METHYLPHENIDATE HYDROCHLORIDE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lannett Company, Inc.

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Composition:

METHYLPHENIDATE HYDROCHLORIDE 18 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Methylphenidate HCl Extended-Release Tablets, USP are available in 18 mg, 27 mg, 36 mg, and 54 mg dosage strengths.  The 18 mg tablets are pink and imprinted with “18”, 27 mg tablets are yellow and imprinted with “27”, 36 mg tablets are pink and imprinted with “36”, and 54 mg tablets are pink and imprinted with “54”. All four dosage strengths are supplied in bottles containing 100 tablets. 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride tablet,
extended
release
Lannett Company, Inc.
----------
Dispense with Medication Guide available at:
www.lannett.com/med-guide/methylphenidate-er-tabs-bx
MEDICATION GUIDE
Methylphenidate (meth” il fen’ i date) HCl Extended-Release
Tablets, USP
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 y

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED RELEASE
LANNETT COMPANY, INC.
----------
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 TABLETS.
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 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 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 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 hyperse