dexmethylphenidate

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dexmethylphenidate

(dex-meth-ill-fen-i-date) ,

Focalin

(trade name),

Focalin XR

(trade name)

Classification

Therapeutic: central nervous system stimulants
Pregnancy Category: C

Indications

Adjunctive treatment of ADHD.

Action

Produces CNS and respiratory stimulation with weak sympathomimetic activity.

Therapeutic effects

Increased attention span in ADHD.

Pharmacokinetics

Absorption: Readily absorbed following oral administration.
Distribution: Unknown.
Metabolism and Excretion: Mostly metabolized by the liver; inactive metabolites are renally excreted.
Half-life: 2.2 hr.

Time/action profile (improvement in symptoms)

ROUTEONSETPEAKDURATION
PO7 days1 mounknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Hyperexcitable states (marked anxiety, agitation, or tension);Hyperthyroidism;Psychotic personalities, suicidal or homicidal tendencies;Glaucoma;Motor tics, family history or diagnosis of Tourette's syndrome;Concurrent use of MAO inhibitors;Should not be used to treat depression or prevent/treat normal fatigue;Psychoses (may exacerbate symptoms).
Use Cautiously in: Cardiovascular disease (sudden death has occurred in children with structural cardiac abnormalities or other serious heart problems);Hyperthyroidism;Hypertension;Diabetes mellitus; Geriatric: Geriatric/debilitated patients;Continual use (may result in psychological or physical dependence);Seizure disorders (may lower seizure threshold); Obstetric / Lactation / Pediatric: Pregnancy, lactation, or children <6 yr (safety not established; use in pregnancy only if clearly needed).

Adverse Reactions/Side Effects

Central nervous system

  • behavioral disturbances
  • hallucinations
  • insomnia
  • mania
  • nervousness
  • thought disorder

Ear, Eye, Nose, Throat

  • visual disturbances

Cardiovascular

  • sudden death (life-threatening)
  • peripheral vasculopathy
  • tachycardia

Gastrointestinal

  • abdominal pain (most frequent)
  • anorexia
  • nausea

Metabolic

  • growth suppression
  • weight loss (may occur with prolonged use)

Neurologic

  • twitching

Miscellaneous

  • anaphylaxis (life-threatening)
  • angioedema (life-threatening)
  • fever

Interactions

Drug-Drug interaction

Concurrent use with or use within 14 days following discontinuation of MAO inhibitors may result in hypertensive crisis and is contraindicated.May ↓ effects of antihypertensives.May ↑ effects of vasopressors.May ↑ effects of warfarin, phenobarbital, phenytoin, some antidepressants ; dose adjustments may be necessary.

Route/Dosage

Tablets

Oral (Adults and Children ≥6 yr) Patients not previously taking methylphenidate—2.5 mg twice daily, may be ↑ weekly as needed up to 10 mg twice daily; Patients currently taking methylphenidate—starting dose is 1/2 of the methylphenidate dose, up to 10 mg twice daily.

Extended-release capsules

Oral (Adults) Patients not previously taking methylphenidate—10 mg once daily, may be ↑ by 10 mg up to 40 mg/day; Patients currently taking methylphenidate—starting dose is 1/2 of the methylphenidate dose, up to 40 mg/day given as a single daily dose; Patients currently taking dexmethylphenidate—give same daily dose as a single dose.
Oral (Children ≥6 yr) Patients not previously taking methylphenidate—5 mg once daily, may be ↑ by 5 mg weekly up to 30 mg/day; Patients currently taking methylphenidate—starting dose is 1/2 of the methylphenidate dose, up to 30 mg/day, given as a single daily dose; Patients currently taking dexmethylphenidate—give same daily dose as a single dose.

Availability (generic available)

Tablets: 2.5 mg, 5 mg, 10 mg
Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg

Nursing implications

Nursing assessment

  • Assess child's attention span, impulse control, and interactions with others. Therapy may be interrupted at intervals to determine whether symptoms are sufficient to continue therapy.
  • Monitor BP, pulse, and respiration before administering and periodically during therapy. Obtain a history (including assessment of family history of sudden death or ventricular arrhythmia), physical exam to assess for cardiac disease, and further evaluation (ECG and echocardiogram), if indicated. If exertional chest pain, unexplained syncope, or other cardiac symptoms occur, evaluate promptly.
  • Monitor weight biweekly and inform health care professional of significant loss. Pediatric: Monitor height periodically in children; report growth inhibition.
  • Monitor closely for behavior change.
  • Dexmethylphenidate has the potential for dependence and abuse. Prolonged use may result in tolerance.
  • Assess patient's fingers periodically for signs of peripheral vasculopathy (digital ulceration, soft tissue breakdown).
  • Monitor for signs of anaphylaxis (wheezing, shortness of breath, rash) during therapy.
  • Lab Test Considerations: Monitor CBC, differential, and platelet count periodically in patients receiving prolonged therapy.

Potential Nursing Diagnoses

Disturbed thought process (Side Effects)

Implementation

  • Do not confuse dexmethylphenidate with methadone.
  • Oral: Administer twice daily at least 4 hr apart without regard to meals.
    • Administer XR tablets once daily in the morning. Capsules should be swallowed whole. For patients with difficulty swallowing, capsules can be opened and sprinkled on a spoonful of applesauce. Mixture should be consumed immediately; do not store for future use.

Patient/Family Teaching

  • Instruct patient to take medication as directed. If more than prescribed amount is taken, notify health care professional immediately. If a dose is missed, take the remaining doses for that day at regularly spaced intervals; do not double doses. Take the last dose before 6 pm to minimize the risk of insomnia. Instruct patient not to alter dose without consulting health care professional. Abrupt cessation with high doses may cause extreme fatigue and mental depression. Advise patient and parents to read the Medication Guide prior to starting therapy and with each Rx refill.
    • Inform patient that sharing this medication may be dangerous.
    • Inform patients starting therapy of risk of peripheral vasculopathy. Instruct patients to notify health care professional of any new numbness; pain; skin color change from pale, to blue, to red; or coolness or sensitivity to temperature in fingers or toes, and call if unexplained wounds appear on fingers or toes. May require rheumatology consultation.
    • Advise patient to check weight 2–3 times weekly and report weight loss to health care professional.
    • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
    • May rarely cause dizziness or drowsiness. Caution patient to avoid driving or activities requiring alertness until response to medication is known.
    • Advise patient to notify health care professional if nervousness, restlessness, insomnia, dizziness, anorexia, or dry mouth becomes severe. Pediatric: If reduced appetite and weight loss are a problem, advise parents to provide high calorie meals when drug levels are low (at breakfast and or bedtime).
    • Advise patient and/or parents to notify health care professional of behavioral changes.
    • Inform patient that health care professional may order periodic holidays from the drug to assess progress and to decrease dependence.
    • Caution patients to inform health care professional if they have ever abused or been dependent on alcohol or drugs, or if they are now abusing or dependent on alcohol or drugs.
    • Advise patient to notify health care professional if pregnancy is planned or suspected, or if breast feeding.
    • Emphasize the importance of routine follow-up exams to monitor progress.
  • Home Care Issues: Advise parents to notify school nurse of medication regimen.

Evaluation/Desired Outcomes

  • Improved attention span, decreased impulsiveness and hyperactivity in ADHD. If improvement is not seen within 1 mo, discontinue dexmethylphenidate.

dexmethylphenidate

a central nervous system stimulant used to treat attention deficit hyperactivity disorder.
References in periodicals archive ?
Only four stimulants are approved by the Food and Drug Administration for adults: Adderal XR (dextroam-phetamine/amphetamine), with a 9-hour duration of action and 15- to 30-mg dosage range; Focalin XR (dexmethylphenidate), with an 8- to 12-hour duration of action and dosage range of 20-40 mg; Vyvanse (lisdexamfetamine dimesylate), with a duration of 12 hours and dosing at 30-70 mg; and Concerta (methylphenidate extended-release), with a 12-hour duration of action and dosage range of 18-54 mg.
Some of the more popular stimulants prescribed are Concerta, Adderall, Ritalin, Dexedrine, and Focalin (U.
The filing of a generic version of Seroquel XR(R) is one of the company's performance milestones for 2011 and another important addition to our product portfolio filed for approval with the FDA, which includes generics of Focalin XR(R), Effexor XR(R), Protonix(R) DR and Glucophage(R) XR," commented Dr.
Many products which compete with the Group's ADHD products in the US contain methylphenidate, including the following once-daily formulations: CONCERTA, launched in 2000 by J&J (in conjunction with Alza); METADATE CD, launched in 2001 by UCB; RITALIN LA, launched by Novartis in 2002; DAYTRANA launched in 2006 by Shire (and subsequently divested to Noven in October 2010), and FOCALIN XR, launched by Novartis (in conjunction with Celgene Corporation) in 2005.
IPC's lead product candidates include Dexmethylphenidate XR, a generic version of the marketed drug Focalin XR, which is partnered with Par Pharmaceutical and is currently the subject of an Abbreviated New Drug application (ANDA) filing with the United States Food and Drug Administration (FDA), and Carvedilol CR, a generic version of the brand name drug Coreg CR, an internal pipeline product now ready for entry into pivotal bioequivalence studies.
The warnings, contained in letters sent in late September to the makers of Adder-all XR, Concerta, Focalin XR, Methylin, and Strattera, "cite issues we've been seeing across the promotion for this therapeutic area," said FDA spokeswoman Sandra Walsh in an interview.
Table 1 Participant Characteristics Student Age Grade Gender Ethnicity Disability Abby 14 7 Female Latin American E/BD Sara 15 8 Female African American E/BD Trey 15 9 Male African American E/BD Chris 16 9 Male Caucasian E/BD Katie 13 7 Female Caucasian E/BD Student Age Grade DSM-IV Medications Global Diagnosis Assessment of Functioning Score Abby 14 7 3, 1, 10 Risperdal, Prozac 65 Sara 15 8 3, 4, 1 Neurontin, Effexor 55 Trey 15 9 5, 3, 6 Paxil, Seroquel, Concerta 65 Chris 16 9 7, 2 Seroquel, Focalin 55 Katie 13 7 8, 9, 2, Risperdal, Effexor 20 1, 11 Note.
The litigation involved a generic version of the Attention Deficit Hyperactivity Disorder drug Focalin XR(R) (dexmethylphenidate hydrochloride).
Drugs for attention deficit/hyperactivity disorder (ADHD) include Ritalin, Adderall, Focalin, Methylin, Metadate, and Concerta.
BYDUREON([R]) is a registered trademark of Amylin Pharmaceuticals, LLC; TRICOR([R]) is a registered trademark of Fournier Industrie et Sante Corporation; and RITALIN LA([R]) and FOCALIN XR([R]) are registered trademarks of Novartis AG Corporation.
8 million over the same period last year, excluding a US$20 million milestone payment for the NDA approval of FOCALIN XR(TM).
Dexmethylphenidate has a 4-6 hour duration of effect (a long-acting formulation, Focalin XR, which spans 12 hours is also available and has been shown to be as effective as racemic d,1-methylphenidate XR (Concerta, Ritalin LA), with flexible dosing and good tolerability.