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Lyrica CR PREGABALIN 82.5 mg Tablet, Film Coated, Extended Release, 30-count — NDC 58151-0245-93 package photo

Lyrica CR PREGABALIN 82.5 mg Tablet, Film Coated, Extended Release, 30-count

by Viatris Specialty LLC · 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-245-93)
NDC 58151-0245-93
🏷️ FDA NDC (as labeled) 58151-245-93 billing pads the product segment with a zero
Rx only Brand On market CV
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Pregabalin (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · May 16, 2024 — Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg. (Rising Pharma Holding, Inc.) · FDA recall D-0541-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 58151-245-93
Product NDC 58151-245
11-digit billing NDC 58151024593
NCPDP billing unit EA — each (per item)
RxCUI 1988974, 1988977, 1988980, 1994389, 1994392, 1994395
UNII 55JG375S6M
Application # NDA209501
SPL Set ID f280bbd8-2af2-444a-bd96-e409337ca6dd
DEA schedule CV
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-11-26
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance PREGABALIN
GPI-14 62540060007520
GCN Seq No 077834
GCN 43986
HICL code 026470
Ingredient (HICL) Pregabalin
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H5
Therapeutic class — intermediate (HIC2) Neurotonics/Cerebrovascular Agents
HIC3 code H5B
Therapeutic class — specific (HIC3) Neuropathic Agents
AHFS code 28:12.28.00
AHFS class Gaba-Mediated Anticonvulsants
FDB label name LYRICA CR 82.5 MG TABLET
FDB brand name Lyrica Cr
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 58151-245-93 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 58151-0245-93. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Gabapentinoids class.

Drug family (ATC) Gabapentinoids
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerViatris Specialty LLC
Application holderUPJOHN US 2 LLC
FDA applicationNDA209501 (NDA)
Labeler code58151
First marketedNov 2024
DEA scheduleCV
Product typeHuman Prescription Drug
Portfolio120 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name LYRICA CR 82.5 MG TABLET Ingredient Pregabalin
📖 What it is MedlinePlus · NLM

Pregabalin capsules, oral solution (liquid), and extended-release (long-acting) tablets are used to relieve neuropathic pain (pain from damaged nerves) that can occur in your arms, hands, fingers, legs, feet, or toes if you have diabetes and postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Pregabalin capsules and oral solution are also used to relieve neuropathic pain that can occur after a spinal cord injury and to treat fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, t...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Pregabalin is used for a few different conditions depending on which product you're taking. Most commonly it's prescribed for nerve pain — either from diabetes (diabetic peripheral...
  • Yes, dizziness and drowsiness are the most common side effects — and they're the main reason some people end up stopping the medication. They tend to show up shortly after you star...
  • Will pregabalin make me feel dizzy or drowsy?
  • Please don't stop abruptly. Stopping pregabalin suddenly can cause withdrawal symptoms like insomnia, nausea, headache, and anxiety. If you have a seizure disorder, stopping sudden...
📖 Read our full Pregabalin guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Blue / Brown / Pink
ShapeOval
ImprintVLE;PGN;330
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII S34RY76LK6
    Kollidon SR is a synthetic polymer used as a binder and film-former in tablets and capsules. It helps hold ingredients together and can control how quickly the medicine dissolves in your stomach.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pregabalin 82.5 mg 72205-0077-30 Novadoz 30 tablets $3.644 AB Availability likely —
Pregabalin 82.5 mg 72888-0049-30 Advagen 30 tablets $3.644 AB Availability likely —
Pregabalin Extended Release 82.5 mg 50228-0462-05 ScieGen 500 tablets — — FDA listed —
Lyrica CR 82.5 mgthis 58151-0245-93 Viatris 30 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2017
First FDA approval
Oct 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2027
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2027. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 11, 2017 AB TE-rated RLD RS ⏳ ~0.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10022447 — method of use (U-2137)
US 8945620 — method of use (U-2136)
US 8945620 — method of use (U-2137)
US 8945620 — method of use (U-2136)
US 10022447 — method of use (U-2137)
US 10022447 — method of use (U-2136)
US 10022447 — method of use (U-2137)
US 10022447 — method of use (U-2136)
US 10022447 — method of use (U-2136)
US 8945620 — method of use (U-2137)
US 8945620 — method of use (U-2137)
US 8945620 — method of use (U-2136)
US 9144559 — drug product
US 9144559 — drug product
US 9144559 — drug product
US 9144559*PED — drug product
US 9144559*PED — drug product
US 9144559*PED — drug product
US 10022447*PED — drug product
US 10022447*PED — drug product
US 10022447*PED — drug product
US 8945620*PED — drug product
US 8945620*PED — drug product
US 8945620*PED — drug product
2017 2019 2021 2023 2025 2027
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (24)
PatentTypeUse codeExpires
US 10022447 ↗ Method of use U-2137 Nov 2, 2026
US 8945620 ↗ Method of use U-2136 Nov 2, 2026
US 8945620 ↗ Method of use U-2137 Nov 2, 2026
US 8945620 ↗ Method of use U-2136 Nov 2, 2026
US 10022447 ↗ Method of use U-2137 Nov 2, 2026
US 10022447 ↗ Method of use U-2136 Nov 2, 2026
US 10022447 ↗ Method of use U-2137 Nov 2, 2026
US 10022447 ↗ Method of use U-2136 Nov 2, 2026
US 10022447 ↗ Method of use U-2136 Nov 2, 2026
US 8945620 ↗ Method of use U-2137 Nov 2, 2026
US 8945620 ↗ Method of use U-2137 Nov 2, 2026
US 8945620 ↗ Method of use U-2136 Nov 2, 2026
US 9144559 ↗ Drug product — Nov 2, 2026
US 9144559 ↗ Drug product — Nov 2, 2026
US 9144559 ↗ Drug product — Nov 2, 2026
US 9144559*PED ↗ Drug product — May 2, 2027
US 9144559*PED ↗ Drug product — May 2, 2027
US 9144559*PED ↗ Drug product — May 2, 2027
US 10022447*PED ↗ Drug product — May 2, 2027
US 10022447*PED ↗ Drug product — May 2, 2027
US 10022447*PED ↗ Drug product — May 2, 2027
US 8945620*PED ↗ Drug product — May 2, 2027
US 8945620*PED ↗ Drug product — May 2, 2027
US 8945620*PED ↗ Drug product — May 2, 2027
Common questions
Is there a generic version of LYRICA CR 82.5 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for LYRICA CR 82.5 MG TABLET. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lyrica Cr — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lyrica Cr. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$43.7K
Claims incl. refills
55
Beneficiaries
30
Spend / beneficiary
$1,457.00
Spend / claim
$794.73
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Lyrica CR (this brand).

Top reported reactions

Fatigue5,568
Pain4,973
Nausea4,906
Toxicity To Various Agents4,402
Headache4,327
Dyspnoea4,144
Dizziness4,097

Age at onset

Neonate114
Infant33
Child51
Adolescent172
Adult9,174
Elderly6,165

Reporter sex

78,756 reports
Male · 41%
Female · 59%
Unknown · 0%

Serious outcomes

Hospitalization32,805
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 9,906 4,704
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
58151-0245-93 You're viewing this 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-245-93) 2024-11-26 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 58151-245-93, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 58151-0245-93, written without dashes as 58151024593. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 58151-0245-93, the first segment (58151) is the labeler code FDA assigned to Viatris Specialty LLC; the middle segment (0245) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (93) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Viatris Specialty LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Viatris Specialty LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 98 words ▾

1 INDICATIONS AND USAGE LYRICA CR is indicated for the management of: • Neuropathic pain associated with diabetic peripheral neuropathy • Postherpetic neuralgia Efficacy of LYRICA CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures. LYRICA CR is indicated for the management of: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) • Postherpetic neuralgia (PHN) ( 1 ) Efficacy of LYRICA CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • LYRICA CR should be administered once daily after an evening meal. It should be swallowed whole and should not be split, crushed, or chewed. ( 2.1 ) • Dosing recommendations for LYRICA CR: Indication Dosing Regimen Initial Dose Maximum Dose DPN Pain ( 2.2 ) Single dose per day 165 mg/day 330 mg/day within 1 week.

PHN ( 2.3 ) Single dose per day 165 mg/day 330 mg/day within 1 week. Maximum dose of 660 mg/day. • Conversion from LYRICA Capsules or Oral Solution to LYRICA CR: See full prescribing information. ( 2.4 ) • Dose modification recommended in patients with renal impairment.

( 2.5 )

2.1Important Dosage and Administration Instructions LYRICA CR should be administered once daily after an evening meal. LYRICA CR should be swallowed whole and should not be split, crushed, or chewed. When discontinuing LYRICA CR, taper gradually over a minimum of 1 week.

Instruct patients that if they miss taking their dose of LYRICA CR after an evening meal, then they should take their usual dose of LYRICA CR prior to bedtime following a snack. If they miss taking the dose of LYRICA CR prior to bedtime, then they should take their usual dose of LYRICA CR following a morning meal. If they miss taking the dose of LYRICA CR following the morning meal, then they should take their usual dose of LYRICA CR at the usual time that evening following an evening meal [see Patient Counseling Information (17) ] .

2.2Neuropathic Pain Associated with Diabetic Peripheral Neuropathy Begin dosing at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of LYRICA CR is 330 mg once daily. Although LYRICA was studied at 600 mg/day, there was no evidence that this dose conferred additional significant benefit and this dose was less well tolerated.

In view of the dose-dependent adverse reactions with LYRICA, treatment with doses above 330 mg/day is not recommended for LYRICA CR.

2.3Postherpetic Neuralgia Begin dosing at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate LYRICA CR, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily.

The maximum recommended dose of LYRICA CR is 660 mg once daily.

2.4Conversion from LYRICA Capsules or Oral Solution to LYRICA CR When switching from LYRICA to LYRICA CR on the day of the switch, instruct patients to take their morning dose of LYRICA as prescribed and initiate LYRICA CR therapy after an evening meal. Table 1. Conversion from LYRICA Capsules or Oral Solution to LYRICA CR LYRICA Total Daily Dose (dosed 2 or 3 times daily) LYRICA CR Dose (dosed once a day) 75 mg/daily 82.5 mg/day 150 mg/daily 165 mg/day 225 mg/daily 247.5 mg/day 247.5 mg = 3 × 82.5 mg tablets taken once a day.

300 mg/daily 330 mg/day 450 mg/daily 495 mg/day 495 mg = 3 × 165 mg tablets taken once a day. 600 mg/daily 660 mg/day 660 mg = 2 × 330 mg tablets taken once a day.

2.5Patients with Renal Impairment Use of LYRICA CR is not recommended for patients with creatinine clearance (CLcr) less than 30 mL/min or who are undergoing hemodialysis. Those patients should receive LYRICA. In view of dose-dependent adverse reactions and because pregabalin is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function.

Base the dose adjustment in patients with renal impairment on CLcr, as indicated in Table 2. To use the dosing tables, an estimate of the patient’s CLcr in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination us…

💊 Dosage Forms and Strengths 103 words ▾

3 DOSAGE FORMS AND STRENGTHS Extended-release tablets: 82.5 mg, 165 mg, and 330 mg [see Description (11) and How Supplied/Storage and Handling (16) ] . LYRICA CR Tablets Tablet Strength (mg) Tablet Description 82.5 mg Light blue, film-coated, almond-shaped tablet debossed with “VLE” on one side and “PGN 82.5” on the other side 165 mg Beige, film-coated, almond-shaped tablet debossed with “VLE” on one side and “PGN 165” on the other side 330 mg Rose, film-coated, almond-shaped tablet debossed with “VLE” on one side and “PGN 330” on the other side Extended-release tablets: 82.5 mg, 165 mg, and 330 mg.

( 3 )

⛔ Contraindications 54 words ▾

4 CONTRAINDICATIONS LYRICA CR is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see Warnings and Precautions (5.1 , 5.2) , Adverse Reactions (6) ] . Known hypersensitivity to pregabalin or any of its components. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Angioedema : Angioedema [e.g., swelling of the face, mouth (tongue, lips, and gums) and neck (throat and larynx)] can occur and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue LYRICA CR immediately in patients with these symptoms. ( 5.1 ) • Hypersensitivity Reactions : Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur.

Discontinue LYRICA CR immediately in these patients. ( 5.2 ) • Suicidal Behavior and Ideation : Antiepileptic drugs, including pregabalin, the active ingredient in LYRICA CR, increase the risk of suicidal thoughts or behavior. ( 5.3 ) • Abrupt or rapid discontinuation may increase the risk for seizures.

Withdrawal symptoms or suicidal behavior and ideation have been observed after discontinuation. Taper LYRICA CR gradually over a minimum of 1 week. ( 5.4 ) • Respiratory Depression : May occur with LYRICA when used with concomitant CNS depressants or in the setting of underlying respiratory impairment.

Monitor patients and adjust dosage as appropriate. ( 5.5 ) • Dizziness and Somnolence : May cause dizziness and somnolence and impair patient’s ability to drive or operate machinery. ( 5.6 ) • Peripheral Edema : May cause peripheral edema.

Monitor patients for the development of edema when co-administering LYRICA CR and thiazolidinedione antidiabetic agents. ( 5.7 )

5.1Angioedema There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment.

Discontinue LYRICA CR immediately in patients with these symptoms. Exercise caution when prescribing LYRICA CR to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema.

5.2Hypersensitivity Reactions There have been postmarketing reports of hypersensitivity reactions in patients shortly after initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue LYRICA CR immediately in patients with these symptoms.

5.3Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including pregabalin, the active ingredient in LYRICA CR, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Suicidal behavior and ideation have also been reported in patients after discontinuation of pregabalin [see Warnings and Precautions (5.4) ] . Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated.

There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duratio…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Angioedema [see Warnings and Precautions (5.1) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] • Suicidal Behavior and Ideation [see Warnings and Precautions (5.3) ] • Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.4) ] • Respiratory Depression [see Warnings and Precautions (5.5) ] • Dizziness and Somnolence [see Warnings and Precautions (5.6) ] • Peripheral Edema [see Warnings and Precautions (5.7) ] • Weight Gain [see Warnings and Precautions (5.8) ] • Ophthalmological Effects [see Warnings and Precautions (5.10) ] • Creatine Kinase Elevations [see Warnings and Precautions (5.11) ] • Decreased Platelet Count [see Warnings and Precautions (5.12) ] Most common adverse reactions reported in greater than or equal to 4% of patients treated with LYRICA CR are dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Two randomized placebo-controlled clinical trials were conducted in patients with postherpetic neuralgia and fibromyalgia in which a total of 1242 patients received LYRICA CR. Both studies were randomized withdrawal design where a 6-week single-blind, dose optimization phase was followed by a 13-week double-blind phase.

The most common adverse events leading to discontinuation from the single-blind phase of the study occurring in greater than or equal to 0.3% of patients were dizziness, somnolence, peripheral edema, fatigue, blurred vision, and increased weight. Sixty-four percent of patients experienced adverse events during the single-blind phase, with the most common adverse events occurring in greater than or equal to 4% of patients being dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain.

Controlled Study in Postherpetic Neuralgia Adverse Reactions Leading to Discontinuation In a clinical trial in patients with postherpetic neuralgia, 8.9% of patients treated with LYRICA CR discontinued prematurely during the single-blind phase due to adverse reactions. The most common reasons for discontinuation due to adverse reactions were dizziness (2.1%), somnolence (0.87%), and peripheral edema (0.50%). Most Common Adverse Reactions Table 4 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with postherpetic neuralgia who received LYRICA CR, regardless of the phase of the study.

Table 4. Incidence of Adverse Reactions Reported in Greater Than or Equal to 1% of Subjects in Any Phase of the LYRICA CR Study in Patients with Postherpetic Neuralgia* * Table is limited to adverse reactions that occurred with higher incidence in LYRICA CR-treated patients than in placebo-treated patients for the DB Phase of the study. System Organ Class Preferred Term Single-Blind Phase Double-Blind Phase LYRICA CR [N=801] n (%) LYRICA CR [N=208] n (%) Placebo [N=205] n (%) Ear and labyrinth disorders Vertigo 31 (3.9) 2 (1.0) 1 (0.5) Eye disorders Vision blurred 30 (3.7) 1 (0.5) 0 Diplopia 8 (1.0) 1 (0.5) 0 Gastrointestinal disorders Dry mouth 30 (3.7) 1 (0.5) 0 Nausea 24 (3.0) 7 (3.4) 0 Constipation 22 (2.7) 0 0 Diarrhea 11 (1.4) 2 (1.0) 1 (0.5) Vomiting 9 (1.1) 3 (1.4) 1 (0.5) General disorders and administration site conditions Edema peripheral 39 (4.9) 8 (3.8) 1 (0.5) Fatigue 31 (3.9) 3 (1.4) 2 (1.0) Edema 3 (0.4) 3 (1.4) 0 Infections and infestations Nasopharyngitis 12…

🔄 Drug Interactions 201 words ▾

7 DRUG INTERACTIONS Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (less than 2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement. In vitro studies showed that pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions [see Clinical Pharmacology (12) ] . The interactions of LYRICA CR with co-administration of other drugs have not been systematically evaluated.

Co-administration of the prokinetic drug erythromycin with LYRICA CR did not result in any clinically important changes in the pharmacokinetics of LYRICA CR [see Clinical Pharmacology (12) ] . Additional studies have been performed with LYRICA. No pharmacokinetic interactions were observed between LYRICA and carbamazepine, gabapentin, lamotrigine, oral contraceptive, phenobarbital, phenytoin, topiramate, and valproic acid.

A similar lack of pharmacokinetic interactions would be expected to occur with LYRICA CR. Pharmacodynamics Although no pharmacokinetic interactions were seen with LYRICA and ethanol, lorazepam, or oxycodone, additive effects on cognitive and gross motor functioning were seen when LYRICA was co-administered with these drugs. No clinically important effects on respiration were seen in studies of LYRICA.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Lactation: Breastfeeding is not recommended. ( 8.2 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information regarding the effects of in utero exposure to LYRICA CR, physicians are advised to recommend that pregnant patients taking LYRICA CR enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves.

Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. Risk Summary Observational studies on the use of Lyrica CR during pregnancy suggest a possible small increase in the rate of overall major birth defects, but there was no consistent or specific pattern of major birth defects identified (see Data ) . Available postmarketing data on miscarriage and other maternal, fetal, and long term developmental adverse effects were insufficient to identify risk associated with pregabalin.

Postmarketing data suggest that extended gabapentinoid use with opioids close to delivery may increase the risk of neonatal withdrawal versus opioids alone (see Clinical Considerations ) . There are no comparative epidemiologic studies evaluating this association. Therefore, it is not known whether exposure to pregabalin alone late in pregnancy may cause withdrawal signs and symptoms.

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 18 times human exposure at the maximum recommended dose (MRD) of 660 mg/day (see Data ) . In an animal development study, lethality, growth retardation, and nervous and reproductive system functional impairment were observed in the offspring of rats given pregabalin during gestation and lactation.

The no-effect dose for developmental toxicity was approximately twice the human exposure at MRD. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Neonatal withdrawal syndrome has been reported in newborns exposed to gabapentinoids in utero for an extended period of time when also exposed to opioids close to delivery. Neonatal withdrawal signs and symptoms reported have included tachypnea, vomiting, diarrhea, hypertonia, irritability, sneezing, poor feeding, hyperactivity, abnormal sleep pattern, and tremor.

Reported signs and symptoms that may also be related to withdrawal include tongue thrusting, wandering eye movements while awake, back arching, and continuous extremity movements. Observe neonates exposed to LYRICA CR and opioids for signs and symptoms of neonatal withdrawal and manage accordingly. Data Human Data One database study, which included over 2,700 pregnancies exposed to pregabalin (monotherapy) during the first trimester compared to 3,063,251 pregnancies unexposed to antiepileptics demonstrated prevalence ratios for major malformations overall of 1.14 (CI 95% 0.96-1.35) for pregabalin, 1.29 (CI 95% 1.01-1.65) for lamotrigine, 1.39 (CI 95% 1.07-1.82) for duloxetine, and 1.24 (CI 95% 1.00-1.54) for exposure to either lamotrigine or duloxetine.

Important study limitations include uncertainty of whether women who filled a prescription took the medication and inability to a…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information regarding the effects of in utero exposure to LYRICA CR, physicians are advised to recommend that pregnant patients taking LYRICA CR enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves.

Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. Risk Summary Observational studies on the use of Lyrica CR during pregnancy suggest a possible small increase in the rate of overall major birth defects, but there was no consistent or specific pattern of major birth defects identified (see Data ) . Available postmarketing data on miscarriage and other maternal, fetal, and long term developmental adverse effects were insufficient to identify risk associated with pregabalin.

Postmarketing data suggest that extended gabapentinoid use with opioids close to delivery may increase the risk of neonatal withdrawal versus opioids alone (see Clinical Considerations ) . There are no comparative epidemiologic studies evaluating this association. Therefore, it is not known whether exposure to pregabalin alone late in pregnancy may cause withdrawal signs and symptoms.

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 18 times human exposure at the maximum recommended dose (MRD) of 660 mg/day (see Data ) . In an animal development study, lethality, growth retardation, and nervous and reproductive system functional impairment were observed in the offspring of rats given pregabalin during gestation and lactation.

The no-effect dose for developmental toxicity was approximately twice the human exposure at MRD. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Neonatal withdrawal syndrome has been reported in newborns exposed to gabapentinoids in utero for an extended period of time when also exposed to opioids close to delivery. Neonatal withdrawal signs and symptoms reported have included tachypnea, vomiting, diarrhea, hypertonia, irritability, sneezing, poor feeding, hyperactivity, abnormal sleep pattern, and tremor.

Reported signs and symptoms that may also be related to withdrawal include tongue thrusting, wandering eye movements while awake, back arching, and continuous extremity movements. Observe neonates exposed to LYRICA CR and opioids for signs and symptoms of neonatal withdrawal and manage accordingly. Data Human Data One database study, which included over 2,700 pregnancies exposed to pregabalin (monotherapy) during the first trimester compared to 3,063,251 pregnancies unexposed to antiepileptics demonstrated prevalence ratios for major malformations overall of 1.14 (CI 95% 0.96-1.35) for pregabalin, 1.29 (CI 95% 1.01-1.65) for lamotrigine, 1.39 (CI 95% 1.07-1.82) for duloxetine, and 1.24 (CI 95% 1.00-1.54) for exposure to either lamotrigine or duloxetine.

Important study limitations include uncertainty of whether women who filled a prescription took the medication and inability to adequately control for the underlying disease and other potential confounders. A publi…

🧒 Pediatric Use 175 words ▾

8.4Pediatric Use The safety and effectiveness of LYRICA CR in pediatric patients have not been established. Juvenile Animal Toxicity Data In studies in which pregabalin (50 to 500 mg/kg) was orally administered to young rats from early in the postnatal period (Postnatal Day 7) through sexual maturity, neurobehavioral abnormalities (deficits in learning and memory, altered locomotor activity, decreased auditory startle responding and habituation) and reproductive impairment (delayed sexual maturation and decreased fertility in males and females) were observed at doses greater than or equal to 50 mg/kg.

The neurobehavioral changes of acoustic startle persisted at greater than or equal to 250 mg/kg and locomotor activity and water maze performance at greater than or equal to 500 mg/kg in animals tested after cessation of dosing and, thus, were considered to represent long‑term effects. The low effect dose for developmental neurotoxicity and reproductive impairment in juvenile rats (50 mg/kg) was associated with a plasma pregabalin exposure (AUC) approximately equal to human exposure at the maximum recommended dose of 660 mg/day.

A no‑effect dose was not established.

🧓 Geriatric Use 201 words ▾

8.5Geriatric Use In controlled clinical studies of LYRICA in neuropathic pain associated with diabetic peripheral neuropathy, 246 patients were 65 to 74 years of age, and 73 patients were 75 years of age or older. In controlled clinical studies of LYRICA in neuropathic pain associated with postherpetic neuralgia, 282 patients were 65 to 74 years of age, and 379 patients were 75 years of age or older. In the LYRICA CR neuropathic pain associated with postherpetic neuralgia study, 422 patients 65 years of age and older received pregabalin.

No overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Pregabalin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

See Dosage and Administration (2.5) for recommendations for dosing in patients with renal impairment.

🆘 Overdosage 157 words ▾

10 OVERDOSAGE Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans In the postmarketing experience, the most commonly reported adverse events observed with pregabalin when taken in overdose include reduced consciousness, depression/anxiety, confusional state, agitation, and restlessness. Seizures and heart block have also been reported. Deaths have been reported in the setting of lone LYRICA overdose and in combination with other CNS depressants.

Treatment or Management of Overdose There is no specific antidote for overdose with pregabalin. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; observe usual precautions to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.

Contact a Certified Poison Control Center for up-to-date information on the management of overdose with pregabalin. Pregabalin can be removed by hemodialysis. Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pregabalin binds with high affinity to the alpha 2 ‑delta site (an auxiliary subunit of voltage‑gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, results with genetically modified mice and with compounds structurally related to pregabalin (such as gabapentin) suggest that binding to the alpha 2 ‑delta subunit may be involved in pregabalin’s anti‑nociceptive and antiseizure effects in animals. In animal models of nerve damage, pregabalin has been shown to reduce calcium‑dependent release of pro‑nociceptive neurotransmitters in the spinal cord, possibly by disrupting alpha 2 ‑delta-containing calcium channel trafficking and/or reducing calcium currents.

Evidence from other animal models of nerve damage and persistent pain suggest the anti‑nociceptive activities of pregabalin may also be mediated through interactions with descending noradrenergic and serotonergic pathways originating from the brainstem that modulate pain transmission in the spinal cord. While pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), it does not bind directly to GABA A , GABA B , or benzodiazepine receptors, does not augment GABA A responses in cultured neurons, does not alter rat brain GABA concentration or have acute effects on GABA uptake or degradation.

However, in cultured neurons prolonged application of pregabalin increases the density of GABA transporter protein and increases the rate of functional GABA transport. Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake.

12.3Pharmacokinetics LYRICA CR has linear pharmacokinetics with dose‑proportional increases in maximum plasma concentration (C max ) and area under the plasma concentration‑time curve (AUC) from 82.5‑660 mg/day. Following repeated administration, steady state is achieved within approximately 48‑72 hours. LYRICA CR administered once daily following an evening meal has equivalent AUC and lower C max relative to a comparative dose of LYRICA administered without food twice daily (Table 5).

Variability in C max and AUC for LYRICA CR is less than or equal to 25%. Table 5. Steady-State Pharmacokinetics for LYRICA CR 165 mg Once Daily and LYRICA 75 mg Twice Daily Note: Geometric mean (%CV) for AUC 24 , C max , C min ; median (range) for T max .

Abbreviations: AUC 24 =area under the curve over 24 hours; BID=every 12 hours; C max =peak concentrations; C min =minimum concentrations; N=Number of subjects; T max =time to peak concentrations. LYRICA CR Once Daily LYRICA BID N 24 24 C max (µg/mL) 2.0 (17) 3.2 (21) T max (h) 8.0 (5.0 - 12.0) 0.7 (0.7 - 1.5) AUC 24 (µg•h/mL) 29.4 (17) 31.5 (18) C min (µg/mL) 0.44 (24) 0.59 (25) Absorption Pregabalin is absorbed from the small intestine and proximal colon. LYRICA CR absorption is linear and dose proportional.

The bioavailability of LYRICA CR is reduced if taken on an empty stomach. The AUC is approximately 30% lower when LYRICA CR is administered fasted relative to following an evening meal. When LYRICA CR is administered following a 600 to 750 calorie (50% carbohydrates, 20% protein, 30% fat) evening meal, peak plasma concentrations occur within approximately 8 to 10 hours and AUC is approximately 93% to 97% relative to a comparative dose of LYRICA.

The rate and extent of LYRICA CR absorption is similar when administered following a 400 to 500 calorie, 30% fat or an 800 to 1000 calorie, 15%, 30%, or 50% fat evening meal. When LYRICA CR is administered following an 800 to 1000 calorie (50% carbohydrates, 20% protein, 30% fat) morning meal, peak plasma concentrations occur within approximately 12 hours and AUC is 99% relative to a comparative dose of LYRICA. AUC decreases…

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action Pregabalin binds with high affinity to the alpha 2 ‑delta site (an auxiliary subunit of voltage‑gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, results with genetically modified mice and with compounds structurally related to pregabalin (such as gabapentin) suggest that binding to the alpha 2 ‑delta subunit may be involved in pregabalin’s anti‑nociceptive and antiseizure effects in animals. In animal models of nerve damage, pregabalin has been shown to reduce calcium‑dependent release of pro‑nociceptive neurotransmitters in the spinal cord, possibly by disrupting alpha 2 ‑delta-containing calcium channel trafficking and/or reducing calcium currents.

Evidence from other animal models of nerve damage and persistent pain suggest the anti‑nociceptive activities of pregabalin may also be mediated through interactions with descending noradrenergic and serotonergic pathways originating from the brainstem that modulate pain transmission in the spinal cord. While pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), it does not bind directly to GABA A , GABA B , or benzodiazepine receptors, does not augment GABA A responses in cultured neurons, does not alter rat brain GABA concentration or have acute effects on GABA uptake or degradation.

However, in cultured neurons prolonged application of pregabalin increases the density of GABA transporter protein and increases the rate of functional GABA transport. Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake.

📦 How Supplied / Storage and Handling 130 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING LYRICA CR is supplied in the following strengths and package configurations: LYRICA CR Tablets Package Configuration Tablet Strength (mg) NDC Tablet Description Bottles of 30 tablets 82.5 mg NDC 58151-245-93 Light blue, film-coated, almond-shaped tablet debossed with “VLE” on one side and “PGN 82.5” on the other side Bottles of 30 tablets 165 mg NDC 58151-246-93 Beige, film-coated, almond-shaped tablet debossed with “VLE” on one side and “PGN 165” on the other side Bottles of 30 tablets 330 mg NDC 58151-247-93 Rose, film-coated, almond-shaped tablet debossed with “VLE” on one side and “PGN 330” on the other side Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) in the original package.

(See USP Controlled Room Temperature)

📋 Description 143 words ▾

11 DESCRIPTION LYRICA CR (pregabalin extended-release) tablets are for oral use and contain pregabalin. Pregabalin is described chemically as ( S )-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8 H 17 NO 2 and the molecular weight is 159.23.

The chemical structure of pregabalin is: Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is - 1.35.

LYRICA CR extended-release tablets are administered orally and contain 82.5, 165, or 330 mg of pregabalin, along with carbomer, colorants, crospovidone, Kollidon SR (polyvinyl acetate, povidone, sodium lauryl sulphate, and silica), magnesium stearate, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, talc, and titanium dioxide as inactive ingredients. chemical structure of pregabalin

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Angioedema Advise patients that LYRICA CR may cause angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue LYRICA CR and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.1) ] .

Hypersensitivity Advise patients that LYRICA CR has been associated with hypersensitivity reactions such as skin redness, blisters, hives, rash, dyspnea, and wheezing. Instruct patients to discontinue LYRICA CR and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.2) ] . Suicidal Thinking and Behavior Counsel patients, their caregivers, and families that AEDs, including pregabalin, the active ingredient in LYRICA CR, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.

Instruct patients, caregivers, and families to report behaviors of concern immediately to a healthcare provider. Also inform patients who plan to or have discontinued LYRICA CR that suicidal thoughts and behavior can appear even after the drug is stopped [see Warnings and Precautions (5.3) ] . Respiratory Depression Inform patients about the risk of respiratory depression.

Include information that the risk is greatest for those using concomitant central nervous system (CNS) depressants (such as opioid analgesics) or in those with underlying respiratory impairment. Teach patients how to recognize respiratory depression and advise them to seek medical attention immediately if it occurs [see Warnings and Precautions (5.5) ] . Dizziness and Somnolence Inform patients that LYRICA CR may cause dizziness, somnolence, blurred vision, and other CNS signs and symptoms.

Accordingly, advise patients not to drive, operate complex machinery, or engage in other hazardous activities until they have gained sufficient experience on LYRICA CR to gauge whether or not it affects their mental, visual, and/or motor performance adversely [see Warnings and Precautions (5.6) ] . CNS Depressants Inform patients who require concomitant treatment with central nervous system depressants such as opiates or benzodiazepines that they may experience additive CNS side effects, such as respiratory depression, somnolence, and dizziness [see Warnings and Precautions (5.5 , 5.6) and Drug Interactions (7) ] .

Advise patients to avoid consuming alcohol while taking LYRICA CR, as LYRICA CR may potentiate the impairment of motor skills and sedating effects of alcohol [see Drug Interactions (7) ] . Abrupt or Rapid Discontinuation Advise patients to take LYRICA CR as prescribed. Abrupt or rapid discontinuation may result in insomnia, nausea, headache, anxiety, or diarrhea.

Advise patients with seizure disorders that abrupt or rapid discontinuation may increase seizure frequency [see Warnings and Precautions (5.4) ] . Missed Dose Instruct patients that if they miss taking their dose of LYRICA CR after an evening meal, then they should take their usual dose of LYRICA CR prior to bedtime following a snack. If they miss taking the dose of LYRICA CR prior to bedtime, then they should take their usual dose of LYRICA CR following a morning meal.

If they miss taking the dose of LYRICA CR following the morning meal, then they should take their usual dose of LYRICA CR at the usual time that evening following an evening meal. Weight Gain and Edema Inform patients that LYRICA CR may cause edema and weight gain. Advise patients that concomitant treatment with LYRICA CR and a thiazolidinedione antidiabetic agent may lead to an additive effect on edema and weight gain.

Advise patients with…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE LYRICA (LEER-i-kah) CR (pregabalin) extended-release tablets, CV Read this Medication Guide before you start taking LYRICA CR and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

If you have any questions about LYRICA CR, ask your healthcare provider or pharmacist. What is the most important information I should know about LYRICA CR? LYRICA CR may cause serious side effects including: • Serious, even life-threatening, allergic reactions • Suicidal thoughts or actions • Serious breathing problems • Swelling of your hands, legs and feet • Dizziness and sleepiness These serious side effects are described below: • Serious, even life-threatening, allergic reactions.

Stop taking LYRICA CR and call your healthcare provider right away if you have any of these signs of a serious allergic reaction: o swelling of your face, mouth, lips, gums, tongue, throat, or neck o trouble breathing o rash, hives (raised bumps), or blisters o skin redness • Like other antiepileptic drugs, LYRICA CR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. This can happen while you take LYRICA CR or after stopping. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: o thoughts about suicide or dying o attempts to commit suicide o new or worse depression o new or worse anxiety o feeling agitated or restless o panic attacks o trouble sleeping (insomnia) o new or worse irritability o acting aggressive, being angry, or violent o acting on dangerous impulses o an extreme increase in activity and talking (mania) o other unusual changes in behavior or mood If you have suicidal thoughts or actions, do not stop LYRICA CR without first talking to a healthcare provider. o Stopping LYRICA CR suddenly can cause serious problems. o Suicidal thoughts or actions can be caused by things other than medicines.

If you have suicidal thoughts or actions, your healthcare provider may check for other causes. How can I watch for early symptoms of suicidal thoughts and actions? o Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. o Keep all follow-up visits with your healthcare provider as scheduled. o Call your healthcare provider between visits as needed, especially if you are worried about symptoms. • Serious breathing problems can occur when LYRICA is taken with other medicines that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems.

Watch for increased sleepiness or decreased breathing when starting LYRICA or when the dose is increased. Get help right away if breathing problems occur. • Swelling of your hands, legs and feet. This swelling can be a serious problem for people with heart problems. • Dizziness and sleepiness.

Do not drive a car, work with machines, or do other dangerous activities until you know how LYRICA CR affects you. Ask your healthcare provider about when it will be okay to do these activities. What is LYRICA CR?

LYRICA CR is a prescription medicine used to treat: • pain from damaged nerves (neuropathic pain) that happens with diabetes • pain from damaged nerves (neuropathic pain) that follows healing of shingles It is not known if LYRICA CR is safe and effective in children. It is not known if LYRICA CR is effective when used for the treatment of fibromyalgia, or when taken with other seizure medicines for adults with partial onset seizures. Who should not take LYRICA CR?

Do not take LYRICA CR if you are allergic to pregabalin or any of the ingredients in LYRICA CR. See “What is the most important information I should know about LYRICA CR?” for the signs of an allergic reaction. See the end of this leaflet for a complete list of ingredients in LYRICA CR.

What should I tell my healthcare provide…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.