General Information

Ritalin (methylphenidate hydrochloride) is a central nervous system (CNS) stimulant.

Ritalin and Ritalin SR (sustained release) are indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy

Ritalin LA (long acting) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age

The recommended dosing/administration is as follows:

Ritalin Tablets:

• Pediatric Patients 6 Years and Older: Start with 5 mg twice daily (before breakfast and lunch), titrating the dose weekly in 5- to 10-mg increments. Dosages above 60 mg/day are not recommended.
• Adults: Average daily dosage is 20 mg to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg.

Ritalin-SR Extended-Release Tablets

May switch to Ritalin-SR when the 8-hour dosage of Ritalin-SR corresponds to the titrated 8-hour dosage of Ritalin. Must be swallowed whole and never crushed or chewed.

Ritalin LA:

• Administer orally once daily in the morning.
• Capsules may be swallowed whole, or opened and the entire contents sprinkled on applesauce. Should not be crushed, chewed, or divided.
• Patients new to methylphenidate: Start at 20 mg daily, titrating the dose weekly in 10-mg increments. Doses above 60 mg daily are not recommended.
• For patients currently using Ritalin or Ritalin-SR: Dosage is based on current dose regimen.
• If switching from other methylphenidate products, discontinue treatment and titrate with Ritalin LA

Mechanism of Action

Methylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD and narcolepsy is not known.

Side Effects

Adverse events associated with the use of Ritalin LA may include (but are not limited to) the following:

• Headache
• Insomnia
• Upper abdominal pain
• Decreased appetite
• Anorexia

Adverse events associated with the use of Ritalin and Ritalin SR may include (but are not limited to) the following:

• tachycardia
• palpitations
• headache
• insomnia
• anxiety
• hyperhidrosis
• weight loss
• decreased appetite
• dry mouth
• nausea
• abdominal pain

Clinical Trial Results

The approval of Ritalin LA is based on results from a randomized, double-blind, placebo-controlled study involving 134 pediatric subjects, ages 6 to 12, with DSM IV diagnoses of ADHD. Subjects received a single morning dose of Ritalin LA or placebo, for up to two weeks. Efficacy was measured through the Conners ADHD Scale for Teachers (CADS-T), completed at baseline and the end of each week by the child's regular school teacher. The CADS-T assesses symptoms of hyperactivity and inattention. The change from baseline scores to those during the last week of treatment was analyzed as the primary efficacy parameter. Subjects treated with Ritalin LA showed a statistically significant improvement in symptom scores from baseline over those who received placebo.