METHYLPHENIDATE HYDROCHLORIDE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Composition:

METHYLPHENIDATE HYDROCHLORIDE 18 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methylphenidate hydrochloride 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; lose

Product summary:

Methylphenidate Hydrochloride Extended-Release Tablets, USP are available containing 18 mg, 27 mg, 36 mg or 54 mg of methylphenidate hydrochloride, USP. The 18 mg tablets are yellow, film-coated, round, unscored tablets imprinted with M over D18 in black ink on one side of the tablet and blank on the other side of the tablet. They are available as follows: NDC 0378-8155-77 bottles of 90 tablets NDC 0378-8155-01 bottles of 100 tablets The 27 mg tablets are gray, film-coated, round, unscored tablets imprinted with M over D27 in black ink on one side of the tablet and blank on the other side of the tablet. They are available as follows: NDC 0378-8156-77 bottles of 90 tablets NDC 0378-8156-01 bottles of 100 tablets The 36 mg tablets are white, film-coated, round, unscored tablets imprinted with M over D36 in black ink on one side of the tablet and blank on the other side of the tablet. They are available as follows: NDC 0378-8157-77 bottles of 90 tablets NDC 0378-8157-01 bottles of 100 tablets The 54 mg tablets are pink-orange, film-coated, round, unscored tablets imprinted with M over D54 in black ink on one side of the tablet and blank on the other side of the tablet. They are available as follows: NDC 0378-8158-77 bottles of 90 tablets NDC 0378-8158-01 bottles of 100 tablets Storage and Handling: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

release
Mylan Pharmaceuticals Inc.
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Medication Guide
Methylphenidate Hydrochloride Extended-Release Tablets, USP CII
(meth" il fen' i date hye" droe klor' ide)
Read the Medication Guide that comes with methylphenidate
hydrochloride 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 hydrochloride extended-release tablets.
What is the most important information I should know about
methylphenidate hydrochloride
extended-release 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 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 depr

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
FILM COATED, EXTENDED RELEASE
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS.
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
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 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
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DOSAGE FORMS AND STRENGTHS
Tablets: 18, 27, 36, and 54 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
•
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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/