Cotempla Xr-odt

— THERAPEUTIC CATEGORIES —
  • ADHD

Cotempla Xr-odt Generic Name & Formulations

General Description

Methylphenidate 8.6mg, 17.3mg, 25.9mg; ext-rel orally disintegrating tabs.

Pharmacological Class

CNS stimulant.

How Supplied

Blister pack—30 (5×6)

Manufacturer

Generic Availability

NO

Mechanism of Action

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

Cotempla Xr-odt Indications

Indications

Attention deficit hyperactivity disorder.

Cotempla Xr-odt Dosage and Administration

Adults and Children

<6yrs: not established. Place tab on tongue and allow it to disintegrate; do not chew or crush. 6–17yrs: Individualize. Initially 17.3mg once daily in the AM. May titrate in increments of 8.6–17.3mg weekly; max 51.8mg daily. Discontinue if no improvement seen after dose adjustment over 1 month.

Cotempla Xr-odt Contraindications

Contraindications

During or within 14 days of MAOIs.

Cotempla Xr-odt Boxed Warnings

Boxed Warning

Abuse, misuse, and addiction.

Cotempla Xr-odt 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 heart rhythm abnormalities, coronary artery disease, or other cardiac disease. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors in developing a manic episode prior to initiation. Consider discontinuing if psychotic/manic symptoms occur. Peripheral vasculopathy, including Raynaud’s phenomenon; monitor for digital changes. 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 occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.

Cotempla Xr-odt Pharmacokinetics

Absorption

Median time to maximum plasma concentration: 5 hours after dosing.

Metabolism

Primarily via de-esterification.

Elimination

Renal (90%). Half-life: ~4 hours.

Cotempla Xr-odt Interactions

Interactions

See Contraindications. Concomitant gastric pH modulators (eg, omeprazole, famotidine, sodium bicarbonate): not recommended. May decrease effectiveness of 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 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.

Cotempla Xr-odt Adverse Reactions

Adverse Reactions

Appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, BP increased; priapism, glaucoma, motor/verbal tics.

Cotempla Xr-odt Clinical Trials

See Literature

Cotempla Xr-odt Note

Notes

Register pregnant patients exposed to Cotempla XR-ODT by calling (866) 961-2388.

Cotempla Xr-odt Patient Counseling

See Literature