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Check Drug InteractionsMethylphenidate Hydrochloride Prescribing Information
WARNING: ABUSE, MISUSE, AND ADDICTION
Methylphenidate hydrochloride tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride tablets, can result in overdose and death [
Before prescribing methylphenidate hydrochloride tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout methylphenidate hydrochloride tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [
see Overdosage (10)
], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.Before prescribing methylphenidate hydrochloride tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout methylphenidate hydrochloride tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [
see Warnings and Precautions (5.1) and Drug Abuse and Dependence (9.2)
].| Boxed Warning | 10/2023 |
| Dosage and Administration (2.1) | 10/2023 |
Warnings and Precautions (5.1, 5.2, 5.8, 5.9, 5.10) | 10/2023 |
Methylphenidate hydrochloride tablets are indicated for the treatment of:
• Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults
• Narcolepsy
• Pediatric Patients 6 Years and Older: Start with 5 mg twice daily (before breakfast and lunch), titrating the dose weekly in 5- to 10-mg increments. Dosages above 60 mg/day are not recommended (2.2).
• Adults: Average daily dosage is 20 mg to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg (2.2).
- yellow, round, uncoated tablets debossed with a logo and identification number “NP018” on one side and “5” on the other side.Tablets 5 mg-
- white, round, uncoated, partially scored tablets debossed with a logo and identification number “NP019” on one side and “10” on the other side.Tablets 10 mg-
- light yellow, round, uncoated, partially scored tablets debossed with a logo and identification number “NP020” on one side and “20” on the other side.Tablets 20 mg-
Pregnancy
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available