Relexxii Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Ext-rel tabs 18mg, 27mg, 36mg, 54mg—100; 45mg, 63mg, 72mg—30
Manufacturer
Generic Availability
NO
Mechanism of Action
The mode of therapeutic action of methylphenidate HCl in ADHD is not known. Methylphenidate HCl is a CNS stimulant.
Relexxii Indications
Indications
Attention deficit hyperactivity disorder.
Relexxii Dosage and Administration
Adults and Children
Swallow whole with liquids. Take once daily in the AM. <6yrs: not established. Methylphenidate-naive: 6–12yrs: initially 18mg once daily, max 54mg/day; 13–17yrs: initially 18mg once daily, max 72mg daily or 2mg/kg/day (whichever is less). 18–65yrs: initially 18mg or 36mg/day; max 72mg/day. Switching from methylphenidate 5mg 2 or 3 times daily: initially Relexxii 18mg once daily. Switching from methylphenidate 10mg 2 or 3 times daily: initially Relexxii 36mg once daily. Switching from methylphenidate 15mg 2 or 3 times daily: initially Relexxii 54mg once daily. Switching from methylphenidate 20mg 2 or 3 times daily: initially Relexxii 72mg once daily. For all: may adjust in 18mg/day increments at 1-week intervals; max 54mg/day for children; max 72mg/day for adolescents and adults.
Relexxii Contraindications
Contraindications
During or within 14 days of MAOIs.
Relexxii Boxed Warnings
Boxed Warning
Abuse, misuse, and addiction.
Relexxii Warnings/Precautions
Warnings/Precautions
High potential for abuse, misuse, and addiction; assess patient's risk before prescribing. Assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, or other cardiac disease. 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. Seizure disorder. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Pre-existing GI narrowing. Risk for acute angle closure glaucoma. History of increased IOP or open angle glaucoma; monitor closely. Assess family history and evaluate for tics or Tourette’s syndrome before initiating; monitor for emergence or worsening, and discontinue if clinically appropriate. Monitor BP, HR, growth in children. Reduce dose or discontinue if paradoxical aggravation of symptoms occurs. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.
Relexxii Pharmacokinetics
Absorption
Mean times to reach peak plasma concentration: 5.5 hours.
Elimination
Renal (90%). Half-life: ~3.5 hours.
Relexxii Interactions
Interactions
See Contraindications. Hypertensive crisis with MAOIs. Caution with pressor agents. May potentiate coumarin anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone), tricyclics, SSRIs. Risk of serotonin syndrome with serotonergic drugs. Concomitant halogenated anesthetics may increase the risk of sudden BP and HR increase during surgery; avoid use. Concomitant risperidone may increase risk of extrapyramidal symptoms; monitor.
Relexxii Adverse Reactions
Adverse Reactions
Upper abdominal pain, decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability, hyperhidrosis; priapism, hypertension, tachycardia, visual disturbances, possible GI obstruction, motor/verbal tics.
Relexxii Clinical Trials
See Literature
Relexxii Note
Not Applicable
Relexxii Patient Counseling
See Literature
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