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Horizant Generic Name & Formulations
Legal Class
Rx
General Description
Gabapentin enacarbil 300mg, 600mg; extended-rel tabs.
How Supplied
Tabs—30
Manufacturer
Horizant Indications
Indications
Postherpetic neuralgia.
Horizant Dosage and Administration
Adult
Swallow whole. Take with food. Initially 600mg in the AM for 3 days, then increase to 600mg twice daily beginning on Day 4 (no additional benefit seen with >1200mg daily dose). If dose is not taken at recommended time, skip this dose, and the next dose should be taken at the time of the next scheduled dose. Renal impairment: CrCl 30–59mL/min: initially 300mg in the AM for 3 days, then 300mg twice daily; may increase to 600mg twice daily if needed or tolerated. CrCl 15–29mL/min: 300mg in the AM on Day 1 and Day 3, then continue with 300mg in AM; may increase to 300mg twice daily if needed. CrCl <15mL/min: Maintenance: 300mg every other day in the AM, may increase to 300mg once daily if needed. CrCl <15mL/min on hemodialysis: Maintenance: 300mg after every session, may increase to 600mg if needed. Tapering doses: see full labeling.
Children
Not studied.
Horizant Contraindications
Not Applicable
Horizant Boxed Warnings
Not Applicable
Horizant Warnings/Precautions
Warnings/Precautions
Not interchangeable with other gabapentin products. May cause significant driving impairment; do not drive until impairment is assessed. Epilepsy. Increased risk of suicidal thoughts/behavior. Monitor for new or worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood/behavior. Underlying respiratory depression; monitor and consider initiating at a low dose. Multiorgan hypersensitivity. Renal impairment. Avoid abrupt cessation (see full labeling). Elderly. Pregnancy. Nursing mothers.
Horizant Pharmacokinetics
See Literature
Horizant Interactions
Interactions
Avoid alcohol. Increased somnolence/sedation with morphine. Increased risk for serious respiratory depression when concomitant CNS depressants, opioids.
Horizant Adverse Reactions
Adverse Reactions
Somnolence/sedation, dizziness, headache, nausea, dry mouth, fatigue, irritability, feeling drunk, vertigo.
Horizant Clinical Trials
See Literature
Horizant Note
Not Applicable
Horizant Patient Counseling
See Literature
Horizant Generic Name & Formulations
Legal Class
Rx
General Description
Gabapentin enacarbil 300mg, 600mg; extended-rel tabs.
How Supplied
Tabs—30
Manufacturer
Horizant Indications
Indications
Treatment of moderate to severe primary restless legs syndrome. Not recommended for patients who are required to sleep during the daytime and remain awake at night.
Horizant Dosage and Administration
Adult
Swallow whole. Take with food. 600mg once daily at about 5pm (no additional benefit seen with 1200mg dose). If dose is not taken at recommended time, next dose should be taken the following day. Renal impairment: CrCl 30–59mL/min: initially 300mg/day and increase to 600mg as needed. CrCl 15–29mL/min: 300mg/day. CrCl <15mL/min: 300mg every other day. CrCl <15mL/min on hemodialysis: not recommended.
Children
Not studied.
Horizant Contraindications
Not Applicable
Horizant Boxed Warnings
Not Applicable
Horizant Warnings/Precautions
Warnings/Precautions
Not interchangeable with other gabapentin products. May cause significant driving impairment; do not drive until impairment is assessed. Epilepsy. Increased risk of suicidal thoughts/behavior. Monitor for new or worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood/behavior. Underlying respiratory depression; monitor and consider initiating at a low dose. Multiorgan hypersensitivity. Renal impairment. Avoid abrupt cessation (see full labeling). Elderly. Pregnancy. Nursing mothers.
Horizant Pharmacokinetics
See Literature
Horizant Interactions
Interactions
Avoid alcohol. Increased somnolence/sedation with morphine. Increased risk for serious respiratory depression when concomitant CNS depressants, opioids.
Horizant Adverse Reactions
Adverse Reactions
Somnolence/sedation, dizziness, headache, nausea, dry mouth, fatigue, irritability, feeling drunk, vertigo.
Horizant Clinical Trials
See Literature
Horizant Note
Not Applicable
Horizant Patient Counseling
See Literature
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