Pregabalin (Lexi-Drugs)

Pronunciation

(pre GAB a lin)

Brand Names: US

Lyrica; Lyrica CR

Brand Names: Canada

ACT Pregabalin; AG-Pregabalin; APO-Pregabalin; Auro-Pregabalin; DOM-Pregabalin; GD-Pregabalin [DSC]; JAMP-Pregabalin; Lyrica; M-Pregabalin; Mar-Pregabalin; MINT-Pregabalin; MYL-Pregabalin [DSC]; MYLAN-Pregabalin [DSC]; NRA-Pregabalin; PMS-Pregabalin; Pregabalin-150 [DSC]; Pregabalin-25 [DSC]; Pregabalin-50 [DSC]; Pregabalin-75 [DSC]; RAN-Pregabalin; RIVA-Pregabalin; SANDOZ Pregabalin; TEVA-Pregabalin

Pharmacologic Category

Anticonvulsant, MiscellaneousGABA Analog

Dosing: Adult

Note: When discontinuing, taper off gradually over at least 1 week.

Cough, chronic refractory (alternative agent) (off-label use): Immediate release: Oral: Initial: 75 mg once daily; may increase gradually over the first week in increments of 75 mg/day based on response and tolerability up to a maximum of 300 mg/day in 3 divided doses (eg, 75 mg in morning and midday with 150 mg in the evening) (Vertigan 2016).

Fibromyalgia (alternative agent): Note: For patients who do not respond to or tolerate preferred agents (Goldenberg 2018).

Immediate release: Oral: Initial: 75 mg twice daily; may increase to 150 mg twice daily within 1 week based on response and tolerability; maximum dose: 450 mg/day (manufacturer’s labeling). Note: Some experts suggest lower initial doses of 25 to 50 mg at bedtime; some patients may respond to maintenance doses <300 mg/day (Goldenberg 2018).

Generalized anxiety disorder (alternative agent) (off-label use): Note: Monotherapy or adjunctive therapy for patients who do not tolerate or respond to preferred agents (BAP [Baldwin 2014]; Craske 2018).

Immediate release: Oral: Initial: 150 mg/day in 2 to 3 divided doses; may increase based on response and tolerability at weekly intervals in increments of 150 mg/day up to a usual dose of 300 mg/day. May further increase up to 600 mg/day (Kasper 2014; WFSBP [Bandelow 2008]); however, additional benefit of doses >300 mg/day is uncertain (Lydiard 2010). Note: Some experts suggest a lower initial dose of 50 mg/day (Bystritsky 2018).

Neuropathic pain:

General dosing recommendations: Immediate release: Oral: Initial: 25 to 150 mg/day once daily or in 2 divided doses; may increase in increments of 25 to 150 mg/day at intervals ≥1 week based on response and tolerability up to a usual dose of 300 to 600 mg/day in 2 divided doses (CPS [Moulin 2014]; IASP [Finnerup 2015]).

Diabetic neuropathy:

Immediate release: Oral: Initial: 25 to 75 mg/day once daily or in 2 to 3 divided doses; may increase within 1 week based on response and tolerability up to a maximum dose of 300 to 450 mg/day (ADA [Pop-Busui 2017]; Feldman 2018). Higher doses up to 600 mg/day may have greater adverse effects without additional benefit (Arnold 2017).

Extended release: Oral: Initial: 165 mg once daily; may increase within 1 week based on response and tolerability up to maximum dose of 330 mg once daily.

Postherpetic neuralgia:

Immediate release: Oral: Initial: 150 mg/day in divided doses (75 mg twice daily or 50 mg 3 times daily); may increase to 300 mg/day within 1 week based on response and tolerability; after 2 to 4 weeks, may further increase up to the maximum dose of 600 mg/day.

Extended release: Oral: Initial: 165 mg once daily; may increase to 330 mg once daily within 1 week based on response and tolerability; after 2 to 4 weeks, may further increase up to the maximum dose of 660 mg/day.

Spinal cord injury-associated neuropathic pain: Immediate release: Oral: Initial: 75 mg twice daily; may increase within 1 week based on response and tolerability to 150 mg twice daily; after 2 to 3 weeks, may further increase up to a maximum of 600 mg/day.

Postoperative pain (off-label use): Immediate release: Oral: 75 to 300 mg as a single dose, 1 to 2 hours prior to surgery as part of a multimodal analgesia regimen. The use of multiple doses has not been found to provide additional benefit (APS [Chou 2016]; Mishriky 2015).

Pruritus, chronic (alternative agent) (off-label use): Note: For patients with pruritus resistant to preferred therapies (Matsuda 2016; Weisshaar 2012).

Neuropathic (eg, brachioradial pruritus, notalgia paresthetica) or malignancy related: Based on limited data: Immediate release: Oral: Initial: 75 mg twice daily; may increase based on response and tolerability up to 150 to 300 mg/day in 2 to 3 divided doses (Atis 2017; Fazio 2018; Matsuda 2016; Vestita 2016). Higher doses up to 600 mg/day have been used in oncology populations (Dalal 2018).

Uremic: Immediate release: Oral: Variable dosing has been used and includes: 50 mg every other day given after dialysis on hemodialysis days (Foroutan 2017) or 25 mg daily (Kobrin 2018), each increased based on response and tolerability to 50 or 75 mg daily; 75 mg twice weekly given after dialysis on hemodialysis days also appears effective (Yue 2015).

Restless legs syndrome (off-label use): Immediate release: Oral: Initial: 50 to 75 mg once daily, 1 to 3 hours before bedtime; gradually increase (eg, in increments of 75 to 150 mg) every 5 to 7 days based on response and tolerability to a usual effective dose of 150 to 450 mg/day (Allen 2010; Allen 2014; Garcia-Borreguero 2014).

Seizures, focal (partial) onset (adjunctive therapy with other anticonvulsants): Immediate release: Oral: Initial: 150 mg/day in 2 or 3 divided doses; may increase based on response and tolerability at weekly intervals up to a maximum dose of 600 mg/day.

Social anxiety disorder (alternative agent) (off-label use): Note: Monotherapy or adjunctive therapy for patients who do not tolerate or respond to preferred agents (Stein 2018). Immediate release: Oral: Initial: 100 mg 3 times daily; may increase over 1 week in increments of 150 mg/day based on response and tolerability up to 600 mg/day (Feltner 2011; Greist 2011; Pande 2004).

Vasomotor symptoms associated with menopause (alternative agent) (off-label use): Note: Used as a nonhormonal alternative in patients unable or unwilling to take preferred agents (Stuenkel 2015). Some experts prefer gabapentin over pregabalin as an alternative agent because of greater available evidence (Santen 2018).

Immediate release: Oral: Initial: 50 mg once daily at bedtime; may increase at weekly intervals based on response and tolerability to 50 mg twice daily, and then up to 75 mg twice daily; may further increase up to 150 mg twice daily (Loprinzi 2010).

Dosing conversion from immediate-release oral formulations to extended-release oral formulation: Note: On the day of the switch, administer morning dose of immediate-release product as prescribed, and initiate extended-release therapy after the evening meal.

Immediate-release total daily dose of 75 mg is equivalent to extended-release dose of 82.5 mg once daily

Immediate-release total daily dose of 150 mg is equivalent to extended-release dose of 165 mg once daily

Immediate-release total daily dose of 225 mg is equivalent to extended-release dose of 247.5 mg once daily

Immediate-release total daily dose of 300 mg is equivalent to extended-release dose of 330 mg once daily

Immediate-release total daily dose of 450 mg is equivalent to extended-release dose of 495 mg once daily

Immediate-release total daily dose of 600 mg is equivalent to extended-release dose of 660 mg once daily

Discontinuation of therapy: In patients receiving pregabalin chronically, unless safety concerns require a more rapid withdrawal, pregabalin should be withdrawn gradually over ≥1 week to minimize the potential of increased seizure frequency (in patients with epilepsy) or other withdrawal symptoms (eg, agitation, confusion, delirium, delusions, GI symptoms, mood changes, sweating, withdrawal seizures) (Bonnet 2017; “Gabapentin and Pregabalin” 2012).

Dosing: Geriatric

Refer to adult dosing; use with caution. In the management of restless legs syndrome, a starting dose of 50 mg once daily in patients >65 years has been recommended (Garcia-Borreguero 2016).

Dosing: Renal Impairment: Adult

Immediate release: Renal function may be estimated using the Cockcroft-Gault formula. Then determine recommended dosage regimen based on the indication-specific total daily dose for normal renal function (CrCl ≥60 mL/minute). For example, if the indication-specific daily dose is 450 mg daily for normal renal function, the daily dose should be reduced to 225 mg daily (in 2 to 3 divided doses) for a creatinine clearance of 30 to 60 mL/minute (see table).

Immediate-Release Pregabalin Renal Impairment Dosing
CrCl

(mL/minute)

Total Pregabalin Daily Dose

(mg/day)

Dosing Frequency
Hemodialysis: Dialyzable (~50%); supplementary dosage posthemodialysis (as a single additional dose):

25 mg/day schedule: Single supplementary dose of 25 mg or 50 mg

25 to 50 mg/day schedule: Single supplementary dose of 50 mg or 75 mg

50 to 75 mg/day schedule: Single supplementary dose of 75 mg or 100 mg

75 mg/day schedule: Single supplementary dose of 100 mg or 150 mg

≥60 (normal renal function) 150 300 450 600 2 to 3 divided doses
30 to 60 75 150 225 300 2 to 3 divided doses
15 to 30 25 to 50 75 100 to 150 150 1 to 2 divided doses
<15 25 25 to 50 50 to 75 75 Single daily dose

Extended release: Renal function may be estimated using the Cockcroft-Gault formula. Then determine recommended dosage regimen based on the indication-specific total daily dose for normal renal function (CrCl ≥60 mL/minute). For example, if the indication-specific daily dose is 495 mg once daily for normal renal function, the daily dose should be reduced to 247.5 mg once daily for a creatinine clearance of 30 to 60 mL/minute (see table).

Extended-Release Pregabalin Renal Impairment Dosing
CrCl (mL/minute) Total Pregabalin Daily Dose (mg/day) Dosing Frequency
≥60 (normal renal function) 165 330 495 660 Once daily
30 to 60 82.5 165 247.5 330 Once daily
<30 Extended-release product not recommended; use immediate-release product
Hemodialysis
Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, no adjustment is expected since undergoes minimal hepatic metabolism.

Dosing: Pediatric

Note: When discontinuing, taper off gradually over at least 1 week.

Seizures, partial onset; adjunctive therapy: Immediate release:

Children ≥4 years and Adolescents <17 years:

11 to <30 kg: Oral: Initial dose: 3.5 mg/kg/day in 2 or 3 divided doses; dose may be increased weekly based on clinical response and tolerability; maximum daily dose: 14 mg/kg/day

≥30 kg: Oral: Initial dose: 2.5 mg/kg/day in 2 or 3 divided doses; dose may be increased weekly based on clinical response and tolerability; maximum daily dose: 10 mg/kg/daynot to exceed 600 mg/day

Adolescents ≥17 years: Oral: Initial dose: 150 mg daily in 2 or 3 divided doses; may be increased weekly based on tolerability and effect; maximum daily dose: 600 mg/day

Dosing: Renal Impairment: Pediatric

Immediate release: There are no dosage adjustments provided in manufacturer’s labeling; based on experience in adult patients, dosing adjustment may be necessary.

Dosing: Hepatic Impairment: Pediatric

Immediate release: There are no dosage adjustments provided in the manufacturer’s labeling; however, no adjustment is expected since pregabalin undergoes minimal hepatic metabolism.

Use: Labeled Indications

Fibromyalgia (immediate release only): Management of fibromyalgia

Neuropathic pain associated with diabetic peripheral neuropathy (immediate release and extended release): Management of neuropathic pain associated with diabetic peripheral neuropathy

Neuropathic pain associated with spinal cord injury (immediate release only): Management of neuropathic pain associated with spinal cord injury

Postherpetic neuralgia (immediate release and extended release): Management of postherpetic neuralgia

Seizures, focal (partial) onset (immediate release only): Adjunctive therapy in patients ≥4 years of age with focal onset (partial-onset) seizures

Use: Off-Label: Adult

  Cough, chronic refractoryLevel of Evidence [C]

Data from a limited number of patients studied suggest that pregabalin may be beneficial for the treatment of refractory chronic cough Ref.

  Generalized anxiety disorderLevel of Evidence [B, G]

Data from several meta-analyses support the use of pregabalin in the treatment of generalized anxiety disorder Ref.

Based on the World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the pharmacological treatment of anxiety disorders, obsessive-compulsive disorder, and posttraumatic stress disorders and Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress, and obsessive-compulsive disorders, pregabalin is effective and recommended as a first-line agent in the management of generalized anxiety disorder. The British Association for Psychopharmacology guidelines for evidence-based pharmacological treatment of anxiety disorders, posttraumatic stress disorder, and obsessive-compulsive disorder recommend pregabalin as an alternative initial treatment if SSRIs are considered unsuitable and for augmentation after nonresponse to initial SSRI or SNRI treatment. Access Full Off-Label Monograph

  Postoperative pain (as a component of multimodal analgesia in select patients)Level of Evidence [B]

Data from several meta-analyses support the use of preemptive doses of pregabalin to decrease postoperative pain, opioid use, and nausea and vomiting Ref.

  Pruritus, neuropathic or malignancy relatedLevel of Evidence [C]

Data from a limited number of patients studied suggest that pregabalin may be beneficial for the treatment of chronic neuropathic or malignancy-related pruritus Ref.

  Pruritus, uremicLevel of Evidence [B, G]

Data from several randomized, controlled trials support the use of pregabalin in the treatment of chronic uremic pruritus in dialysis patients Ref.

Based on the European Dermatology Forum and European Academy of Dermatology and Venerology guidelines on chronic pruritus, pregabalin is recommended in the management of chronic kidney disease-associated pruritus Ref.

  Restless legs syndromeLevel of Evidence [B, G]

Data from randomized, double-blind, placebo-controlled studies support the use of pregabalin in the treatment of moderate to severe primary restless legs syndrome (RLS) with predominant evening symptoms Ref.

Based on American Academy of Neurology guidelines and guidelines from the International Restless Legs Syndrome Study Group for the long-term treatment of RLS, pregabalin is effective and recommended in the management of primary RLS Ref

Based on the International Restless Legs Syndrome Study Group (IRLSSG), European Restless Legs Syndrome Study Group (EURLSSG), and Restless Legs Syndrome Foundation guidelines for the prevention and treatment of dopaminergic augmentation in RLS, alpha-2-delta ligands (eg, pregabalin), are effective and should be considered for the initial treatment of patients with RLS due to their minimal risk of augmentation. Additionally, patients who experience augmentation on dopaminergic agents may benefit from a switch to alpha-2-delta ligands (eg, pregabalin). Access Full Off-Label Monograph

  Social anxiety disorderLevel of Evidence [B]

Data from 2 double-blind, placebo-controlled, fixed-dose studies and a relapse prevention study support the use of pregabalin in the treatment of social anxiety disorder Ref.

  Vasomotor symptoms associated with menopauseLevel of Evidence [B, G]

Data from a randomized, double-blind, placebo-controlled trial support the use of pregabalin in the treatment of vasomotor symptoms (eg, hot flashes) associated with menopause, including women previously treated for breast cancer Ref.

Based on the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) position statement on menopause, the Endocrine Society guideline on the treatment of symptoms of menopause, and the North American Menopause Society (NAMS) position statement on nonhormonal management of menopause-associated vasomotor symptoms, pregabalin is an effective and recommended alternative for the management of vasomotor symptoms associated with menopause in patients with contraindications to hormonal therapy or who prefer not to use hormonal therapy. Access Full Off-Label Monograph

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Menopause:

Endocrine Society (ES), Treatment of Symptoms of the Menopause, 2015

North American Menopause Society (NAMS), Nonhormonal management of menopause-associated vasomotor symptoms, 2015

Neuropathic Pain:

American Academy of NeurologyAmerican Association of Neuromuscular and Electrodiagnostic Medicine and the American Academy of Physical Medicine and Rehabilitation, “Evidence-Based Guideline: Treatment of Painful Diabetic Neuropathy,” April 2011

American Academy of Neurology (AAN), “Practice parameter: Treatment of postherpetic neuralgia: An evidence-based report of the quality standards subcommittee of the American Academy of Neurology,” 2004

American Diabetes Association, “Diabetic Neuropathy: A Position Statement by the American Diabetes Association,” 2017

European Federation of Neurological Societies (EFNS), “EFNS guidelines on the pharmacological treatment of neuropathic pain, 2010 revision,” 2010

International Association for the Study of Pain,” Pharmacotherapy for Neuropathic Pain in Adults: Systematic Review, Meta-analysis and Updated NeuPSIG Recommendations,” 2015

National Institute for Health and Care Excellence, “Neuropathic Pain in Adults: Pharmacological Management in Non-specialist Settings,” 2013

Toronto Diabetic Neuropathy Expert Group, “Diabetic Neuropathies: Update on Definitions, Diagnostic Criteria, Estimation of Severity, and Treatments,” 2010

Restless Legs Syndrome:

American Academy of Neurology, “Practice Guideline Summary: Treatment of Restless Legs Syndrome in Adults,” November 2016

American Academy of Sleep Medicine, “The treatment of restless legs syndrome and periodic limb movement disorder in adults – An update for 2012: Practice parameters with an evidence-based systematic review and meta-analysis,” 2012

European Federation of Neurological Societies, the European Neurological Society and the European Sleep Research Society, “European guidelines on management of restless legs syndrome: Report of a joint task force by the European Federation of Neurological Societies, the European Neurological Society and the European Sleep Research Society,” November 2012

International Restless Legs Syndrome Study Group (IRLSSG), European Restless Legs Syndrome Study Group (EURLSSG), and Restless Legs Syndrome Foundation, “Guidelines for the first-line treatment of restless legs syndrome/Willis-Ekbom disease, prevention and treatment of dopaminergic augmentation: A combined task force of the IRLSSG, EURLSSG and the RLS Foundation, “ May 2016

Seizure Disorders:

American Academy of Neurology and American Epilepsy Society, “Practice guideline update summary: Efficacy and tolerability of the new antiepileptic drugs I: Treatment of new-onset epilepsy,” 2018

American Academy of Neurology and American Epilepsy Society, “Practice guideline update summary: Efficacy and tolerability of the new antiepileptic drugs II: Treatment-resistant epilepsy, “ 2018

Administration: Oral

Immediate release: May be administered with or without food.

Extended release: Administer once daily after an evening meal; swallow whole, do not split, crush, or chew. A missed dose should be taken before bedtime following a snack. If missed before bedtime, administer in the morning with a meal. If missed in the morning, wait until the evening meal to take the next scheduled dose.

Administration: Pediatric

Oral:

Immediate release: May be administered with or without food.

Extended release: Administer once daily after an evening meal; swallow whole; do not split, crush, or chew. A missed dose should be taken before bedtime following a snack. If missed before bedtime, administer in the morning with a meal. If missed in the morning, wait until the evening meal to take the next scheduled dose.

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dizziness, weight gain, fatigue, difficulty focusing, headache, dry mouth, loss of strength and energy, constipation, joint pain, nausea, or increased hunger. Have patient report immediately to prescriber signs of depression (suicidal ideation, anxiety, emotional instability, or illogical thinking), vision changes, blurred vision, muscle pain, muscle weakness, seizures, bruising, bleeding, change in balance, confusion, tremors, memory impairment, shortness of breath, excessive weight gain, swelling of arms or legs, tachycardia, abnormal heartbeat, chills, pharyngitis, skin sores, difficulty speaking, insomnia, abnormal gait, feeling high, twitiching, agitation, irritability, panic attacks, or mood changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Other safety concerns:
Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Lyrica: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf#page=54

Lyrica CR: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209501s000lbl.pdf#page=29

Contraindications

Hypersensitivity (eg, angioedema) to pregabalin or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Angioedema: Angioedema has been reported during initial and chronic treatment; may be life-threatening. Symptoms reported include facial, mouth (tongue, lips, and gums), and neck (throat and larynx) swelling. Use with caution in patients with a history of angioedema episodes. Concurrent use with other drugs known to cause angioedema (eg, ACE inhibitors) may increase risk. Discontinue treatment immediately if angioedema occurs.

• CNS effects: Dizziness and somnolence are commonly reported; effects generally occur shortly after initiation and occur more frequently at higher doses. Patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Hematologic effects: May decrease platelet count. Severe thrombocytopenia is extremely rare.

• Hypersensitivity: Hypersensitivity reactions, including skin redness, blistering, hives, rash, dyspnea, and wheezing have been reported shortly after initiation of treatment; discontinue treatment if hypersensitivity occurs.

• Peripheral edema: Use may cause peripheral edema; use with caution in patients with heart failure (NYHA Class III or IV) due to limited data in this patient population. In addition, effect on weight gain/edema may be additive with the thiazolidinedione class of antidiabetic agents; use caution when coadministering these agents, particularly in patients with prior cardiovascular disease.

• PR interval: May cause mild prolongation of PR interval. Clinical significance unknown.

• Rhabdomyolysis: Has been associated with increases in creatine kinase and rare cases of rhabdomyolysis; patients should be instructed to notify their prescriber if unexplained muscle pain, tenderness, or weakness, particularly if fever and/or malaise are associated with these symptoms. Discontinue treatment if myopathy is suspected or diagnosed or if markedly elevated creatine kinase levels occur.

• Suicidal ideation: Pooled analysis of trials involving various antiepileptics (regardless of indication) showed an increased risk of suicidal thoughts/behavior (incidence rate: 0.43% treated patients compared to 0.24% of patients receiving placebo); risk observed as early as 1 week after initiation and continued through duration of trials (most trials ≤24 weeks). Monitor all patients for notable changes in behavior that might indicate suicidal thoughts or depression; notify healthcare provider immediately if symptoms occur.

• Visual disturbances: Blurred vision, decreased acuity and visual field changes have been associated with therapy; patients should be instructed to notify their physician if these effects are noted.

• Weight gain: Use may cause weight gain; weight gain generally associated with dose and duration (average weight gain was 5.2 kg for diabetic patients receiving pregabalin for ≥2 years); weight gain was not limited to patients with edema and did not appear to be associated with baseline BMI, gender, age, or loss of glycemic control in diabetic patients.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with severe cardiovascular disease, including heart failure; weight gain and/or peripheral edema may occur. In a scientific statement from the American Heart Association, pregabalin has been determined to be an agent that may exacerbate underlying myocardial dysfunction (magnitude: minor to moderate) (AHA [Page 2016]).

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required.

• Substance abuse: Use with caution in patients with a history of substance abuse; potential for behavioral dependence in this population exists (Bonnet 2017).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Tumorigenic potential: Increased incidence of hemangiosarcoma noted in animal studies; significance of these findings in humans is unknown.

• Withdrawal: Anticonvulsants should not be discontinued abruptly because of the possibility of increasing seizure frequency; therapy should be withdrawn gradually unless safety concerns require a more rapid withdrawal. Tapering over at least 1 week is recommended. Abrupt discontinuation with pregabalin has been associated with anxiety, diarrhea, headache, hyperhidrosis, insomnia, and nausea.

Geriatric Considerations

In clinical studies, no differences in safety and efficacy were noted between elderly. Since pregabalin is primarily excreted renally, dosage adjustment, based on CrCl, is necessary.

Pregnancy Considerations

Pregabalin crosses the placenta (Ohman 2011). Studies which evaluated neonatal outcomes following pregabalin exposure during pregnancy are limited (Mostacci 2017; Patorno 2017; Veiby 2014; Winterfeld 2016). Pregabalin has been evaluated as an adjuvant pain medication following cesarean section and pregnancy termination (El Kenany 2016; Lavand’homme 2010).

In a study conducted in males, pregabalin was found to temporarily decrease mean sperm concentrations; no effects on sperm morphology or motility were observed. Concentrations increased after pregabalin was discontinued. The clinical relevance of this is not known.

Data collection to monitor pregnancy and infant outcomes following exposure to pregabalin is ongoing. Patients exposed to pregabalin during pregnancy are encouraged to enroll themselves into the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334. Additional information is available at www.aedpregnancyregistry.org.

Breast-Feeding Considerations

Pregabalin is present in breast milk.

The relative infant dose (RID) of pregabalin is ~7% when calculated using an average breast milk concentration compared to a weight-adjusted maternal dose of 300 mg/day.

In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000).

The RID of pregabalin was calculated using an average milk concentration of 2.05 mcg/mL, providing an estimated daily infant dose via breast milk of 0.31 mg/kg/day. This milk concentration was obtained following maternal administration of pregabalin 150 mg orally twice daily for 4 doses. The study included 10 women who were ~37 weeks’ postpartum (range: 15 to 81 weeks). Infants were not breastfed during the study period. Peak concentrations in breast milk were generally lower than those in the maternal plasma (Lockwood 2016). A slightly higher RID of ~8% was noted in a case report (Ohman 2011). Poor latching on, lasting ~8 hours, was observed in three infants immediately postpartum following a single maternal dose of pregabalin for pain during cesarean delivery (El Kenany 2016). Breastfeeding is not recommended by the manufacturer.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

>10%:

Cardiovascular: Peripheral edema (4% to 16%)

Central nervous system: Dizziness (3% to 45%), drowsiness (≤36%; children and adolescents: 17% to 26%), headache (2% to 14%), fatigue (4% to 11%)

Endocrine & metabolic: Weight gain (2% to 14%)

Gastrointestinal: Xerostomia (≤15%)

Ophthalmic: Visual field loss (13%), blurred vision (≤12%)

1% to 10%:

Cardiovascular: Edema (≤8%), facial edema (1% to 3%), chest pain (2%), hypertension (2%), hypotension (2%)

Central nervous system: Ataxia (2% to 9%), equilibrium disturbance (2% to 9%), abnormal gait (1% to 8%), euphoria (2% to 7%), confusion (1% to 7%), disturbance in attention (4% to 6%), abnormality in thinking (1% to 6%), neuropathy (5%), pain (3% to 5%), myasthenia (1% to 5%), insomnia (4%), amnesia (1% to 4%), memory impairment (1% to 4%), vertigo (1% to 4%), hypoesthesia (2% to 3%), feeling abnormal (1% to 3%), speech disturbance (1% to 3%), anxiety (2%), paresthesia (2%), disorientation (1% to 2%), intoxicated feeling (1% to 2%), lethargy (1% to 2%), anorgasmia (≥1%), depersonalization (≥1%), hypertonia (≥1%), sedation (≥1%), stupor (≥1%), twitching (≥1%; includes myokymia), nervousness (1%)

Dermatologic: Pressure ulcer (3%), ecchymoses (≥1%), pruritus (≥1%), contact dermatitis (1%)

Endocrine & metabolic: Fluid retention (2% to 3%), hypoglycemia (2% to 3%), decreased libido (≥1%)

Gastrointestinal: Constipation (3% to 10%), increased appetite (3% to 10%), nausea (3% to 5%), sialorrhea (children and adolescents: 1% to 4%), flatulence (2% to 3%), vomiting (1% to 3%), abdominal distension (2%), abdominal pain (≥1%), gastroenteritis (≥1%), diarrhea (1%), viral gastroenteritis (≤1%)

Genitourinary: Urinary incontinence (1% to 3%), impotence (≥1%), urinary frequency (≥1%), erectile dysfunction (≤1%), urinary tract infection (1%)

Hematologic & oncologic: Thrombocytopenia (3%)

Hepatic: Increased serum alanine aminotransferase (≤1%), increased serum aspartate aminotransferase (≤1%)

Hypersensitivity: Hypersensitivity reaction (≥1%)

Infection: Infection (6% to 8%)

Neuromuscular & skeletal: Asthenia (4% to 7%), arthralgia (1% to 6%), muscle spasm (4%), back pain (1% to 4%), limb pain (3%), neck pain (3%), increased creatine phosphokinase (2% to 3%), tremor (1% to 3%), joint swelling (≤2%), lower limb cramp (≥1%), myalgia (≥1%)

Ophthalmic: Decreased visual acuity (7%), visual disturbance (1% to 5%), diplopia (≤4%), eye disease (1% to 2%), conjunctivitis (≥1%), nystagmus (≥1%)

Otic: Otitis media (≥1%), tinnitus (≥1%)

Respiratory: Nasopharyngitis (1% to 8%), sinusitis (≤7%), bronchitis (3%), pharyngolaryngeal pain (3%), dyspnea (2%), flu-like symptoms (2%), cough (1%), respiratory tract infection (1%)

Miscellaneous: Accidental injury (3% to 6%), fever (≥1%)

Frequency not defined: Cardiovascular: Prolongation P-R interval on ECG

<1%, postmarketing, and/or case reports: Abnormal dreams, abscess, accommodation disturbance, acute renal failure, ageusia, agitation, albuminuria, alopecia, altered sense of smell, amenorrhea, anaphylactoid shock, anemia, angioedema, anisocoria, apathy, aphasia, aphthous stomatitis, apnea, arthropathy, ascites, atelectasis, balanitis, bladder neoplasm, blepharitis, blepharoptosis, blindness, bradykinesia, breast hypertrophy, bronchiolitis, cardiac failure, cellulitis, cerebellar syndrome, cervicitis, chills, cholecystitis, cholelithiasis, chondrodystrophy, cognitive dysfunction, cogwheel rigidity, colitis, coma, corneal ulcer, cutaneous nodule, decreased glucose tolerance, delirium, delusions, depression of ST segment on ECG, dermal ulcer, drug dependence, dry mucous membranes, dysarthria, dysautonomia, dysgeusia, dyskinesia, dysmenorrhea, dyspareunia, dysphagia, dystonia, dysuria, eczema, ejaculatory disorder, encephalopathy, eosinophilia, epididymitis, erythema, esophageal ulcer, esophagitis, exfoliative dermatitis, exophthalmos, extraocular palsy, extrapyramidal reaction, facial pain, gastritis, gastrointestinal hemorrhage, glomerulonephritis, glycosuria, granuloma, Guillain-Barre syndrome, gynecomastia, hallucination, hangover effect, heavy menstrual bleeding, hematuria, hemophthalmos, hiccups, hirsutism, hostility, hypalgesia, hyperacusis, hyperalgesia, hyperesthesia, hyperkinesia, hypochromic anemia, hypokinesia, hypoprothrombinemia, hypotonia, impaired consciousness, increased libido, increased neutrophils, increased serum lipase, intentional injury, intracranial hypertension, iritis, irritability, joint stiffness, keratitis, keratoconjunctivitis, lactation (females), laryngismus, leukocytosis, leukopenia, leukorrhea, lichenoid dermatitis, local inflammation (coccydynia), lymphadenopathy, malaise, manic reaction, melanosis, melena, miosis, mydriasis, myelofibrosis, myoclonus, nail disease, neck stiffness, nephritis, nephrolithiasis, neuralgia, nocturnal amblyopia, nonthrombocytopenic purpura, oliguria, ophthalmoplegia, optic atrophy, oral mucosa ulcer, oral paresthesia, orthostatic hypotension, ovarian disease, palpitations, pancreatitis, papilledema, paranoia, pelvic pain, periodontal abscess, periorbital edema, peripheral neuritis, personality disorder, petechial rash, photophobia, pneumonia, polycythemia, proteinuria, psychomotor disturbance, psychotic depression, pulmonary edema, pulmonary fibrosis, purpuric rash, pustular rash, pyelonephritis, rectal hemorrhage, retinal edema, retinal vascular disease, retroperitoneal fibrosis, rhabdomyolysis, sciatica, schizophrenia, severe thrombocytopenia, shock, skin atrophy, skin blister, skin necrosis, skin photosensitivity, skin rash, sleep disorder, Stevens-Johnson syndrome, subcutaneous nodule, syncope, tachycardia, thrombocythemia, thrombophlebitis, tongue edema, torticollis, trismus, urate crystalluria, urinary retention, urine abnormality, urticaria, uterine hemorrhage, uveitis, ventricular fibrillation, vesiculobullous dermatitis, wheezing, xeroderma, xerophthalmia, yawning

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

None known.

Drug Interactions 

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of Pregabalin. Specifically, the risk of angioedema may be increased. Risk C: Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Risk X: Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Risk D: Consider therapy modification

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants.Risk D: Consider therapy modification

Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Risk C: Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk D: Consider therapy modification

Esketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Risk D: Consider therapy modification

HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.Risk D: Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk C: Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Mefloquine: May diminish the therapeutic effect of Anticonvulsants. Mefloquine may decrease the serum concentration of Anticonvulsants. Management: Mefloquine is contraindicated for malaria prophylaxis in persons with a history of convulsions. Monitor anticonvulsant concentrations and treatment response closely with concurrent use. Risk D: Consider therapy modification

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Risk D: Consider therapy modification

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy

Mianserin: May diminish the therapeutic effect of Anticonvulsants. Risk C: Monitor therapy

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Risk C: Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.Risk D: Consider therapy modification

Orlistat: May decrease the serum concentration of Anticonvulsants. Risk C: Monitor therapy

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Risk D: Consider therapy modification

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Risk D: Consider therapy modification

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Tetrahydrocannabinol and Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination

Thiazolidinediones: Pregabalin may enhance the fluid-retaining effect of Thiazolidinediones. Risk C: Monitor therapy

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification

Food Interactions

Extended release: Bioavailability is reduced if taken on an empty stomach. The AUC is approximately 30% lower when fasting relative to following an evening meal. Management: Administer after evening meal.

Monitoring Parameters

Measures of efficacy (pain intensity/seizure frequency); degree of sedation; symptoms of myopathy; creatine kinase (as clinically indicated); symptoms of ocular disturbance; weight gain/edema; skin integrity (in patients with diabetes); signs and symptoms of suicidality (eg, suicidal thoughts, anxiety, depression, behavioral changes); platelet count (as clinically indicated)

Advanced Practitioners Physical Assessment/Monitoring

Obtain baseline renal function tests; dosage adjustment may be needed. Measure for effectiveness of treatment (pain intensity/seizure frequency). Assess for angioedema, sedation, myopathy, visual disturbances, weight gain, skin integrity (diabetes patients), and signs of suicide.

Nursing Physical Assessment/Monitoring

Check ordered labs and report abnormalities. Monitor weight. Monitor for signs of angioedema, sedation, visual disturbances, or signs of suicidal ideation; instruct patient to report.

Controlled Substance

C-V

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Lyrica: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg [contains corn starch]

Solution, Oral:

Lyrica: 20 mg/mL (473 mL) [contains methylparaben, propylparaben]

Tablet Extended Release 24 Hour, Oral:

Lyrica CR: 82.5 mg, 165 mg, 330 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Lyrica: 25 mg, 50 mg, 75 mg, 150 mg, 225 mg, 300 mg

Generic: 25 mg, 50 mg, 75 mg, 100 mg [DSC], 150 mg, 200 mg [DSC], 225 mg, 300 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • N03AX16
Generic Available (US)

No

Pricing: US

Capsules (Lyrica Oral)

25 mg (per each): $9.36

50 mg (per each): $9.36

75 mg (per each): $9.36

100 mg (per each): $9.36

150 mg (per each): $9.36

200 mg (per each): $9.36

225 mg (per each): $9.36

300 mg (per each): $9.36

Solution (Lyrica Oral)

20 mg/mL (per mL): $2.49

Tablet, 24-hour (Lyrica CR Oral)

82.5 mg (per each): $16.09

165 mg (per each): $16.09

330 mg (per each): $16.09

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Binds to alpha-2-delta subunit of voltage-gated calcium channels within the CNS and modulates calcium influx at the nerve terminals, thereby inhibiting excitatory neurotransmitter release including glutamate, norepinephrine (noradrenaline), serotonin, dopamine, substance P, and calcitonin gene-related peptide (Gajraj 2007; McKeage 2009). Although structurally related to GABA, it does not bind to GABA or benzodiazepine receptors. Exerts antinociceptive and anticonvulsant activity. Pregabalin may also affect descending noradrenergic and serotonergic pain transmission pathways from the brainstem to the spinal cord.

Pharmacodynamics/Kinetics

Onset of action: Pain management: Effects may be noted as early as the first week of therapy.

Absorption: Extended release: AUC is approximately 30% lower when administered while fasting

Distribution: Vd: 0.5 L/kg

Protein binding: 0%

Metabolism: Negligible

Bioavailability: ≥90%

Half-life elimination: Mean: Children 4 to 6 years: 3 to 4 hours; Children ≥7 years and Adolescents <17 years: 4 to 6 hours; Adults: 6.3 hours

Time to peak, plasma:

Extended release: Median: 8 hours with food (range: 5 to 12 hours)

Immediate release: Children ≥4 years and Adolescents <17 years: 0.5 to 2 hours fasting; Median: 0.7 hours fasting (range: 0.7 to 1.5 hours), 3 hours with food

Excretion: Urine (90% as unchanged drug; minor metabolites)

Pharmacodynamics/Kinetics: Additional Considerations

Geriatric: Oral clearance tends to decrease with increasing age.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia and changes in salivation (normal salivary flow resumes upon discontinuation).

Effects on Bleeding

May be associated with thrombocytopenia (3%). No information available to require routine special precautions

Index Terms

CI-1008; S-(+)-3-isobutylgaba

FDA Approval Date
December 30, 2004
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Mishriky BM, Waldron NH, Habib AS. Impact of pregabalin on acute and persistent postoperative pain: a systematic review and meta-analysis. Br J Anaesth. 2015;114(1):10-31. doi: 10.1093/bja/aeu293.[PubMed 25209095]

Mostacci B, Poluzzi E, D’Alessandro R, et al. Adverse pregnancy outcomes in women exposed to gabapentin and pregabalin: data from a population-based study. J Neurol Neurosurg Psychiatry. 2017.[PubMed 19761281]

Moulin D, Boulanger A, Clark AJ, et al; Canadian Pain Society. Pharmacological management of chronic neuropathic pain: revised consensus statement from the Canadian Pain Society. Pain Res Manag. 2014;19(6):328-335.[PubMed 25479151]

North American Menopause Society. Nonhormonal management of menopause-associated vasomotor symptoms: 2015 position statement of The North American Menopause Society. Menopause. 2015;22(11):1155-1172.[PubMed 26382310]

Ohman I, De Flon P, Tomson T. Pregabalin kinetics in the neonatal period, and during lactation. Epilepsia. 2011;52 (suppl 6):249-250. Abstract p824.

Page RL 2nd, O’Bryant CL, Cheng D, et al; American Heart Association Clinical Pharmacology and Heart Failure and Transplantation Committees of the Council on Clinical Cardiology; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Drugs That May Cause or Exacerbate Heart Failure: A Scientific Statement From the American Heart Association [published correction appears in Circulation. 2016;134(12):e261]. Circulation. 2016;134(6):e32-e69.[PubMed 27400984]

Pande AC, Feltner DE, Jefferson JW, et al. Efficacy of the novel anxiolytic pregabalin in social anxiety disorder: a placebo-controlled, multicenter study. J Clin Psychopharmacol. 2004;24(2):141-149.[PubMed 15206660]

Patorno E, Bateman BT, Huybrechts KF, et al. Pregabalin use early in pregnancy and the risk of major congenital malformations. Neurology. 2017;88(21):2020-2025.[PubMed 28446648]

Pop-Busui R, Boulton AJ, Feldman EL, et al. Diabetic neuropathy: a position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154. doi: 10.2337/dc16-2042.[PubMed 27999003]

Reid R, Abramson BL, Blake J, et al; Menopause and Osteoporosis Working Group; Society of Obstetricians and Gynaecologists of Canada. Managing menopause. J Obstet Gynaecol Can. 2014;36(9):830-838.[PubMed 25222364]

Santen R, Loprinzi C, Casper R. Menopausal hot flashes. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed December 5, 2018.

Solak Y, Biyik Z, Atalay H, et al. Pregabalin versus gabapentin in the treatment of neuropathic pruritus in maintenance haemodialysis patients: a prospective, crossover study. Nephrology (Carlton). 2012;17(8):710-717. doi: 10.1111/j.1440-1797.2012.01655.x.[PubMed 22909343]

Stein M. Pharmacotherapy for social anxiety disorder in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed December 5, 2018.

Stuenkel CA, Davis SR, Gompel A, et al. Treatment of symptoms of the menopause: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(11):3975-4011. doi: 10.1210/jc.2015-2236[PubMed 26444994]

Weisshaar E, Szepietowski JC, Darsow U, et al. European guideline on chronic pruritus. Acta Derm Venereol. 2012;92(5):563-581. doi: 10.2340/00015555-1400.[PubMed 22790094]

Winkelman JW, Armstrong MJ, Allen RP, et al. Practice guideline summary: treatment of restless legs syndrome in adults. Neurology. 2016;87(24):2585-2593. doi: 10.1212/WNL.0000000000003388[PubMed 27856776]

Winterfeld U, Merlob P, Baud D, et al. Pregnancy outcome following maternal exposure to pregabalin may call for concern. Neurology 2016;86(24):2251-2257[PubMed 27194385]

Veiby G, Daltveit AK, Engelsen BA, Gilhus NE. Fetal growth restriction and birth defects with newer and older antiepileptic drugs during pregnancy. J Neurol. 2014;261(3):579-588. doi: 10.1007/s00415-013-7239-x.[PubMed 24449062]

Vertigan AE, Kapela SL, Ryan NM, Birring SS, McElduff P, Gibson PG. Pregabalin and speech pathology combination therapy for refractory chronic cough: a randomized controlled trial. Chest. 2016;149(3):639-648. doi: 10.1378/chest.15-1271.[PubMed 26447687]

Vestita M, Cerbone L, Calista D. Brachioradial pruritus in a 47-year-old woman treated with pregabalin. G Ital Dermatol Venereol. 2016;151(6):727-728.[PubMed 27824228]

Yue J, Jiao S, Xiao Y, Ren W, Zhao T, Meng J. Comparison of pregabalin with ondansetron in treatment of uraemic pruritus in dialysis patients: a prospective, randomized, double-blind study. Int Urol Nephrol. 2015;47(1):161-167. doi: 10.1007/s11255-014-0795-x.[PubMed 25099523]

Zhang J, Ho KY, Wang Y. Efficacy of pregabalin in acute postoperative pain: a meta-analysis. Br J Anaesth. 2011;106(4):454-462. doi: 10.1093/bja/aer027.[PubMed 21357616]

Brand Names: International

Algecia (NL); Andogablin (EG); Aprion (ID); Axual (AR); Balinozar (EG); Brieka (CZ, IE); Egzsta (VN); Egzysta (CZ); Erclany (CZ); Funxion (PH); Gabarol (BD); Gabi (PH); Gabica (PH, PK, VN); Gabrika (LB); Gacela (CR, DO, GT, HN, NI, PA, SV); Galica (LB); Gavin (AR); Gloryca (VN); Innikra (ZW); Kemirica (EG); Lalaca (KR); Lecaent (GB); Leptica (ID); Ligaba (PH); Linefor (NL); Lingabat (NL); Lipapyn (ZW); Lirystad (VN); Lybalin (TH); Lyrica (AE, AR, AT, AU, BB, BE, BG, BH, BR, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IS, IT, JO, JP, KR, KW, LB, LK, LT, LU, LV, MT, MX, MY, NI, NL, NO, NZ, PA, PE, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, UY, VE, VN, ZW); Lyrigab (LK); Martesia (CR, DO, EC, GT, HN, NI, PA, SV); Neo Gaba (BH); Neogabin (UA); Nervax (BH, LB); Nervica (TH); Neugalin (BD); Neurocover-PG (KR); Neurovan (BD); Neurum (CL, EC); PGB (ID); Plenica (LB); Prebarin (TH); Prebicta (CR, DO, GT, HN, NI, PA, SV); Prega 150 (ZW); Pregaba (ZW); Pregabadin (PY); Pregadex (BH); Pregalex (EC); Pregalin (KR); Pregasafe-150 (TZ); Pregasafe-75 (TZ); Pregax (LK); Pregeb (PH); Prelyx (CR, DO, GT, HN, NI, PA, SV); Preneurin (PH); Prepentin (VN); Prex (BH); Provelyn (ID); Regab (BD); Rewisca (GB); Silica (KR); Toprelin (TH); Vexer (LK, PH); Xablin (BD); Zeegap (LK); Zyzyx (PH)

Pregabalin (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(pre GAB a lin)

Brand Names: US

Lyrica; Lyrica CR

Brand Names: Canada

Lyrica

What is this drug used for?
  • It is used to help control certain kinds of seizures.
  • It is used to treat painful nerve diseases.
  • It is used to treat fibromyalgia.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to pregabalin or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have kidney disease.
  • If you are breast-feeding. Do not breast-feed while you take this drug.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this drug affects you.
  • Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
  • Avoid drinking alcohol while taking this drug.
  • Talk with your doctor before you use other drugs and natural products that slow your actions.
  • A very bad reaction called angioedema has happened with this drug. Sometimes, this may be life-threatening. Signs may include swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; or unusual hoarseness. Get medical help right away if you have any of these signs.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Talk with your doctor if you plan to father a child. This drug made male animals less fertile and caused sperm changes. Birth defects also happened in the young of male animals treated with this drug. It is not known if these problems happen in humans.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Change in eyesight.
  • Blurred eyesight.
  • Muscle pain or weakness.
  • If seizures are new or worse after starting this drug.
  • Change in balance.
  • Feeling confused.
  • Shakiness.
  • Memory problems or loss.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Fever or chills.
  • Sore throat.
  • Skin sores.
  • Trouble speaking.
  • Not able to sleep.
  • Trouble walking.
  • Feeling high (easy laughing and feeling good).
  • Twitching.
  • Patients who take this drug may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
  • Low platelet counts have rarely happened with this drug. This may lead to a higher chance of bleeding. Call your doctor right away if you have any unexplained bruising or bleeding.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Dizziness.
  • Weight gain.
  • Feeling sleepy.
  • Not able to focus.
  • Headache.
  • Dry mouth.
  • Feeling tired or weak.
  • Constipation.
  • More hungry.
  • Upset stomach.
  • Joint pain.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Extended-release tablets:
  • Take after the evening meal if taking once daily.
  • Swallow whole. Do not chew, break, or crush.
  • All other products:
  • Take with or without food.
  • Liquid:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • All products:
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
What do I do if I miss a dose?
  • Extended-release tablets:
  • Take a missed dose just before bedtime after eating a snack or after the next day’s morning meal.
  • If you miss taking the missed dose after the next day’s morning meal, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • All other products:
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store in the original container at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Pregabalin (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(pre GAB a lin)

Brand Names: US

Lyrica; Lyrica CR

Brand Names: Canada

Lyrica

What is this drug used for?
  • It is used to help control certain kinds of seizures.
  • It may be given to your child for other reasons. Talk with the doctor.
  • Extended-release tablets:
  • If your child has been given this form of this drug, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions or concerns about giving this drug to your child.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has kidney disease.
  • If your child is breast-feeding a baby:
  • Be sure your child does not breast-feed a baby while taking this drug.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness or clear eyesight until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of side effects. If your child needs to stop this drug, you will want to slowly stop it as told by the doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Talk with your child’s doctor before giving your child other drugs and natural products that may slow your child’s actions.
  • A very bad reaction called angioedema has happened with this drug. Sometimes, this may be life-threatening. Signs may include swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; or unusual hoarseness. Get medical help right away if your child has any of these signs.
  • Talk with your child’s doctor about your child’s fertility later in life. This drug made male animals less fertile and caused sperm changes. Birth defects also happened in the young of male animals treated with this drug. It is not known if these problems happen in humans.
  • If your child is pregnant:
  • Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • If seizures are new or worse after starting this drug.
  • Change in eyesight.
  • Blurred eyesight.
  • Muscle pain or weakness.
  • Change in balance.
  • Feeling confused.
  • Shakiness.
  • Memory problems or loss.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Fever or chills.
  • Sore throat.
  • Skin sores.
  • Trouble speaking.
  • Not able to sleep.
  • Trouble walking.
  • Feeling high (easy laughing and feeling good).
  • Twitching.
  • Patients who take this drug may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
  • Low platelet counts have rarely happened with this drug. This may lead to a higher chance of bleeding. Call your child’s doctor right away if your child has any unexplained bruising or bleeding.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Dizziness.
  • Weight gain.
  • Feeling sleepy.
  • Not able to focus.
  • Headache.
  • Dry mouth.
  • Feeling tired or weak.
  • Constipation.
  • More hungry.
  • Upset stomach.
  • Joint pain.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Give this drug with or without food.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Liquid:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store in the original container at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.