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(DEX-meth-ill-FEN-ih-date HIGH-droe-KLOR-ide)
Focalin
Tablets
2.5 mg
Tablets
5 mg
Tablets
10 mg
Class: Psychotherapeutic
CNS stimulant

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

  Indications Treatment of attention deficit hyperactivity disorder (ADHD).

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

  Route/Dosage

Patients New To Methylphenidate

ADULTS AND CHILDREN > 6 Yr: PO 2.5 mg bid; adjust dose in 2.5 to 5 mg increments at weekly intervals (max, 10 mg bid).

Patients Currently Receiving Methylphenidate

ADULTS AND CHILDREN > 6 Yr: PO 50% the dose of racemic methylphenidate initially (max, 10 mg bid).

  Interactions

Antihypertensive Agents, Pressor Agents (eg, Dopamine): Effects may be decreased by dexmethylphenidate. Coumarin Anticoagulants (eg, Warfarin), Anticonvulsants (eg, Phenytoin), Tricyclic Antidepressants (eg, Amitriptyline), Selective Serotonin Reuptake Inhibitors (eg, Fluoxetine): Effects may be increased by dexmethylphenidate, necessitating a decrease in dosage. MAO Inhibitors (eg, Phenelzine): Discontinue MAO inhibitor therapy ³ 14 days before starting dexmethylphenidate.

  Lab Test Interferences None well documented.

  Adverse Reactions

CARDIOVASCULAR: Tachycardia; angina; arrhythmia; palpitations; increased or decreased pulse; increased or decreased blood pressure; cerebral arteritis or occlusion. CNS: Twitching; insomnia; nervousness; dizziness; drowsiness; dyskinesia; headache; Tourette syndrome; toxic psychosis; depressed mood; neuroleptic malignant syndrome. DERMATOLOGIC: Skin rash; urticaria; exfoliative dermatitis; erythema multiforme with necrotizing vasculitis; thrombocytopenia purpura; alopecia. GI: Anorexia; abdominal pain; nausea; loss of appetite. HEMATOLOGIC: Leukopenia; anemia. HEPATIC: Abnormal liver function. METABOLIC: Weight loss. OTHER: Fever; arthralgia.

  Precautions

Pregnancy: Category C. Lactation: Undetermined. CHILDREN: Safety and efficacy not established in children < 6 yr. Depression or Fatigue: Do not administer. Drug Dependence: Use with caution in patients with a history of drug dependence or alcoholism. Psychosis: Symptoms of behavior disturbance and thought disorder might be exacerbated in psychotic children. Seizures: May lower convulsive threshold in patients with history of seizures. Hypertension: Use with caution, monitoring BP. Cardiovascular Conditions: Use with caution. Visual Disturbances: Blurring of vision and difficulties with accommodation may occur.

PATIENT CARE CONSIDERATIONS

  Administration/Storage

  • Discontinue MAO inhibitors ³ 14 days before initiating therapy.
  • Administer prescribed dose twice daily, ³ 4 hr apart.
  • Administer last dose ³ 8 hr before bedtime to avoid sleeplessness.
  • Administer without regard to food.
  • Dosage adjustments may be made at weekly intervals.
  • Store at controlled room temperature (59° to 86°F).

  Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies. Note history of marked anxiety, tension, and agitation; glaucoma; motor tics; Tourette syndrome; family history of Tourette syndrome; seizures, history of drug dependence or alcoholism.
  • Ensure that medication is used as part of a total treatment program for ADHD that may include psychological, educational, and social interventions.
  • Monitor patient for response to therapy.
  • Monitor height and weight in children before starting therapy and periodically during therapy.
  • Monitor CBC, differential, and platelet count periodically during long-term treatment.
  • Monitor patient for CNS, CV, GI, and general body side effects. Report to health care provider if noted and significant.
  • Discontinue medication periodically to assess behavior and determine need to continue therapy.
OVERDOSAGE: SIGNS & SYMPTOMS
  Vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions, euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, dryness of mucous membranes, coma

  Patient/Family Education

  • Explain name, dose, action, and potential side effects of drug.
  • Advise patient or caregiver to read “Patient Information” sheet provided with medication.
  • Advise patient or caregiver that doses should be separated ³ 4 hr.
  • Advise patient or caregiver that last dose should be taken ³ 8 hr before bedtime to avoid sleeplessness.
  • 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 that the 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 to do so by the health care provider.
  • Advise patient or caregiver that health care provider may discontinue medication periodically to assess behavior and determine need to continue therapy.
  • Caution patient that drug may impair their ability to drive or perform other tasks requiring mental alertness.
  • Advise patient or caregiver to notify health care provider if appetite loss, nervousness, or difficulty sleeping occur and are bothersome.
  • Advise patient or caregiver to notify health care provider if any unusual or unexplained symptoms are noted.
  • Advise female patient to inform the health care provider if becoming pregnant, planning on becoming pregnant, or are breastfeeding.
  • Warn patient or caregiver not to take any prescription or otc drugs or dietary supplements without consulting the health care provider.
  • Advise patient or caregiver that follow-up visits and lab tests may be necessary to monitor therapy and to be sure to keep appointments.

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