METHYLPHENIDATE HYDROCHLORIDE tablet, extended release

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

AvKARE

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Methylphenidate hydrochloride (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; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics. Methylphenidate hydrochloride (HCl) extended-release tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient’s symptoms. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate HCl extended-release tablets. Therefore, methylphenidate HCl extended-release tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see Adverse Reactions (6.6)] . Methylphenidate HCl extended-release tablets are contraindicated in patients with marked anxiety, tension and agitation, since the drug may aggravate these symptoms. Methylphenidate HCl extended-release tablets are contraindicated in patients with glaucoma. Methylphenidate HCl extended-release tablets are contraindicated in patients with motor tics or with a family history or diagnosis of Tourette's syndrome [see Adverse Reactions (6.4)] . Methylphenidate HCl extended-release tablets are contraindicated during treatment with monoamine oxidase (MAO) inhibitors, and also within a minimum of 14 days following discontinuation of a MAO inhibitor (hypertensive crises may result) [see Drug Interactions (7.1)] . Pregnancy Category C Methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times the maximum recommended human dose on a mg/kg and mg/m 2 basis, respectively. A reproduction study in rats revealed no evidence of harm to the fetus at oral doses up to 30 mg/kg/day, approximately 15-fold and 3-fold the maximum recommended human dose of methylphenidate HCl extended-release tablets on a mg/kg and mg/m 2 basis, respectively. The approximate plasma exposure to methylphenidate plus its main metabolite PPAA in pregnant rats was 1 to 2 times that seen in trials in volunteers and patients with the maximum recommended dose of methylphenidate HCl extended-release tablets based on the AUC. The safety of methylphenidate for use during human pregnancy has not been established. There are no adequate and well-controlled studies in pregnant women. Methylphenidate HCl extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effect of methylphenidate HCl extended-release tablets on labor and delivery in humans is unknown. It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if methylphenidate HCl extended-release tablets are administered to a nursing woman. In lactating female rats treated with a single oral dose of 5 mg/kg radiolabeled methylphenidate, radioactivity (representing methylphenidate and/or its metabolites) was observed in milk and levels were generally similar to those in plasma. Methylphenidate HCl extended-release tablets should not be used in children under six years, since safety and efficacy in this age group have not been established. Long-term effects of methylphenidate in children have not been well established. Methylphenidate HCl extended-release tablets have not been studied in patients greater than 65 years of age. Methylphenidate is a Schedule II controlled substance under the Controlled Substances Act. As noted in the Box 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. Frank psychotic episodes can occur, especially with parenteral abuse. In two placebo-controlled human abuse potential studies, single oral doses of methylphenidate HCl extended-release tablets were compared to single oral doses of immediate-release methylphenidate (IR MPH) and placebo in subjects with a history of recreational stimulant use to assess relative abuse potential. For the purpose of this assessment, the response for each of the subjective measures was defined as the maximum effect within the first 8 hours after dose administration. In one study (n=40), both methylphenidate HCl extended-release tablets (108 mg) and 60 mg IR MPH compared to placebo produced statistically significantly greater responses on the five subjective measures suggestive of abuse potential. In comparisons between the two active treatments, however, methylphenidate HCl extended-release tablets (108 mg) produced variable responses on positive subjective measures that were either statistically indistinguishable from (Abuse Potential, Drug Liking, Amphetamine and Morphine Benzedrine Group [Euphoria]) or statistically less than (Stimulation – Euphoria) responses produced by 60 mg IR MPH. In another study (n=49), both doses of methylphenidate HCl extended-release tablets (54 mg and 108 mg) and both doses of IR MPH (50 mg and 90 mg) produced statistically significantly greater responses compared to placebo on the two primary scales used in the study (Drug Liking, Euphoria). When doses of methylphenidate HCl extended-release tablets (54 mg and 108 mg) were compared to IR MPH (50 mg and 90 mg), respectively, methylphenidate HCl extended-release tablets produced statistically significantly lower subjective responses on these two scales than IR MPH. Methylphenidate HCl extended-release tablets (108 mg) produced responses that were statistically indistinguishable from the responses on these two scales produced by IR MPH (50 mg). Differences in subjective responses to the respective doses should be considered in the context that only 22% of the total amount of methylphenidate in methylphenidate extended-release tablets is available for immediate release from the drug overcoat [see System Components and Performance (11.1)] . Although these findings reveal a relatively lower response to methylphenidate HCl extended-release tablets on subjective measures suggestive of abuse potential compared to IR MPH at roughly equivalent total MPH doses, the relevance of these findings to the abuse potential of methylphenidate HCl extended-release tablets in the community is unknown. As noted in the Box Warning, careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Termék összefoglaló:

Methylphenidate HCl extended-release tablets, USP, 18 mg, are supplied as yellow, round, film-coated biconvex tablets, debossed “18” on one side and plain on the other side. They are available as follows: Bottles of 90: NDC 42291-568-90 Methylphenidate HCl extended-release tablets, USP, 27 mg, are supplied as gray, round, film-coated biconvex tablets, debossed “27” on one side and plain on the other side. They are available as follows: Bottles of 90: NDC 42291-569-90 Methylphenidate HCl extended-release tablets, USP, 36 mg, are supplied as white, round, film-coated biconvex tablets, debossed “36” on one side and plain on the other side. They are available as follows: Bottles of 90: NDC 42291-570-90 Methylphenidate HCl extended-release tablets, USP, 54 mg, are supplied as red, round, film-coated biconvex tablets, debossed “54” on one side and plain on the other side. They are supplied as follows: Bottles of 90: NDC 42291-571-90 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from humidity.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED
RELEASE
AvKARE
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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
extended-release tablets 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 d

Termékjellemzők

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED RELEASE
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
METHYLPHENIDATE HCL EXTENDED-RELEASE TABLETS, USP CII
RX ONLY
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 HCL EXTENDED-RELEASE TABLETS, FOR ORAL ADMINISTRATION
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 an