s Experience 6.2 Adverse Events Associated With Gabapentin 7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.2 Labor and Delivery 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance 9.2 Abuse 9.3 Dependence 10 OVERDOSAGE
10.1 Human Overdose Experience 10.2 Overdosage Management 11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.3 Pharmacokinetics 12.6 Cardiac Electrophysiology 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES
14.1 Restless Legs Syndrome (RLS) 12 Week Pivotal Studies 14.2 Postherpetic Neuralgia (PHN) 12 Week Study 14.3 Effects on Driving 16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Effects on Driving 17.2 Somnolence/Sedation and Dizziness 17.3 Suicidal Behavior and Ideation 17.4 Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity 17.5 Lack of Interchangeability With Gabapentin 17.6 Dosing Instructions 17.7 Alcohol * Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
1.1 Treatment of Restless Legs SyndromeHORIZANT® (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.
1.2 Management of Postherpetic NeuralgiaHORIZANT (gabapentin enacarbil) Extended-Release Tablets are indicated for the management of postherpetic neuralgia (PHN) in adults.
2 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 (5.3)].
2.1 Restless Legs SyndromeThe 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 (6.1)].
If the dose is not taken at the recommended time, the next dose should be taken the following day as prescribed.
2.2 Postherpetic NeuralgiaThe 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 (6.1)].
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.
2.3 Renal ImpairmentDosing of HORIZANT is adjusted in accordance with renal function, as represented by creatinine clearance [see Clinical Pharmacology (12.3)]. 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 |
