Methylphenidate Hydrochloride Extended-release
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Uses
Methylphenidate hydrochloride extended-release tablets USP 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 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.
History
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Other Information
Methylphenidate Hydrochloride Extended-Release Tablets USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride.
Its structural formula is:
Methylphenidate HCl USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.
Methylphenidate hydrochloride extended-release tablets also contain the following inert ingredients: silicified microcrystalline cellulose, ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, medium-chain triglycerides, oleic acid, polyethylene glycol, polyvinyl alcohol, propylene glycol, talc, titanium dioxide, triacetin, shellac.
Each tablet also contains the following additional inert ingredients: 27 mg: yellow iron oxide, red iron oxide, black iron oxide; 36 mg: red iron oxide, black iron oxide; 54 mg: red iron oxide, black iron oxide.
Methylphenidate hydrochloride extended-release tablets use a precisely designed diffusion process to deliver methylphenidate hydrochloride at a controlled rate. The system comprises a polymeric core surrounded by a diffusion controlling membrane with an immediate release drug overcoat. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water enters the tablet core through the diffusion controlling membrane, and methylphenidate is released in a controlled fashion resulting in Cmax at 6 to 7 hours. The non-absorbed components of the tablet pass through the gastrointestinal tract and are eliminated in the stool. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.
Sources
Methylphenidate Hydrochloride Extended-release Manufacturers
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Mallinckrodt, Inc.
![Methylphenidate Hydrochloride Extended-release (Methylphenidate Hydrochloride) Tablet [Mallinckrodt, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Methylphenidate Hydrochloride Extended-release | Mallinckrodt, Inc.
2.1 General Dosing InformationMethylphenidate hydrochloride extended-release tablets should be administered orally once daily in the morning with or without food.
Methylphenidate hydrochloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed [see Patient Counseling Information (17)].
2.2 Patients New to MethylphenidateThe recommended starting dose of methylphenidate hydrochloride extended-release tablets for patients who are not currently taking methylphenidate or stimulants other than methylphenidate is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults (see Table 1).
Table 1. Methylphenidate Hydrochloride Extended-Release Tablets Recommended Starting Doses and Dose Ranges
Patient Age
Recommended Starting Dose
Dose Range
Children
6-12 years of age18 mg/day
18 mg - 54 mg/day
Adolescents
13-17 years of age18 mg/day
18 mg - 72 mg/day not to exceed
2 mg/kg/dayAdults
18-65 years of age18 or 36 mg/day
18 mg - 72 mg/day
2.3 Patients Currently Using MethylphenidateThe recommended dose of methylphenidate hydrochloride extended-release tablets for patients who are currently taking methylphenidate twice daily or three times daily at doses of 10 to 60 mg/day is provided in Table 2. Dosing recommendations are based on current dose regimen and clinical judgment. Conversion dosage should not exceed 72 mg daily.
Table 2. Recommended Dose Conversion from Methylphenidate Regimens to Methylphenidate Hydrochloride Extended-Release Tablets
Previous Methylphenidate Daily Dose
Recommended Methylphenidate Hydrochloride Extended-Release Tablets Starting Dose
5 mg Methylphenidate twice daily or three times daily
18 mg every morning
10 mg Methylphenidate twice daily or three times daily
36 mg every morning
15 mg Methylphenidate twice daily or three times daily
54 mg every morning
20 mg Methylphenidate twice daily or three times daily
72 mg every morning
Other methylphenidate regimens: Clinical judgment should be used when selecting the starting dose.
2.4 Dose TitrationDoses may be increased in 18 mg increments at weekly intervals for patients who have not achieved an optimal response at a lower dose. Daily dosages above 54 mg in children and 72 mg in adolescents have not been studied and are not recommended. Daily dosages above 72 mg in adults are not recommended.
A 27 mg dosage strength is available for physicians who wish to prescribe between the 18 mg and 36 mg dosages.
2.5 Maintenance/Extended TreatmentThere is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with methylphenidate hydrochloride extended-release tablets. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods.
The effectiveness of methylphenidate hydrochloride extended-release tablets for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use methylphenidate hydrochloride extended-release tablets for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
2.6 Dose Reduction and DiscontinuationIf paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
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