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Drugs reference index «Dexmethylphenidate Hydrochloride»

Dexmethylphenidate Hydrochloride

Pronunciation: (dex-METH-il-FEN-i-date HYE-droe-KLOR-ide)Class: CNS stimulant

Trade Names:Focalin- Tablets 2.5 mg- Tablets 5 mg- Tablets 10 mg

Trade Names:Focalin XR- Capsules, extended-release 5 mg- Capsules, extended-release 10 mg- Capsules, extended-release 15 mg- Capsules, extended-release 20 mg

Pharmacology

Exact mechanism of action is unknown; however, the drug may block the reuptake of norepinephrine and dopamine into presynaptic neurons and increase release of these monoamines into extraneuronal spaces.

Pharmacokinetics

Absorption

Readily absorbed. T max is 1 to 1.5 h. Extended-release (ER) T max is 6.5 h. Absolute bioavailability is 22% to 25%. High-fat food increased tablet T max to 2.9 h.

Distribution

Vd is approximately 2.65 L/kg.

Metabolism

Metabolized by deesterification to d-ritalinic acid (inactive).

Elimination

Approximately 90% recovered in urine (approximately 80% as ritalinic acid). The t ½ is approximately 2 to 4.5 h.

Indications and Usage

Treatment of attention deficit hyperactivity disorder (ADHD).

Contraindications

Marked anxiety, tension, or agitation; glaucoma; motor tics; family history or diagnosis of Tourette syndrome; MAOI treatment and within 14 days following discontinuation of an MAOI; hypersensitivity to methylphenidate or other components of product.

Dosage and Administration

Patients New to MethylphenidateAdults and Children older than 6 yr of age

PO Tablets: 2.5 mg twice daily; adjust dose in 2.5 to 5 mg increments at weekly intervals (max, 10 mg twice daily).

Adults

PO ER capsules: 10 mg once daily; adjust dose in 10 mg increments at weekly intervals (max, 20 mg once daily).

Children older than 6 yr of age

PO ER capsules: 5 mg once daily; adjust dose in 5 mg increments at weekly intervals (max, 20 mg once daily).

Patients Currently Receiving MethylphenidateAdults and children older than 6 yr of age

PO Tablets: 50% of the dose of racemic methylphenidate (max, 10 mg twice daily). ER capsules: 50% of the dose of racemic methylphenidate (max, 20 mg once daily); use same daily dose of dexmethylphenidate tablets when switching from tablets to ER capsules (max, 20 mg once daily).

General Advice

  • Administer without regard to meals. Administer with food if GI upset occurs.
  • Administer tablets at least 4 h apart.
  • Administer ER capsules once daily in the morning.
  • Do not crush, chew, or divide contents of ER capsules.
  • For patients who have difficulty swallowing ER capsules, the capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. Patients should consume the mixture immediately without chewing. Do not prepare the drug and applesauce mixture ahead of time and store for future use.

Storage/Stability

Store at controlled room temperature (59° to 86°F). Protect from light and moisture.

Drug Interactions

Acid suppressants, antacids

Coadministration could alter the release of dexmethylphenidate.

Anticonvulsants (eg, phenytoin), coumarin anticoagulants (eg, warfarin), SSRIs (eg, fluoxetine), tricyclic antidepressants (eg, amitriptyline)

Effects may be increased by dexmethylphenidate, necessitating a decrease in dosage.

Antihypertensive agents, pressor agents (eg, clonidine, dopamine)

Effects may be decreased by dexmethylphenidate. Although an interaction has not been established, serious adverse reactions have been associated with coadministration of clonidine.

MAOIs (eg, phenelzine)

Discontinue MAOI therapy at least 14 days before starting dexmethylphenidate.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Tachycardia.

CNS

Insomnia, twitching (motor or vocal tics).

ER

Headache (39%); decreased appetite (30%); feeling jittery (12%); anxiety (11%); dizziness (6%); anorexia (1%).

GI

Abdominal pain (15%); nausea (9%); anorexia (6%).

ER

Dry mouth (20%); dyspepsia (9%).

Respiratory

ER

Pharyngolaryngeal pain (7%).

Miscellaneous

Fever (5%).

Precautions

Warnings

Drug dependence

Give dexmethylphenidate cautiously to patients with a history of drug dependence or alcohol abuse. 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 because severe depression may occur. Withdrawal following chronic therapy may unmask symptoms of the underlying disorder that may require follow-up.

Monitor

When starting treatment, monitor for appearance or worsening of aggressive behavior or hostility.

Bipolar illness

Use with caution to treat ADHD in patients with comorbid bipolar disorder because of possible induction of mixed/manic episode.

New psychotic or manic symptoms

Treatment-emergent psychotic or manic symptoms (eg, delusional thinking) can occur in children and adolescents without a history of psychotic illness or mania.

Psychosis

Symptoms of behavior disturbances and thought disorder may be exacerbated in patients with a preexisting psychotic disorder.

Seizures

Convulsive threshold may be lowered in patients with a history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, rarely, in patients without a history of seizures and no prior EEG evidence of seizures. Discontinue therapy in presence of seizures.

Sudden death

Sudden death has occurred in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities. Sudden death, stroke, and MI have occurred in adults taking stimulant drugs at usual doses for ADHD. Do not use stimulant drugs in children, adolescents, or adults with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems.

Overdosage

Symptoms

Agitation, cardiac arrhythmias, confusion, delirium, dryness of mucous membranes, euphoria, flushing, hallucinations, headache, hyperpyrexia, hyperreflexia, hypertension, muscle twitching, mydriasis, palpitations, seizures (may be followed by coma), sweating, tachycardia, tremors, vomiting.

Patient Information

  • Advise patient or caregiver to read the patient information leaflet provided with medication before starting therapy and with each refill.
  • Advise patient or caregiver that this drug is part of a total treatment program for ADHD that should also include psychological, educational, and social interventions.
  • Advise patient or caregiver to notify school or day care personnel about medication use and administration.
  • Advise patient or caregiver that health care provider may periodically change the dose to obtain maximal benefit and to take as prescribed and not to stop taking or change the dose unless advised by the health care provider.
  • Advise patient or caregiver that health care provider may periodically discontinue medication to assess behavior and determine need to continue therapy.
  • Caution patient that drug may cause dizziness or drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Advise patient or caregiver to notify health care provider if visual changes, appetite loss, nervousness, or difficulty sleeping occur and are bothersome, or if any unusual or unexplained symptoms or feelings are noted.
  • Tablets
  • Advise patient or caregiver that tablets can be taken without regard to meals, but to take with food if stomach upset occurs.
  • Advise patient or caregiver that prescribed doses should be separated by 4 h or more.
  • Advise patient or caregiver that last dose should be taken at least 8 h before bedtime to avoid sleeplessness.
  • ER Capsules
  • Advise patient or caregiver that prescribed dose should be taken once daily in the morning without regard to meals, but to take with food if stomach upset occurs.
  • Caution patient or caregiver that capsules should be swallowed whole and not crushed, chewed, or the divided.
  • If patient has difficulty swallowing capsules, advise patient or caregiver that capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The mixture should be consumed immediately without chewing. Caution patient or caregiver not to prepare the drug and applesauce mixture ahead of time and store for future use.

Copyright © 2009 Wolters Kluwer Health.

  • Dexmethylphenidate Prescribing Information (FDA)
  • dexmethylphenidate Advanced Consumer (Micromedex) - Includes Dosage Information
  • Dexmethylphenidate MedFacts Consumer Leaflet (Wolters Kluwer)
  • Focalin Prescribing Information (FDA)
  • Focalin Detailed Consumer Information (PDR)
  • Focalin Consumer Overview
  • Focalin XR Prescribing Information (FDA)
  • Focalin XR Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

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