FOCALIN

AbsorptionDexmethylphenidate hydrochloride is readily absorbed following oral administration of Focalin. In patients with ADHD, plasma dexmethylphenidate concentrations increase rapidly, reaching a maximum in the fasted state at about 1 to 1.5 hours postdose. No differences in the pharmacokinetics of Focalin were noted following single and repeated twice daily dosing, thus indicating no significant drug accumulation in children with ADHD. After single dose administration of Focalin to pediatric...

The efficacy of Focalin for the treatment of ADHD was established in two double-blind, parallel-group, placebo-controlled trials in untreated or previously treated patients (ages 6 to 17 years old) who met The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD inattentive, hyperactive-impulsive, or combined inattentive/hyperactive-impulsive subtypes. The sample was predominantly younger (ages 6 to 12 years); thus, the findings are most pertinent to this age group. In Study 1, patients were randomized to receive either Focalin (5, 10, or 20 mg/day t...

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 Focalin [see Contraindications ( 4 )]
• Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )]
• Risks to Patients with Serious Cardiac Disease [see Warn...

• Hypersensitivity to methylphenidate or other components of Focalin. 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 h...

• Risks to Patients with Serious Cardiac Disease : Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac 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 Focalin, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider disco...

7 DRUG INTERACTIONS

• Antihypertensive Drugs : Monitor blood pressure. Adjust dosage of antihypertensive drug as needed ( 7.1 ). 7.1 Clinically Important Drug Interactions with Focalin Table 2 presents clinically important drug interactions with Focalin.

Table 2Clinically Important Drug Interactions with Focalin Monoamine Oxidase Inhibitors (MAOIs) Clinical impact Concomitant use of MAOIs and CN...