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.
During or within 14 days of MAOIs.
Abuse and dependence.
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. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.
See Contraindications. Concomitant gastric pH modulators (eg, omeprazole, famotidine, sodium bicarbonate): not recommended.
Appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, BP increased; priapism.
Register pregnant patients exposed to Cotempla XR-ODT by calling (866) 961-2388.
Blister pack—30 (5x6)