Immediate-release and extended-release:

• Treatment of the following conditions:
  • Neuropathic pain associated with diabetic peripheral neuropathy,
  • Postherpetic neuralgia.

Immediate-release:

• Treatment of the following conditions:
  • Fibromyalgia,
  • Neuropathic pain associated with spinal cord injury,
  • Partial-onset seizures (adjunctive therapy).

Contraindicated in:

• Hypersensitivity
• Known/suspected myopathy
• Severe renal impairment (CCr <30 mL/min) (extended-release only)
• Lactation: Lactation.

Use Cautiously in:

• All patients (may ↑ risk of suicidal thoughts/behaviors)
• Renal impairment (dose alteration recommended for CCr <60 mL/min)
• HF
• History of drug dependence/drug-seeking behavior
• Respiratory impairment (↑ risk of respiratory depression)
• OB: Safety not established in pregnancy
• Pedi: Children <1 mo (safety and effectiveness not established)
• Geri: Consider age-related ↓ in renal function when determining dose in older adults.

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, (INCLUDING ANGIOEDEMA)HYPERSENSITIVITY REACTIONS .

Drug-Drug:

• Concurrent use with pioglitazone may ↑ risk of fluid retention.
• ↑ risk of CNS and respiratory depression with other CNS depressants including opioids, alcohol, benzodiazepines, or other sedatives/hypnotics.

(Generic available)

• Immediate-release capsules: 25 mg; 50 mg; 75 mg; 100 mg; 150 mg; 200 mg; 225 mg; 300 mg;
• Extended-release tablets: 82.5 mg; 165 mg; 330 mg;
• Oral solution: 20 mg/mL;

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.

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.

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.

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.

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.

Lyrica, Lyrica CR

• Binds to calcium channels in CNS tissues which regulate neurotransmitter release. Does not bind to opioid receptors.

• Decreased neuropathic or postherpetic pain.
• Decreased partial-onset seizures.

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.

Schedule V (C-V)

(↓ post–herpetic pain)

• Instruct patient to take medication as directed. Take missed doses as soon as remembered unless almost time for next dose; do not double doses. Do not discontinue abruptly. Advise patient to read the Patient Information Leaflet prior to taking pregabalin and with each Rx refill in case of changes.
• May cause dizziness, drowsiness, and blurred vision. Caution patient to avoid driving or activities requiring alertness until response to medication is known. Advise patient to notify health care professional if changes in vision occur. Patients with seizures should not resume driving until health care professional gives clearance based on control of seizure disorder.
• Instruct patient to promptly report unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever. Discontinue therapy if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.
• Advise patient and family to notify health care professional if thoughts about suicide or dying, attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking, other unusual changes in behavior or mood occur.
• Inform patient that pregabalin may cause edema and weight gain.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Caution patient to avoid alcohol or other CNS depressants, including opioids, with pregabalin, may cause respiratory depression and overdose.
• Instruct patient to notify health care professional of medication regimen before treatment or surgery.
• Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy. May impair male fertility. Encourage patients who become pregnant to enroll in the NAAED Pregnancy Registry by calling 1-800-233-2334. Information can be found at www.aedpregnancyregistry.org/.
• Advise patient to carry identification describing disease process and medication regimen at all times.

pre-GAB-a-lin