Indications for: RITALIN LA
Attention deficit hyperactivity disorder.
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.
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.
RITALIN LA Classification:
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.
Headache, insomnia, abdominal pain, decreased appetite, anorexia, tachycardia, palpitations, anxiety, hyperhidrosis, weight loss, dry mouth, nausea; priapism, hypertension.
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: