METHYLPHENIDATE HYDROCHLORIDE tablet, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Lannett Company, Inc.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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; loses

Tóm tắt sản phẩm:

Methylphenidate Hydrochloride Extended-Release Tablets, USP are available in 18 mg, 27 mg, 36 mg, and 54 mg dosage strengths. 18 mg tablets are yellow, capsule shaped film coated tablets, and imprinted with “A18” on one side and plain on the other side, 27 mg tablets are gray, capsule shaped film coated tablets, and imprinted with “A27” on one side and plain on the other side, 36 mg tablets are white, capsule shaped film coated tablets, and imprinted with “A36” on one side and plain on the other side, and 54 mg tablets are red, capsule shaped film coated tablets, and imprinted with “A54” on one side and plain on the other side. 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. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Keep this and all medication out of reach of children.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

Lannett Company, Inc.
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Dispense with Medication Guide available at:
www.lannett.com/med-guide/methylphenidate-er-tabs-ab
MEDICATION GUIDE
Methylphenidate Hydrochloride (meth'' il fen' i date hye'' droe klor'
ide) Extended-Release Tablets CII
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 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 chi

Đặc tính sản phẩm

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED RELEASE
LANNETT COMPANY, 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
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 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 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 FORMS AND STRENGTHS