failure symptoms when using pregabalin Pregabalin may cause dizziness and somnolence; inform patients that pregabalin may impair their ability to perform tasks such as driving or operating machinery; concomitant use of pregabalin with other central nervous system (CNS) depressants may exacerbate these effects; for patients 1 month to less than 4 years of age, somnolence includes related terms lethargy, sluggishness, and hypersomnia Weight gain may occur; long-term cardiovascular effects of pregabalin-associated weight gain are unknown Symptoms including, insomnia, nausea, headache, anxiety, and diarrhea were reported following abrupt or rapid discontinuation of treatment; increased seizure frequency may occur in patients with seizure disorders and have rapid discontinued treatment; taper pregabalin gradually over a minimum of 1 week rather than discontinuing the drug abruptly Unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice; the clinical significance of this finding is unknown In controlled studies, blurred vision and other vision-related events were reported with treatment; clinical significance of the ophthalmologic findings is unknown, inform patients to notify their physician if changes in vision occur; if visual disturbance persists, consider further assessment Creatine kinase elevations has been associated with treatment; monitor for symptoms (eg, unexplained muscle pain, tenderness, or weakness, particularly if these muscle symptoms are accompanied by malaise or fever); discontinue treatment if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur Serious, life-threatening, or fatal respiratory depression reported when coadministered with central nervous system depressants, including opioids, or in the setting of underlying respiratory impairment; consider initiating therapy at low dose and monitor for symptoms of respiratory depression and sedation if co-prescribing of another CNS depressant, like opioid, or prescribing to patients with underlying respiratory impairment Monitor for decreased platelet count (rare) May cause prolongation of PR interval Suicidal thoughts or behaviors 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 Inform patients, their caregivers, and families of the increase the risk of suicidal thoughts and behavior; advise to be alert for the emergence or worsening of signs and symptoms Angioedema 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 There are no adequate and well-controlled studies with pregabalin in pregnant women Animal data In the animal fertility study with pregabalin in male rats, adverse reproductive and developmental effects were observed In animal reproduction studies, increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity, including skeletal malformations, retarded ossification, and decreased fetal body weight were observed in the offspring of rats and rabbits given pregabalin orally during organogenesis, at doses that produced plasma pregabalin exposures (AUC) greater than or equal to 16 times human exposure at the maximum recommended dose (MRD) of 600 mg/day Pregnancy Registry Monitors pregnancy outcomes in women exposed to pregabalin during pregnancy Enroll pregnant patients in the North American Antiepileptic Drug (NAAED) Pregnancy Registry; contact 1-888-233-2334 or find more information at http://www.aedpregnancyregistry.org/ Lactation Small amounts of pregabalin have been detected in the milk of lactating women Based on animal studies, there is a potential risk of tumorigenicity with pregabalin exposure via breast milk to the breastfed infant Available clinical study data in patients greater than 12 years of age do not provide a clear conclusion about the potential risk of tumorigenicity with pregabalin Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatmentPregnancy Categories 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 Absorption Bioavailability: >90% AUC (24 hr): 31.5 mcg·h/mL (75 mg capsule BID); 29.4 mcg·h/mL (165 mg ER tablet) Peak plasma concentration: 3.2 mcg/mL (75 mg capsule BID); 2 mcg/mL (165 mg ER tablet) Peak plasma time, fasting: 1.5 hr (capsule) Peak plasma time, with food: 3 hr (ER tablet) Steady-state is achieved within 24-48 hr Distribution Vd: 0.5 L/kg Protein bound: None Although there are no data in humans, pregabalin has been shown to cross the blood brain barrier in mice, rats, and monkeys Metabolism Minimal Elimination Half-life: 6.3 hr Clearance: 67-80.9 mL/min Excretion: Urine Oral Administration Capsules/oral solution Take orally with or without food When discontinuing treatment, taper gradually over a minimum of 1 week ER tablets Take once daily after an evening meal Swallow whole and should not be split, crushed, or chewed When discontinuing treatment, taper gradually over a minimum of 1 week Missed dose after an evening meal, then take usual dose prior to bedtime following a snack Missed dose prior to bedtime, then take usual dose following a morning meal Missed dose following the morning meal, then take usual dose at the usual time that evening following an evening meal Storage Store at 20-25°C (68-77°F), excursions permitted between 15-30°C (between 59-86°F) in the original package BRAND FORM. UNIT PRICE PILL IMAGE pregabalin oral- 100 mg capsulepregabalin oral- 75 mg capsulepregabalin oral- 300 mg capsulepregabalin oral- 200 mg capsulepregabalin oral- 50 mg capsulepregabalin oral- 25 mg capsulepregabalin oral- 200 mg capsulepregabalin oral- 150 mg capsulepregabalin oral- 25 mg capsulepregabalin oral- 100 mg capsulepregabalin oral- 200 mg capsulepregabalin oral- 150 mg capsulepregabalin oral- 25 mg capsulepregabalin oral- 75 mg capsulepregabalin oral- 225 mg capsulepregabalin oral- 100 mg capsulepregabalin oral- 75 mg capsulepregabalin oral- 50 mg capsulepregabalin oral- 225 mg capsulepregabalin oral- 300 mg capsulepregabalin oral- 75 mg capsulepregabalin oral- 100 mg capsulepregabalin oral- 50 mg capsulepregabalin oral- 75 mg capsulepregabalin oral- 165 mg tabletpregabalin oral- 82.5 mg tabletpregabalin oral- 300 mg capsulepregabalin oral- 225 mg capsulepregabalin oral- 150 mg capsulepregabalin oral- 100 mg capsulepregabalin oral- 300 mg capsulepregabalin oral- 50 mg capsulepregabalin oral- 25 mg capsulepregabalin oral- 150 mg capsulepregabalin oral- 100 mg capsulepregabalin oral- 200 mg capsulepregabalin oral- 150 mg capsulepregabalin oral- 25 mg capsulepregabalin oral- 225 mg capsulepregabalin oral- 150 mg capsulepregabalin oral- 50 mg capsulepregabalin oral- 150 mg capsulepregabalin oral- 300 mg capsulepregabalin oral- 300 mg capsulepregabalin oral- 225 mg capsulepregabalin oral- 200 mg capsulepregabalin oral- 150 mg capsulepregabalin oral- 100 mg capsulepregabalin oral- 75 mg capsulepregabalin oral- 50 mg capsulepregabalin oral- 25 mg capsulepregabalin oral- 75 mg capsulepregabalin oral- 225 mg capsulepregabalin oral- 300 mg capsulepregabalin oral- 225 mg capsulepregabalin oral- 200 mg capsulepregabalin oral- 150 mg capsulepregabalin oral- 100 mg capsulepregabalin oral- 75 mg capsulepregabalin oral- 50 mg capsulepregabalin oral- 100 mg capsulepregabalin oral- 300 mg capsulepregabalin oral- 50 mg capsulepregabalin oral- 150 mg capsulepregabalin oral- 50 mg capsulepregabalin oral- 300 mg capsulepregabalin oral- 165 mg tabletpregabalin oral- 225 mg capsulepregabalin oral- 200 mg capsulepregabalin oral- 82.5 mg tabletpregabalin oral- 100 mg capsulepregabalin oral- 75 mg capsulepregabalin oral- 50 mg capsulepregabalin oral- 75 mg capsulepregabalin oral- 200 mg capsulepregabalin oral- 225 mg capsulepregabalin oral- 150 mg capsulepregabalin oral- 300 mg capsulepregabalin oral- 300 mg capsulepregabalin oral- 25 mg capsulepregabalin oral- 330 mg tabletpregabalin oral- 75 mg capsulepregabalin oral- 50 mg capsulepregabalin oral- 25 mg capsulepregabalin oral- 225 mg capsulepregabalin oral- 82.5 mg tabletpregabalin oral- 150 mg capsulepregabalin oral- 200 mg capsulepregabalin oral- 25 mg capsulepregabalin oral- 200 mg capsulepregabalin oral- 25 mg capsulepregabalin oral- 25 mg capsulepregabalin oral- 200 mg capsulepregabalin oral- 225 mg capsulepregabalin oral- 330 mg tabletpregabalin oral- 300 mg capsulepregabalin oral- 100 mg capsulepregabalin oral- 75 mg capsulepregabalin oral- 50 mg capsulepregabalin oral- 200 mg capsulepregabalin oral- 100 mg capsuleLyrica oral- 25 mg capsuleLyrica oral- 75 mg capsuleLyrica oral- 150 mg capsuleLyrica oral- 200 mg capsuleLyrica oral- 50 mg capsuleLyrica oral- 100 mg capsuleLyrica oral- 225 mg capsuleLyrica oral- 300 mg capsuleLyrica oral- 20 mg/mL solutionCopyright © 2010 First DataBank, Inc.Print Patient Educationpregabalin oral PREGABALIN - ORAL (pree-GAH-ba-lin) COMMON BRAND NAME(S): Lyrica USES: This medication is used to treat pain caused by nerve damage due to diabetes, shingles (herpes zoster) infection, or spinal cord injury. This medication is also used to treat pain in people with fibromyalgia.It is also used with other medications to treat certain types of seizures (focal seizures). HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using pregabalin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually 2 to 3 times a day. The dosage is based on your medical condition and response to treatment. Children's dosage is also based on weight.If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.To reduce your risk of side effects (such as dizziness and drowsiness), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. This drug works best when the amount of medicine in your body is kept at a constant level. It is best to take pregabalin at evenly spaced intervals throughout the day and night.Do not stop taking this medication without consulting your doctor. Some conditions (such as seizures) may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as difficulty sleeping, nausea, headache and diarrhea. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Report any new or worsening symptoms right away.Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.Tell your doctor if your condition lasts or gets worse. SIDE EFFECTS: Drowsiness, dizziness, dry mouth, constipation, difficulty concentrating, or weight gain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have serious side effects, including: blurred vision, unusual bleeding/bruising, unsteadiness, confusion, muscle pain/tenderness/weakness (especially if you are tired or have a fever), swelling of hands/legs/feet, signs of kidney problems (such as change in the amount of urine).A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.Get medical help right away if you have any very serious side effects, including: slow/shallow breathing.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash,