EpilepsyRx

Pregabalin

Lyrica · generic IR (Lyrica CR is not epilepsy-approved)

Seizure aggravation / coverage
May aggravate absence or myoclonic seizures; review syndrome before use (NICE NG217, UK guidance).

DailyMed-verified antiseizure indications

Indication / use

Label / evidence summary
Immediate-release pregabalin capsules and oral solution: adjunctive focal-onset seizure treatment from age 1 month. Lyrica CR is not an epilepsy product.
Role
Maintenance
Class
α2δ calcium-channel-subunit ligand; no direct GABA-receptor agonism

Indications checked 26 September 2026. Product, route, age, and treatment-role limits apply. A DailyMed listing alone does not establish FDA approval.

Formulations & strengths

U.S. products unless another country is named. Strengths are per unit or stated volume.

Brand & formulation labels

Each link names the product and formulation it covers. Archived labels do not establish current availability.

Dosing & administration

Adult / product-specific schedule
IR only, age ≥17: start 150 mg/day in 2 or 3 divided doses; increase approximately weekly as tolerated to maximum 600 mg/day. Adjust for renal function.
Pediatric
IR, ≥1 month: ≥30 kg, start 2.5 mg/kg/day, max 10 mg/kg/day (≤600 mg/day), in 2–3 doses. <30 kg, start 3.5 mg/kg/day, max 14 mg/kg/day; divide 3 times daily if <4 years, 2–3 times daily if ≥4 years.
Titration / repeat dosing
Increase approximately weekly based on response/tolerability. These are IR epilepsy doses, not CR pain-treatment conversion doses.

Dose adjustment & concentrations

Renal impairment
Dose by creatinine clearance; supplement after hemodialysis.
Hepatic impairment
No adjustment expected.
Serum reference information
No established therapeutic range

Safety

Boxed warning
No boxed warning.
Contraindications
Hypersensitivity to pregabalin or ingredients.
Serious precautions & monitoring
Angioedema/hypersensitivity and respiratory depression (especially with CNS depressants or respiratory impairment). Monitor edema, weight, vision and sedation. Renal dose adjustment is required; taper over at least 1 week.

Common / selected adverse effects

  • Dizziness
  • Somnolence
  • Peripheral edema
  • Weight gain
  • Blurred vision

Drug interactions: toxicity & clinical action

Partner / combinationClinical effectClinical action
Opioids / CNS depressantsAdditive sedation and respiratory depression despite few metabolic interactions.Monitor breathing/alertness and adjust for renal impairment.
Thiazolidinediones / ACE inhibitorsGreater edema/weight gain with thiazolidinediones; angioedema risk with ACE inhibitors.Monitor swelling and weight; urgently assess facial/tongue swelling.

Pregnancy & contraception

Fetal / neonatal risk
Observational pregabalin studies suggest a possible small increase in major birth defects without a consistent defect pattern. Prolonged gabapentinoid/opioid co-exposure near delivery may increase neonatal withdrawal risk; risk from pregabalin alone is uncertain.
Pregnancy / postpartum monitoring
Observe infants after prolonged pregabalin/opioid co-exposure near delivery for withdrawal.

Clinical evidence

Research summaries describe studied populations and outcomes; they do not add indications or constitute treatment recommendations.

Direct pivotal trial

Trial summary

Study design / duration
Randomized, double-blind, placebo-controlled fixed-dose adjunctive trials after 6–8-week baselines, with 12-week treatment and seizure-frequency endpoints.
Primary endpoint
No single pivotal endpoint is identified in the cited source.
Results
Pivotal adjunctive focal-seizure trials showed approximately 35–51% median seizure reductions at 150–600 mg/day versus about 10% with placebo, with dose-related responder rates.

Trial publications

Mechanism of action

  • Binds the α2δ auxiliary subunit of voltage-gated calcium channels. Experimental models support reduced calcium-dependent neurotransmitter release; the full antiseizure pathway is not established.
  • Structural similarity to GABA does not imply GABAergic receptor action: pregabalin does not directly bind GABA-A, GABA-B or benzodiazepine receptors. It is not a calcium-channel pore blocker.

Pharmacology

Adult values unless specified. Vd/F denotes apparent oral distribution volume.

Pharmacokinetics

Bioavailability
At least 90% oral bioavailability, independent of dose (immediate-release products).
Elimination half-life
Approximately 6.3 hours with normal renal function. In children up to age 6, mean values are approximately 3–4 hours.
Volume of distribution
Apparent oral volume approximately 0.5 L/kg.
Active metabolite(s)
No clinically significant active metabolite; approximately 90% of a radiolabeled dose is recovered in urine as unchanged pregabalin.
Active-metabolite half-life
Not applicable — no clinically established active metabolite.
Protein binding
None
Metabolism / elimination
Negligible; renal excretion unchanged

Renal function governs clearance. These epilepsy data apply to immediate-release products, not a Lyrica CR epilepsy indication.

Molecular structure

Molecular structure of Pregabalin
Principal compound; salt and product forms may differ.
NIH PubChem structure and record ↗

Product history

Initial U.S. approval
2004
Market / formulation history
2005
Brands
Lyrica · generic IR (Lyrica CR is not epilepsy-approved)
Manufacturer / marketer
Viatris/Pfizer legacy brand (Lyrica)
Generic availability
Yes
Related drugs
Close pharmacologic relative of gabapentin; higher, more predictable bioavailability.

Sources & review status

Representative sources are selected product labels, not an exhaustive list of generic manufacturers. Consult the exact product and formulation prescribed. Brand-name package inserts are linked separately.

Brand reference: Lyrica capsules / solution ↗

Indications and DailyMed PDFs checked: 2026-09-26. Other profile sources reviewed: 2026-09-15 · label revision noted at that review: 9/2025. This is a draft reference; final review is pending.

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