Generic Name: methylphenidate hydrochloride
Brand Name: Apo-Methylphenidate (CAN), Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, PMS-Methylphenidate (CAN), Ritalin, Ritalin LA, Ritalin SR
Other Info: Pregnancy Category C, Controlled Substance C-II
Drug class: CNS stimulant
Mild cortical stimulant with CNS actions similar to those of the amphetamines; efficacy in hyperkinetic syndrome, attention-deficit disorders in children appearsparadoxical 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 CVA 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 Tourettesyndrome; severe depression of endogenous or exogenous origin; normal fatigue states.
- Use cautiously with seizure disorders; hypertension; drug dependence, alcoholism; emotional instability; lactation, pregnancy.
Available forms: 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); transdermal patch—1, 1.6, 2.2, 3.3 mg/hr
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).
PEDIATRIC PATIENTS 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).
PEDIATRIC PATIENTS > 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. Or, 10-30 mg/day by transdermal patch; apply patch 2 hr before effect needed and remove after 9 hr.
PEDIATRIC PATIENTS < 6 YR
|Oral||Varies||1–3 hr||4–6 hr|
Metabolism: Hepatic; T1/2: 1–3 hr (6.8 hr ER)
Distribution: Crosses placenta; may enter 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
- BLACK BOX WARNING: Be aware that drug has potential for abuse, use caution with emotionally unstable patients.
- 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.
- Apply transdermal patch to clean, dry area of the hip approximately 2 hr before effect needed. Remove after 9 hr. Alternate hips.
- 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 smallest 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. Transdermal patch should be applied to clean, dry area of the hip. Remove after 9 hr. Alternate hips.
- Take drug before 6 PM to avoid nighttime sleep disturbance.
- Avoid alcohol and over-the-counter drugs, including nose drops, cold remedies; some over-the-counter 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.
- Keep drug in secure place; do not share with others.
- Report nervousness, insomnia, palpitations, vomiting, rash, fever.