RITALIN LA

Ritalin LA produces a bi-modal plasma concentration-time profile (i.e., 2 distinct peaks approximately 4 hours apart) when administered orally to children diagnosed with ADHD and healthy adults. No accumulation of methylphenidate is expected following multiple once daily oral dosing with Ritalin LA, however, there is a slight upward trend in the methylphenidate area under the curve and peak plasma concentrations (C max1 and C max2 ) after oral administration of Ritalin LA 20 mg and 40 mg capsule...

14.1 Children and Adolescents Ritalin LA was evaluated in a randomized, double-blind, placebo-controlled, parallel group clinical study in which 134 children, ages 6 to 12 years, with DSM-IV diagnoses of ADHD received a single morning dose of Ritalin LA in the range of 10 to 40 mg/day, or placebo, for up to 2 weeks. The doses used were the optimal doses established in a previous individual dose titration phase. In that titration phase, 53 of 164 patients (32%) started on a daily dose of 10 mg and 111 of 164 patients (68%) started on a daily dose of 20 mg or higher. The patient’s regular school...

The following are discussed in more detail in other sections of the labeling:

• Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )]
• Known hypersensitivity to methylphenidate or other ingredients of Ritalin LA [see Contraindications ( 4 )]
• Hypertensive crisis when used concomitantly with Monoamine Oxidase Inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )]
• Risks to Patients with Serious Cardiac Disease [...

• 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 ...

• Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac rhythm arrhythmias, coronary artery disease, or other serious cardiac disease ( 5.2 ).
• Increased Blood Pressure and Heart Rate : Monitor blood pressure and pulse ( 5.3 ).
• Psychiatric Adverse Reactions : Prior to initiating Ritalin LA, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consi...

7 DRUG INTERACTIONS

• Antihypertensive Drugs: Monitor blood pressure and heart. Adjust dosage of antihypertensive drug as needed ( 7.1 ). 7.1 Clinically Important Drug Interactions with Ritalin LA Table 3 presents clinically important drug interactions with Ritalin LA.

Table 3Clinically Important Drug Interactions with Ritalin LA Monoamine Oxidase Inhibitors (MAOI) Clinical impact Concomitant us...