Usual Adult Dose for Opiate Withdrawal

Initial dose: 0.54 mg orally 4 times a day during period of peak withdrawal

• Dosing should be guided by symptoms and side effects

• The period of peak withdrawal symptoms is generally the first 5 to 7 days following last use of opioid.
• Treatment may be continued for up to 14 days with dosing guided by symptoms; lower doses may be appropriate as opioid withdrawal symptoms wane.
• Discontinuation should occur over a 2 to 4-day period to mitigate withdrawal effects of lofexidine (e.g. reducing by 1 tablet per dose every 1 to 2 days).

Renal Dose Adjustments

Mild or moderate renal impairment (GFR: 30 to 89.9 mL/min/1.73 m2): 0.36 mg orally 4 times a day; Maximum daily dose: 1.44 mg/day
Severe Impairment or ESRD (GFR: less than 30 mL/min/1.73 m2): 0.18 mg orally 4 times a day; Maximum daily dose: 0.72 mg/day

Liver Dose Adjustments

Mild impairment (Child-Pugh score 5 to 6): Initial dose: 0.54 mg orally 4 times a day; Maximum daily dose 2.16 mg/day
Moderate impairment (Child-Pugh 7 to 9): Initial dose: 0.36 mg orally 4 times a day; Maximum daily dose: 1.44 mg/day
Severe impairment (Child-Pugh greater than 9): 0.18 mg orally 4 times a day; Maximum daily dose: 0.72 mg/day

Dose Adjustments

Elderly: Use with caution; consider not exceeding renal doses in all elderly patients.

Discontinuation:

• Upon discontinuation, gradually reduce dose over a 2 to 4-day period to mitigate withdrawal symptoms of lofexidine.

Precautions

CONTRAINDICATIONS: NONE

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Initial dose: 0.18 mg orally 4 times a day
Maximum daily dose: 0.72 mg/day

Other Comments

Administration advice:

• Take orally with or without food

• Dosing should be guided by symptoms.
• The maximum recommend single dose is 0.72 mg (four 0.18 mg tablets); the maximum recommended daily dose is 2.88 mg (sixteen 0.18 mg tablets).

• Monitor vital signs before dosing, monitor symptoms related to bradycardia and orthostasis
• Monitor ECG in patients with congestive heart failure, bradyarrhythmias, hepatic impairment, renal impairment, patients with electrolyte abnormalities (correct abnormalities prior to administration), and for patients concomitantly taking other products that may lead to QT prolongation.

• Read the US FDA-approved Patient Information.
• Patients should understand that this drug may mitigate, but not completely prevent the symptoms associated with opioid withdrawal; they should expect that withdrawal will not be easy.
• Patients should be instructed on how to monitor for hypotension and bradycardia and what to do if these occur; patients should avoid becoming dehydrated or overheated which may increase risk of these occurring.
• Patients should be instructed to discuss all medication use with their healthcare provider, especially CNS depressant and alcohol use; they should not abruptly discontinue this drug without instructions.
• Patients should understand that tolerance to opioid medications will lessen after a period of abstinence; if they return to opioids, they are at great risk for overdose.
• This drug may impair their ability to perform hazardous tasks; patients should avoid driving or operating machinery until they have sufficient experience with this drug to determine how it affects them.

Frequently asked questions

• How do you get Lucemyra (lofexidine)?
• Is Lucemyra (lofexidine) a controlled drug?
• How long does it take to work?