Aptensio Xr

— THERAPEUTIC CATEGORIES —
  • ADHD

Aptensio Xr Generic Name & Formulations

General Description

Methylphenidate HCl 10mg, 15mg, 20mg, 30mg, 40mg, 50mg, 60mg; ext-rel caps.

Pharmacological Class

CNS stimulant.

How Supplied

Ext-rel caps—90

Manufacturer

Generic Availability

YES

Mechanism of Action

The mode of therapeutic action of methylphenidate HCl in ADHD is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.

Aptensio Xr Indications

Indications

Attention deficit hyperactivity disorder.

Limitations of Use

Pediatrics <6yrs: experienced higher rates of adverse reactions (esp. weight loss).

Aptensio Xr Dosage and Administration

Adults and Children

Individualize. Swallow whole or may open capsule and sprinkle contents onto applesauce. <6yrs: not established. ≥6yrs: 10mg once daily in the AM. May titrate dose in weekly increments of 10mg/day. Max 60mg/day. Discontinue if no improvement after dose adjustment over a 1-month period.

Aptensio Xr Contraindications

Contraindications

During or within 14 days of MAOIs.

Aptensio Xr Boxed Warnings

Boxed Warning

Abuse, misuse, and addiction.

Aptensio Xr 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. 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. Peripheral vasculopathy including Raynaud's phenomenon; monitor for digital changes. Monitor BP, HR, growth in children. Reduce dose or discontinue if paradoxical aggravation of symptoms occurs. Write ℞ for smallest practical amount. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.

Aptensio Xr Pharmacokinetics

Absorption

Maximum plasma concentration reached an initial maximum at about 2 hours, then reaches a second peak at ~8 hours. Relative bioavailability: 102%.

Metabolism

Deesterification to alpha-phenyl-piperidine acetic acid.

Elimination

Renal (90%). Half-life: 5.09–5.43 hours.

Aptensio Xr Interactions

Interactions

See Contraindications. Hypertensive crisis with concomitant MAOIs. Risk of serotonin syndrome with serotonergic drugs. May antagonize antihypertensive drugs; monitor BP and adjust dose of antihypertensives as needed. Concomitant halogenated anesthetics may increase the risk of sudden BP and HR increase during surgery; avoid use. Concomitant use with risperidone may increase risk of extrapyramidal symptoms; monitor.

Aptensio Xr Adverse Reactions

Adverse Reactions

Headache, insomnia, abdominal pain, decreased appetite, nausea, vomiting, dizziness; hypertension, tachycardia, priapism, glaucoma, motor/verbal tics.

Aptensio Xr Clinical Trials

See Literature

Aptensio Xr Note

Not Applicable

Aptensio Xr Patient Counseling

See Literature