METHYLPHENIDATE HYDROCHLORIDE tablet, extended release

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Trigen Laboratories, LLC

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

রচনা:

METHYLPHENIDATE HYDROCHLORIDE 54 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Methylphenidate hydrochloride extended-release tablets USP is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)] . A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; lo

পণ্য সারাংশ:

Methylphenidate hydrochloride extended-release tablets are available in 18, 27, 36, 54, and 72 mg strengths.  The 18 mg tablets are yellow with “TL706” imprinted in black ink, 27 mg tablets are gray with “TL707” imprinted in black ink, 36 mg tablets are white with “TL708” imprinted in black ink, 54 mg tablets are pink with “TL709" imprinted in black ink, and 72 mg tablets are blue with “TL710” imprinted in black ink. The tablets are supplied: Storage and Handling Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from humidity.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Trigen Laboratories, LLC
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MedGuide
MEDICATION GUIDE
Methylphenidate hydrochloride extended-release tablets USP CII
(METH-il-FEN-i-date)
Read the Medication Guide that comes with methylphenidate
hydrochloride extended-release tablets USP
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 USP.
What is the most important information I should know about
methylphenidate hydrochloride extended-
release tablets?
The following have been reported with use of methylphenidate HCl 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 has 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, or
about a family history of suicide,
bipolar illness, or depression.
Call your doctor right away

পণ্য বৈশিষ্ট্য

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED RELEASE
TRIGEN LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS
USP.
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, FOR ORAL
USE CII
INITIAL U.S. APPROVAL: 2000
WARNING: DRUG DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS SHOULD BE GIVEN
CAUTIOUSLY TO
PATIENTS WITH A HISTORY OF DRUG DEPENDENCE OR ALCOHOLISM. CHRONIC
ABUSIVE USE CAN
LEAD TO MARKED TOLERANCE AND PSYCHOLOGICAL DEPENDENCE, WITH VARYING
DEGREES OF
ABNORMAL BEHAVIOR.
INDICATIONS AND USAGE
Methylphenidate hydrochloride extended-release tablets USP is a CNS
stimulant indicated for the
treatment of Attention Deficit Hyperactivity Disorder (ADHD) in
children 6 years of age and older,
adolescents, and adults up to the age of 65. (1)
DOSAGE AND ADMINISTRATION
Methylphenidate hydrochloride extended-release tablets should be taken
once daily in the morning and
swallowed whole with the aid of liquids. Methylphenidate hydrochloride
extended-release tablets should
not be chewed or crushed. Methylphenidate hydrochloride
extended-release tablets may be taken with
or without food. (2.1)
For children and adolescents new to methylphenidate, the recommended
starting dosage is 18 mg
once daily. Dosage may be increased by 18 mg/day at weekly intervals
and should not exceed 54
mg/day in children and 72 mg/day in adolescents. (2.2)
For adult patients new to methylphenidate, the recommended starting
dose is 18 or 36 mg/day.
Dosage may be increased by 18 mg/day at weekly intervals and should
not exceed 72 mg/day for
adults. (2.2)
For patients currently using methylphenidate, dosing is based on
current dose regimen and clinical
judgment. (2.3)
DOSAGE F