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Methylphenidate capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The efficacy of methylphenidate capsules (CD) in the treatment of ADHD was established in one controlled trial of children aged 6 to 15 who met DSM-IV criteria for ADHD
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.
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.
Methylphenidate capsules (CD) are 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 methylphenidate capsules (CD) for long-term use, i.e., for more than 3 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use methylphenidate capsules (CD) for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Methylphenidate capsules (CD) are administered once daily in the morning, before breakfast.
Methylphenidate capsules (CD) may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of applesauce and given immediately, and not stored for future use. Drinking some fluids, e.g., water, should follow the intake of the sprinkles with applesauce. The capsules and the capsule contents must not be crushed or chewed. Patients should be advised to avoid alcohol while taking methylphenidate capsules (CD).
Dosage should be individualized according to the needs and responses of the patient.
The recommended starting dose of methylphenidate capsules (CD) is 20 mg once daily. Dosage may be adjusted in weekly 10 to 20 mg increments to a maximum of 60 mg/day taken once daily in the morning, depending upon tolerability and degree of efficacy observed. Daily dosage above 60 mg is not recommended.
There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with methylphenidate capsules (CD). It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use methylphenidate capsules (CD) 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.
Methylphenidate capsules (CD) are contraindicated in patients with marked anxiety, tension and agitation, since the drug may aggravate these symptoms.
Methylphenidate capsules (CD) are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product.
Methylphenidate capsules (CD) contain sucrose. Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.
Methylphenidate capsules (CD) are contraindicated in patients with glaucoma.
Methylphenidate capsules (CD) are contraindicated in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome
Methylphenidate capsules (CD) are contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).
Methylphenidate capsules (CD) are contraindicated in patients with severe hypertension, angina pectoris, cardiac arrhythmias, heart failure, recent myocardial infarction, hyperthyroidism or thyrotoxicosis.
There is a risk of sudden blood pressure increase during surgery. If surgery is planned, methylphenidate capsules (CD) should not be taken on the day of the surgery.
Patients with an element of agitation may react adversely; discontinue therapy if necessary. Periodic CBC, differential, and platelet counts are advised during prolonged therapy.
Drug treatment is not indicated in all cases of this behavioral syndrome and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe methylphenidate hydrochloride should depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of 1 or more of the behavioral characteristics.
When these symptoms are associated with acute stress reactions, treatment with methylphenidate hydrochloride is usually not indicated.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methylphenidate and should counsel them in its appropriate use. A patient Medication Guide is available for methylphenidate hydrochloride. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.
Abnormal behavior, aggression, anxiety, bruxism, cardiac arrest, depression, fixed drug eruption, hyperactivity, irritability, libido changes, migraine, obsessive-compulsive disorder, peripheral coldness, Raynaud’s phenomenon, reversible ischaemic neurological deficit, rhabdomyolysis, serotonin syndrome in combination with serotonergic drugs, sudden death, suicidal behavior (including completed suicide), and thrombocytopenia. Data are insufficient to support an estimation of incidence or establish causation.
Because of possible effects on blood pressure, methylphenidate capsules (CD) should be used cautiously with pressor agents.
Human pharmacologic studies have shown that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), phenylbutazone and some antidepressants (tricyclics and selective serotonin reuptake inhibitors). Downward dose adjustment of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentrations (or, in the case of coumarin, coagulation times), when initiating or discontinuing concomitant methylphenidate.
In theory, there is a possibility that the clearance of methylphenidate might be affected by urinary pH, either being increased with acidifying agents or decreased with alkalizing agents. This should be considered when methylphenidate is given in combination with agents that alter urinary pH.