Dexmethylphenidate Hydrochloride
Loading...Dexmethylphenidate Hydrochloride Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs.
Stimulant medications cause a modest increase in average blood pressure (about 2‑4 mmHg) and average heart rate (about 3‑6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with preexisting hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.
Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.
Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder.
Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.
Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.
Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or nonmedication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and nonmedication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.
Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
Stimulants, including dexmethylphenidate hydrochloride tablets, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.
Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
Dexmethylphenidate hydrochloride tablets should not be used in children under 6 years, since safety and efficacy in this age group have not been established.
Dexmethylphenidate hydrochloride 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. Careful supervision is required during drug 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The efficacy of dexmethylphenidate hydrochloride tablets in the treatment of ADHD was established in 2 controlled trials of patients aged 6 to 17 years of age who met DSM-IV criteria for ADHD (see Clinical Studies).
A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause 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 2 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 6 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 6 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 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.
Dexmethylphenidate hydrochloride tablets 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 patients with this syndrome. Stimulants are not intended for use in the patient 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 patient’s symptoms.
The effectiveness of dexmethylphenidate hydrochloride tablets for long-term use, i.e., for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dexmethylphenidate hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
History
There is currently no drug history available for this drug.
Other Information
Dexmethylphenidate hydrochloride is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Dexmethylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant, available in 3 tablet strengths. Each tablet contains dexmethylphenidate hydrochloride 2.5, 5, or 10 mg for oral administration. 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 centers
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.
Dexmethylphenidate hydrochloride tablets also contain the following inert ingredients: pregelatinized starch, lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, and FD&C Blue No.1 #5516 aluminum lake (2.5 mg tablets), D&C Yellow Lake #10 (5 mg tablets); the 10 mg tablet contains no dye.
Sources
Dexmethylphenidate Hydrochloride Manufacturers
-
Sandoz Inc
![Dexmethylphenidate Hydrochloride Tablet [Sandoz Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Dexmethylphenidate Hydrochloride | Sandoz Inc
Dexmethylphenidate hydrochloride tablets are administered twice daily, at least 4 hours apart. Dexmethylphenidate hydrochloride tablets may be administered with or without food.
Dosage should be individualized according to the needs and responses of the patient.
Patients New to MethylphenidateThe recommended starting dose of dexmethylphenidate hydrochloride tablets for patients who are not currently taking racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day (2.5 mg twice daily).
Dosage may be adjusted in 2.5 to 5 mg increments to a maximum of 20 mg/day (10 mg twice daily). In general, dosage adjustments may proceed at approximately weekly intervals.
Patients Currently Using MethylphenidateFor patients currently using methylphenidate, the recommended starting dose of dexmethylphenidate hydrochloride tablets is half the dose of racemic methylphenidate. The maximum recommended dose is 20 mg/day (10 mg twice daily).
Maintenance/Extended TreatmentThere is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with dexmethylphenidate hydrochloride tablets. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use dexmethylphenidate hydrochloride tablets for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with periods off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
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 1-month period, the drug should be discontinued.
-
Mylan Pharmaceuticals Inc.
Dexmethylphenidate Hydrochloride | Prime Packaging, Inc.
Hold container 4 to 6 inches from the skin & spray to apply. Spread evenly by hand 15 minutes before sun exposure DO NOT spray directly into face. Spray on hands then apply to face. Do not apply in windy conditions. Use in a well ventilated areaReapply:
After 80 minutes of swimming or sweating immediately after towel drying at least every 2 hoursSun Protection Measures
Spending time in the sun increases your risk of skin cancer & early aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and othre sun protection measures including:
limit time in the sun, especially from 10am - 2 pm wear long-sleeve shirts, pants, hats, and sunglassesChildren under 6 months: Ask a doctor
-
Actavis Inc.
Dexmethylphenidate Hydrochloride | Bejing Rimeng Biological Technology Co Ltd
For External Use Only.
-
Teva Pharmaceuticals Usa Inc
Dexmethylphenidate Hydrochloride | Teva Pharmaceuticals Usa Inc
Dexmethylphenidate hydrochloride extended-release capsules are for oral administration once daily in the morning.
Dexmethylphenidate hydrochloride extended-release capsules may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Dexmethylphenidate hydrochloride extended-release capsules and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.
Dosage should be individualized according to the needs and responses of the patient.
2.1 Patients New to MethylphenidateThe recommended starting dose of dexmethylphenidate hydrochloride extended-release capsules for patients who are not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day for pediatric patients and 10 mg/day for adult patients.
Dosage may be adjusted in 5 mg increments for pediatric patients and in 10 mg increments for adult patients. In general, dosage adjustments may proceed at approximately weekly intervals. The patient should be observed for a sufficient duration at a given dose to ensure that a maximal benefit has been achieved before a dose increase is considered. In dose-response (fixed-dose) studies (pediatric from 10 to 30 mg/day and adult from 20 to 40 mg/day), all doses were effective vs. placebo. There was no clear finding, however, of greater average benefits for the higher doses compared to the lower doses. Adverse events and discontinuations, however, were dose-related. Doses above 30 mg/day in pediatrics and 40 mg/day in adults have not been studied and are not recommended.
2.2 Patients Currently Using MethylphenidateFor patients currently using methylphenidate, the recommended starting dose of dexmethylphenidate hydrochloride extended-release capsules is half the total daily dose of racemic methylphenidate. Patients currently using dexmethylphenidate hydrochloride tablets may be switched to the same daily dose of dexmethylphenidate hydrochloride extended-release capsules.
2.3 Maintenance/Extended TreatmentThere is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with dexmethylphenidate hydrochloride extended-release capsules. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use dexmethylphenidate hydrochloride extended-release capsules for extended periods in patients with ADHD should periodically reevaluate the long-term usefulness of the drug for the individual patient with periods off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
2.4 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 1 month period, the drug should be discontinued.
-
Teva Pharmaceuticals Usa Inc
Dexmethylphenidate Hydrochloride | Unifirst First Aid Corporation
■ do not use more than directed
Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.
Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
-
Teva Pharmaceuticals Usa Inc
Dexmethylphenidate Hydrochloride | Teva Pharmaceuticals Usa Inc
Dexmethylphenidate hydrochloride tablets are administered twice daily, at least 4 hours apart. Dexmethylphenidate hydrochloride tablets may be administered with or without food.
Dosage should be individualized according to the needs and responses of the patient.
Patients New to MethylphenidateThe recommended starting dose of dexmethylphenidate hydrochloride tablets for patients who are not currently taking racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day (2.5 mg twice daily).
Dosage may be adjusted in 2.5 to 5 mg increments to a maximum of 20 mg/day (10 mg twice daily). In general, dosage adjustments may proceed at approximately weekly intervals.
Patients Currently Using MethylphenidateFor patients currently using methylphenidate, the recommended starting dose of dexmethylphenidate hydrochloride tablets is half the dose of racemic methylphenidate. The maximum recommended dose is 20 mg/day (10 mg twice daily).
Maintenance/Extended TreatmentThere is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with dexmethylphenidate hydrochloride tablets. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use dexmethylphenidate hydrochloride tablets for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with periods off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
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 1 month period, the drug should be discontinued.
-
Mylan Pharmaceuticals Inc.
Dexmethylphenidate Hydrochloride | Mylan Pharmaceuticals Inc.
Dexmethylphenidate hydrochloride extended-release capsules are for oral administration once daily in the morning.
Dexmethylphenidate hydrochloride extended-release capsules may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Dexmethylphenidate hydrochloride extended-release capsules and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.
Dosage should be individualized according to the needs and responses of the patient.
2.1 Patients New to MethylphenidateThe recommended starting dose of dexmethylphenidate hydrochloride extended-release capsules for patients who are not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day for pediatric patients and 10 mg/day for adult patients.
Dosage may be adjusted in 5 mg increments for pediatric patients and in 10 mg increments for adult patients. In general, dosage adjustments may proceed at approximately weekly intervals. The patient should be observed for a sufficient duration at a given dose to ensure that a maximal benefit has been achieved before a dose increase is considered. In dose-response (fixed-dose) studies (pediatric from 10 to 30 mg/day and adult from 20 to 40 mg/day), all doses were effective vs. placebo. There was no clear finding, however, of greater average benefits for the higher doses compared to the lower doses. Adverse events and discontinuations, however, were dose related. Doses above 30 mg/day in pediatrics and 40 mg/day in adults have not been studied and are not recommended.
2.2 Patients Currently Using MethylphenidateFor patients currently using methylphenidate, the recommended starting dose of dexmethylphenidate hydrochloride extended-release capsules is half the total daily dose of racemic methylphenidate. Patients currently using dexmethylphenidate hydrochloride tablets may be switched to the same daily dose of dexmethylphenidate hydrochloride extended-release capsules.
2.3 Maintenance/Extended TreatmentThere is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with dexmethylphenidate hydrochloride extended-release capsules. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use dexmethylphenidate hydrochloride extended-release capsules for extended periods in patients with ADHD should periodically reevaluate the long-term usefulness of the drug for the individual patient with periods off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
2.4 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.
-
Mylan Pharmaceuticals Inc.
Dexmethylphenidate Hydrochloride | Mylan Pharmaceuticals Inc.
Dexmethylphenidate hydrochloride extended-release capsules are for oral administration once daily in the morning.
Dexmethylphenidate hydrochloride extended-release capsules may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Dexmethylphenidate hydrochloride extended-release capsules and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.
Dosage should be individualized according to the needs and responses of the patient.
2.1 Patients New to MethylphenidateThe recommended starting dose of dexmethylphenidate hydrochloride extended-release capsules for patients who are not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day for pediatric patients and 10 mg/day for adult patients.
Dosage may be adjusted in 5 mg increments for pediatric patients and in 10 mg increments for adult patients. In general, dosage adjustments may proceed at approximately weekly intervals. The patient should be observed for a sufficient duration at a given dose to ensure that a maximal benefit has been achieved before a dose increase is considered. In dose-response (fixed-dose) studies (pediatric from 10 to 30 mg/day and adult from 20 to 40 mg/day), all doses were effective vs. placebo. There was no clear finding, however, of greater average benefits for the higher doses compared to the lower doses. Adverse events and discontinuations, however, were dose related. Doses above 30 mg/day in pediatrics and 40 mg/day in adults have not been studied and are not recommended.
2.2 Patients Currently Using MethylphenidateFor patients currently using methylphenidate, the recommended starting dose of dexmethylphenidate hydrochloride extended-release capsules is half the total daily dose of racemic methylphenidate. Patients currently using dexmethylphenidate hydrochloride tablets may be switched to the same daily dose of dexmethylphenidate hydrochloride extended-release capsules.
2.3 Maintenance/Extended TreatmentThere is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with dexmethylphenidate hydrochloride extended-release capsules. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use dexmethylphenidate hydrochloride extended-release capsules for extended periods in patients with ADHD should periodically reevaluate the long-term usefulness of the drug for the individual patient with periods off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
2.4 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.
-
Mylan Pharmaceuticals Inc.
Dexmethylphenidate Hydrochloride | Mylan Pharmaceuticals Inc.
Dexmethylphenidate hydrochloride extended-release capsules are for oral administration once daily in the morning.
Dexmethylphenidate hydrochloride extended-release capsules may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Dexmethylphenidate hydrochloride extended-release capsules and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.
Dosage should be individualized according to the needs and responses of the patient.
2.1 Patients New to MethylphenidateThe recommended starting dose of dexmethylphenidate hydrochloride extended-release capsules for patients who are not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day for pediatric patients and 10 mg/day for adult patients.
Dosage may be adjusted in 5 mg increments for pediatric patients and in 10 mg increments for adult patients. In general, dosage adjustments may proceed at approximately weekly intervals. The patient should be observed for a sufficient duration at a given dose to ensure that a maximal benefit has been achieved before a dose increase is considered. In dose-response (fixed-dose) studies (pediatric from 10 to 30 mg/day and adult from 20 to 40 mg/day), all doses were effective vs. placebo. There was no clear finding, however, of greater average benefits for the higher doses compared to the lower doses. Adverse events and discontinuations, however, were dose related. Doses above 30 mg/day in pediatrics and 40 mg/day in adults have not been studied and are not recommended.
2.2 Patients Currently Using MethylphenidateFor patients currently using methylphenidate, the recommended starting dose of dexmethylphenidate hydrochloride extended-release capsules is half the total daily dose of racemic methylphenidate. Patients currently using dexmethylphenidate hydrochloride tablets may be switched to the same daily dose of dexmethylphenidate hydrochloride extended-release capsules.
2.3 Maintenance/Extended TreatmentThere is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with dexmethylphenidate hydrochloride extended-release capsules. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use dexmethylphenidate hydrochloride extended-release capsules for extended periods in patients with ADHD should periodically reevaluate the long-term usefulness of the drug for the individual patient with periods off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
2.4 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.
![Dexmethylphenidate Hydrochloride (Dexmethylphenidate) Capsule, Extended Release [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ea7b06cb-0a88-480a-9c86-ab187a2ee146&name=13630-0081-4.jpg)
![Dexmethylphenidate Hydrochloride Capsule, Extended Release [Actavis Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=23c8b614-173c-4e4a-88ce-0ea808638c16&name=carton.jpg)
![Dexmethylphenidate Hydrochloride Capsule, Extended Release [Teva Pharmaceuticals Usa Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c7beed0d-a4cb-4c4d-933a-c17c4bab6ef1&name=b507e95a-3885-40ed-abf5-619e47d0d5d9-03.jpg)
![Dexmethylphenidate Hydrochloride Capsule, Extended Release [Teva Pharmaceuticals Usa Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f196f2c5-a100-42b1-bd01-0327b223838e&name=819RMFSinusPPLabel1.jpg)
![Dexmethylphenidate Hydrochloride Tablet [Teva Pharmaceuticals Usa Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d334e2f1-7497-4131-a5c0-7ac30d4741cb&name=image-04.jpg)
![Dexmethylphenidate Hydrochloride (Dexmethylphenidate) Capsule, Extended Release [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=da26462a-1a4b-42dd-b238-c8d693594a52&name=image-01.jpg)
![Dexmethylphenidate Hydrochloride (Dexmethylphenidate) Capsule, Extended Release [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a30ac4c6-5178-4378-a211-a6dd8b1fbc59&name=image-09.jpg)
![Dexmethylphenidate Hydrochloride (Dexmethylphenidate) Capsule, Extended Release [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0e7542c-3fb6-41fa-9f45-8ea39f1e10e7&name=image-05.jpg)
Login To Your Free Account