Adult Dosing
Moderate-severe primary restless legs syndrome
- Recommended dose: 600 mg PO once daily with food at 5 pm
Note:
- Not recommended for patients who are required to sleep during daytime and remain awake at night
- Do not double the dosage as it provides no additional benefits but causes increase in adverse reactions
- If dose not taken at recommended time, take the next dose the following day as prescribed
- Swallow the tablets whole; do not cut, crush, or chew
- If higher than recommended dose is used, reduce the dose to 600 mg/day for 1 week prior to discontinuation to minimize the risk of withdrawal seizure
Management of post-herpetic neuralgia
- 600 mg PO qam for 1- 3 days, and then increase to 600 mg PO bid on day 4
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
60 mL/min: Administer 600 mg daily- 30-59 mL/min: Start 300 mg/day and increase to 600 mg as needed
- 15-29 mL/min: Administer 300 mg daily
- <15 mL/min: Give 300 mg qod
- <15 mL/min on hemodialysis: Not recommended
Hepatic Dose Adjustment
- Hepatic impairment: Dose adjustments not defined
See Supplemental Patient Information
- Gabapentin enacarbil can cause somnolence/sedation and dizziness and may be associated with significant driving impairment. Advise patients receiving this drug not to drive a car or operate other complex machinery until sufficient experience is gained to assess whether the drug impairs their ability to perform these tasks
- Gabapentin enacarbil is not interchangeable with other gabapentin products due to their differing pharmacokinetic profiles
- Safety and effectiveness of gabapentin enacarbil in epileptic patients have not been established
- As gabapentin enacarbil is a prodrug of gabapentin (antiepileptic drug), it may increase the risk of suicidal thoughts or behavior in patients receiving these drugs for any indication. Monitor patients receiving therapy for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
- Drug reaction with eosinophilia and systemic symptoms (DRESS), also referred to as multiorgan hypersensitivity, has been associated with antiepileptic drugs. DRESS typically manifests as fever, rash, and/or lymphadenopathy in association with other organ system involvement, including hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Discontinue therapy if such reaction occurs
- While stopping therapy, discontinue the drug directly without tapering in patients receiving recommended dose of 600 mg daily. If receiving higher than recommended dose, first reduce it to 600 mg daily for 1 week prior to discontinuation to minimize the potential of withdrawal seizure
Cautions: Use cautiously in
- Renal impairment
- Elderly patients
- Hx of depression
- Alcohol use
- CNS depressant use
Supplemental Patient Information
- Instruct patients receiving therapy not to drive a car or operate dangerous machinery until they have gained sufficient experience on gabapentin enacarbil to assess whether therapy impairs their ability to perform such tasks
- Advise patients, their caregivers, and families to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm and instruct them to report any such behaviors to the healthcare provider
Pregnancy Category:C
Breastfeeding: As per manufacturer's data, it is unknown whether gabapentin derived from gabapentin enacarbil is secreted in human milk; however, gabapentin is secreted into human milk following oral administration of gabapentin products. Due to the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
