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

by Novadoz Pharmaceuticals LLC · 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-077-30)

NDC 72205-0077-30

🏷️ FDA NDC (as labeled) 72205-077-30 billing pads the product segment with a zero

Rx only Generic 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 Dr. Brian Staiger, PharmD

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) 72205-077-30

Product NDC 72205-077

11-digit billing NDC 72205007730

NCPDP billing unit EA — each (per item)

RxCUI 1988974, 1988977, 1988980

UNII 55JG375S6M

UPC 0372205079304, 0372205078307, 0372205077300

Application # ANDA213226

SPL Set ID f6aa5977-97c8-4a56-8e35-d9ab5cc24369

DEA schedule CV

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2021-04-13

Route ORAL

Dosage form TABLET, FILM COATED, EXTENDED RELEASE

Substance PREGABALIN

GPI-14 62540060007520

GPI class Pregabalin ER

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 PREGABALIN ER 82.5 MG TABLET

FDB brand name Pregabalin Er

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 72205-077-30 — 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 → 72205-0077-30. 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

LabelerNovadoz Pharmaceuticals LLC

Application holderMSN LABORATORIES PRIVATE LTD

FDA applicationANDA213226 (ANDA)

Labeler code72205

First marketedApr 2021

DEA scheduleCV

Product typeHuman Prescription Drug

Portfolio246 products on file

🔎 All NDCs from Novadoz Pharmaceuticals LLC

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 PREGABALIN ER 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Pregabalin — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Pregabalin (95 interactions) — ranked by severity →

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 Brown / Pink / Yellow

ShapeOval

ImprintMP10

Size21 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 F68VH75CJC
A synthetic polymer made from acrylic acid that thickens and stabilizes liquid or gel formulations. It's used as a gelling agent and emulsifier to create the desired texture and consistency in topical medicines.
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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.

13 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 system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$3.644	$109.32 / 30 tablets
Medicaid paysCMS SDUD · 12 mo	$3.98	$119.51 / 30 tablets
Medicare drug plans payPart D · Q2 2026	$9.78	$293.26 / 30 tablets

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 5% over the last 9 months.

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Pregabalin 82.5 mgthis 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 mg 58151-0245-93	Viatris	30 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

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

🏛️

2021

On the market since

Apr 2021

📍

2026

Currently FDA-listed

5 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 72205-0077-30, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

Units reimbursed last 4 qtrs

4.4K

Gross reimbursed last 4 qtrs

$17.6K

Avg / prescription

$185.73

Avg / unit

$3.9838

Latest quarter Q4 2025

34Rx

Medicaid pays / ea

$3.9838

gross reimbursed

NADAC / ea

$3.6439

acquisition cost

Spread

+$0.3399

+9% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

100% FFS

Fee-for-service · 95 Rx Managed care · 0 Rx

State Medicaid map

Units reimbursed · per 100k residents

6.89.0

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 New York 9.0 /100k

2 California 6.8 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Pregabalin — the program that covers self-administered drugs. 20 manufacturers.

⚠️ 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 Pregabalin. 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

$62.72M

Claims incl. refills

2.1M

Beneficiaries

1.1M

Spend / beneficiary

$56.99

Spend / claim

$30.01

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 Pregabalin — the ingredient across all brands.

Top reported reactions

Pain26,330

Fatigue15,629

Dizziness14,844

Nausea14,507

Headache13,067

Malaise12,884

Somnolence11,821

Reporter sex

Male · 34%

Female · 65%

Unknown · 1%

Serious outcomes

Life-threatening12,531

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
72205-0077-30 You're viewing this	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-077-30)	2021-04-13	Active

📄 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 Pregabalin extended-release tablets are indicated for the management of: Neuropathic pain associated with diabetic peripheral neuropathy Postherpetic neuralgia Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures. Pregabalin extended-release tablets are indicated for the management of: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) Postherpetic neuralgia (PHN) ( 1 ) Efficacy of pregabalin extended-release tablets 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 Pregabalin extended-release tablets 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 pregabalin extended-release tablets: 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 Pregabalin Capsules or Oral Solution to Pregabalin extended-release tablets: See full prescribing information.

( 2.4 ) Dose modification recommended in patients with renal impairment. ( 2.5 )

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

Instruct patients that if they miss taking their dose of pregabalin extended-release tablets after an evening meal, then they should take their usual dose of pregabalin extended-release tablets prior to bedtime following a snack. If they miss taking the dose of pregabalin extended-release tablets prior to bedtime, then they should take their usual dose of pregabalin extended-release tablets following a morning meal. If they miss taking the dose of pregabalin extended-release tablets following the morning meal, then they should take their usual dose of pregabalin extended-release tablets 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 pregabalin extended-release tablets are 330 mg once daily. Although pregabalin tablets were 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 pregabalin capsules, treatment with doses above 330 mg/day is not recommended for pregabalin extended-release tablets.

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 pregabalin extended-release tablets, 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 pregabalin extended-release tablets is 660 mg once daily.

2.4Conversion from Pregabalin Capsules or Oral Solution to Pregabalin Extended-Release Tablets When switching from pregabalin to pregabalin extended-release tablets on the day of the switch, instruct patients to take their morning dose of pregabalin as prescribed and initiate pregabalin extended-release tablets therapy after an evening meal. Table 1.Conversion from Pregabalin Capsules or Oral Solution to Pregabalin Extended-Release Tablets Pregabalin Total Daily Dose (dosed 2 or 3 times daily) Pregabalin Extended-Release Tablets 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 a 300 mg/daily 330 mg/day 450 mg/daily 495 mg/day b 600 mg/daily 660 mg/day c a.247.5 mg = 3× 82.5 mg tablets taken once a day. b.495 mg= 3× 165 mg tablets taken once a day. c.660 mg= 2× 330 mg tablets taken once a day.

2.5 Patients with Renal Impairment Us…

💊 Dosage Forms and Strengths 112 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) ]. Pregabalin Extended-Release Tablets Tablet Strength (mg) Tablet Description 82.5 mg Brown colored, almond shaped, biconvex, film coated tablets debossed with “MP 12” on one side and plain on other side. 165 mg Pink colored, almond shaped, biconvex, film coated tablets debossed with “MP 11” on one side and plain on other side.

330 mg Cream yellow colored, almond shaped, biconvex, film coated tablets debossed with “MP 10” on one side and plain on other side. Extended-release tablets: 82.5 mg, 165 mg, and 330 mg. ( 3 )

⛔ Contraindications 51 words ▾

4 CONTRAINDICATIONS Pregabalin extended-release tablets 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 ~2 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 pregabalin extended-release tabletsimmediately in patients with these symptoms. ( 5.1 ) Hypersensitivity Reactions: Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur.

Discontinue pregabalin extended-release tablets immediately in these patients. ( 5.2 ) Suicidal Behavior and Ideation: Antiepileptic drugs, including pregabalin, the active ingredient in pregabalin extended-release tablets, 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 pregabalin extended-release tablets gradually over a minimum of 1 week. ( 5.4 ) Respiratory Depression : May occur with pregabalin 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 pregabalin extended-release tablets and thiazolidinedione antidiabetic agents. ( 5.7 )

5.1Angioedema There have been postmarketing reports of angioedema in patients during initial and chronic treatment with pregabalin. 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 pregabalin extended-release tablets immediately in patients with these symptoms. Exercise caution when prescribing pregabalin extended-release tablets 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 pregabalin. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue pregabalin extended-release tablets immediately in patients with these symptoms.

5.3Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including pregabalin, the active ingredient in pregabalin extended-release tablets, 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 t…

🤒 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 pregabalin extended-release tablets are dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369or 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 pregabalin extended-release tablets. 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 pregabalin extended-release tabletsdiscontinued 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 pregabalin extended-release tablets, 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 Pregabalin Extended-Release Tablets Study in Patients with Postherpetic Neuralgia* System Organ Class Preferred Term Single-Blind Phase Double-Blind Phase Pregabalin Extended-Release Tablets [N=801] n (%) Pregabalin Extended-Release Tablets [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 (1.5)…

🔄 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 pregabalin extended-release tabletswith co-administration of other drugs have not been systematically evaluated.

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

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

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Risk Summary Observational studies on the use of pregabalin extended-release tablets 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. Inanimal 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 estimatedbackground risk of major birth defects and miscarriage for the indicated populations are unknown.

All pregnancies have abackground 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 pregabalin extended-release tablets 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 published study included results from two separate databases. One database, which included 353 pregnancies exposed to pregabalin (monotherapy) during the first trimester compared to 368,489 pregnancies unexposed to antiepileptics, showed no increase in risk of major birth defects; adjusted relative risk 0.87 (CI 95% 0.53 - 1.42). The second database, which included 118 pregnancies exposed to pregabalin (monotherapy) during the first trimester compared…

🤰 Pregnancy ~3 min read ▾

🧒 Pediatric Use 176 words ▾

8.4Pediatric Use The safety and effectiveness of pregabalin extended-release tablets 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 202 words ▾

8.5Geriatric Use In controlled clinical studies of pregabalin 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 pregabalin 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 pregabalin extended-release tablets 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 pregabalin 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 Pregabalin extended-release tabletshas linear pharmacokinetics with dose-proportional increases in maximum plasma concentration (C max ) and area under the plasma concentration-time curve (AUC) from 82.5 to 660 mg/day. Following repeated administration, steady state is achieved within approximately 48-72 hours. Pregabalin extended-release tablets administered once daily following an evening meal has equivalent AUC and lower C max relative to a comparative dose of pregabalin administered without food twice daily (Table 5).

Variability in C max and AUC for pregabalin extended-release tablets is less than or equal to 25%. Table 5. Steady-State Pharmacokinetics for Pregabalin Extended-Release Tablets 165 mg Once Daily and Pregabalin 75 mg Twice Daily Pregabalin Extended-Release Tablets Once Daily Pregabalin BID N 24 24 C max (mcg/mL) 2.0 (17) 3.2 (21) T max (h) 8.0 (5.0 – 12.0) 0.7 (0.7 – 1.5) AUC 24 (mcg•h/mL) 29.4 (17) 31.5 (18) C min (mcg/mL) 0.44 (24) 0.59 (25) 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. Absorption Pregabalin is absorbed from the small intestine and proximal colon. Pregabalin extended-release tabletsabsorption is linear and dose proportional.

The bioavailability of pregabalin extended-release tabletsis reduced if taken on an empty stomach. The AUC is approximately 30% lower when pregabalin extended-release tablets is administered fasted relative to following an evening meal. When pregabalin extended-release tabletsis 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 pregabalin.

The rate and extent of pregabalin extended-release tablets absorption is similar when administered following a 400 to 500 calorie, 30% fat or an 800 to 1,000 calorie, 15%, 30%,…

🧬 Mechanism of Action ~1 min read ▾

📦 How Supplied / Storage and Handling 140 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Pregabalin extended-release tablets are supplied in the following strengths and package configurations: Pregabalin Extended-Release Tablets Package Configuration Tablet Strength (mg) NDC Tablet Description Bottles of 30 tablets 82.5 mg NDC 72205-077-30 Brown colored, almond shaped, biconvex, film coated tablets debossed with “MP 12” on one side and plain on other side. Bottles of 30 tablets 165 mg NDC 72205-078-30 Pink colored, almond shaped, biconvex, film coated tablets debossed with “MP 11” on one side and plain on other side.

Bottles of 30 tablets 330 mg NDC 72205-079-30 Cream yellow colored, almond shaped, biconvex, film coated tablets debossed with “MP 10” on one side and plain on 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 150 words ▾

11 DESCRIPTION Pregabalin extended-release tablets are for oral use and contain pregabalin. Pregabalin USP 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 USP is: Pregabalin USP is a white to off-white, crystalline solid with a pKa of 4.2 – 10.6. It is sparingly soluble in water and freely soluble in both basic and acidic aqueous solution. Pregabalin extended-release tablets are administered orally and contain 82.5 mg, 165 mg, or 330 mg of pregabalin, along with carbopol, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, silicon dioxide.

Film Coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red (for 82.5 mg, 165 mg and 330 mg tablets), black iron oxide, (82.5 mg tablets) iron oxide yellow (for 330 mg tablets) and colorants as inactive ingredients. str

💬 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 pregabalin extended-release tabletsmay 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 pregabalin extended-release tabletsand immediately seek medical care if they experience these symptoms [ see Warnings and Precautions (5.1) ].

Hypersensitivity Advise patients that pregabalin extended-release tabletshas been associated with hypersensitivity reactions such as skin redness, blisters, hives, rash, dyspnea, and wheezing. Instruct patients to discontinue pregabalin extended-release tablets 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 pregabalin extended-release tablets, 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 pregabalin extended-release tablets 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 pregabalin extended-release tablets 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 pregabalin extended-release tabletsto 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 pregabalin extended-release tablets, as pregabalin extended-release tablets may potentiate the impairment of motor skills and sedating effects of alcohol [see Drug Interactions (7) ]. Abrupt or Rapid Discontinuation Advise patients to take pregabalin extended-release tablets 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 pregabalin extended-release tabletsafter an evening meal, then they should take their usual dose of pregabalin extended-release tablets prior to bedtime following a snack. If they miss taking the dose of pregabalin extended-release tabletsprior to bedtime, then they should take their usual dose of pregabalin extended-release tablets following a morning meal.

If they miss taking the dose of pregabalin extended-release tabl…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE MEDICATION GUIDE Pregabalin (pree gab' a lin) extended-release tablets, CV Read this Medication Guide before you start taking pregabalin extended-release tablets 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 pregabalin extended-release tablets, ask your healthcare provider or pharmacist. What is the most important information I should know about pregabalin extended-release tablets? Pregabalin extended-release tablets may cause serious side effects including: Serious, even life-threatening, allergic reactions.

Swelling of your hands, legs and feet Suicidal thoughts or actions Dizziness and sleepiness Serious breathing problems These serious side effects are described below: Serious, even life-threatening, allergic reactions. Stop taking pregabalin extended-release tablets and call your healthcare provider right away if you have any of these signs of a serious allergic reaction: swelling of your face, mouth, lips, gums, tongue, throat, or neck trouble breathing rash, hives (raised bumps), or blisters skin redness Like other antiepileptic drugs,Pregabalin extended-release tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

This can happen while you take Pregabalin extended-release tablets 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: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood If you have suicidal thoughts or actions, do not stop pregabalin extended-release tablets without first talking to a healthcare provider.

Stopping pregabalin extended-release tablets suddenly can cause serious problems. 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? Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Serious breathing problems can occur when pregabalin 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 pregabalin 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 pregabalin extended-release tablets affects you. Ask your healthcare provider about when it will be okay to do these activities.

What are pregabalin extended-release tablets? Pregabalin extended-release tablets are 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 pregabalin extended-release tablets are safe and effective in children. It is not known if pregabalin extended-release tablets are 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 Pregabalin Extende…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adjunctive therapy: A medicine added alongside a main treatment to help it work better.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatine kinase: A protein measured in a blood test that rises when muscle is being damaged.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

diplopia: Double vision, or seeing two images of a single object.

displacement: When one medicine knocks another off the blood proteins it was riding on, briefly raising the free, active amount of the second medicine.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

fertility: The natural ability to become pregnant or to father a child.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

in utero: Inside the womb, describing a baby before it is born.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

linear pharmacokinetics: When blood levels of a medicine rise in direct proportion to the size of the dose.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

maximum recommended dose: The largest amount of a medicine that should be taken within a given period.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

monotherapy: Treatment using a single medicine by itself.

nasopharyngitis: Inflammation of the nose and throat, commonly known as the common cold.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

peripheral edema: Swelling, usually in the feet, ankles, or legs, caused by extra fluid building up in the tissues.

peripheral neuropathy: Damage to the nerves outside the brain and spinal cord, often causing numbness, tingling, or pain in the hands and feet.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

suicidal behavior: Actions a person takes to try to end their own life, or steps taken in preparation for it.

tachypnea: Breathing that is faster than normal.

taper: Gradually lowering a dose in steps before stopping, rather than quitting all at once.

transporter: A protein that moves drugs across cell membranes, carrying them either into or out of cells.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

wheezing: A high-pitched whistling sound made while breathing, usually when the airways are narrowed.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 72205-0076-30 · Novadoz 72205-0078-30 · Novadoz →

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.

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

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🏷️ RxNorm drug class

🏭 Manufacturer & labeler

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Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

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

🔬 Reported adverse events (FAERS)

Top reported reactions

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

📄 Full prescribing information FDA SPL

2.5 Patients with Renal Impairment Us…

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