Drug Detail:Lucemyra (Lofexidine [ floe-fex-i-deen ])
Generic Name: LOFEXIDINE HYDROCHLORIDE 0.2mg
Dosage Form: tablet, film coated
Drug Class: Antiadrenergic agents, centrally acting
Drug Detail:Lucemyra (Lofexidine [ floe-fex-i-deen ])
Generic Name: LOFEXIDINE HYDROCHLORIDE 0.2mg
Dosage Form: tablet, film coated
Drug Class: Antiadrenergic agents, centrally acting
The usual LUCEMYRA starting dosage is three 0.18 mg tablets taken orally 4 times daily during the period of peak withdrawal symptoms (generally the first 5 to 7 days following last use of opioid) with dosing guided by symptoms and side effects. There should be 5 to 6 hours between each dose. The total daily dosage of LUCEMYRA should not exceed 2.88 mg (16 tablets) and no single dose should exceed 0.72 mg (4 tablets).
LUCEMYRA treatment may be continued for up to 14 days with dosing guided by symptoms.
Discontinue LUCEMYRA with a gradual dose reduction over a 2- to 4-day period to mitigate LUCEMYRA withdrawal symptoms (e.g., reducing by 1 tablet per dose every 1 to 2 days) [see Warnings & Precautions (5.5)]. The LUCEMYRA dose should be reduced, held, or discontinued for individuals who demonstrate a greater sensitivity to LUCEMYRA side effects [see Warnings and Precautions (5.1), Adverse Reactions (6.1)]. Lower doses may be appropriate as opioid withdrawal symptoms wane.
LUCEMYRA can be administered in the presence or absence of food.
Recommended dosage adjustments based on the degree of hepatic impairment are shown in Table 1. [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
Mild Impairment | Moderate Impairment | Severe Impairment | |
---|---|---|---|
Child-Pugh score | 5-6 | 7-9 | > 9 |
Recommended dose | 3 tablets 4 times daily (2.16 mg per day) |
2 tablets 4 times daily (1.44 mg per day) |
1 tablet 4 times daily (0.72 mg per day) |
Recommended dosage adjustments based on the degree of renal impairment are shown in Table 2. LUCEMYRA may be administered without regard to the timing of dialysis [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
Moderate Impairment | Severe Impairment, End-Stage Renal Disease, or on Dialysis | |
---|---|---|
Estimated GFR, mL/min/1.73 m2 | 30-89.9 | < 30 |
Recommended dose | 2 tablets 4 times daily (1.44 mg per day) |
1 tablet 4 times daily (0.72 mg per day) |