(meth ill fen' i date)
Concerta, Metadate CD, Metadate ER, Methylin, Methylin ER, PMS-Methylphenidate (CAN), Riphenidate (CAN), Ritalin, Ritalin LA, Ritalin SR
Pregnancy Category C
Controlled Substance C-II
Mild cortical stimulant with CNS actions similar to those of the amphetamines; efficacy in hyperkinetic syndrome, attention-deficit disorders in children appears paradoxical and is not understood
· Ritalin, Ritalin SR, Metadate ER, Methylin: Narcolepsy
· Attention-deficit disorders, hyperkinetic syndrome, minimal brain dysfunction in children or adults with a behavioral syndrome characterized by the following symptoms: Moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity, not secondary to environmental factors or psychiatric disorders
· Unlabeled use: Treatment of depression in the elderly, cancer and stroke patients; alleviation of neurobehavioral symptoms after traumatic brain injury; improvement in pain control and sedation in patients receiving opiates
Contraindications and cautions
· Contraindicated with hypersensitivity to methylphenidate; marked anxiety, tension, and agitation; glaucoma; motor tics, family history or diagnosis of Tourette syndrome; severe depression of endogenous or exogenous origin; normal fatigue states.
· Use cautiously with seizure disorders; hypertension; drug dependence, alcoholism; emotional instability; lactation, pregnancy.
Tablets—5, 10, 20 mg; chewable tablets—2.5, 5, 10 mg; SR tablets—20 mg; ER tablets—10, 18, 20, 27, 36, 54 mg; ER capsules—20, 30 mg (Metadate CD); and 20, 30, 40 mg (Ritalin LA)
Individualize dosage. Give orally in divided doses bid or tid, preferably 30–45 min before meals; dosage ranges from 10–60 mg/day PO. If insomnia is a problem, drug should be taken before 6 PM. Timed-release tablets have a duration of 8 hr and may be used when timing and dosage are adjusted to the 8-hr daily regimen. ER forms: 18 mg PO daily in the morning; may be increased by 18 mg/day at 1-wk intervals to a maximum of 54 mg/day (Concerta); 20 mg/day to a maximum 60 mg/day (Metadate CD, Ritalin LA).
< 6 yr: Not recommended.
> 6 yr: Start with small oral doses (5 mg PO before breakfast and lunch with gradual increments of 5–10 mg weekly). Daily dosage > 60 mg not recommended. Discontinue use after 1 mo if no improvement. Discontinue periodically to assess condition; usually discontinued after puberty. ER forms: Use adult dosage.
13–17 yr: Initially 18 mg/day PO taken in the morning without regard to food; titrate to a maximum 72 mg/day PO. Do not exceed 2 mg/kg/day. Tablets must be swallowed whole and should not be cut, crushed, or chewed (Concerta).
Metabolism: Hepatic; T1/2: 1–3 hr (6.8 hr ER)
Distribution: Crosses placenta; enters breast milk
· CNS: Nervousness, insomnia, dizziness, headache, dyskinesia, chorea, drowsiness, Tourette syndrome, toxic psychosis, blurred vision, accommodation difficulties
· CV: Increased or decreased pulse and BP; tachycardia, angina, cardiac arrhythmias, palpitations
· Dermatologic: Rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with necrotizing vasculitis and thrombocytopenic purpura, loss of scalp hair
· GI: Anorexia, nausea, abdominal pain, weight loss
· Hematologic: Leukopenia, anemia
· Other: Tolerance, psychological dependence, abnormal behavior with abuse
· Decreased effects of guanethidine; avoid this combination
· Increased effects and toxicity of methylphenidate with MAOIs
· Increased serum levels of phenytoin, TCAs, oral anticoagulants, SSRIs with methylphenidate; monitor for toxicity
· Methylphenidate may increase the urinary excretion of epinephrine
· History: Hypersensitivity to methylphenidate; marked anxiety, tension, and agitation; glaucoma; motor tics, Tourette syndrome; severe depression; normal fatigue state; seizure disorders; hypertension; drug dependence, alcoholism, emotional instability; pregnancy, lactation
· Physical: Weight; T; skin color, lesions; orientation, affect, ophthalmologic examination (tonometry); P, BP, auscultation; R, adventitious sounds; bowel sounds, normal output; CBC with differential, platelet count, baseline ECG
· Ensure proper diagnosis before administering to children for behavioral syndromes; drug should not be used until other causes or concomitants of abnormal behavior (learning disability, EEG abnormalities, neurologic deficits) are ruled out.
· Interrupt drug dosage periodically in children to determine if symptoms warrant continued drug therapy.
· Monitor growth of children on long-term methylphenidate therapy.
· Ensure that all timed-release tablets and capsules are swallowed whole, not chewed or crushed.
· Dispense the least feasible dose to minimize risk of overdose.
· Give before 6 PM to prevent insomnia.
· Monitor CBC and platelet counts periodically in patients on long-term therapy.
· Monitor BP frequently early in treatment.
· Take this drug exactly as prescribed. Timed-release tablets and capsules must be swallowed whole, not chewed or crushed. Metadate CD capsules may be opened and entire contents sprinkled on soft food—do not chew or crush granules.
· Take drug before 6 PM to avoid nighttime sleep disturbance.
· Avoid alcohol and OTC drugs, including nose drops, cold remedies; some OTC drugs could cause dangerous effects.
· You may experience these side effects: Nervousness, restlessness, dizziness, insomnia, impaired thinking (may lessen; avoid driving or engaging in activities that require alertness); headache, loss of appetite, dry mouth.
· Report nervousness, insomnia, palpitations, vomiting, rash, fever.
Adverse effects in Italic are most common; those in Bold are life-threatening.