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:

Physicians Total Care, Inc.

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

রচনা:

METHYLPHENIDATE HYDROCHLORIDE 18 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Methylphenidate HCl Extended-Release Tablets are 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; loses things; e

পণ্য সারাংশ:

Methylphenidate HCl Extended-Release Tablets are available in 18 mg and 27 mg dosage strengths. The 18 mg tablets are yellow and imprinted with "alza 18." The 27 mg tablets are gray and imprinted with "alza 27." All dosage strengths are supplied in bottles containing: 18 mg: 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:

New Drug Application Authorized Generic

তথ্য লিফলেট

METHYLPHENIDATE HYDROCHLORIDE - METHYLPHENIDATE HYDROCHLORIDE TABLET
Physicians Total Care, Inc.
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MEDICATION GUIDE
Methylphenidate (meth-ill-fen-i-date) HCl Extended-Release Tablets CII
Read the Medication Guide that comes with Methylphenidate HCl
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 HCl Extended-Release Tablets.
What is the most important information I should know about
Methylphenidate HCl 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
HCl Extended-Release Tablets.
Your doctor should check your or your child's blood pressure and heart
rate regularly during treatment
with Methylphenidate HCl 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 HCl
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 if you or yo

পণ্য বৈশিষ্ট্য

METHYLPHENIDATE HYDROCHLORIDE - METHYLPHENIDATE HYDROCHLORIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE HCL EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
METHYLPHENIDATE HCL EXTENDED-RELEASE
T ABLE TS.
METHYLPHENIDATE HCL EXTENDED-RELEASE TABLETS CII
INITIAL U.S. APPROVAL: 2000
WARNING: DRUG DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
METHYLPHENIDATE HCL 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 HCl Extended-Release Tablets are 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 HCl Extended-Release Tablets should be taken once
daily in the morning and swallowed whole with
the aid of liquids.Methylphenidate HCl Extended-Release Tablets should
not be chewed or crushed. Methylphenidate
HCl 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 FORMS AND STRENGTHS
Tablets: 18, 27, 36, and 54 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to the product (4.1)
Marked