Names and pronunciation
(dex′meth-ul-fen′ih-dayt) Focalin, Focalin XR
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Drug reference
(dex′meth-ul-fen′ih-dayt) Focalin, Focalin XR
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Func. class.: Central nervous system (CNS) stimulant, psychostimulant Controlled Substance Schedule II
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Do not confuse: dexmethylphenidate/methylphenidate
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ACTION: Increases release of norepi- nephrine and DOPamine into the extraneuronal space; also blocks the reup- take of norepinephrine and DOPamine into the presynaptic neuron; mode of action for treating attention-deficit/hyperactivity disor- der (ADHD) is unknown
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USES: ADHD
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CONTRAINDICATIONS: Hyper- sensitivity to methylphenidate, anxiety, history of Gilles de la Tourette’s syn- drome, tics, glaucoma, concurrent treat- ment with MAOIs or within 14 days of discontinuing treatment with MAOIs Precautions: Pregnancy, hypertension, depression, seizures, CV disorders, breast- feeding, child <6 yr, geriatric patients, psy- chosis, thyrotoxicosis
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Black Box Warning: Substance abuse, alcoholism Black Box Warning: Assess for sub- stance abuse, past or current; psychotic episodes may occur, especially with parenteral abuse; avoid use in a history of substance abuse or alcoholism, as dependence may occur • Toxicity: rhabdomyolysis, headache, flush- ing, vomiting, agitation, tachycardia, tremor, euphoria, hallucinations, hyperreflexia • VS, B/P; may reverse antihyperten- sives; check patients with cardiac disease more often for increased B/P • CBC, differential platelet counts dur- ing long-term therapy, urinalysis; with diabetes: blood glucose, urine glucose; insulin changes may have to be made because eating will decrease • Height, growth rate q3mo in children; growth rate may be decreased; weight loss, anorexia may occur • Mental status: mood, sensorium, affect, stimulation, insomnia, aggressiveness, hos- tility • Withdrawal symptoms: headache, nausea, vomiting, muscle pain, weakness • Appetite, sleep, speech patterns • For attention span, decreased hyper- activity in persons with ADHD • Pregnancy/breastfeeding: no well- controlled studies; use only if benefit outweighs fetal risk; avoid breastfeeding, excretion is unknown
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SIDE EFFECTS CNS: Dizziness, headache, drowsiness, nervousness, insomnia, toxic psychosis, neuroleptic malignant syndrome (rare), Tourette’s syndrome CV: Palpitations, B/P changes, angina, dysrhythmias, tachycardia, MI, stroke GI: Nausea, anorexia, abnormal hepatic function, hepatic coma, abdominal pain HEMA: Leukopenia, anemia, thrombocy- topenic purpura INTEG: Exfoliative dermatitis, urticaria, rash, erythema multiforme MISC: Fever, arthralgia, scalp hair loss, rhabdomyolysis
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INTERACTIONS Increase: hypertensive crisis—MAOIs or within 14 days of MAOIs, vasopressors Increase: sympathomimetic effect— decongestants, vasoconstrictors Increase: effects of anticonvulsants, tricy- clics, SSRIs, coumarin Increase: serious adverse reactions with clonidine, other centrally acting alpha-2 agonists, avoid concurrent use Decrease: effects of antihypertensives, monitor B/P Decrease: metabolism of anticoagulants, phenytoins, barbiturates, TCAs, dose adjustment may be needed Drug/Herb • Synergistic effect—melatonin
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TREATMENT OF OVERDOSE: Administer fluids; hemodialysis: or peri- D toneal dialysis; antihypertensive for increased B/P; administer short-acting barbiturate prior to lavage
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DOSAGE AND ROUTES • Adult/adolescent/child ≥6 yr: (imme- diate release) PO 2.5 mg bid with doses at least 4 hr apart, gradually increase to a maximum of 20 mg/day (10 mg bid); for those taking methylphenidate, use ½ of methylphenidate dose initially, then in- crease as needed to a max of 20 mg/day • Adolescent/child ≥6 yr: EXTENDED RELEASE 5 mg/day, (not taking methyl- phenidate/dexmethylphenidate) may adjust to 20 mg/day in 5-mg increments, max 30 mg/day • Adult: PO EXTENDED RELEASE 10 mg/day, may adjust to 20 mg/day in 10- mg increments, max 40 mg/day
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Available forms: Tablets 2.5, 5, 10 mg; extended-release capsules 5, 10, 15, 20, 25, 30, 35, 40 mg
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Administer: • Twice daily at least 4 hr apart; extended release once a day; in the morning, ex- tended-release capsule may be opened and contents sprinkled onto applesauce and consumed without chewing • Without regard to meals • Do not break, crush, or chew ex- tended-release product • Med guide should be provided by dispenser
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Assess:
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Evaluate: • Therapeutic response: decreased hy- peractivity or ability to stay awake
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To decrease caffeine consumption (coffee, tea, cola, chocolate); may in- crease irritability, stimulation • To take early in day to prevent insom- nia; not to take more than prescribed, dependence may occur • To avoid OTC preparations unless ap- proved by prescriber; to avoid alcohol in- gestion • To taper off product over several weeks to avoid depression, increased sleeping, lethargy • To report weight loss; anorexia may occur • To avoid hazardous activities until sta- bilized on medication • To get needed rest; patients will feel more tired at end of day • To notify all health care workers, including school nurse, of medication and schedule • About information, instructions pro- vided in patient information section • To notify prescriber if pregnancy is planned or suspected; to avoid breastfeeding • To report toxicity immediately: vomiting, agitation, tremor, hyperreflexia, euphoria, confusion, hallucinations, flushing, headache, tachycardia, rhabdomyolysis
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PHARMACOKINETICS Readily absorbed, elimination half-life 2.2 hr, metabolized by liver, excreted by kidneys PO: Peak 1½ hr, onset ½-1 hr PO-ER: Onset unknown, peak 4 hr
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• Adult/adolescent/child ≥6 yr: (imme- diate release) PO 2.5 mg bid with doses at least 4 hr apart, gradually increase to a maximum of 20 mg/day (10 mg bid); for those taking methylphenidate, use ½ of methylphenidate dose initially, then in- crease as needed to a max of 20 mg/day
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• Adolescent/child ≥6 yr: EXTENDED RELEASE 5 mg/day, (not taking methyl- phenidate/dexmethylphenidate) may adjust to 20 mg/day in 5-mg increments, max 30 mg/day
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• Adult: PO EXTENDED RELEASE 10 mg/day, may adjust to 20 mg/day in 10- mg increments, max 40 mg/day
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