Methylphenidate Hydrochloride (15 brand names, 7 dosage forms, 1 route)
Available dosage forms: SOLUTION, TABLET, EXTENDED RELEASE, CAPSULE, EXTENDED RELEASE, TABLET, CHEWABLE, TABLET, FOR SUSPENSION, EXTENDED RELEASE, TABLET, EXTENDED RELEASE, CHEWABLE.
Routes of administration: ORAL.
Brand Names
- ADHANSIA XR
- APTENSIO XR
- CONCERTA
- JORNAY PM
- METADATE CD
- METADATE ER
- METHYLIN
- METHYLIN ER
- METHYLPHENIDATE HYDROCHLORIDE
- QUILLICHEW ER
- QUILLIVANT XR
- RELEXXII
- RITALIN
- RITALIN LA
- RITALIN-SR
Boxed Warning
QuilliChew ER 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 QuilliChew ER, 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 QuilliChew ER, 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 QuilliChew ER 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)].
Indications and Usage
QuilliChew ER is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 ) ]. Limitations of Use The use of QuilliChew ER is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ) , Use in Specific Populations ( 8.4 ) ].
Adverse Reactions
The following are discussed in more detail in other sections of the labeling: • Known hypersensitivity to methylphenidate products or other ingredients of QuilliChew ER [see Contraindications (4.1)] • Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4.2), Drug Interactions (7.1)] • Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)] • Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2)] • Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3)] • Psychiatric Adverse Reactions [see Warnings and Precautions (5.4)] • Priapism [see Warnings and Precautions (5.5)] • Peripheral Vasculopathy, including Raynaud’s phenomenon [see Warnings and Precautions (5.6)] • Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.7)] • Risks in Phenylketonuria [see Warnings and Precautions (5.8)] • Acute Angle Closure Glaucoma [see Warnings and Precautions (5.9)] • Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.10)] • Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.11)]
Mechanism of Action
Methylphenidate is a central nervous system (CNS) stimulant.
Overdosage
Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of QuilliChew ER should be considered when treating patients with overdose. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.