Ritalin LA

RITALIN LA- methylphenidate hydrochloride capsule, extended release
Novartis Pharmaceuticals Corporation

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Ritalin LA, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)].

1 INDICATIONS AND USAGE

Ritalin LA® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 Pretreatment Screening

Prior to initiating treatment with central nervous system (CNS) stimulants, including Ritalin LA, assess for the presence of cardiac disease (i.e., perform a careful history, including family history of sudden death or ventricular arrhythmia, and physical examination) [see Warnings and Precautions (5.2)].

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate the need for Ritalin LA use [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)].

2.2 General Dosing Information

The recommended starting dose for Ritalin LA is 20 mg once daily. Increase dosage gradually, in increments of 10 mg weekly. Daily dosage above 60 mg is not recommended. When a lower initial dose is appropriate, patients may begin treatment with 10 mg.

Administer Ritalin LA orally once daily in the morning. Ritalin LA may be swallowed as whole capsules or may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Ritalin LA and/or their contents should not be crushed, chewed, or divided.

The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.

Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of Ritalin and Ritalin-SR, and adjust dosage as needed.

2.3 Patients Currently Using Ritalin or Ritalin-SR

The recommended dose of Ritalin LA for patients currently taking Ritalin twice daily or Ritalin extended-release (SR) is provided below.

Table 1: Recommended Dose Conversion from Ritalin or Ritalin-SR
Previous Ritalin or Ritalin-SR Dose Recommended Ritalin LA Dose
5 mg Ritalin twice daily 10 mg once daily
10 mg Ritalin twice daily or 20 mg Ritalin-SR 20 mg once daily
15 mg Ritalin twice daily 30 mg once daily
20 mg Ritalin twice daily or 40 mg Ritalin-SR 40 mg once daily
30 mg Ritalin twice daily or 60 mg Ritalin-SR 60 mg once daily

2.4 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 for other methylphenidate products on a milligram-per-milligram basis, because different methylphenidate base compositions and differing pharmacokinetic profiles [see Description (11), Clinical Pharmacology (12.3)].

Clinical judgment should be used when selecting the starting dose. Daily dosage above 60 mg is not recommended.

2.5 Dose Reduction and Discontinuation

If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue Ritalin LA. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

3 DOSAGE FORMS AND STRENGTHS

10 mg extended-release capsules white/light brown, (imprinted NVR R10)

20 mg extended-release capsules white, (imprinted NVR R20)

30 mg extended-release capsules yellow, (imprinted NVR R30)

40 mg extended-release capsules light brown, (imprinted NVR R40)

4 CONTRAINDICATIONS

  • Hypersensitivity to methylphenidate or other components of Ritalin LA. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [see Adverse Reactions (6.1)].
  • Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions (7.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Potential for Abuse and Dependence

CNS stimulants, including Ritalin LA, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Boxed Warning, Drug Abuse and Dependence (9.2, 9.3)].

5.2 Serious Cardiovascular Reactions

Sudden death, stroke, and myocardial infarction have been reported in adults with CNS-stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Ritalin LA treatment.

5.3 Blood Pressure and Heart Rate Increases

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 beats per minute). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

5.4 Psychiatric Adverse Reactions

Exacerbation of Preexisting Psychosis

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disorder

CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

New Psychotic or Manic Symptoms

CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Ritalin LA. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0 in placebo-treated patients.

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