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gabapentin enacarbil - HORIZANT® Extended-Release Tablets

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

geq60

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

geq60

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.
Creatinine clearance for males = [140-age (years)]× [body wt (kg)]
72 × [serum creatinine (mg/dL)]
Creatinine clearance for females = [140-age (years)]× [body wt (kg)]× 0.85
72 × [serum creatinine (mg/dL)]

Hemodialysis

dialysis Not recommended.

Reference(s)

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.

Disclaimer

The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.   Read the disclaimer
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