Brand names: Dexmethylphenidate Hydrochloride
Route: Oral
FDA Black Box Warning
WARNING: ABUSE, MISUSE, AND ADDICTION Dexmethylphenidate hydrochloride extended-release has 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 dexmethylphenidate hydrochloride extended-release, can result in overdose and death [see Overdosage ( 10 )], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dexmethylphenidate hydrochloride extended-release, 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 dexmethylphenidate hydrochloride extended-release treatment, reasses s 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 ), Drug Abuse and Dependence ( 9.2 )]. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. Dexmethylphenidate hydrochloride extended-release has 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 dexmethylphenidate hydrochloride extended-release, can result in overdose and death (5.1, 9.2, 10). Before prescribing dexmethylphenidate hydrochloride extended-release , 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 treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6.1 )]. Concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions ( 7.1 )]. Known hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release ( 4 ). Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 4 ).
Pregnancy & Breastfeeding
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including dexmethylphenidate hydrochloride extended-release, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. Risk Summary Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants during pregnancy ( see Clinical Considerations ). Embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 5 times the maximum recommended human dose (MRHD) of 20 mg/day given to adults based on plasma levels. A decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 5 times the MRHD of 20 mg/day given to adults based on plasma levels ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions CNS stimulants such as dexmethylphenidate hydrochloride extended-release, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylp
25 interactions on record
Concomitant use can cause hypertensive crisis with potential outcomes including death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Source: NLP:dexmethylphenidate hydrochloride
Concomitant use can cause hypertensive crisis with potential outcomes including death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Source: NLP:dexmethylphenidate hydrochloride
Dexmethylphenidate hydrochloride extended-release should not be used in patients being treated with MAO Inhibitors currently or within the preceding 2 weeks.
Source: NLP:dexmethylphenidate hydrochloride
Concomitant use can cause hypertensive crisis with potential outcomes including death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Source: NLP:dexmethylphenidate hydrochloride
Concomitant use can cause hypertensive crisis with potential outcomes including death, stroke, myocardial infarction, aortic dissection, and renal failure.
Source: NLP:dexmethylphenidate hydrochloride
Concomitant use can cause hypertensive crisis with potential outcomes including death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Source: NLP:dexmethylphenidate hydrochloride
Concomitant use can cause hypertensive crisis with potential outcomes including death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Source: NLP:dexmethylphenidate hydrochloride
Concomitant use can cause hypertensive crisis with potential outcomes including death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Source: NLP:dexmethylphenidate hydrochloride
Methylphenidate may inhibit the metabolism of clomipramine. Downward dose adjustments may be required and plasma drug concentration should be monitored.
Source: NLP:dexmethylphenidate hydrochloride
Concomitant use may increase risk of sudden blood pressure and heart rate increase during surgery. Avoid use on day of surgery.
Source: NLP:dexmethylphenidate hydrochloride
Methylphenidate may inhibit the metabolism of desipramine. Downward dose adjustments may be required and plasma drug concentration should be monitored.
Source: NLP:dexmethylphenidate hydrochloride
Concomitant use may increase risk of sudden blood pressure and heart rate increase during surgery. Avoid use on day of surgery.
Source: NLP:dexmethylphenidate hydrochloride
Concomitant use may increase risk of sudden blood pressure and heart rate increase during surgery. Avoid use on day of surgery.
Source: NLP:dexmethylphenidate hydrochloride
Methylphenidate may inhibit the metabolism of imipramine. Downward dose adjustments may be required and plasma drug concentration should be monitored.
Source: NLP:dexmethylphenidate hydrochloride
Concomitant use may increase risk of sudden blood pressure and heart rate increase during surgery. Avoid use on day of surgery.
Source: NLP:dexmethylphenidate hydrochloride
Methylphenidate may inhibit the metabolism of coumarin anticoagulants. Downward dose adjustments may be required and coagulation times should be monitored.
Source: NLP:dexmethylphenidate hydrochloride
Methylphenidate may inhibit the metabolism of phenobarbital. Downward dose adjustments may be required and plasma drug concentration should be monitored.
Source: NLP:dexmethylphenidate hydrochloride
Methylphenidate may inhibit the metabolism of phenytoin. Downward dose adjustments may be required and plasma drug concentration should be monitored.
Source: NLP:dexmethylphenidate hydrochloride
Dexmethylphenidate hydrochloride extended-release should be used cautiously with pressor agents due to possible effects on blood pressure.
Source: NLP:dexmethylphenidate hydrochloride
Methylphenidate may inhibit the metabolism of primidone. Downward dose adjustments may be required and plasma drug concentration should be monitored.
Source: NLP:dexmethylphenidate hydrochloride
Concomitant use may increase risk of sudden blood pressure and heart rate increase during surgery. Avoid use on day of surgery.
Source: NLP:dexmethylphenidate hydrochloride
Concomitant use may increase risk of sudden blood pressure and heart rate increase during surgery. Avoid use on day of surgery.
Source: NLP:dexmethylphenidate hydrochloride
Coadministration of acid suppressants could alter the release of dexmethylphenidate due to pH-dependent modified release characteristics.
Source: NLP:dexmethylphenidate hydrochloride
Coadministration of antacids could alter the release of dexmethylphenidate due to pH-dependent modified release characteristics.
Source: NLP:dexmethylphenidate hydrochloride
Combined use with dosage changes in either or both medications may increase risk of extrapyramidal symptoms. Monitor for EPS signs.
Source: NLP:dexmethylphenidate hydrochloride