Ritalin LA

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

WARNING: ABUSE, MISUSE, AND ADDICTION

Ritalin LA has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Ritalin LA, can result in overdose and death [see Overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing Ritalin LA, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout Ritalin LA treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2)].

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 treating patients with Ritalin LA, assess:

for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].
the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating Ritalin LA [see Warnings and Precautions ( 5.10 )] .

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.

2.3 Patients Currently Using Ritalin

The recommended dose of Ritalin LA for patients currently taking Ritalin twice daily is provided below in Table 1.

Table 1: Recommended Dose Conversion from Ritalin

Previous Ritalin dose

Recommended Ritalin LA dose

5 mg Ritalin twice daily

10 mg once daily

10 mg Ritalin twice daily

20 mg once daily

15 mg Ritalin twice daily

30 mg once daily

20 mg Ritalin twice daily

40 mg once daily

30 mg Ritalin twice daily

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 Dosage 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 Abuse, Misuse, and Addiction

Ritalin LA has a high potential for abuse and misuse. The use of Ritalin LA exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Ritalin LA can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2)]. Misuse and abuse of CNS stimulants, including Ritalin LA, can result in overdose and death [see Overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing Ritalin LA, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store Ritalin LA in a safe place, preferably locked, and instruct patients to not give Ritalin LA to anyone else. Throughout Ritalin LA treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

5.2 Risks to Patients with Serious Cardiac Disease

Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who are treated with CNS stimulants at the recommended ADHD dosage.

Avoid Ritalin LA use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.

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