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:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methylphenidate hydrochloride extended-release tablets USP is 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 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 hydrochloride extended-release tablets. Therefore, methylphenidate hydrochloride 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 hydrochloride extended-release tablets are contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms. Methylphenidate hydrochloride extended-release tablets are contraindicated in patients with glaucoma. Methylphenidate hydrochloride 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 hydrochloride 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/m2 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 hydrochloride extended-release tablets on a mg/kg and mg/m2 basis, respectively. The approximate plasma exposure to methylphenidate plus its main metabolite PPAA in pregnant rats was 1–2 times that seen in trials in volunteers and patients with the maximum recommended dose of methylphenidate hydrochloride 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 hydrochloride extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effect of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 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. Frank psychotic episodes can occur, especially with parenteral abuse. In two placebo-controlled human abuse potential studies, single oral doses of methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets (54 mg and 108 mg) were compared to IR MPH (50 mg and 90 mg), respectively, methylphenidate hydrochloride extended-release tablets produced statistically significantly lower subjective responses on these two scales than IR MPH. Methylphenidate hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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.

Product summary:

Methylphenidate hydrochloride extended-release tablets are available in 27 mg strength. The 27 mg tablets are gray with “TL707” imprinted in black ink. The tablets are supplied: 27 mg 100-count bottle NDC 63629-2460-1 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Bryant Ranch Prepack
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MEDGUIDE
MEDICATION GUIDE
Methylphenidate hydrochloride extended-release tablets USP CII
(METH-il-FEN-i-date)
Read the Medication Guide that comes with methylphenidate
hydrochloride extended-release tablets USP
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
USP.
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 child have, or
about a family history of suicide,
bipolar illness, or depression.
Call your doctor right away if y

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED RELEASE
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS
USP.
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 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 USP 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 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