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PREGABALIN 225 mg Capsule, 90-count

by Direct Rx · 90 CAPSULE in 1 BOTTLE (72189-328-90)
NDC 72189-0328-90
🏷️ FDA NDC (as labeled) 72189-328-90 billing pads the product segment with a zero
This package
Contains90-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.1702/unit — full pricing hub ↓
Also comes in: 60 capsules 72189-0328-60
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

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) 72189-328-90
Product NDC 72189-328
11-digit billing NDC 72189032890
RxCUI 577127
UNII 55JG375S6M
Application # ANDA208677
SPL Set ID d88925b8-9be6-d862-e053-2995a90a1612
DEA schedule CV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-02-21
Route ORAL
Dosage form CAPSULE
Substance PREGABALIN
GPI-14 72600057000150
GPI class Pregabalin
GCN Seq No 059401
GCN 25019
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 225 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 72189-328-90 — 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 → 72189-0328-90. 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

LabelerDirect Rx
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA208677 (ANDA)
Labeler code72189
First marketedFeb 2022
DEA scheduleCV
Product typeHuman Prescription Drug
Portfolio204 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PREGABALIN 225 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 →
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
ImprintSG;356
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1702 $15.32 / 90 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pregabalin 225 mg 00904-7004-04 Major 30 capsules $0.063 AB Availability likely —
Pregabalin 225 mg 31722-0616-05 Camber 500 capsules $0.063 AB Availability likely —
Pregabalin 225 mg 43547-0512-09 Solco 90 capsules $0.063 AB Availability likely —
Pregabalin 225 mg 50228-0651-05 ScieGen 500 capsules $0.063 AB Availability likely —
Pregabalin 225 mg 67877-0468-05 Ascend 500 capsules $0.063 AB Availability likely —
Pregabalin 225 mg 69238-1316-09 Amneal 90 capsules $0.063 AB Availability likely —
Pregabalin 225 mg 69367-0330-09 Westminster 90 capsules $0.063 AB Availability likely —
Pregabalin 225 mg 69097-0961-05 Cipla 90 capsules $0.086 AB FDA listed —
Lyrica 225 mg 58151-0243-77 Viatris 90 capsules $9.684 AB Availability likely —
Pregabalin 225 mg 13668-0364-01 Torrent 100 capsules — AB FDA listed —
pregabalin 225 mg 14445-0127-90 Indoco 90 capsules — AB FDA listed —
Pregabalin 225 mg 25000-0185-07 MARKSANS 90 capsules — AB FDA listed —
Pregabalin 225 mg 27808-0240-01 Tris 90 capsules — AB FDA listed —
Pregablin 225 mg 33342-0171-10 Macleods 90 capsules — — FDA listed —
pregabalin 225 mg 43598-0297-05 Dr.Reddys 500 capsules — AB FDA listed —
Pregabalin 225 mg 46708-0125-10 Alembic 100 capsules — AB FDA listed —
Pregabalin 225 mg 47335-0692-08 Sun 100 capsules — — FDA listed —
Pregabalin 225 mg 50228-0356-05 ScieGen 500 capsules — AB FDA listed —
Pregabalin 225 mg 51407-0580-90 Golden 90 capsules — AB FDA listed —
Pregabalin 225 mg 60219-1316-09 Amneal 90 capsules — AB FDA listed —
Pregabalin 225 mg 62332-0125-10 Alembic 100 capsules — AB FDA listed —
Pregabalin 225 mg 63629-8239-01 Bryant 30 capsules — AB Discontinued —
Pregabalin 225 mg 64980-0416-01 Rising 100 capsules — AB FDA listed —
Pregabalin 225 mg 65862-0764-05 Aurobindo 500 capsules — AB FDA listed —
PREGABALIN capsules, CV 225 mg 69097-0684-02 Cipla 30 capsules — — Discontinued —
Pregabalin 225 mg 69367-0430-05 Westminster 500 capsules — AB FDA listed —
Pregabalin 225 mg 70518-4569-00 REMEDYREPACK 90 capsules — AB FDA listed —
Pregabalin 225 mg 71205-0875-00 Proficient 100 capsules — AB FDA listed —
Pregabalin 225 mg 71209-0038-04 Cadila 90 capsules — — FDA listed —
Pregabalin 225 mg 71335-1744-01 Bryant 30 capsules — AB FDA listed —
Pregabalin 225 mg 71335-9671-01 Bryant 30 capsules — AB FDA listed —
Pregabalin 225 mg 71610-0319-53 Aphena 60 capsules — AB FDA listed —
Pregabalin 225 mg 71610-0760-46 Aphena 56 capsules — AB FDA listed —
Pregabalin 225 mg 71610-0946-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 225 mg 71610-0947-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 225 mg 71610-0995-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 225 mg 72162-1547-09 Bryant 90 capsules — AB FDA listed —
Pregabalin 225 mg 72189-0045-30 Direct_Rx 30 capsules — AB FDA listed —
Pregabalin 225 mgthis 72189-0328-90 Direct 90 capsules — AB FDA listed —
Pregabalin 225 mg 72205-0017-06 Novadoz 1000 capsules — AB FDA listed —
Pregabalin 225 mg 72658-0813-01 Eskayef 60 capsules — AB FDA listed —
Pregabalin 225 mg 73190-0059-50 AvKARE 500 capsules — AB Discontinued —
Pregabalin 225 mg 76282-0574-05 Exelan 500 capsules — AB FDA listed —
Pregabalin 225 mg 76420-0101-30 Asclemed 30 capsules — AB FDA listed —
Pregabalin 225 mg 76420-0123-30 Asclemed 30 capsules — AB FDA listed —
Pregabalin 225 mg 80425-0399-01 Advanced 30 capsules — AB FDA listed —
Pregabalin 225 mg 82619-0128-01 Creekwood 90 capsules — AB FDA listed —
Pregabalin 225 mg 82804-0949-00 Proficient 100 capsules — AB FDA listed —
Pregabalin 225 mg 82968-0012-01 FOURRTS 90 capsules — AB FDA listed —
Pregabalin 225 mg 29300-0445-19 Unichem 90 capsules — AB FDA listed —
Pregabalin 225 mg 58118-0764-08 Clinical 30 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

🏛️
2022
On the market since
Feb 2022
📍
2026
Currently FDA-listed
4 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.

📊 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

270,557 reports
Male · 34%
Female · 65%
Unknown · 1%

Serious outcomes

Life-threatening12,531
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 22,946 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72189-0328-60 60 CAPSULE in 1 BOTTLE (72189-328-60) 2022-02-21 Active
72189-0328-90 You're viewing this 90 CAPSULE in 1 BOTTLE (72189-328-90) 2022-02-21 Active

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

Pack size FAQ

What quantity is in NDC 72189-0328-90?
NDC 72189-0328-90 is a 90-count package — 90 capsule in 1 bottle.
What is the difference between NDC 72189-0328-90 and NDC 72189-0328-60?
Both are PREGABALIN 225 mg Capsule — the drug itself is identical. NDC 72189-0328-90 is the 90-count package, while NDC 72189-0328-60 is the 60 capsules package.
What NDC number is used to bill for this package of PREGABALIN 225 mg Capsule?
Bill NDC 72189-0328-90 — the 11-digit billing format is 72189032890. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72189-328-90, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72189-0328-90, written without dashes as 72189032890. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72189-0328-90, the first segment (72189) is the labeler code FDA assigned to Direct Rx; the middle segment (0328) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Direct Rx. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 60 capsules (72189-0328-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Direct Rx is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 🤒 Adverse Reactions 🆘 Overdosage 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide
🎯 Indications and Usage 82 words ▾

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 17 years of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

⏱️ Dosage and Administration ~3 min read ▾

2.1Important Administration Instructions Pregabalin capsules are given orally with or without food. When discontinuing pregabalin, taper gradually over a minimum of 1 week [see WARNINGS AND PRECAUTIONS (5.6)]. 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 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 (150mg/day 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, 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 17 Years of Age and Older The recommended dosage for adult patients 17 years 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. Based on clinical response and tolerability, dosage may be increased, approximately weekly.

Table 1: Recommended Dosage for Adult Patients 17 Years 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 Both the efficacy and adverse event profiles of pregabalin have been shown to be dose-related. The effect of dose escalation rate on the tolerability of pregabalin has not been formally studied. The efficacy of adjunctive pregabalin in patients taking gabapentin has not been evaluated in controlled trials.

Consequently, dosing recommendations for the use of pregabalin with gabapentin cannot be offered. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.5Management of Fibromyalgia in Adults The recommended dose of pregabalin capsules for fibromyalgia is 300 mg/day to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability.

Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Although pregabalin was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended [see ADVERSE REACTIONS (6.1)].

2.6 Neuropathic Pain Associated with Spinal Cord Injury in Adults The reco…

🤒 Adverse Reactions ~3 min read ▾

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)] Respiratory Depression [see WARNINGS AND PRECAUTIONS (5.4)] Dizziness and Somnolence [see WARNINGS AND PRECAUTIONS (5.5)] Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [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)]

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 5000 patients were treated for 6 months or more, over 3100 patients were treated for 1 year or longer, and over 1400 patients were treated for at least 2 years.

Adverse Reactions Most Commonly Leading to Discontinuation in All Premarketing Controlled Clinical Studies In premarketing controlled trials of all 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 dizziness (3%) and somnolence (2%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence.

Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin group than in the placebo group, were asthenia, confusion, and peripheral edema. Each of these events led to withdrawal in approximately 1% of patients. Most Common Adverse Reactions Table 4 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with diabetic neuropathy in the combined pregabalin group for whic…

🆘 Overdosage 155 words ▾

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).

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

25 mg capsules: White to off white powder filled in size “4” hard gelatin capsules with white opaque colored cap and white opaque colored body imprinted “SG” on cap and “350” on body with black ink; available in Bottles of 30: Bottles of 90: Bottles of 1000: 50 mg capsules: White to off white powder filled in size “3” hard gelatin capsules with white opaque colored cap and white opaque colored body imprinted “SG” on cap and “351” on body with black ink; available in Bottles of 30: Bottles of 90: Bottles of 1000: 75 mg capsules: White to off white powder filled in size “4” hard gelatin capsules with orange opaque colored cap and white opaque colored body imprinted “SG” on cap and “352” on body with black ink; available in Bottles of 30: Bottles of 90: Bottles of 1000: 100 mg capsules: White to off white powder filled in size “3” hard gelatin capsules with orange opaque colored cap and orange opaque colored body imprinted “SG” on cap and “353” on body with black ink; available in Bottles of 30: Bottles of 90: Bottles of 1000: 150 mg capsules: White to off white powder filled in size “2” hard gelatin capsules with white opaque colored cap and white opaque colored body imprinted “SG” on cap and “354” on body with black ink; available in Bottles of 30: Bottles of 90: Bottles of 1000: 200 mg capsules: White to off white powder filled in size “1” hard gelatin capsules with light orange colored cap and light orange colored body imprinted “SG” on cap and “355” on body with black ink; available in Bottles of 30: Bottles of 90: Bottles of 500: 225 mg capsules: White to off white powder filled in size “1” hard gelatin capsules with light orange colored cap and white opaque colored body imprinted “SG” on cap and “356” on body with black ink; available in Bottles of 30: Bottles of 90: Bottles of 500: 300 mg capsules: White to off white powder filled in size “0” hard gelatin capsules with orange opaque colored cap and white opaque colored body imprinted “SG” on cap and “357” on body with black ink; available in Bottles of 30: Bottles of 90: Bottles of 500: Storage and Handling Storage and Handling Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description 160 words ▾

Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is: Chemical Structure Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6.

It is sparingly soluble in water. 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 as inactive ingredients.

The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Pregabalin (pre-GAB-a-lin) Capsules, CV Read this Medication Guide before you start taking pregabalin 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, 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. 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 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 capsules affects you. Ask your healthcare provider about when it will be okay to do these activities.

What is pregablin capsule? Pregabalin capsule is 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 is 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 is a prescription medicine used in people 17 years of age and older to treat: partial onset seizures when taken together with other seizure medicines. For the treatment of partial onset seizures when taken together with other seizure medicines, it is not known if pregabalin is safe and effective in children und…

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