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Horizant

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Horizant (gabapentin enacarbil) has been approve"...

Horizant

Horizant

INDICATIONS

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

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
aBased on tolerability and efficacy

In patients with stable renal function, CrCl can be estimated using the equation of Cockcroft and Gault:

for males: CrCl= (weight in kg) x (140 – age)
(72) x (SCr)
for females: CrCl= (0.85) x (140-age)(weight)/[(72)(SCr)

where age is in years, weight is in kilograms, and SCr is serum creatinine in mg/dL.

HOW SUPPLIED

Dosage Forms And Strengths

HORIZANT Extended-Release Tablets, 300 mg, are red, 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.

Storage And Handling

HORIZANT Extended-Release Tablets containing 300 mg of gabapentin enacarbil are red, 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 0173-0832-13: Bottles of 30
600 mg: NDC 0173-0806-01: 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. Dispense in original bottle.

Manufactured by: Patheon Inc. Research Triangle Park, NC 27709 for: GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: June 2012

Last reviewed on RxList: 6/14/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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