![]() If such symptoms occur, consider discontinuing methylphenidate hydrochloride. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).ĬNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. Induction of a Manic Episode in Patients with Bipolar DisorderĬNS stimulants may induce a manic or mixed mood episode in patients. ![]() Long-Term Suppression of Growth: Monitor height and weight at appropriate intervals in pediatric patients (įULL PRESCRIBING INFORMATION: CONTENTS * WARNING: ABUSE AND DEPENDENCE 1 INDICATIONS AND USAGE 2ĝOSAGE AND ADMINISTRATION 2.1 Pretreatment Screening 2.2 General Dosing Information 2.3ĝose Reduction and Discontinuation 3ĝOSAGE FORMS AND STRENGTHS 4ĜONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Potential for Abuse and Dependence 5.2 Serious Cardiovascular Reactions 5.3ělood Pressure and Heart Rate Increases 5.4 Psychiatric Adverse Reactions 5.5 Priapism 5.6 Peripheral Vasculopathy, Including Raynaud’s Phenomenon 5.7 Long-Term Suppression of Growth 6ĚDVERSE REACTIONS 7ĝRUG INTERACTIONS 7.1Ĝlinically Important Drug Interactions With Methylphenidate Hydrochloride 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 9ĝRUG ABUSE AND DEPENDENCE 9.1Ĝontrolled Substance 9.2Ěbuse 9.3ĝependence 10 OVERDOSAGE 11ĝESCRIPTION 12ĜLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1Ĝarcinogenesis, Mutagenesis, and Impairment of Fertility 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.ĬNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder.Careful observation for digital changes is necessary during treatment with ADHD stimulants ( Peripheral Vasculopathy, Including Raynaud’s Phenomenon: Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon.Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed ( Priapism: Cases of painful and prolonged penile erections, and priapism have been reported with methylphenidate products.Evaluate for preexisting psychotic or bipolar disorder prior to methylphenidate hydrochloride use ( ![]() Psychiatric Adverse Reactions: Use of stimulants may cause psychotic or manic symptoms in patients with no prior history or exacerbation of symptoms in patients with preexisting psychiatric illness.Consider the benefits and risk in patients for whom an increase in blood pressure or heart rate would be problematic ( Blood Pressure and Heart Rate Increases: Monitor blood pressure and pulse.Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm arrhythmias, or coronary artery disease ( In adults, sudden death, stroke, and myocardial infarction have been reported. Serious Cardiovascular Events: Sudden death has been reported in association with CNS-stimulant treatment at usual doses in pediatric patients with structural cardiac abnormalities or other serious heart problems.
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