Indications for: RITALIN LA

Attention deficit hyperactivity disorder.

Clinical Trials:

Children and Adolescents

  • Approval of Ritalin LA was based on a randomized, double-blind, placebo-controlled, parallel group clinical study in 134 children ages 6 to 12 with DSM-IV diagnoses of ADHD. Patients received a single morning dose of Ritalin LA 10 to 40 mg/day or placebo for up to 2 weeks.

  • The patient’s regular schoolteacher completed the Conners ADHD/DSM-IV Scale for Teachers (CADS-T) at baseline and the end of each week. The CADS-T assesses symptoms of hyperactivity and inattention. The change from baseline of the (CADS-T) scores during the last week of treatment was analyzed as the primary efficacy parameter.

  • Ritalin LA achieved a statistically significant improvement in symptom scores from baseline (-10.7 points) compared with placebo (+2.8 points).

Adults and Children:

<6yrs: not established. Swallow whole or sprinkle contents onto applesauce (swallow immediately); do not crush, chew, or divide beads. ≥6yrs: initially 20mg once daily in the AM, may increase by 10mg weekly; max 60mg/day. Switching from other methylphenidate products: see full labeling.

RITALIN LA Contraindications:

During or within 14 days of MAOIs.

Boxed Warning:

Abuse and dependence.

RITALIN LA Warnings/Precautions:

High potential for abuse and dependence: monitor. Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors of developing a manic episode prior to initiation. Consider discontinuing if new psychotic/manic symptoms occur. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Monitor growth (esp. children), BP, HR. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.

See Also:

RITALIN LA Classification:

CNS stimulant.

RITALIN LA Interactions:

See Contraindications. Hypertensive crisis with MAOIs. Avoid concomitant use with halogenated anesthetics (eg, halothane, isoflurane), alcohol. May antagonize antihypertensive drugs (eg, K+-sparing or thiazide diuretics, CCBs, ACE inhibitors, ARBs, beta blockers, centrally acting alpha-2 receptor agonists); monitor and adjust dose of antihypertensives as needed. Concomitant risperidone may increase risk of extrapyramidal symptoms; monitor.

Adverse Reactions:

Headache, insomnia, abdominal pain, decreased appetite, anorexia, tachycardia, palpitations, anxiety, hyperhidrosis, weight loss, dry mouth, nausea; priapism, hypertension.


  • The absolute oral bioavailability of methylphenidate in children was 22 ± 8% for d-methylphenidate and 5 ± 3% for lmethylphenidate, suggesting pronounced presystemic metabolism. Biotransformation of methylphenidate by the carboxylesterase CES1A1 is rapid and extensive leading to the main, de-esterified metabolite α-phenyl-2-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity.

Drug Elimination:

  • After oral administration, 78% to 97% of the dose is excreted in the urine and 1% to 3% in feces in the form of metabolites within 48 to 96 hours.

  • Most of the dose is excreted in the urine as alpha-phenyl-2-piperidine acetic acid (60% to 86%).

  • The systemic clearance is 0.40 ± 0.12 L/h/kg for d-methylphenidate and 0.73 ± 0.28 L/h/kg for l-methylphenidate.

  • Elimination half-life is about 3.5 hours (range, 1.3 to 7.7 hours) in adults, and 2.5 hours (range, 1.5 to 5.0 hours) in children.

Generic Drug Availability:


How Supplied:

Caps, tabs—100