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Horizant (Gabapentin Enacarbil) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Treatment of Restless Legs Syndrome

HORIZANT® (gabapentin enacarbil) Extended-Release Tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults.
HORIZANT is not recommended for patients who are required to sleep during the daytime and remain awake at night.

Management of Postherpetic Neuralgia

HORIZANT (gabapentin enacarbil) Extended-Release Tablets are indicated for the management of postherpetic neuralgia (PHN) in adults.

DOSAGE AND ADMINISTRATION

Tablets should be swallowed whole and should not be cut, crushed, or chewed.
Tablets should be taken with food.
HORIZANT is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles [see Warnings and Precautions ].

Restless Legs Syndrome

The recommended dosage for HORIZANT is 600 mg once daily at about 5 PM. A daily dose of 1,200 mg provided no additional benefit compared with the 600-mg dose, but caused an increase in adverse reactions [see Adverse Reactions].
If the dose is not taken at the recommended time, the next dose should be taken the following day as prescribed.

Postherpetic Neuralgia

The recommended dosage of HORIZANT is 600 mg twice daily. HORIZANT should be initiated at a dose of 600 mg in the morning for 3 days of therapy, then increased to 600 mg twice daily (1,200 mg/day) on day four. In the 12-week principal efficacy study, additional benefit of using doses greater than 1,200 mg a day was not demonstrated, and these higher doses resulted in an increase in adverse reactions [see Adverse Reactions ].
If the dose is not taken at the recommended time, skip this dose, and the next dose should be taken at the time of the next scheduled dose.

Renal Impairment

Dosing of HORIZANT is adjusted in accordance with renal function, as represented by creatinine clearance [see Clinical Pharmacology]. Target dose regimens are listed in Table 1 and Table 2.

Table 1. 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

Table 2. Dosage of HORIZANT for Patients With Postherpetic Neuralgia in Accordance With Creatinine Clearance

a Based on tolerability and efficacy

 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

In patients with stable renal function, CrCl can be estimated using the equation of Cockcroft and Gault:
         for males: CrCl = (140-age)(weight)/[(72)(SCr)]
         for females: CrCl = (0.85)(140-age)(weight)/[(72)(SCr)]
where age is in years, weight is in kilograms, and SCr is serum creatinine in mg/dL.

DOSAGE FORMS AND STRENGTHS

HORIZANT Extended-Release Tablets, 300 mg, are white to off-white, oval-shaped tablets debossed with “GS TF7” and 600 mg, are white to off-white, oval-shaped tablets debossed with “GS LFG”. Both the 300 mg and 600 mg tablets may contain occasional black/grey spots.

HOW SUPPLIED/STORAGE AND HANDLING

HORIZANT Extended-Release Tablets containing 300 mg of gabapentin enacarbil are white to off-white, with occasional black/grey spots, oval-shaped tablets debossed with "GS TF7".

HORIZANT Extended-Release Tablets containing 600 mg of gabapentin enacarbil are white to off-white, with occasional black/grey spots, oval-shaped tablets debossed with "GS LFG". They are supplied as follows:
    300 mg: NDC 53451-0103-1: Bottles of 30
    600 mg: NDC 53451-0101-1: Bottles of 30

Store at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Do not remove desiccants.

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