Ritalin

INDICATIONS AND USAGE

Ritalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy.

WARNINGS AND PRECAUTIONS

ABUSE AND DEPENDENCE CNS stimulants, including Ritalin and Ritalin-SR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence.

ADVERSE REACTIONS

The following are discussed in more detail in other sections of the labeling: Abuse and Dependence, Drug Abuse and Dependence. Known hypersensitivity to methylphenidate or other ingredients of Ritalin and Ritalin-SR. Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors, Drug Interactions. Serious Cardiovascular Reactions Blood Pressure and Heart Rate Increases, Psychiatric Adverse Reactions, Priapism, Peripheral Vasculopathy, including Raynaud’s Phenomenon, Long-term Suppression of Growth

OVERDOSE

Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions (which may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, hypotension, tachypnea, mydriasis, dryness of mucous membranes, and rhabdomyolysis. Fatal poisoning is usually preceded by convulsions and coma.

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf