Ritalin

— THERAPEUTIC CATEGORIES —
  • ADHD
  • Sleep-wake disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Ritalin Generic Name & Formulations

    Legal Class

    CII

    General Description

    Methylphenidate HCl 5mg, 10mg+, 20mg+; tabs; +scored.

    Pharmacological Class

    CNS stimulant.

    See Also

    How Supplied

    Caps, tabs—100

    How Supplied

    Ritalin Tablets is supplied in bottles of 100 in the following strengths:

    • 5 mg: round, yellow, imprinted “CIBA 7”

    • 10 mg: round, pale green, scored, imprinted “CIBA 3”

    • 20 mg: round, pale yellow, scored, imprinted “CIBA 34”

    Storage

    Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP controlled room temperature]. Protect from light. Dispense in tight, light-resistant container (USP).  

    Manufacturer

    Novartis Pharmaceuticals Corp

    Generic Availability

    YES

    Mechanism of Action

    The mechanism of action of methylphenidate is not completely understood, but it presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

    Ritalin Indications

    Indications

    Attention deficit hyperactivity disorder.

    Ritalin Dosage and Administration

    Prior to Treatment Evaluations

    • Assess for the presence of cardiac disease (eg, a careful history, family history of sudden death or ventricular arrhythmia, and physical exam).

    • Assess the risk of abuse. After prescribing, keep prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for Ritalin use.

    Adult

    Give in 2–3 divided doses preferably 30–45mins before meals. Usual dose: 20–30mg/day. Max 60mg/day.

    Children

    <6yrs: not established. ≥6yrs: initially 5mg twice daily before breakfast and lunch. May increase by 5–10mg weekly; max 60mg/day.

    Ritalin Contraindications

    Contraindications

    During or within 14 days of MAOIs.

    Ritalin Boxed Warnings

    Boxed Warning

    Abuse and dependence.

    Boxed Warning

    Abuse and Dependence

    • High potential for abuse and dependence.

    • Assess the risk of abuse prior to prescribing and monitor during therapy.

    Ritalin Warnings/Precautions

    Warnings/Precautions

    High potential for abuse and dependence: monitor. Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors of developing a manic episode prior to initiation. Consider discontinuing if new psychotic/manic symptoms occur. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Monitor growth (esp. children), BP, HR. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.

    Warnings/Precautions

    Potential for Abuse and Dependence 

    • High potential for abuse and dependence.

    • Assess the risk of abuse prior to prescribing and monitor during therapy.

    Serious Cardiovascular Reactions 

    • Sudden death, stroke, and myocardial infarction have been reported in adults receiving CNS stimulants. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems receiving CNS stimulants.

    • Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems.

    • Evaluate further if exertional chest pain, unexplained syncope, or arrhythmias develop during treatment.

    Blood Pressure and Heart Rate Increases

    • Monitor all patients for potential tachycardia and hypertension.

    Psychiatric Adverse Reactions

    • Exacerbation of pre-existing psychosis: May exacerbate symptoms of behavior disturbance and thought disorders in patients with pre-existing psychotic behavior.

    • Induction of a manic episode in patients with bipolar disorder: May induce a mixed/manic episode in patients with bipolar disorder. Screen for risk factors for developing a manic episode prior to treatment (eg, comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, and depression).

    • New psychotic or manic symptoms: May cause psychotic or manic symptoms in patients without a history of psychotic illness or mania. Consider discontinuing if symptoms occur.

    Priapism

    • Prolonged and painful erections, sometimes requiring surgical intervention, have been reported.

    • Priapism has not been reported during drug initiation but developed after some time on the drug.

    • Seek immediate medical attention if priapism occurs.

    Peripheral Vasculopathy, including Raynaud’s Phenomenon

    • Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown.

    • These signs and symptoms generally improve after reduction in dose or discontinuation.

    • Observe carefully for digital changes during treatment. Evaluate further (eg, rheumatology referral) for certain patients.

    Suppression of Growth 

    • In pediatric patients, closely monitor growth (weight and height).

    • May need to interrupt treatment in patients who are not growing or gaining height or weight as expected.

    Pregnancy Considerations

    Pregnancy Exposure Registry 

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Ritalin, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/.

    Risk Summary

    • Use in pregnant women have not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. 

    • The estimated background risk of major birth defects and miscarriage is unknown.

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: May cause vasoconstriction and may decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported, but premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. 

    Nursing Mother Considerations

    Risk Summary  

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Ritalin and any potential adverse effects on the breastfed infant from Ritalin or from the underlying maternal condition. 

    Clinical Considerations

    • Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

    Pediatric Considerations

    • The safety and efficacy of Ritalin in pediatric patients less than 6 years have not been established.

    • The long-term efficacy of Ritalin in pediatric patients has not been established.

    • Long-Term Suppression of Growth: Monitor growth during treatment with stimulants, including Ritalin. May need to interrupt treatment in pediatric patients who are not growing or gaining weight as expected.

    Geriatric Considerations

    • Ritalin has not been studied in the geriatric population.

    Ritalin Pharmacokinetics

    Absorption

    • The time to peak rate in children was 1.9 hours (0.3 to 4.4 hours) for the Ritalin tablets.

    Distribution

    • Binding to plasma proteins is low (10% to 33%). 

    • The volume of distribution was 2.65 ± 1.11 L/kg for d- methylphenidate and 1.80 ± 0.91 L/kg for l-methylphenidate.

    Metabolism

    • Methylphenidate is metabolized primarily by de-esterification to alpha-phenyl-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity.

    Elimination

    • After oral administration, 78% to 97% of the dose is excreted in the urine and 1% to 3% in feces in the form of metabolites within 48 to 96 hours.

    • Most of the dose is excreted in the urine as alpha-phenyl-2-piperidine acetic acid (60% to 86%).

    Ritalin Interactions

    Interactions

    See Contraindications. Hypertensive crisis with MAOIs. Avoid concomitant use with halogenated anesthetics (eg, halothane, isoflurane), alcohol. May antagonize antihypertensive drugs (eg, K+-sparing or thiazide diuretics, CCBs, ACE inhibitors, ARBs, beta blockers, centrally acting alpha-2 receptor agonists); monitor and adjust dose of antihypertensives as needed. Concomitant risperidone may increase risk of extrapyramidal symptoms; monitor.

    Ritalin Adverse Reactions

    Adverse Reactions

    Headache, insomnia, abdominal pain, decreased appetite, anorexia, tachycardia, palpitations, anxiety, hyperhidrosis, weight loss, dry mouth, nausea; priapism, hypertension.

    Ritalin Clinical Trials

    See Literature

    Ritalin Note

    Not Applicable

    Ritalin Patient Counseling

    Patient Counseling

    Controlled Substance Status/High Potential for Abuse and Dependence

    • Advise patients that Ritalin can be abused and lead to dependence. Do not give Ritalin to anyone else. Store Ritalin in a safe place, preferably locked, to prevent abuse.

    Serious Cardiovascular Risks

    • Advise patients that there is a potential serious cardiovascular risk, including sudden death, myocardial infarction, stroke, and hypertension with Ritalin use. Contact healthcare provider if patients experience symptoms, such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease.

    Blood Pressure and Heart Rate Increases 

    • May cause elevations to blood pressure and pulse rate.

    Psychiatric Risks

    • May cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania.

    Priapism

    • May cause painful or prolonged penile erections. Seek immediate medical attention in the event of priapism.

    Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud’s Phenomenon] 

    • May cause peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. 

    • Contact physician immediately if any signs of unexplained wounds appear on fingers or toes during treatment.

    Suppression of Growth

    • May cause slowing of growth and weight loss.

    Pregnancy Registry

    • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including Ritalin, during pregnancy.

    Ritalin Generic Name & Formulations

    Legal Class

    CII

    General Description

    Methylphenidate HCl 5mg, 10mg+, 20mg+; tabs; +scored.

    Pharmacological Class

    CNS stimulant.

    See Also

      How Supplied

      Tabs—100

      How Supplied

      Ritalin Tablets is supplied in bottles of 100 in the following strengths:

      • 5 mg: round, yellow, imprinted “CIBA 7”

      • 10 mg: round, pale green, scored, imprinted “CIBA 3”

      • 20 mg: round, pale yellow, scored, imprinted “CIBA 34”

       

      Storage

      Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP controlled room temperature]. Protect from light. Dispense in tight, light-resistant container (USP).  

      Manufacturer

      Novartis Pharmaceuticals Corp

      Generic Availability

      YES

      Mechanism of Action

      The mechanism of action of methylphenidate is not completely understood, but it presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

      Ritalin Indications

      Indications

      Narcolepsy.

      Ritalin Dosage and Administration

      Prior to Treatment Evaluations

      • Assess for the presence of cardiac disease (eg, a careful history, family history of sudden death or ventricular arrhythmia, and physical exam).

      • Assess the risk of abuse. After prescribing, keep prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for Ritalin use.

      Adult

      Give in 2–3 divided doses preferably 30–45mins before meals. Usual dose: 20–30mg/day. Max 60mg/day.

      Children

      <6yrs: not established. ≥6yrs: initially 5mg twice daily before breakfast and lunch. May increase by 5–10mg weekly; max 60mg/day.

      Ritalin Contraindications

      Contraindications

      During or within 14 days of MAOIs.

      Ritalin Boxed Warnings

      Boxed Warning

      Abuse and dependence.

      Boxed Warning

      Abuse and Dependence

      • High potential for abuse and dependence.

      • Assess the risk of abuse prior to prescribing and monitor during therapy.

      Ritalin Warnings/Precautions

      Warnings/Precautions

      High potential for abuse and dependence: monitor. Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors of developing a manic episode prior to initiation. Consider discontinuing if new psychotic/manic symptoms occur. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Monitor growth (esp. children), BP, HR. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.

      Warnings/Precautions

      Potential for Abuse and Dependence 

      • High potential for abuse and dependence.

      • Assess the risk of abuse prior to prescribing and monitor during therapy.

      Serious Cardiovascular Reactions 

      • Sudden death, stroke, and myocardial infarction have been reported in adults receiving CNS stimulants. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems receiving CNS stimulants.

      • Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems.

      • Evaluate further if exertional chest pain, unexplained syncope, or arrhythmias develop during treatment.

      Blood Pressure and Heart Rate Increases

      • Monitor all patients for potential tachycardia and hypertension.

      Psychiatric Adverse Reactions

      • Exacerbation of pre-existing psychosis: May exacerbate symptoms of behavior disturbance and thought disorders in patients with pre-existing psychotic behavior.

      • Induction of a manic episode in patients with bipolar disorder: May induce a mixed/manic episode in patients with bipolar disorder. Screen for risk factors for developing a manic episode prior to treatment (eg, comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, and depression).

      • New psychotic or manic symptoms: May cause psychotic or manic symptoms in patients without a history of psychotic illness or mania. Consider discontinuing if symptoms occur.

      Priapism

      • Prolonged and painful erections, sometimes requiring surgical intervention, have been reported.

      • Priapism has not been reported during drug initiation but developed after some time on the drug.

      • Seek immediate medical attention if priapism occurs.

      Peripheral Vasculopathy, including Raynaud’s Phenomenon

      • Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown.

      • These signs and symptoms generally improve after reduction in dose or discontinuation.

      • Observe carefully for digital changes during treatment. Evaluate further (eg, rheumatology referral) for certain patients.

      Suppression of Growth 

      • In pediatric patients, closely monitor growth (weight and height).

      • May need to interrupt treatment in patients who are not growing or gaining height or weight as expected.

      Pregnancy Considerations

      Pregnancy Exposure Registry 

      • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Ritalin, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/.

      Risk Summary

      • Use in pregnant women have not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. 

      • The estimated background risk of major birth defects and miscarriage is unknown.

      Clinical Considerations

      • Fetal/Neonatal Adverse Reactions: May cause vasoconstriction and may decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported, but premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. 

      Nursing Mother Considerations

      Risk Summary  

      • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Ritalin and any potential adverse effects on the breastfed infant from Ritalin or from the underlying maternal condition. 

      Clinical Considerations

      • Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

      Pediatric Considerations

      • The safety and efficacy of Ritalin in pediatric patients less than 6 years have not been established.

      • The long-term efficacy of Ritalin in pediatric patients has not been established.

      • Long-Term Suppression of Growth: Monitor growth during treatment with stimulants, including Ritalin. May need to interrupt treatment in pediatric patients who are not growing or gaining weight as expected.

      Geriatric Considerations

      • Ritalin has not been studied in the geriatric population.

      Ritalin Pharmacokinetics

      Absorption

      • The time to peak rate in children was 1.9 hours (0.3 to 4.4 hours) for the Ritalin tablets.

      Distribution

      • Binding to plasma proteins is low (10% to 33%). 

      • The volume of distribution was 2.65 ± 1.11 L/kg for d- methylphenidate and 1.80 ± 0.91 L/kg for l-methylphenidate.

      Metabolism

      • Methylphenidate is metabolized primarily by de-esterification to alpha-phenyl-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity.

      Elimination

      • After oral administration, 78% to 97% of the dose is excreted in the urine and 1% to 3% in feces in the form of metabolites within 48 to 96 hours.

      • Most of the dose is excreted in the urine as alpha-phenyl-2-piperidine acetic acid (60% to 86%).

      Ritalin Interactions

      Interactions

      See Contraindications. Hypertensive crisis with MAOIs. Avoid concomitant use with halogenated anesthetics (eg, halothane, isoflurane), alcohol. May antagonize antihypertensive drugs (eg, K+-sparing or thiazide diuretics, CCBs, ACE inhibitors, ARBs, beta blockers, centrally acting alpha-2 receptor agonists); monitor and adjust dose of antihypertensives as needed. Concomitant risperidone may increase risk of extrapyramidal symptoms; monitor.

      Ritalin Adverse Reactions

      Adverse Reactions

      Headache, insomnia, abdominal pain, decreased appetite, anorexia, tachycardia, palpitations, anxiety, hyperhidrosis, weight loss, dry mouth, nausea; priapism, hypertension.

      Ritalin Clinical Trials

      See Literature

      Ritalin Note

      Not Applicable

      Ritalin Patient Counseling

      Patient Counseling

      Controlled Substance Status/High Potential for Abuse and Dependence

      • Advise patients that Ritalin can be abused and lead to dependence. Do not give Ritalin to anyone else. Store Ritalin in a safe place, preferably locked, to prevent abuse.

      Serious Cardiovascular Risks

      • Advise patients that there is a potential serious cardiovascular risk, including sudden death, myocardial infarction, stroke, and hypertension with Ritalin use. Contact healthcare provider if patients experience symptoms, such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease.

      Blood Pressure and Heart Rate Increases 

      • May cause elevations to blood pressure and pulse rate.

      Psychiatric Risks

      • May cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania.

      Priapism

      • May cause painful or prolonged penile erections. Seek immediate medical attention in the event of priapism.

      Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud’s Phenomenon] 

      • May cause peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. 

      • Contact physician immediately if any signs of unexplained wounds appear on fingers or toes during treatment.

      Suppression of Growth

      • May cause slowing of growth and weight loss.

      Pregnancy Registry

      • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including Ritalin, during pregnancy.

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