Dexmethylphenidate has a high potential for abuse. Administration of stimulants for a prolonged period of time may lead to physical and psychological drug. Focalin XR should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked. Formulation Pearls (capsule). Duration of Effect 8–12 hours. Initial Dose 5 mg. Maximum daily dose 30 mg. Available unit dose forms 5, 10, 15, 20, 25, 30,
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Dexmethylphenidate has a high potential for abuse. Administration of stimulants for a prolonged period of time may lead to physical and psychological drug dependence. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events. Caution is advisable in patients with a known history of substance abuse, including alcoholism. Psychotic episodes can occur, especially with parenteral abuse. The least amount reasonable should be prescribed or dispensed at one time in order to limit the potential for overuse or drug diversion.
Symptoms of chronic abuse of dexmethylphenidate may include insomnia, irritability, change in personality, and psychotic symptoms that may be clinically indistinguishable from psychotic disorders, particularly with parenteral or inhalational abuse.
Close supervision is required during drug withdrawal from misuse since severe depression may occur. Withdrawal or abrupt discontinuation after chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up. Drug ‘holidays’, the temporary discontinuation of drug during weekends, holidays, summer vacations and etc.
Dexmethylphenidate is not recommended for use in patients with a history of anorexia nervosa or other eating disorders due to its association with reduced appetite and weight loss. Dexmethylphenidate is not FDA-approved for obesity treatment. Misuse of stimulants in any nature may cause sudden death and serious cardiovascular events. When converting from methylphenidate to dexmethylphenidate, the recommended starting dose is one-half of the oral daily dose of racemic methylphenidate.
FOCALIN XR Dosage & Rx Info | Uses, Side Effects – MPR
May adjust dose at weekly intervals in 2. If paradoxical aggravation of symptoms or other adverse reactions occur, the dosage should be reduced, or, if necessary, discontinued. If improvement is not ineert after appropriate dosage adjustment over a 1-month period, discontinue the drug.
When converting from methylphenidate to dexmethylphenidate, the recommended starting dose is one-half of the total daily dose of racemic methylphenidate for example, if the patient is currently receiving methylphenidate 10 mg PO twice daily, begin with dexmethylphenidate 5 mg PO twice daily.
May titrate daily dose in 2. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or discontinue the drug. Initially, 10 mg PO once daily in the morning if not currently taking methylphenidate or dexmethylphenidate. When converting from immediate-release dexmethylphenidate to extended-release dexmethylphenidate, give the total daily dexmethylphenidate dose once daily in the morning. When converting from methylphenidate to dexmethylphenidate, the recommended starting dose is one-half of the oral daily dose of racemic methylphenidate given once daily in the morning.
Adjust dose at weekly intervals in 10 mg increments if needed. If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or if necessary, discontinued.
Initially, 5 mg PO once daily in the morning if not currently taking methylphenidate or dexmethylphenidate. When converting from immediate-release dexmethylphenidate to extended-release dexmethylphenidate, give the total daily dexmethylphenidate dose once daily in the morning for example, if the patient is currently receiving immediate-release dexmethylphenidate 10 mg PO twice daily, then begin with extended-release dexmethylphenidate 20 mg PO once daily.
When converting from methylphenidate to dexmethylphenidate, the recommended starting dose is one-half of the total daily dose of racemic methylphenidate, given once daily in the morning for example, if the patient is currently fodalin extended-release methylphenidate 20 mg PO once daily, they should begin with extended-release dexmethylphenidate 10 mg PO once daily. May titrate daily dose in 5 mg increments at weekly intervals. Safety an efficacy have not been established.
Specific guidelines packag dosage adjustments in hepatic impairment are not available; use with caution, as dexmethylphenidate is metabolized by the liver. Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
A MedGuide is available which informs patients about the cardiac and psychiatric risks associated with use, and should be provided by the authorized dispenser to each patient receiving a prescription. Administer twice daily, with doses at least 4 hours apart. Depending on the patient’s needs, twice-daily dosages may be administered in the morning and around noon.
Individualized timing of the midday dose may be necessary.
May be administered with or without food. Administer oackage daily in the morning. May be administered without regard to meals and swallowed whole with the aid of liquids. Do NOT crush, chew, or cut in half.
If swallowing is difficult, the capsule may be opened and the contents gently sprinkled on one tablespoon of cold applesauce not warm- warm applesauce could change the characteristics of the medication and swallowed.
The capsule contents beads should not be crushed or chewed. Prepare the sprinkle dose just prior to administration do not store for future use.
Drinking some fluids e. Dexmethylphenidate is contraindicated in patients with focain hypersensitivity to dexmethylphenidate, methylphenidate, or any components of these products.
Dexmethylphenidate is contraindicated in patients with marked anxiety, tension, or agitation because the drug can aggravate the symptoms associated with these conditions. An assessment should be performed prior to initiation of therapy to determine the risk for bipolar disorder in patients presenting with symptoms of depression. Due to its toxic effects in overdose, dexmethylphenidate should only be used in those with major depression or suicidal ideation when absolutely necessary.
Aggression, hostility, and suicidal ideation or behaviors have been packagge in both clinical trials and post-marketing experience with ADHD medications. Although causality has not foclin established and these behaviors may be inherent to ADHD, close monitoring is recommended. Patients and their insdrt should be advised to promptly report any changes in mood or behavior. If suicide-related events emerge during treatment, consideration should be given to dose reduction or drug discontinuation, especially if symptoms are severe, abrupt in onset, or packwge not part of the patient’s presenting symptoms.
In patients with pre-existing psychosis e. New onset psychotic symptoms may occur in individuals without a prior history of psychosis. If such symptoms occur, discontinuation of treatment should be considered. Dexmethylphenidate is contraindicated in patients with motor tics, Tourette’s syndrome, or a family history of Tourette’s syndrome because the drug may precipitate motor or phonetic tics. Dexmethylphenidate innsert contraindicated in patients with glaucoma, due to the ability of the drug to increase sympathetic stimulation and to raise intraocular pressure.
Occasionally, a visual disturbance, such as changes in visual accommodation or ffocalin vision, has been reported in other individuals without ocular disease. Use stimulant medications, such as dexmethylphenidate, with caution in patients with pre-existing hypertension, tachycardia, cardiac rhythm disturbances e.
Stimulant medications cause a modest increase in average blood pressure approximately 2—4 mmHg and average heart focwlin approximately 3—6 bpm ; however, some individuals may have larger increases. Periodic blood pressure and heart rate monitoring is recommended in all patients taking dexmethylphenidate. The FDA recommends that, in general, stimulant medications such as dexmethylphenidate not be used in patients with known serious cardiac structural abnormalities, a history of acute myocardial infarction, aortic stenosis, prosthetic heart valves, valvular heart disease, cardiomyopathy, ventricular dysfunction or heart failure, cardiac arrhythmias, coronary artery disease, advanced arteriosclerosis, or other serious cardiac problems.
Stimulant medications inserh increase blood pressure or heart rate in some individuals; more serious cardiac effects have also been associated with focallin use. Sudden unexplained death SUD and myocardial infarction have occurred in adults receiving stimulants at standard dosages for attention-deficit hyperactivity-disorder ADHD. Sudden death has also been associated with stimulant medications at usual doses in pediatrics with structural cardiac abnormalities or other serious heart problems.
A large retrospective cohort study including over 1. Similar results packaye seen when current users of ADHD drugs were compared to former users and when current users ffocalin severe underlying cardiovascular disease were included in the analysis. The authors concluded that although the absolute magnitude of risk appears to be low, a modest increase in risk could not be ruled out.
The American Heart Association AHA states that it is reasonable to consider the use of these medications in pediatric patients with congenital heart disease without current hemodynamic or arrhythmic concerns paclage congenital heart disease that is considered stable by the patient’s pediatric cardiologist, unless the cardiologist has specific concerns.
However, these patients should be closely monitored and treatment discontinuation should be considered if the patient develops pacmage of the following conditions: All patients being considered for treatment with stimulant medications should have a careful history isnert, including assessment for a family history inssert sudden death or ventricular arrhythmias, and a physical exam to assess for the presence of cardiac disease.
If cardiac disease is suspected, further cardiac evaluation including an ECG and echocardiogram is warranted. For pediatric patients, the AHA states that it is reasonable to obtain a baseline ECG as a part of the initial evaluation.
If a child or adolescent has any significant findings on physical examination, ECG, or family history, consult a pediatric cardiologist before initiating the stimulant medication. Once the medication is started, a repeat ECG may be helpful if the original ECG was obtained before the child was 12 years old, if cardiac symptoms develop, or there is a change in family history.
Stroke has occurred in adults receiving stimulants at usual doses for ADHD ; therefore, patients with cerebrovascular disease should be closely monitored. Stimulant medications may increase blood pressure or heart rate in some individuals. Children 6 years of age and older have been successfully treated for attention-deficit hyperactivity disorder ADHD with dexmethylphenidate; clinical use in infants and children younger than 6 years is not FDA-approved.
It should be noted that not all children with ADHD will require medication; non-drug measures are often instituted concurrently with drug therapy.
Monitoring of the effectiveness of stimulant therapy by the health care prescriber, parents, and teachers is important; periodic reassessment of the need for medication is recommended. Appropriate stimulant therapy should not suppress normal emotions or intellectual ability; the occurrence of certain side unsert may indicate a need for dosage reduction.
In psychotic children, dexmethylphenidate may exacerbate behavioral disturbances, psychosis, or thought disorders.
New onset psychotic or manic symptoms may develop in children and adolescents receiving therapeutic doses of stimulants. Discontinuation of therapy may be required. Although a pacckage causal relationship has not been established, aggressive behavior and hostility have been reported during pakage of some stimulants for ADHD in children. It is recommended to monitor for signs of aggression or worsening of pre-existing aggressive behavior when treatment is initiated.
The potential for growth inhibition in pediatric patients should be monitored during stimulant therapy. Monitor height and weight parameters inswrt to age at treatment padkage and periodically thereafter at minimum yearly. Patients who are not inserrt or gaining weight as expected may need to have their treatment interrupted. Data are inadequate to determine whether chronic use of stimulants causes long-term growth inhibition.
Although data are limited, available studies do not indicate that stimulant use compromises the attainment of normal adult height and weight in most children.
Sudden death has been reported in focalib with CNS stimulant treatment at usual doses in children with structural cardiac abnormalities or other serious heart problems e. Some case reports have involved concomitant medications, such as tricyclic antidepressants. Focali some structural cardiac abnormalities alone may carry an increased risk of sudden death, stimulant products generally should not be used in patients with known structural cardiac abnormalities or other serious heart conditions.
Exceptions to this warning do exist, but careful screening and monitoring is recommended by the American Heart Association see separate paragraph detailing cardiac contraindications packagr precautions. Caution is advisable during use of dexmethylphenidate in patients with hyperthyroidism or thyrotoxicosis, as sympathomimetic stimulation may induce cardiac arrhythmias or other side effects.
Use dexmethylphenidate with caution in patients with a history of a seizure disorder because the seizure threshold can be reduced, particularly during excess CNS stimulation i.