Gabapentin ER

Class
Anticonvulsants and anxiolytics
Subclass
Gabapentinoids
Substance name
Gabapentin enacarbil ER
Brand names
Horizant®
Common formulations
Tablet
See also
Gabapentin (Neurontin®, Gralise®)
Dosage and administration
Adults patients
Symptomatic relief
Neuropathic pain • Off-label
•
600-1,800 mg PO BID
Treatment
Postherpetic neuralgia
•
Start at: 600 mg PO qAM for 3 days
•
Maintenance: 600 mg PO BID
Restless legs syndrome • Moderate-to-severe
•
600 mg PO daily at 5 PM
Indications for use
Labeled indications
Adults
•
Treatment of postherpetic neuralgia
•
Treatment of restless legs syndrome (moderate-to-severe)
Off-label indications
Adults
•
Symptomatic relief of neuropathic pain
Safety risks
Contraindications
Hypersensitivity to gabapentin or its components
Warnings and precautions
DRESS syndrome
•
Maintain a high level of suspicion, as gabapentin has been associated with an increased risk for this adverse event.
Pancreatic cancer
•
Maintain a high level of suspicion, as gabapentin has been associated with an increased incidence of pancreatic acinar cell tumors in rats.
Respiratory depression
•
Use caution in patients taking CNS depressants, including opioids.
Seizure
•
Do not discontinue abruptly in patients with seizure disorder.
Somnolence
•
Use extreme caution in patients performing activities requiring mental alertness, such as driving or operating machinery.
Suicidal ideation
•
Maintain a high level of suspicion, as an increased risk of suicidal thoughts and behavior has been reported in patients receiving gabapentin. Monitor closely for suicidality and unusual changes in behavior.
Specific populations
Renal impairment
CrCl ≥ 60 mL/min
•
Use acceptable. No dose adjustment required.
CrCl 30-59 mL/min
•
Start at dose of 300 mg daily.
CrCl 15-29 mL/min
•
Reduce dose by 50%.
CrCl < 15 mL/min
•
Maximal dose of 300 mg. Do not exceed frequency of q48h.
Renal replacement therapy
Continuous renal replacement
•
Dose as in CrCl < 15 mL/min. Not recommended for restless legs syndrome.
Intermittent hemodialysis
•
Administer the dose after dialysis session. Dose as in CrCl < 15 mL/min. Not recommended for restless legs syndrome.
Peritoneal dialysis
•
Dose as in CrCl < 15 mL/min. Not recommended for restless legs syndrome.
Hepatic impairment
Any severity
•
Use acceptable. No dose adjustment required.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals. Enroll patients in a dedicated pregnancy outcome monitoring registry.
Breastfeeding
Use only if benefits outweigh potential risks.
Low levels in breastfed infants (5-25%).
Unlikely to cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
Dizziness, headache, somnolence
Common 1-10%
•
Disorientation, loss of balance, lethargy, peripheral edema, blurred vision, confusion, ↓ libido, depression, vertigo, dry mouth, fatigue, asthenia, flatulence, ↑ appetite, insomnia, irritability, nausea, weight gain
Unknown frequency
•
Breast enlargement, gynecomastia, ↑ serum CK, respiratory depression, bullous pemphigoid
Interactions
Drug(s)
Check Interactions
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