Lucemyra

— THERAPEUTIC CATEGORIES —
  • Addiction/dependence

Lucemyra Generic Name & Formulations

General Description

Lofexidine (as HCl) 0.18mg; tabs.

Pharmacological Class

Central alpha-2 agonist.

How Supplied

Tabs—36, 96

Manufacturer

Generic Availability

NO

Lucemyra Indications

Indications

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

Lucemyra Dosage and Administration

Adult

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

Not established.

Lucemyra Contraindications

Not Applicable

Lucemyra Boxed Warnings

Not Applicable

Lucemyra Warnings/Precautions

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 Pharmacokinetics

See Literature

Lucemyra Interactions

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.

Lucemyra Adverse Reactions

Adverse Reactions

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

Lucemyra Clinical Trials

See Literature

Lucemyra Note

Not Applicable

Lucemyra Patient Counseling

See Literature

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