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INDICATIONS AND USAGE
HORIZANT is indicated for the treatment of moderate-to-severe primary
Restless Legs Syndrome (RLS) in adults.
USE IN SPECIFIC POPULATIONS Pregnancy: based on animal data, may cause fetal harm.
Renal impairment: Dosage adjustments necessary.
HORIZANT is not recommended for use in patients with creatinine
clearance (CrCl) <30 mL/min or in patients on hemodialysis.
DOSAGE AND ADMINISTRATION Restless Legs Syndrome
The recommended dosage for HORIZANT is 600 mg once daily taken with food
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
If the dose is not taken at the recommended time, the next dose should
be taken the following day as prescribed.
Tablets should be swallowed whole and should not be cut, crushed, or
Renal Impairment and Hemodialysis
In patients with compromised renal function (creatinine clearance [CrCl]
30 to 59 mL/min), 600 mg of HORIZANT should be administered on Day 1,
Day 3, and every day thereafter.
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.
HORIZANT is not recommended for use in patients with a CrCl <30 mL/min
or on hemodialysis because the dose cannot be reduced below 600 mg.
HORIZANT Extended-Release Tablets, 600 mg, are white to off-white,
oval-shaped tablets debossed with “GS LFG”. HORIZANT Extended-Release
Tablets may contain occasional black/grey spots.
NDC 0173-0806-01: Bottles of 30
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