Gabapentin Enacarbil

DEA Class;  Rx

Common Brand Names; Horizant

  • GABA Analogs

Oral analog of GABA.
Used for restless legs syndrome, postherpetic and other neuralgias, and adjunctively for partial seizures; orphan drug for amyotrophic lateral sclerosis (ALS).
Monitor for emerging or worsening suicidal thoughts or actions and/or depression.

Indicated for moderate-to-severe primary restless legs syndrome

Indicated for management of postherpetic neuralgia (PHN)

  • Somnolence/sedation (10-27%)
  • Dizziness (13-30%)
  • Headache (7-15%)
  • Fatigue/asthenia (6-10%)
  • Nausea (4-9%)
  • Fatigue/asthenia (6-10%)
  • Peripheral edema (6-7%)
  • Insomnia (3-7%)
  • Irritability (4%)
  • Weight increase (2-5%)
  • Blurred vision (2-5%)
  • Xerostomia (3-4%)
  • Flatulence (2-3%)
  • Vertigo (1-3%)
  • Peripheral edema (1-3%)
  • Drunk/abnormal sensation (1-3%)
  • Depression (1-3%)
  • Decreased libido (1-2%)

Safety and effectiveness in patients with epilepsy not studied

Pregnancy Category: C

Limited available data in pregnancy; use caution

Lactation: Unknown whether distributed in breast milk

Adults

3600 mg/day PO (immediate-release products, e.g., Neurontin); 1800 mg/day PO (extended-release tablets; Gralise ONLY); 1200 mg/day PO (extended-release tablets; Horizant ONLY).

Geriatric

3600 mg/day PO (immediate-release products, e.g., Neurontin); 1800 mg/day PO (extended-release tablets; Gralise ONLY); 1200 mg/day PO (extended-release tablets; Horizant ONLY).

Adolescents

3600 mg/day PO (immediate-release products, e.g., Neurontin); safety and efficacy of extended-release gabapentin products have not been established.

Children

3—12 years: 50 mg/kg/day PO immediate-release products has been suggested, higher dosages occasionally used in refractory patients. Safety and efficacy of extended-release gabapentin products have not been established.
< 3 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Gabapentin Enacarbil

tablet, extended-release

  • 300mg
  • 600mg

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