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Pregabalin 200 mg Capsule, 90-count

by Amneal Pharmaceuticals NY LLC · 90 CAPSULE in 1 BOTTLE (69238-1315-9)

NDC 69238-1315-09

🏷️ FDA NDC (as labeled) 69238-1315-9 billing pads the package segment with a zero

This package

Contains90-count Cost per ea$0.0566 NADAC Per package$5.09 / 90 capsules Pack sizes2 compare ↓

Also priced by: Medicaid pays $0.2033/unit · Part D plans $0.1702/unit — full pricing hub ↓

Also comes in: 500 capsules 69238-1315-05

Rx only Generic On market CV

🗂️ Data synced Sep 10, 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) 69238-1315-9

Product NDC 69238-1315

11-digit billing NDC 69238131509

NCPDP billing unit EA — each (per item)

RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127

UNII 55JG375S6M

UPC 0369238131291, 0369238131796, 0369238131192, 0369238131451 +10 more

Application # ANDA209743

SPL Set ID 3d9d7123-5886-4b61-a7ea-471b213e77d9

DEA schedule CV

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2019-07-19

Route ORAL

Dosage form CAPSULE

Substance PREGABALIN

GPI-14 72600057000145

GCN Seq No 057804

GCN 23051

HICL code 026470

Ingredient (HICL) Pregabalin

HIC1 code H

Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)

HIC2 code H4

Therapeutic class — intermediate (HIC2) Anticonvulsants

HIC3 code H4B

Therapeutic class — specific (HIC3) Anticonvulsants

AHFS code 28:12.28.00

AHFS class Gaba-Mediated Anticonvulsants

FDB label name PREGABALIN 200 MG CAPSULE

FDB brand name Pregabalin

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 69238-1315-9 — a 5-4-1 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 package segment → 69238-1315-09. 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

LabelerAmneal Pharmaceuticals NY LLC

Application holderAMNEAL PHARMACEUTICALS CO GMBH

FDA applicationANDA209743 (ANDA)

Labeler code69238

First marketedJul 2019

DEA scheduleCV

Product typeHuman Prescription Drug

Portfolio372 products on file

🔎 All NDCs from Amneal Pharmaceuticals NY 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 200 MG CAPSULE Ingredient Pregabalin

📗 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 white / orange

ShapeCapsule

ImprintAN;1317

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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	$0.057	$5.09 / 90 capsules
Medicaid paysCMS SDUD · 12 mo	$0.2033	$18.30 / 90 capsules
Medicare drug plans payPart D · Q2 2026	$0.1702	$15.32 / 90 capsules

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

▼ Down 46% over the last 24 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 200 mg 00904-7003-04	Major	30 capsules	$0.057	AB	Availability likely	—
Pregabalin 200 mg 31722-0615-05	Camber	500 capsules	$0.057	AB	Availability likely	—
Pregabalin 200 mg 43547-0511-09	Solco	90 capsules	$0.057	AB	Availability likely	—
Pregabalin 200 mg 50228-0650-05	ScieGen	500 capsules	$0.057	AB	Availability likely	—
Pregabalin 200 mg 67877-0467-05	Ascend	500 capsules	$0.057	AB	Availability likely	—
Pregabalin 200 mgthis 69238-1315-09	Amneal	90 capsules	$0.057	AB	Availability likely	—
Pregabalin 200 mg 69367-0329-09	Westminster	90 capsules	$0.057	AB	Availability likely	—
Pregabalin 200 mg 69367-0429-05	Westminster	500 capsules	$0.057	AB	Availability likely	—
Pregabalin 200 mg 72603-0357-01	NorthStar	90 capsules	$0.057	AB	Availability likely	—
Pregabalin 200 mg 27808-0239-01	Tris	90 capsules	$0.074	AB	FDA listed	+31%
Pregabalin 200 mg 69097-0959-05	Cipla	90 capsules	$0.074	AB	FDA listed	+31%
Lyrica 200 mg 58151-0241-77	Viatris	90 capsules	$9.690	AB	Availability likely	+17035%
Lyrica 200 mg 00071-1017-68	Parke-Davis	90 capsules	$9.693	AB	Discontinued	+17041%
Pregabalin 200 mg 13668-0363-01	Torrent	100 capsules	—	AB	FDA listed	—
pregabalin 200 mg 14445-0126-90	Indoco	90 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 25000-0184-07	MARKSANS	90 capsules	—	AB	FDA listed	—
Pregablin 200 mg 33342-0170-10	Macleods	90 capsules	—	—	FDA listed	—
pregabalin 200 mg 43598-0296-05	Dr.Reddys	500 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 46708-0124-10	Alembic	100 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 47335-0691-08	Sun	100 capsules	—	—	FDA listed	—
Pregabalin 200 mg 50090-6504-00	A-S	60 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 50090-7983-00	A-S	60 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 50228-0355-05	ScieGen	500 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 51407-0579-90	Golden	90 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 55700-0964-60	Quality	60 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 58118-1467-08	Clinical	30 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 60219-1315-09	Amneal	90 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 60760-0729-30	ST.	30 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 62332-0124-10	Alembic	100 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 63629-8208-01	Bryant	30 capsules	—	AB	Discontinued	—
Pregabalin 200 mg 64980-0415-01	Rising	100 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 65862-0763-05	Aurobindo	500 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 68788-7527-01	Preferred	100 capsules	—	AB	FDA listed	—
PREGABALIN capsules, CV 200 mg 69097-0683-02	Cipla	30 capsules	—	—	Discontinued	—
Pregabalin 200 mg 70518-2763-00	REMEDYREPACK	90 capsules	—	AB	Discontinued	—
Pregabalin 200 mg 71205-0874-00	Proficient	100 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 71209-0037-04	Cadila	90 capsules	—	—	FDA listed	—
Pregabalin 200 mg 71335-1555-01	Bryant	30 capsules	—	AB	Discontinued	—
Pregabalin 200 mg 71335-1822-01	Bryant	30 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 71335-9699-01	Bryant	30 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 71610-0318-53	Aphena	60 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 71610-0754-30	Aphena	30 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 71610-0759-30	Aphena	30 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 71610-0926-30	Aphena	30 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 71610-0948-30	Aphena	30 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 71610-0997-30	Aphena	30 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 72162-1546-09	Bryant	90 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 72189-0241-60	Direct_Rx	60 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 72205-0016-06	Novadoz	1000 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 72658-0849-01	Eskayef	60 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 73190-0058-50	AvKARE	500 capsules	—	AB	Discontinued	—
Pregabalin 200 mg 76282-0573-05	Exelan	500 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 76420-0100-30	Asclemed	30 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 76420-0122-30	Asclemed	30 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 80425-0308-01	Advanced	30 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 82619-0127-01	Creekwood	90 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 82804-0948-00	Proficient	100 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 82968-0011-01	FOURRTS	90 capsules	—	AB	FDA listed	—
Pregabalin 200 mg 29300-0444-19	Unichem	90 capsules	—	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

🏛️

2019

On the market since

Jul 2019

📍

2026

Currently FDA-listed

7 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 69238-1315-09, 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

45.8K

Units reimbursed last 4 qtrs

3.4M

Gross reimbursed last 4 qtrs

$697.7K

Avg / prescription

$15.24

Avg / unit

$0.2033

Latest quarter Q4 2025

10.5KRx

Medicaid pays / ea

$0.2033

gross reimbursed

NADAC / ea

$0.0566

acquisition cost

Spread

+$0.1467

+259% 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 ⓘ

52% FFS 48% MCO

Fee-for-service · 23,959 Rx Managed care · 21,836 Rx

State Medicaid map

Units reimbursed · per 100k residents

32.18,866

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 Vermont 8,866 /100k

2 Maine 6,333 /100k

3 West Virginia 4,681 /100k

4 Kentucky 3,799 /100k

5 Idaho 2,657 /100k

6 New Mexico 2,406 /100k

7 Michigan 2,381 /100k

8 Colorado 2,250 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

90 capsules this page69238-1315-09 45,795 Rx · $697,735

500 capsules69238-1315-05 No Medicaid data

Drug total (last 4 qtrs): 45,795 Rx · 3,432,123 units · $697,735 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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	Per unit	Per pack	Marketing start	Status
69238-1315-09 You're viewing this	90 CAPSULE in 1 BOTTLE (69238-1315-9)	$0.0566 / ea	$5.09	2019-07-19	Active
69238-1315-05	500 CAPSULE in 1 BOTTLE (69238-1315-5)	—	—	2019-07-19	Active

You're viewing the smallest of 2 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 69238-1315-09?

NDC 69238-1315-09 is a 90-count package — 90 capsule in 1 bottle.

What is the difference between NDC 69238-1315-09 and NDC 69238-1315-05?

Both are Pregabalin 200 mg Capsule — the drug itself is identical. NDC 69238-1315-09 is the 90-count package, while NDC 69238-1315-05 is the 500 capsules package.

What NDC number is used to bill for this package of Pregabalin 200 mg Capsule?

Bill NDC 69238-1315-09 — the 11-digit billing format is 69238131509. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 95 words ▾

1 INDICATIONS AND USAGE Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN). (1) Postherpetic neuralgia (PHN) (1) Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older.

(1) Fibromyalgia (1) Neuropathic pain associated with spinal cord injury. (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For adult indications, begin dosing at 150 mg/day. For partial-onset seizure dosing in pediatric patients 1 month of age and older, refer to section 2.4. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) Dosing recommendations: INDICATION D o sing R egi m en M a x i m u m Dose DPN Pain (2.2) 3 divided doses per day 300 mg/day within 1 week PHN (2.3) 2 or 3 divided doses per day 300 mg/day within 1 week.

Maximum dose of 600 mg/day. Adjunctive Therapy for Partial-Onset Seizures in Pediatric and Adult Patients Weighing 30 kg or More (2.4) 2 or 3 divided doses per day Maximum dose of 600 mg/day. Adjunctive Therapy for Partial-Onset Seizures in Pediatric Patients Weighing Less than 30 kg (2.4) 1 month to less than 4 years: 3 divided doses per day 4 years and older: 2 or 3 divided doses per day 14 mg/kg/day.

Fibromyalgia (2.5) 2 di v ided doses per day 300 mg/day within 1 week. Maximum dose of 450 mg/day. Neuropathic Pain Associated with Spinal Cord Injury (2.6) 2 divided doses per day 300 mg/day within 1 week.

Maximum dose of 600 mg/day. Dose should be adjusted in adult patients with reduced renal function. (2.7)

2.1Important Administration Instructions Pregabalin capsules are given orally with or without food. When discontinuing pregabalin capsules, taper gradually over a minimum of 1 week [see Warnings and Precautions (5.4) ] . Because pregabalin is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function [see Dosage and Administration (2.7) ] .

2.2Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in Adults The maximum recommended dose of pregabalin capsule is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.

Although pregabalin capsule was also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 300 mg/day is not recommended [see Adverse Reactions (6.1) ] .

2.3Postherpetic Neuralgia in Adults The recommended dose of pregabalin capsule is 75 mg to 150 mg two times a day, or 50 mg to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.

Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day, and who are able to tolerate pregabalin capsules, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day). In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, reserve dosing above 300 mg/day for those patients who have on-going pain and are tolerating 300 mg daily [see Adverse Reactions (6.1) ] .

2.4Adjunctive Therapy for Partial-Onset Seizures in Patients 1 Month of Age and Older The recommended dosages for adults and pediatric patients 1 month of age and older are included in Table 1. Administer the total daily dosage orally in two or three divided doses as indicated in Table 1. In pediatric patients, the recommended dosing regimen is dependent upon body weight.

Based on clinical response and tolerability, dosage may be increased, approximately weekly. Table 1. Recommended Dosage for Adults and Pediatric Patients 1 Month and Older Age and Body Weight Recommended Initial Dosage Recommended Maximum Dosage Frequency of Administration Adults (17 years and older) 150 mg/day 600 mg/day 2 or 3 divided doses Pediatric patients weighing 30 kg or more 2.5 mg/kg/day 10 mg/kg/day (not to exceed 600 mg/day) 2 or 3 divided doses Pediatric patients weighing less th…

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS Pregabalin Capsules are available in 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg strengths [see Description (11) and How Supplied/Storage and Handling (16) ]. Pregabalin capsules, 25 mg are supplied as white, hard gelatin capsule printed with black ink “AN” on cap & “1310” on body. Pregabalin capsules, 50 mg are supplied as white, hard gelatin capsule printed with black ink “AN” on cap & “1311” on body.

Pregabalin capsules, 75 mg are supplied as white/orange, hard gelatin capsule printed with black ink “AN” on cap & “1312” on body. Pregabalin capsules, 100 mg are supplied as orange, hard gelatin capsule printed with black ink “AN” on cap & “1313” on body. Pregabalin capsules, 150 mg are supplied as white, hard gelatin capsule printed with black ink “AN” on cap & “1314” on body.

Pregabalin capsules, 200 mg are supplied as light orange, hard gelatin capsule printed with black ink “AN” on cap & “1315” on body. Pregabalin capsules, 225 mg are supplied as white/light orange, hard gelatin capsule printed with black ink “AN” on cap & “1316” on body. Pregabalin capsules, 300 mg are supplied as white/orange, hard gelatin capsule printed with black ink “AN” on cap & “1317” on body.

Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg. ( 3 )

⛔ Contraindications 47 words ▾

4 CONTRAINDICATIONS Pregabalin capsules are 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 (5.2) ]. Known hypersensitivity to pregabalin or any of its components. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Angioedema (e.g., swelling of the throat, head and neck) can occur, and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue pregabalin immediately in these cases. ( 5.1 ) Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur.

Discontinue pregabalin immediately in these patients. ( 5.2 ) Antiepileptic drugs, including pregabalin, the active ingredient in pregabalin capsules, 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 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 ) Pregabalin may cause dizziness and somnolence and impair patient's ability to drive or operate machinery. ( 5.6 ) Pregabalin may cause peripheral edema.

Exercise caution when co-administering pregabalin and thiazolidinedione antidiabetic agents. ( 5.7 )

5.1Angioedema There have been post-marketing 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 immediately in patients with these symptoms. Exercise caution when prescribing pregabalin 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 There have been post-marketing reports of hypersensitivity in patients shortly after initiation of treatment with pregabalin. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue pregabalin immediately in patients with these symptoms.

5.3Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including pregabalin, the active ingredient in pregabalin capsules, 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 duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Angioedema [see Warnings and Precautions (5.1) ] Hypersensitivity [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) ] Tumorigenic Potential [see Warnings and Precautions (5.9) ] 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) ] PR Interval Prolongation [see Warnings and Precautions (5.13) ] Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention).

(6.1) Most common adverse reactions (greater than or equal to 5% and twice placebo) in pediatric patients for the treatment of partial-onset seizures are increased weight and increased appetite. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 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. In all controlled and uncontrolled trials across various patient populations during the premarketing development of pregabalin, more than 10,000 patients have received pregabalin. Approximately 5,000 patients were treated for 6 months or more, over 3,100 patients were treated for 1 year or longer, and over 1,400 patients were treated for at least 2 years.

Adverse Reactions Most Commonly Leading to Discontinuation in All Pre-marketing Controlled Clinical Studies In pre-marketing controlled trials of all adult populations combined, 14% of patients treated with pregabalin and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (4%) and somnolence (4%). In the placebo group, 1% of patients withdrew due to dizziness and less than 1% withdrew due to somnolence.

Other adverse reactions that led to discontinuation from controlled trials more frequently in the pregabalin group compared to the placebo group were ataxia, confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral edema (1% each). Most Common Adverse Reactions in All Controlled Clinical Studies in Adults In premarketing controlled trials of all adult patient populations combined (including DPN, PHN, and adult patients with partial-onset seizures), dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and "thinking abnormal" (primarily difficulty with concentration/attention) were more commonly reported by subjects treated with pregabalin than by subjects treated with placebo (greater than or equal to 5% and twice the rate of that seen in placebo).

Controlled Studies with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy Adverse Reactions Leading to Discontinuation In clinical trials in adults with neuropathic pain associated with diabetic peripheral neuropathy, 9% of patients treated with pregabalin and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were…

🔄 Drug Interactions 159 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 and in vivo studies showed that pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions. Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate.

Important pharmacokinetic interactions would also not be expected to occur between pregabalin and commonly used antiepileptic drugs [see Clinical Pharmacology (12) ] . Pharmacodynamics Multiple oral doses of pregabalin were co-administered with oxycodone, lorazepam, or ethanol. Although no pharmacokinetic interactions were seen, 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.

👥 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 pregabalin, physicians are advised to recommend that pregnant patients taking pregabalin 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 pregabalin 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 post-marketing data on miscarriage and other maternal, fetal, and long term developmental adverse effects were insufficient to identify risk associated with pregabalin.

Post-marketing 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 16 times human exposure at the maximum recommended dose (MRD) of 600 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 pregabalin 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 ▾

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 p…

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Neuropathic Pain Associated with Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, and Neuropathic Pain Associated with Spinal Cord Injury Safety and effectiveness in pediatric patients have not been established. Fibromyalgia Safety and effectiveness in pediatric patients have not been established. A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years, at pregabalin total daily doses of 75 mg per day to 450 mg per day.

The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity (derived from an 11-point numeric rating scale) showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia.

Adjunctive Therapy for Partial-Onset Seizures Safety and effectiveness in pediatric patients below the age of 1 month have not been established. 4 to Less Than 17 Years of Age with Partial-Onset Seizures The safety and effectiveness of pregabalin as adjunctive treatment for partial-onset seizures in pediatric patients 4 to less than 17 years of age have been established in a 12-week, double-blind, placebo-controlled study (n = 295) [see Clinical Studies (14.3) ] . Patients treated with pregabalin 10 mg/kg/day had, on average, a 21.0% greater reduction in partial-onset seizures than patients treated with placebo (p = 0.0185).

Patients treated with pregabalin 2.5 mg/kg/day had, on average, a 10.5% greater reduction in partial-onset seizures than patients treated with placebo, but the difference was not statistically significant (p = 0.2577). Responder rates (50% or greater reduction in partial-onset seizure frequency) were a key secondary efficacy parameter and showed numerical improvement with pregabalin compared with placebo: the responder rates were 40.6%, 29.1%, and 22.6%, for pregabalin 10 mg/kg/day, pregabalin 2.5 mg/kg/day, and placebo, respectively.

The most common adverse reactions (≥ 5%) with pregabalin in this study were somnolence, weight increased, and increased appetite [see Adverse Reactions (6.1) ] . The use of pregabalin 2.5 mg/kg/day in pediatric patients is further supported by evidence from adequate and well-controlled studies in adults with partial-onset seizures and pharmacokinetic data from adult and pediatric patients [see Clinical Pharmacology (12.3) ] . 1 Month to Less than 4 Years of Age with Partial-Onset Seizures The safety and effectiveness of pregabalin as adjunctive treatment for partial-onset seizures in pediatric patients 1 month to less than 4 years of age have been established in a 14-day double-blind, placebo-controlled study (N = 175) [see Clinical Studies (14.3) ] .

The youngest subject evaluated was 3 months of age; use in patients 1 month to less than 3 months of age is supported by additional pharmacokinetic analyses. Patients treated with pregabalin 14 mg/kg/day had, on average, 43.9% greater reduction in partial-onset seizures than patients treated with placebo (p = 0.0223). In addition, pediatric patients treated with pregabalin 14 mg/kg/day showed numerical improvement in responder rates (≥ 50% reduction in partial-onset seizure frequency) compared with placebo (53.6% versus 41.5%).

Patients treated with pregabalin 7 mg/kg/day did not show improvement relative to placebo for either endpoint. The most common dose-related adverse reactions (> 5%) with pregabalin in this study were somnolence, pneumonia, and viral infection [see Adverse Reactions (6.1) ] . Juvenile Animal Data In studies in which pregabalin (50 mg/kg to 500 mg/kg) was orally administered to young rats from early in the postnatal period (Postnatal Day 7) through sexual maturity, neurobehavioral…

🧓 Geriatric Use ~1 min read ▾

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 controlled clinical studies of pregabalin in epilepsy, there were only 10 patients 65 to 74 years of age, and 2 patients who were 75 years of age or older.

No overall differences in safety and efficacy were observed between these patients and younger patients. In controlled clinical studies of pregabalin in fibromyalgia, 106 patients were 65 years of age or older. Although the adverse reaction profile was similar between the two age groups, the following neurological adverse reactions were more frequent in patients 65 years of age or older: dizziness, vision blurred, balance disorder, tremor, confusional state, coordination abnormal, and lethargy.

Pregabalin is known to be substantially excreted by the kidney, and the risk of toxic reactions to pregabalin may be greater in patients with impaired renal function. Because pregabalin is eliminated primarily by renal excretion, adjust the dose for elderly patients with renal impairment [see Dosage and Administration (2.7) ] .

🆘 Overdosage 157 words ▾

10 OVERDOSAGE Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans In the post-marketing 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 is well absorbed after oral administration, is eliminated largely by renal excretion, and has an elimination half-life of about 6 hours. Absorption and Distribution Following oral administration of pregabalin capsules under fasting conditions, peak plasma concentrations occur within 1.5 hours. Pregabalin oral bioavailability is greater than or equal to 90% and is independent of dose.

Following single- (25 mg to 300 mg) and multiple-dose (75 mg/day to 900 mg/day) administration, maximum plasma concentrations (C max ) and area under the plasma concentration-time curve (AUC) values increase linearly. Following repeated administration, steady-state is achieved within 24 to 48 hours. Multiple-dose pharmacokinetics can be predicted from single-dose data.

The rate of pregabalin absorption is decreased when given with food, resulting in a decrease in C max of approximately 25% to 30% and an increase in T max to approximately 3 hours. However, administration of pregabalin with food has no clinically relevant effect on the total absorption of pregabalin. Therefore, pregabalin can be taken with or without food.

Pregabalin does not bind to plasma proteins. The apparent volume of distribution of pregabalin following oral administration is approximately

0.5L/kg. Pregabalin is a substrate for system L transporter which is responsible for the transport of large amino acids across the blood brain barrier. Although there are no data in humans, pregabalin has been shown to cross the blood brain barrier in mice, rats, and monkeys.

In addition, pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats. Metabolism and Elimination Pregabalin undergoes negligible metabolism in humans. Following a dose of radiolabeled pregabalin, approximately 90% of the administered dose was recovered in the urine as unchanged pregabalin.

The N-methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for 0.9% of the dose. In preclinical studies, pregabalin (S-enantiomer) did not undergo racemization to the R-enantiomer in mice, r…

🧬 Mechanism of Action ~1 min read ▾

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Pregabalin capsules, 25 mg are supplied as white, hard gelatin capsule printed with black ink “AN” on cap & “1310” on body. They are available as follows: Bottles of 90: NDC 69238-1310-9 Bottles of 500: NDC 69238-1310-5 Pregabalin capsules, 50 mg are supplied as white, hard gelatin capsule printed with black ink “AN” on cap & “1311” on body. They are available as follows: Bottles of 90: NDC 69238-1311-9 Bottles of 500: NDC 69238-1311-5 Pregabalin capsules, 75 mg are supplied as white/orange, hard gelatin capsule printed with black ink “AN” on cap & “1312” on body.

They are available as follows: Bottles of 90: NDC 69238-1312-9 Bottles of 500: NDC 69238-1312-5 Pregabalin capsules, 100 mg are supplied as orange, hard gelatin capsule printed with black ink “AN” on cap & “1313” on body. They are available as follows: Bottles of 90: NDC 69238-1313-9 Bottles of 500: NDC 69238-1313-5 Pregabalin capsules, 150 mg are supplied as white, hard gelatin capsule printed with black ink “AN” on cap & “1314” on body. They are available as follows: Bottles of 90: NDC 69238-1314-9 Bottles of 500: NDC 69238-1314-5 Pregabalin capsules, 200 mg are supplied as light orange, hard gelatin capsule printed with black ink “AN” on cap & “1315” on body.

They are available as follows: Bottles of 90: NDC 69238-1315-9 Bottles of 500: NDC 69238-1315-5 Pregabalin capsules, 225 mg are supplied as white/light orange, hard gelatin capsule printed with black ink “AN” on cap & “1316” on body. They are available as follows: Bottles of 90: NDC 69238-1316-9 Bottles of 500: NDC 69238-1316-5 Pregabalin capsules, 300 mg are supplied as white/orange, hard gelatin capsule printed with black ink “AN” on cap & “1317” on body. They are available as follows: Bottles of 90: NDC 69238-1317-9 Bottles of 500: NDC 69238-1317-5 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP with child-resistant closure.

📋 Description 176 words ▾

11 DESCRIPTION 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. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc.

The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac. df

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

Hypersensitivity Advise patients that pregabalin has been associated with hypersensitivity reactions such as wheezing, dyspnea, rash, hives, and blisters. Instruct patients to discontinue pregabalin 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, 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 healthcare providers. Also inform patients who plan to or have discontinued pregabalin 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 Counsel patients that pregabalin 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 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 pregabalin, as pregabalin may potentiate the impairment of motor skills and sedating effects of alcohol. Adverse Reactions with Abrupt or Rapid Discontinuation Advise patients to take pregabalin as prescribed. Abrupt or rapid discontinuation may result in increased seizure frequency in patients with seizure disorders, and insomnia, nausea, headache, anxiety, hyperhidrosis, or diarrhea [see Warnings and Precautions (5.4) ] .

Missed Dose Counsel patients if they miss a dose, they should take it as soon as they remember. If it is almost time for the next dose, they should skip the missed dose and take the next dose at their regularly scheduled time. Instruct patients not to take two doses at the same time.

Weight Gain and Edema Counsel patients that pregabalin may cause edema and weight gain. Advise patients that concomitant treatment with pregabalin and a thiazolidinedione antidiabetic agent may lead to an additive effect on edema and weight gain. For patients with pre-existing cardiac conditions, this may increase the risk of heart failure [see Warnings and Precautions (5.7 , 5.8) ] .

Ophthalmological Effects Counsel patients that pregabalin may cause visual disturbances. Inform patients that if changes in vision occur, they should notify their physician [s…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Pregabalin (pree gabʹ a lin) C aps u l es, CV Read this Medication Guide before you start taking pregabalin capsules 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 capsules, ask your healthcare provider or pharmacist. What is the most important information I should know about pregabalin capsules ? Pregabalin capsules 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 pregabalin capsules 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 Like other antiepileptic drugs, pregabalin capsules may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. This can happen while you take pragabalin capsules 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 capsules without first talking to a healthcare provider.

Stopping pregabalin capsules 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 capsules are 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 capsules 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 capsule affects you. Ask your healthcare provider about when it will be okay to do these activities.

What are pregabalin capsules? Pregabalin capsules are a prescription medicine used in adults, 18 years of age and older to treat: pain from damaged nerves (neuropathic pain) that happens with diabetes pain from damaged nerves (neuropathic pain) that follows healing of shingles fibromyalgia (pain all over your body) pain from damaged nerves (neuropathic pain) that follows spinal cord injury It is not known if pregabalin capsules are safe and effective in people under 18 years of age for the treatment of fibromyalgia and neuropathic pain with diabetes, shingles, or spinal cord injury.

Pregabalin capsules are a prescription medicine used in people 1 month of age and older to treat: partial-onset seizures when taken together with other seizure medicines. For the treatment of par…

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.

in vivo: In a living person or animal rather than in a laboratory dish.

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.

additive effect: When two medicines that do the same thing are taken together and their effects add up to a larger combined effect.

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.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

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.

asthenia: Unusual weakness or lack of physical strength and energy.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

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

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

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.

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.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

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

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

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

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

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.

endpoint: A specific outcome, such as a symptom or lab value, that a study measures to judge whether a treatment works.

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

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

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.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

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.

metabolite: A new substance formed when the body breaks a medicine down.

monotherapy: Treatment using a single medicine by itself.

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.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

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 excretion: Removal of a medicine from the body through the kidneys into the urine.

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.

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

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.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

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 ↗

← 69238-1314-09 · Amneal 69238-1316-09 · Amneal →

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 200 mg Capsule, 90-count

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