Addiction/dependence:

Indications for: LUCEMYRA

Mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.

Adult Dosage:

Initially 3 tabs 4 times daily (5–6hrs between doses) during peak withdrawal symptoms for up to 14 days; max single dose: 0.72mg (4 tabs); max daily dose: 2.88mg (16 tabs). Discontinue gradually over 2–4 days (eg, reduce by 1 tab/dose every 1–2 days). Hepatic impairment (moderate): 2 tabs 4 times daily; (severe): 1 tab 4 times daily. Renal impairment (mild or moderate): 2 tabs 4 times daily; (severe, ESRD, or on dialysis): 1 tab 4 times daily.

Children Dosage:

Not established.

LUCEMYRA Warnings/Precautions:

Risk of hypotension, bradycardia, syncope. Monitor vital signs before dosing and for symptoms of bradycardia and orthostasis. Avoid in severe coronary insufficiency, recent MI, cerebrovascular disease, chronic renal failure, marked bradycardia, concomitant pulse or BP-lowering medications, congenital long QT syndrome. Correct electrolyte abnormalities prior to initiation. CHF, bradyarrhythmias, hepatic/renal impairment, concomitant QT-prolonging drugs (eg, methadone): monitor ECG. Increased risk of opioid overdose after opioid discontinuation. Use only in conjunction with comprehensive management program for treatment of opioid use disorder. Avoid abrupt cessation. Known CYP2D6 poor metabolizers: monitor. Hepatic or renal impairment: see Adult. Elderly (>65yrs): consider dose adjustment. Pregnancy. Nursing mothers.

LUCEMYRA Classification:

Central alpha-2 agonist.

LUCEMYRA Interactions:

Increased QT prolongation with concomitant methadone; monitor ECG. May antagonize oral naltrexone when concomitant within 2hrs of Lucemyra. Potentiates CNS depressant effects of benzodiazepines. May potentiate alcohol, barbiturates, other sedatives. Potentiated by CYP2D6 inhibitors (eg, paroxetine); monitor for orthostatic hypotension, bradycardia.

Adverse Reactions:

Orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, dry mouth; discontinuation symptoms (eg, diarrhea, insomnia, anxiety, chills, hyperhidrosis, extremity pain).

Generic Drug Availability:

NO

How Supplied:

Tabs—36, 96