REMS
Immediate-release and extended-release:
- Treatment of the following conditions:
Immediate-release:
- Treatment of the following conditions:
CV: peripheral edema, PR interval prolongation.
Derm: bullous pemphigoid, STEVENS-JOHNSON SYNDROME.
EENT: blurred vision, double vision, vertigo.
GI: dry mouth, abdominal pain, constipation, diarrhea, nausea, vomiting.
Hemat: thrombocytopenia.
Metab: ↑ appetite, weight gain.
MS: ↑ creatine kinase.
Neuro: dizziness, drowsiness, headache, impaired attention/concentration/thinking, SUICIDAL THOUGHTS/BEHAVIORS.
Resp: RESPIRATORY DEPRESSION.
Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA).
Diabetic Neuropathic Pain
- PO (Adults): Immediate-release: 50 mg 3 times daily, ↑ over 7 days up to 100 mg 3 times daily. Extended-release: 165 mg once daily after an evening meal; ↑ to 330 mg once daily after an evening meal within 1 wk.
Renal Impairment
- PO (Adults): CCr 30–60 mL/min: Immediate-release: 75–300 mg/day in 2–3 divided doses; Extended-release: 82.5–330 mg once daily after an evening meal; CCr 15–30 mL/min: Immediate-release: 25–150 mg/day in 1–2 divided doses; CCr <15 mL/min: Immediate-release: 25–75 mg/day as a single daily dose.
Postherpetic Neuralgia
- PO (Adults): Immediate-release: 75 mg twice daily or 50 mg 3 times daily initially, may ↑ over 7 days to 300 mg/day in 2–3 divided doses; after 2–4 wk may ↑ to 600 mg/day in 2–3 divided doses. Extended-release: 165 mg once daily after an evening meal; ↑ to 330 mg once daily after an evening meal within 1 wk; if pain is persistent after 2–4 wk, may then ↑ dose of up to 660 mg once daily after an evening meal.
Renal Impairment
- PO (Adults): CCr 30–60 mL/min: Immediate-release: 75–300 mg/day in 2–3 divided doses; Extended-release: 82.5–330 mg once daily after an evening meal; CCr 15–30 mL/min: Immediate-release: 25–150 mg/day in 1–2 divided doses; CCr <15 mL/min: Immediate-release: 25–75 mg/day as a single daily dose.
Fibromyalgia
- PO (Adults): Immediate-release: 75 mg twice daily initially, may ↑ to 150 mg twice daily within 1 wk based on efficacy and tolerability. May ↑ to 225 twice daily.
Renal Impairment
- PO (Adults): CCr 30–60 mL/min: Immediate-release: 75–300 mg/day in 2–3 divided doses CCr 15–30 mL/min: Immediate-release: 25–150 mg/day in 1–2 divided doses; CCr <15 mL/min: Immediate-release: 25–75 mg/day as a single daily dose.
Spinal Cord Injury Neuropathic Pain
- PO (Adults): Immediate-release: 75 mg twice daily initially, may be ↑ to 150 mg twice daily within 1 wk based on efficacy and tolerability; if insufficient pain relief after 2–3 wk, may ↑ to 300 twice daily.
Renal Impairment
- PO (Adults): CCr 30–60 mL/min: Immediate-release: 75–300 mg/day in 2–3 divided doses; CCr 15–30 mL/min: Immediate-release: 25–150 mg/day in 1–2 divided doses; CCr <15 mL/min: Immediate-release: 25–75 mg/day as a single daily dose.
Partial Onset Seizures
- PO (Adults): Immediate-release: 75 mg twice daily or 50 mg 3 times daily initially; may gradually ↑ on a weekly basis up to a max dose of 600 mg/day (in 2–3 divided doses).
- PO (Children ≥1 mo and ≥30 kg): Immediate-release: 2.5 mg/kg/day in 2–3 divided doses; may gradually ↑ on a weekly basis up to a max dose of 10 mg/kg/day in 2–3 divided doses (max = 600 mg/day).
- PO (Children ≥1 mo and <30 kg): Immediate-release: 3.5 mg/kg/day in 2–3 divided doses for patients ≥4 yr old or in 3 divided doses for patients 1 mo-<4 yr old; may gradually ↑ on a weekly basis up to a max dose of 14 mg/kg/day in 2–3 divided doses for patients ≥4 yr old or in 3 divided doses for patients 1 mo-<4 yr old.
Renal Impairment
- PO (Adults): CCr 30–60 mL/min: Immediate-release: 75–300 mg/day in 2–3 divided doses; CCr 15–30 mL/min: Immediate-release: 25–150 mg/day in 1–2 divided doses; CCr <15 mL/min: Immediate-release: 25–75 mg/day as a single daily dose.
Therapeutic Classification: analgesics, anticonvulsants
Pharmacologic Classification: gamma aminobutyric acid gaba analogues, nonopioid analgesics
Absorption: Well absorbed (>90%) following oral administration.
Distribution: Well distributed to tissues; probably crosses the blood-brain barrier.
Metabolism/Excretion: Minimally metabolized; 90% excreted unchanged in urine.
Half-life: 6 hr.
