copies of the printed patient information/medication guide, please visit www.corepharma.com or call 1-800-850-2719.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

CorePharma, LLC
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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 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 or
worsening mental symptoms or
problems while taking methylphenida

পণ্য বৈশিষ্ট্য

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
COREPHARMA, LLC
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METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP
5 MG, 10 MG AND 20 MG
CII
RX ONLY
DESCRIPTION
Methylphenidate hydrochloride, USP is a mild central nervous system
(CNS) stimulant, available as
tablets of 5, 10, 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 to off white powder. 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: _Lactose monohydrate, Microcrystalline
Cellulose, Stearic Acid and FD&C
Yellow No. 6 Aluminum Lake.
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 hydrochloride) 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 below 10 ms for
all time matched comparisons versus placebo. This was below the
threshol