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Cotempla XR-ODT
methylphenidate
Black Box Warnings .
Abuse, Misuse, and Addiction
CNS stimulants have high potential for abuse and misuse, can lead to substance use disorder, incl. addiction; misuse and abuse can result in overdose and death, risk incr. w/ higher doses or unapproved admin. methods; assess risk for abuse, misuse, and addiction before prescribing and throughout tx; educate pts and families about risks and proper drug storage and disposal; monitor frequently for s/sx of abuse, misuse, and addiction during tx
Adult Dosing .
Adult dosing is currently unavailable or not applicable for this drug.
Peds Dosing .
- Dosage forms: ER ODT (25% IR/75% ER): 8.6 mg, 17.3 mg, 25.9 mg
Special Note
- [formulation clarification]
- Info: methylphenidate ER products not interchangeable; do not substitute on a mg to mg basis
ADHD
- [6-17 yo]
- Dose: 17.3-51.8 mg PO qam; Start: 17.3 mg PO qam, may incr. by 8.6-17.3 mg/day q7 days; Max: 51.8 mg/day; Info: duration 12h; give consistently w/ or w/o food; do not crush/chew ODT form
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]