METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

Methylphenidate Hydrochloride (UNII: 4B3SC438HI) (Methylphenidate - UNII:207ZZ9QZ49)

থেকে পাওয়া:

Breckenridge Pharmaceutical, Inc.

INN (আন্তর্জাতিক নাম):

Methylphenidate Hydrochloride

রচনা:

Methylphenidate Hydrochloride 5 mg in 5 mL

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 oral solution 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 wa

পণ্য সারাংশ:

Methylphenidate hydrochloride oral solution 5 mg per 5 mL is a colorless, grape flavored liquid. It is supplied in bottles of 500 mL, NDC 51991-712-50 Methylphenidate hydrochloride oral solution 10 mg per 5 mL is a colorless, grape flavored liquid. It is supplied in bottles of 500 mL, NDC 51991-713-50 Dispense in tight container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE SOLUTION
Breckenridge Pharmaceutical, Inc.
----------
MEDICATION GUIDE
METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION
(METH IL FEN I DATE)
5 MG/5 ML AND 10 MG/5 ML
CII
Read the Medication Guide that comes with Methylphenidate
Hydrochloride Oral Solution 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 oral solution.
What is the most important information I should know about
methylphenidate hydrochloride oral
solution?
The following have been reported with use of Methylphenidate
Hydrochloride Oral Solution 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 oral solution.
Your doctor should check you or your child's blood pressure and heart
rate regularly during treatment
with methylphenidate hydrochloride oral solution.
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 oral solution.
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 depr

পণ্য বৈশিষ্ট্য

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE SOLUTION
BRECKENRIDGE PHARMACEUTICAL, INC.
----------
METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION
5 MG/5 ML AND 10 MG/5 ML
CII
RX ONLY
DESCRIPTION
Methylphenidate hydrochloride oral solution is a mild central nervous
system (CNS) stimulant available
as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration.
Methylphenidate hydrochloride is
methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural
formula is
METHYLPHENIDATE HYDROCHLORIDE C
H NO •HCL
MW = 269.77
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.
Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL
contains 1 mg of methylphenidate
hydrochloride USP.
Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL
contains 2 mg of methylphenidate
hydrochloride USP.
In addition, methylphenidate hydrochloride oral solution also contains
the following inactive
ingredients: artificial grape flavor, glycerin, hydrochloric acid,
polyethylene glycol 1450, and purified
water.
CLINICAL PHARMACOLOGY
Methylphenidate is a racemic mixture comprised of the _d-_ and
_l-threo_ enantiomers. The _d-threo_
enantiomer is more pharmacologically active than the _l-threo_
enantiomer.
Methylphenidate HCl is a central nervous system (CNS) stimulant.
The mode of therapeutic action in humans is not completely understood,
but methylphenidate presumably
activates the brain stem arousal system and cortex to produce its
stimulant effect. Methylphenidate is
thought to block the reuptake of norepinephrine and dopamine into the
presynaptic neuron and increase
the release of these monoamines into the extraneuronal space.
14
19
2
There is neither specific evidence which clearly establishes the
mechanism whereby methylphenidate
hydrochloride produces its mental and behavioral effects in children,
nor conclusive