REMS
Oral, orally distintegrating tablets, and transdermal:
Oral only:
Absorption: Slow and incomplete after oral administration; absorption of sustained or extended-release tablet (SR) is delayed and provides continuous release; well absorbed from skin. Aptensio XR, Metadate CD, Concerta, Ritalin LA provides initial rapid release followed by a second continuous release (biphasic release).
Distribution: Unknown.
Metabolism/Excretion: Mostly metabolized (80%) by the liver.
Half-life: 24 hr.
CV: SUDDEN DEATH, hypertension, palpitations, tachycardia, hypotension, peripheral vasculopathy.
Derm: contact sensitization (erythema, edema, papules, vesicles) (transdermal), erythema, loss of skin pigmentation (transdermal), rash.
EENT: blurred vision, teeth grinding.
GI: anorexia, constipation, cramps, diarrhea, dry mouth, metallic taste, nausea, vomiting.
GU: priapism.
Metab: growth suppression (especially with prolonged use), weight loss (especially with prolonged use).
MS: RHABDOMYOLYSIS.
Neuro: akathisia, dyskinesia, tics , hyperactivity, insomnia, restlessness, tremor, behavioral disturbances, dizziness, hallucinations, headache, irritability, mania, thought disorder.
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), fever, physical dependence, psychological dependence, tolerance.
Attention-Deficit/Hyperactivity Disorder
- PO (Adults <65 yr): Immediate-release tablets 520 mg 23 times daily. When maintenance dose is determined, may change to extended-release formulation. Methylphenidate SR may be used in place of the immediate-release tablets when the 8-hr dose corresponds to the titrated 8-hr dosage of the immediate-release tablets; Concerta (patients who have not taken methylphenidate previously) 1836 mg once daily in the morning initially, may be titrated as needed up to 72 mg/day. Concerta (patients are currently taking other forms of methylphenidate) 18 mg once daily in the morning if previous dose was 5 mg 23 times daily; 36 mg once daily in the morning if previous dose was 10 mg 23 times daily; 54 mg once daily in the morning if previous dose was 15 mg 23 times daily; 72 mg once daily in the morning if previous dose was 20 mg 23 times daily. Aptensio XR 10 mg once daily; may ↑ dose in 10-mg increments at weekly intervals (maximum dose = 60 mg/day). Quillivant XR and Quillichew ER 20 mg once daily; may ↑ dose in 1020-mg increments at weekly intervals (maximum dose = 60 mg/day). Adhansia XR 25 mg once daily; may ↑ dose in 1015-mg increments at weekly intervals (maximum dose = 100 mg/day). Jornay PM 20 mg once daily in the evening; may ↑ dose in 20-mg increments at weekly intervals (maximum dose = 100 mg/day).
- PO (Children
6 yr [Ritalin LA for children 612 yr]): Immediate-release tablets 0.3 mg/kg/dose or 2.55 mg before breakfast and lunch; may ↑ dose by 0.1 mg/kg/dose or by 510 mg/day at weekly intervals (not to exceed 60 mg/day or 2 mg/kg/day). When maintenance dose is determined, may change to extended-release formulation. Methylphenidate SR may be used in place of the immediate-release tablets when the 8-hr dose corresponds to the titrated 8-hr dosage of the immediate-release tablets; Ritalin LA (patients who have not taken methylphenidate previously) 20 mg once daily; may ↑ by 10 mg/day at weekly intervals (max = 60 mg/day); Ritalin LA (patients currently taking other forms of methylphenidate) can be used in place of immediate-release twice daily regimen given once daily at same total dose, or in place of SR product at same dose; Concerta (patients who have not taken methylphenidate previously) 18 mg once daily in the morning initially, may be titrated as needed up to 54 mg/day (children 612 yr old) or up to 72 mg/day (children 1317 yr old). Concerta (patients are currently taking other forms of methylphenidate) 18 mg once daily in the morning if previous dose was 5 mg 23 times daily; 36 mg once daily in the morning if previous dose was 10 mg 23 times daily; 54 mg once daily in the morning if previous dose was 15 mg 23 times daily; 72 mg once daily in the morning if previous dose was 20 mg 23 times daily. Aptensio XR 10 mg once daily; may ↑ dose in 10-mg increments at weekly intervals (maximum dose = 60 mg/day). Metadate CD 20 mg once daily; may ↑ dose in 20-mg increments at weekly intervals (maximum dose = 60 mg/day). Quillivant XR and Quillichew ER 20 mg once daily; may ↑ dose in 1020-mg increments at weekly intervals (maximum dose = 60 mg/day). Adhansia XR 25 mg once daily; may ↑ dose in 1015-mg increments at weekly intervals (maximum dose = 85 mg/day). Jornay PM 20 mg once daily in the evening; may ↑ dose in 20-mg increments at weekly intervals (maximum dose = 100 mg/day). Cotempla XR-ODT 17.3 mg once daily in the morning; may ↑ dose in 8.617.3-mg increments at weekly intervals (maximum dose = 51.8 mg/day). - Transdermal (Children
6 yr): Apply one 10-mg patch initially (should be applied 2 hr before desired effect and removed 9 hr after application); may be titrated based on response and tolerability; may ↑ to 15-mg patch after 1 wk, and then to 20-mg patch after another wk, and then to 30-mg patch after another wk.
Narcolepsy
- PO (Adults): Immediate-release tablets 10 mg 23 times/day; maximum dose 60 mg/day.
Adhansia XR, Aptensio XR, Concerta, Cotempla XR-ODT, Jornay PM, Metadate CD, Methylin, Methylin ER, Quillichew ER, Quillivant XR, Ritalin, Ritalin LA
methylphenidate (Transdermal): Daytrana
Biphentin, Foquest, Ritalin SR
Therapeutic Classification: central nervous system stimulants