COTEMPLA XR-ODT(methylphenidate extended-release orally disintegrating tablets), CII 

COTEMPLA XR-ODT CII

Generic Name and Formulations:

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

Company:

Neos Therapeutics

Indications for COTEMPLA XR-ODT:

Attention deficit hyperactivity disorder.

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.

Contraindications:

During or within 14 days of MAOIs.

Boxed Warning:

Abuse and dependence.

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 heart rhythm abnormalities, coronary artery disease, other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors in developing a manic episode prior to initiating. Consider discontinuing if psychotic/manic symptoms occur. Peripheral vasculopathy, including Raynaud’s phenomenon; monitor for digital changes. Monitor growth (in children), BP, HR. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reeva luate periodically. Pregnancy. Nursing mothers: monitor infants.

Pharmacological Class:

CNS stimulant.

Interactions:

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

Adverse Reactions:

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

Note:

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

Generic Availability:

NO

How Supplied:

Blister pack—30 (5x6)

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=33f70f58-c871-42c8-8adb-345caeafefcd