Dexmethylphenidate Hydrochloride Extended-release Recall
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Dexmethylphenidate Hydrochloride Extended-Release Capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older.
The effectiveness of Dexmethylphenidate Hydrochloride Extended-Release Capsules in the treatment of ADHD in patients aged 6 years and older was established in two placebo-controlled studies in patients meeting DSM-IV criteria for ADHD [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 Types requires both inattentive and hyperactive-impulsive criteria to be met.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of 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 child and not solely on the presence of the required number of DSM-IV characteristics.
Need for Comprehensive Treatment Program
Dexmethylphenidate Hydrochloride Extended-Release Capsules is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits 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 child's symptoms.
The effectiveness of Dexmethylphenidate Hydrochloride Extended-Release Capsules for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Dexmethylphenidate Hydrochloride Extended-Release Capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)].
There is currently no drug history available for this drug.
Dexmethylphenidate Hydrochloride Extended-Release Capsules is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Dexmethylphenidate Hydrochloride Extended-Release Capsules capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a second delayed release of dexmethylphenidate.
Dexmethylphenidate Hydrochloride Extended-Release Capsules are available in 15 and 30 mg strengths. Dexmethylphenidate Hydrochloride Extended-Release Capsules 15 and 30 mg extended-release capsules provide in a single dose the same amount of dexmethylphenidate as dosages of 7.5 or 15 mg of Dexmethylphenidate Hydrochloride Immediate-Release Capsules given b.i.d. as tablets.
Dexmethylphenidate hydrochloride, the d-threo enantiomer of racemic methylphenidate hydrochloride, is a central nervous system (CNS) stimulant.
Dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R')-(+)-. Its empirical formula is C14H19NO2•HCl. Its molecular weight is 269.77 and its structural formula is
Note* = asymmetric carbon center
Dexmethylphenidate hydrochloride is a white to off white 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.
Inactive ingredients: Sugar Spheres, Colloidal Silicon Dioxide, Methacrylic Acid Copolymers, Triethyl Citrate, Talc, Polyethylene Glycol/ Macrogol, Hypromellose, Polydextrose, Triacetin, FD&C Blue #2/ Indigo Carmine Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, Titanium Dioxide and Gelatin.