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Usual Dosing (Adults)
INDICATIONS AND USAGE HORIZANT is indicated for:
-treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. -management of postherpetic neuralgia (PHN) in adults.
DOSAGE AND ADMINISTRATION Instruct patients to swallow tablets whole and not to cut, crush, or chew tablets. Take with food.
RLS: 600 mg once daily taken at about 5 PM.
-A dose of 1,200 mg once daily provided no additional benefit compared with the 600-mg dose, but caused an increase in adverse reactions. -If the dose is not taken at the recommended time, the next dose should be taken the following day as prescribed.
PHN: The starting dose is 600 mg in the morning for 3 days, then increase to 600 mg twice daily beginning on day 4.
-A daily dose greater than 1,200 mg provided no additional benefit. -If the dose is not taken at the recommended time, skip this dose, and the next dose should be taken at the time of next scheduled dose.
Patients with renal impairment: Doses of HORIZANT must be adjusted in accordance with renal function.
DOSAGE FORMS AND STRENGTHS Extended-Release Tablets: 300 mg and 600 mg. (3)
Renal Dosing
Dosage of HORIZANT for Patients With Restless Legs Syndrome in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min)
Target Dose Regimen
≥60
600 mg per day
30 - 59
Start at 300 mg per day and increase to 600 mg as needed
15 - 29
300 mg per day
<15
300 mg every other day
<15 on hemodialysis
Not recommended
Dosage of HORIZANT for Patients With Postherpetic Neuralgia in Accordance With Creatinine Clearance
Creatinine Clearance (mL/min)
Titration
Maintenance
Tapering
≥60
600 mg in AM for 3 days
600 mg twice daily
600 mg in AM for
1 week
30 - 59
300 mg in AM for 3 days
300 mg twice daily. Increase to 600 mg twice daily as neededa
Reduce current maintenance dose to once daily in AM for 1 week
15 - 29
300 mg in AM on Day 1 and Day 3
300 mg in AM. Increase to 300 mg twice daily if neededa
If taking 300 mg twice daily, reduce to 300 mg once daily in AM for 1 week.
If taking 300 mg once daily, no taper needed.
<15
None
300 mg every other day in AM. Increase to 300 mg once daily in AM if neededa
None
<15 on hemodialysis
None
300 mg following every dialysis. Increase to 600 mg following every dialysis if neededa
None
Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.