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Caution with history of drug dependence or alcoholism. Marked tolerance and psychological dependence may result from chronic abusive use. Frank psychotic episodes may occur, especially with parenteral abuse. Careful supervision required for withdrawal from abusive use to avoid severe depression. Withdrawal following chronic use may unmask symptoms of underlying disorder that may require follow-up.
Ritalin SR (Novartis), Ritalin LA (Novartis)
(Cap, Extended-Release) Treatment of attention deficit hyperactivity disorder. (Tab; Tab, Sustained-Release) Treatment of attention deficit disorders and narcolepsy.
Adults: Individualize dose. Reduce dose or d/c if paradoxical aggravation of symptoms occurs. D/C if no improvement after appropriate dose adjustment over a 1-month period. (Tab) 10-60mg/day divided bid-tid 30-45 min ac. Take last dose before 6 pm if insomnia occurs. (Tab, SR) May be used in place of immediate-release (IR) tab when the 8-hr dose corresponds to the titrated 8-hr IR dose. Swallow whole; do not crush or chew. (Cap, ER) Initial: 10-20mg qam. Titrate: May adjust weekly by 10mg. Max: 60mg/day. Currently on Methylphenidate: May be used in place of IR or SR tabs with a qd equivalent dose; refer to PI for recommended dosing. Swallow whole; do not crush, chew, or divide.
Pediatrics: ≥6 yrs: Individualize dose. Reduce dose or d/c if paradoxical aggravation of symptoms occurs. D/C if no improvement after appropriate dose adjustment over a 1-month period. (Tab) Initial: 5mg bid before breakfast and lunch. Titrate: Increase gradually by 5-10mg weekly. Max: 60mg/day. (Tab, SR) May be used in place of IR tab when the 8-hr dose corresponds to the titrated 8-hr IR dose. Swallow whole; do not crush or chew. (Cap, ER) Initial: 10-20mg qam. Titrate: May adjust weekly by 10mg. Max: 60mg/day. Currently on Methylphenidate: May be used in place of IR or SR tabs with a qd equivalent dose; refer to PI for recommended dosing. Swallow whole; do not crush, chew, or divide.
Cap, Extended-Release (Ritalin LA): 10mg, 20mg, 30mg, 40mg; Tab (Ritalin): 5mg, 10mg*, 20mg*; Tab, Sustained-Release (Ritalin SR): 20mg *scored
Marked anxiety, tension, agitation, glaucoma, motor tics or family history or diagnosis of Tourette's syndrome. Treatment with or within a minimum of 14 days following d/c of an MAOI.
Sudden death, stroke, and myocardial infarction (MI) reported; avoid with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease or other serious cardiac problems. May increase BP and HR; caution with preexisting HTN, heart failure, MI, or ventricular arrhythmias. Assess patients for cardiac disease prior to initiating therapy; promptly perform cardiac evaluation if symptoms suggestive of cardiac disease develop. May exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. May induce mixed/manic episode in patients with bipolar disorder; assess for bipolar disease before starting therapy. May cause treatment-emergent psychotic or manic symptoms in children and adolescents without prior history of psychotic illness or mania at usual doses. Aggressive behavior or hostility reported. May cause growth suppression in children. May lower convulsive threshold; d/c if seizures occur. Visual disturbances reported. Not for use in children <6 yrs. (Tab; Tab, SR) Patients with an element of agitation may react adversely; d/c therapy if necessary. Not indicated in all cases of this behavioral syndrome, and in symptoms associated with acute stress reactions. D/C drug periodically to assess child's condition; therapy should not be indefinite. (Cap, ER) Periodically reevaluate the usefulness of therapy.
Nervousness, insomnia, hypersensitivity, anorexia, nausea, dizziness, headache, dyskinesia, drowsiness, BP and pulse changes, tachycardia, weight loss, abdominal pain, decreased appetite.
See Contraindications. Caution with pressor agents. May decrease effectiveness of antihypertensives. May inhibit metabolism of coumarin anticoagulants, anticonvulsants, TCAs; may need to adjust dose of these drugs downward and monitor plasma drug levels/coagulation times when starting/stopping methylphenidate therapy. Possible occurrence of neuroleptic malignant syndrome (NMS) with concurrent therapies associated with NMS; single report of NMS-like event possibly related with concurrent use of venlafaxine. (Cap, ER) Release may be altered by antacids or acid suppressants. May be associated with pharmacodynamic interaction when coadministered with direct and indirect dopamine agonists (eg, DOPA and TCAs) as well as dopamine antagonists (antipsychotics, eg, haloperidol).
Category C, caution in nursing.
Sympathomimetic amine; not established. CNS stimulant, thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of monoamines into the extraneuronal space. Presumably activates the brain stem arousal system and cortex to produce stimulant effect.
Absorption: (Cap, ER 20mg) Adults: Tmax1=2 hrs, Cmax1=5.3ng/mL, Tmax2=5.5 hrs, Cmax2=6.2ng/mL, AUC=45.8ng•hr/mL. Pediatrics: Tmax1=2 hrs, Cmax1=10.3ng/mL, Tmax2=6.6 hrs, Cmax2=10.2ng/mL, AUC=86.6ng•hr/mL. Distribution: (Cap, ER) Plasma protein binding (10%-33%); Vd=2.65L/kg (d-methylphenidate), 1.8L/kg (l-methylphenidate). Metabolism: Rapid and extensive by carboxylesterase CES1A1; α-phenyl-2-piperidine acetic acid (major metabolite). Elimination: (Tab) Urine (78-97% metabolites, <1% unchanged), feces (1-3% metabolites). (Tab, SR) Urine (86% adults; 67% pediatrics). (Tab; Cap, ER) T1/2=3.5 hrs (adults), 2.5 hrs (pediatrics).
Assess for cardiac disease, psychotic disorders, bipolar disorder, seizures, history of drug dependence or alcoholism, acute stress reactions, and any other conditions where treatment is contraindicated or cautioned. Assess pregnancy/nursing status, and for possible drug interactions. Obtain baseline height/weight in children, and CBC, differential and platelet counts.
Monitor for signs and symptoms of cardiac disease, increased BP and HR, exacerbations of behavior disturbances and thought disorders, psychotic or manic symptoms, aggression, hostility, seizures, and visual disturbances. Monitor growth in children. In patients with bipolar disorder, monitor for mixed/manic episode. Perform periodic monitoring of CBC, differential, and platelet counts during prolonged therapy.
Inform about risks, benefits, and appropriate use of treatment. Instruct to read the Medication Guide.
Administration: Oral route. (Cap, ER) May sprinkle contents over spoonful of applesauce if desired. Storage: 25°C (77°F); excursions permitted to 15-30°C (59-86°F). (Tab) Protect from light. (Tab, SR) Protect from moisture.