Ritalin La

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

    • Ritalin La Generic Name & Formulations

    Legal Class

    CII

    General Description

    Methylphenidate HCl 10mg, 20mg, 30mg, 40mg; ext-rel caps (one-half as immediate-release + one-half as enteric-coated, delayed-release beads).

    Pharmacological Class

    CNS stimulant.

    See Also

    How Supplied

    Caps, tabs—100

    How Supplied

    Ritalin LA extended-release capsules are supplied in bottles of 100 in the following strengths:

    • 10 mg: white/light brown, (imprinted “NVR R10”) 

    • 20 mg: white, (imprinted “NVR R20”)

    • 30 mg: yellow, (imprinted “NVR R30”) 

    • 40 mg: light brown, (imprinted “NVR R40”)

    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]. Dispense in tight 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 La Indications

    Indications

    Attention deficit hyperactivity disorder.

    Ritalin La 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.

    Adults and Children

    <6yrs: not established. Swallow whole or sprinkle contents onto applesauce (swallow immediately); do not crush, chew, or divide beads. ≥6yrs: initially 20mg once daily in the AM, may increase by 10mg weekly; max 60mg/day. Switching from other methylphenidate products: see full labeling.

    Adults and Children

    General Dosing Information

    • <6yrs: not established. Swallow whole or sprinkle contents onto applesauce (swallow immediately); do not crush, chew, or divide beads. 

    • ≥6yrs: initially 20mg once daily in the AM, may increase by 10mg weekly; max 60mg/day. 

    • Switching from other methylphenidate products: see full labeling.

    Patients Currently Using Ritalin 

    • Previous or current Ritalin Dose of 5 mg twice daily → Recommended Ritalin LA Dose of 10 mg once daily.

    • Previous or current Ritalin Dose of 10 mg twice daily → Recommended Ritalin LA Dose of 20 mg once daily.

    • Previous or current Ritalin Dose of 15 mg twice daily → Recommended Ritalin LA Dose of 30 mg once daily.

    • Previous or current Ritalin Dose of 20 mg twice daily → Recommended Ritalin LA Dose of 40 mg once daily.

    • Previous or current Ritalin Dose of 30 mg twice daily → Recommended Ritalin LA Dose of 60 mg once daily.

    Switching from other Methylphenidate Products

    • If switching from other methylphenidate products, discontinue that treatment, and titrate with Ritalin LA using the titration schedule.

    • Do not substitute on a mg-per-mg basis with other methylphenidate products.

    • Do not exceed daily dosage of 60 mg.

    Ritalin La Contraindications

    Contraindications

    During or within 14 days of MAOIs.

    Ritalin La 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 La 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 La Pharmacokinetics

    Absorption

    • The absolute oral bioavailability of methylphenidate in children was 22 ± 8% for d-methylphenidate and 5 ± 3% for l-methylphenidate. 

    • The relative bioavailability of Ritalin LA given once daily is comparable to the same total dose of Ritalin tablets given in 2 doses 4 hours apart in both children and adults.  

    • The initial rate of absorption for Ritalin LA is similar to that of Ritalin tablets as shown by the similar rate parameters between the 2 formulations, i.e., initial lag time (Tlag), first peak concentration (Cmax1), and time to the first peak (Tmax1), which is reached in 1 to 3 hours.

    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

    • The absolute oral bioavailability of methylphenidate in children was 22 ± 8% for d-methylphenidate and 5 ± 3% for lmethylphenidate, suggesting pronounced presystemic metabolism. Biotransformation of methylphenidate by the carboxylesterase CES1A1 is rapid and extensive leading to the main, de-esterified metabolite α-phenyl-2-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%).

    • The systemic clearance is 0.40 ± 0.12 L/h/kg for d-methylphenidate and 0.73 ± 0.28 L/h/kg for l-methylphenidate.

    • Elimination half-life is about 3.5 hours (range, 1.3 to 7.7 hours) in adults, and 2.5 hours (range, 1.5 to 5.0 hours) in children.

    Ritalin La 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 La Adverse Reactions

    Adverse Reactions

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

    Ritalin La Clinical Trials

    Clinical Trials

    Children and Adolescents

    • Approval of Ritalin LA was based on a randomized, double-blind, placebo-controlled, parallel group clinical study in 134 children ages 6 to 12 with DSM-IV diagnoses of ADHD. Patients received a single morning dose of Ritalin LA 10 to 40 mg/day or placebo for up to 2 weeks.

    • The patient’s regular schoolteacher completed the Conners ADHD/DSM-IV Scale for Teachers (CADS-T) at baseline and the end of each week. The CADS-T assesses symptoms of hyperactivity and inattention. The change from baseline of the (CADS-T) scores during the last week of treatment was analyzed as the primary efficacy parameter.

    • Ritalin LA achieved a statistically significant improvement in symptom scores from baseline (-10.7 points) compared with placebo (+2.8 points).

    Ritalin La Note

    Not Applicable

    Ritalin La 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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