Dosing & Uses
Dosage Forms & Strengths
capsule: Schedule V
oral solution: Schedule V
Diabetic Peripheral Neuropathic Pain
Initial: 50 mg PO q8hr
Maintenance: May increase to 100 mg PO q8hr within 1 week, as needed; not to exceed 300 mg/day
Initial: 150-300 mg/day PO divided q8-12hr
Maintenance: May increase to 300 mg/day divided q8-12hr after 1 week, as needed
Initial: 150 mg/day PO divided q12hr
Maintenance: May increase to 300-450 mg/day divided q12hr after 1 week, as needed
Initial: 150 mg/d divided q8-12hr PO
Maintenance: May increase to 600 mg/day PO divided q8-12hr, as needed
Neuropathic Pain With Spinal Cord Injury
Initial: 150 mg/day PO divided q12hr; may increase within 1 week to 300 mg/day PO divided q12hr
If there is insufficient pain relief after 2-3 weeks and 300 mg/day dose is tolerated, may increase dose again up to 600 mg/day PO divided q12hr
Renal impairment (CrCl 30-60 mL/min)
- Decrease dose by 50% divided bid/tid
Renal impairment (CrCl 15-30 mL/min)
- If 150 mg/day in normal renal function: Decrease dose to 25-50 mg/day; administer qDay or divided bid
- If 300 mg/day in normal renal function: Decrease dose to 75 mg/day; administer qDay or divided bid
- If 450 mg/day in normal renal function: Decrease dose to 100-150 mg/day; administer qDay or divided bid
- If 600 mg/day in normal renal function: Decrease dose to 150 mg/day; administer qDay or divided bid
Renal impairment (CrCl <15 mL/min)
- If 150 mg/day in normal renal function: Decrease dose to 25 mg/day; single daily dose
- If 300 mg/day in normal renal function: Decrease dose to 25-50 mg/day; single daily dose
- If 450 mg/day in normal renal function: Decrease dose to 50-75 mg/day; single daily doseof divided bid
- If 600 mg/day in normal renal function: Decrease dose to 75 mg/day; single daily dose
Renal impairment (supplemental dosage following hemodialysis)
- 25 mg qDay regimen: Take 1 supplemental dose of 25 mg or 50 mg
- 25-50 mg qDay regimen: Take 1 supplemental dose of 50 mg or 75 mg
- 50-75 mg qDay regimen: Take 1 supplemental dose of 75 mg or 100 mg
- 75 mg qDay regimen: Take 1 supplemental dose of 100 mg or 150 mg
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Dose-dependent; percentages according to highest reported
Peripheral edema (16%)
Weight gain (16%)
Blurred vision (1-12%)
Facial edema (<3%)
Weight gain (4%)
Accidental injury (4%)
Abnormal thinking (2%)
Decreased libido (>1%)
Balance disorder (2-9%)
Nasopharyngitis pain (1-3%)
Flu-like syndrome (1-2%)
Gynecomastia and breast enlargement
Discontinue gradually over at least 1 week
Monitor for physical dependence and withdrawal symptoms
Monitor for decreased platelet count (rare) and increased creatinine kinase levels
May cause prolongation of PR interval
May potentiate effects of other sedatives
Rhabdomyolysis reported (monitor for muscle pain)
History of angioedema, concurrency with drugs associated with angioedema risk (eg, ACEIs)
Increased risk of peripheral edema, dizziness, somnolence, blurred vision, and weight gain
Potential risk of male-mediated teratogenicity
Use caution in cardiovascular disease (heart failure) and renal impairment
May impair ability to drive or perform hazardous tasks
Discontinue treatment if hypersensitivity occurs
Do not discontinue anticonvulsants abruptly as that may increase seizure frequency
Antiepileptic drugs increase risk of suicidal thoughts or behavior in patients taking these drugs for any indication; monitor for emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
- Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported during initial and chronic treatment, including reports of life-threatening angioedema with respiratory compromise requiring emergency intervention
- If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, discontinue therapy and institute appropriate therapy immediately
- Coadministration of ACE inhibitors or mTOR (mammalian target of rapamycin) inhibitors (eg, temsirolimus, sirolimus, everolimus), or previous history of angioedema may increase risk
Pregnancy & Lactation
Pregnancy category: C
Lactation: Unknown if excreted in milk; not recommended
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Precise mechanism of action unknown but is a GABA analogue that binds to a subunit of voltage-gated calcium channels in CNS; does not affect sodium channels, opiate receptors, or cyclo-oxygenase enzyme activity; interactions with descending noradrenergic and serotonergic pathways originating from the brain stem appear to reduce neuropathic pain transmission from spinal cord
Peak plasma time: 1.5 hr
Vd: 0.5 L/kg
Protein bound: None
Half-life: 6.3 hr
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