INDICATIONS AND USAGE
Ritalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy (1).
DOSAGE AND ADMINISTRATION
Ritalin Tablets (2.2):
- 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.
- Adults: Average daily dosage is 20 to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg.
Ritalin-SR Extended-release Tablets (2.2):
- May switch to Ritalin-SR when the 8-hour dosage of Ritalin-SR corresponds to the titrated 8-hour dosage of Ritalin.
- Must be swallowed whole and never crushed or chewed.
———————DOSAGE FORMS AND STRENGTHS———————-
Tablets: 5 mg, 10 mg, and 20 mg (3)
Extended-release Tablets: 20 mg (3)
ADVERSE REACTIONS
Common adverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain (6).
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA1088 or www.fda.gov/medwatch.
CONTRAINDICATIONS
- Known hypersensitivity to methylphenidate or other product components of Ritalin or Ritalin-SR (4).
- Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days (4).
WARNINGS AND PRECAUTIONS
- 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. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm arrhythmias, or coronary artery disease (5.2).
- Blood Pressure and Heart Rate Increases: Monitor blood pressure and pulse. Consider the benefits and risk in patients for whom an increase in blood pressure or heart rate would be problematic (5.3).
- 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. Evaluate for preexisting psychotic or bipolar disorder prior to Ritalin and Ritalin-SR use (5.4).
- Priapism: Cases of painful and prolonged penile erections, and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed (5.5).
- Peripheral Vasculopathy, including Raynaud’s Phenomenon: Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants (5.6).
- Long-Term Suppression of Growth: Monitor height and weight at appropriate intervals in pediatric patients (5.7).
DRUG INTERACTIONS
- Antihypertensive drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed (7).
- Halogenated anesthetics: Avoid use of Ritalin or Ritalin-SR on the day of surgery if halogenated anesthetics will be used (7).
OVERDOSAGE
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.
Overdose Management: Consult with a Certified Poison Control Center (1-800-222-1222) for the latest recommendations.
- Uses
-
INDICATIONS AND USAGE
Ritalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy (1).
DOSAGE AND ADMINISTRATION
Ritalin Tablets (2.2):
- 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.
- Adults: Average daily dosage is 20 to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg.
Ritalin-SR Extended-release Tablets (2.2):
- May switch to Ritalin-SR when the 8-hour dosage of Ritalin-SR corresponds to the titrated 8-hour dosage of Ritalin.
- Must be swallowed whole and never crushed or chewed.
———————DOSAGE FORMS AND STRENGTHS———————-
Tablets: 5 mg, 10 mg, and 20 mg (3)
Extended-release Tablets: 20 mg (3)
- Side Effects
-
ADVERSE REACTIONS
Common adverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain (6).
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA1088 or www.fda.gov/medwatch.
- Precautions
-
CONTRAINDICATIONS
- Known hypersensitivity to methylphenidate or other product components of Ritalin or Ritalin-SR (4).
- Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days (4).
WARNINGS AND PRECAUTIONS
- 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. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm arrhythmias, or coronary artery disease (5.2).
- Blood Pressure and Heart Rate Increases: Monitor blood pressure and pulse. Consider the benefits and risk in patients for whom an increase in blood pressure or heart rate would be problematic (5.3).
- 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. Evaluate for preexisting psychotic or bipolar disorder prior to Ritalin and Ritalin-SR use (5.4).
- Priapism: Cases of painful and prolonged penile erections, and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed (5.5).
- Peripheral Vasculopathy, including Raynaud’s Phenomenon: Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants (5.6).
- Long-Term Suppression of Growth: Monitor height and weight at appropriate intervals in pediatric patients (5.7).
- Interactions
-
DRUG INTERACTIONS
- Antihypertensive drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed (7).
- Halogenated anesthetics: Avoid use of Ritalin or Ritalin-SR on the day of surgery if halogenated anesthetics will be used (7).
- Overdose
-
OVERDOSAGE
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.
Overdose Management: Consult with a Certified Poison Control Center (1-800-222-1222) for the latest recommendations.