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Carvedilol 6.25 mg Tablet, Film Coated, 60-count — NDC 71335-1457-02 package photo

Carvedilol 6.25 mg Tablet, Film Coated, 60-count

by Bryant Ranch Prepack · 60 TABLET, FILM COATED in 1 BOTTLE (71335-1457-2)
NDC 71335-1457-02
🏷️ FDA NDC (as labeled) 71335-1457-2 billing pads the package segment with a zero
This package
Contains60-count Pack sizes8 compare ↓
Also priced by: Part D plans $0.0650/unit — full pricing hub ↓
Also comes in: 10 tablets 71335-1457-08 25 tablets 71335-1457-07 30 tablets 71335-1457-01 90 tablets 71335-1457-05 100 tablets 71335-1457-03 120 tablets 71335-1457-06 180 tablets 71335-1457-04
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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 Carvedilol (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 20, 2025 — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories) · FDA recall D-0594-2025
Class II · Aug 7, 2025 — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0578-2025
Class II · Aug 7, 2025 — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0577-2025
Class II · Aug 7, 2025 — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0579-2025
Class II · Aug 6, 2025 — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0588-2025
Class II · Aug 6, 2025 — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0587-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Feb 2022. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 71335-1457-2
Product NDC 71335-1457
11-digit billing NDC 71335145702
RxCUI 200031
UNII 0K47UL67F2
Application # ANDA078384
SPL Set ID 45233e64-26ee-4117-a896-24363b435fc2
Established class (EPC) alpha-Adrenergic Blocker; beta-Adrenergic Blocker
Mechanism of action Adrenergic alpha-Antagonists; Adrenergic beta1-Antagonists; Adrenergic beta2-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Feb 2022)
Marketing start 2016-10-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance CARVEDILOL
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71335-1457-2 — 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 → 71335-1457-02. 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 alpha-Adrenergic Blocker class.

Pharmacologic class alpha-Adrenergic Blocker, beta-Adrenergic Blocker
Drug family (ATC) Alpha and beta blocking agents
How it works Adrenergic alpha-Antagonists, Adrenergic beta1-Antagonists, Adrenergic beta2-Antagonists
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

LabelerBryant Ranch Prepack
Application holderREGCON HOLDINGS LLC
FDA applicationANDA078384 (ANDA)
Labeler code71335
First marketedOct 2016
Product typeHuman Prescription Drug
Portfolio4,432 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

📖 What it is MedlinePlus · NLM

Carvedilol is used to treat heart failure (condition in which the heart cannot pump enough blood to all parts of the body) and high blood pressure. It also is used to improve survival after a heart attack.  Carvedilol is in a class of medications called beta-blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Carvedilol works by blocking two sets of receptors — beta-receptors and alpha-1 receptors — in your heart and blood vessels. This slows your heart rate, reduces how hard your heart...
  • What is carvedilol actually doing for my heart?
  • Taking carvedilol with food slows down how quickly it's absorbed into your bloodstream. That matters because one of its side effects is dizziness or a drop in blood pressure when y...
  • Please don't stop carvedilol suddenly without talking to your doctor first — this is one of the most important things to know about this medication. Abruptly stopping it, especiall...
📖 Read our full Carvedilol guide →
1
Nutrient depletion considerations

Carvedilol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Carvedilol nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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
ShapeOval
Imprint255
Size9 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0650 $3.90 / 60 tablets
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
Carvedilol 6.25 mg 00093-0135-01 Teva 100 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 00904-7306-61 Major 1 tablet $0.018 AB Availability likely —
Carvedilol 6.25 mg 65862-0143-01 Aurobindo 100 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 68001-0154-00 BluePoint 100 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 68084-0854-01 American 1 tablet $0.018 AB Availability likely —
Carvedilol 6.25 mg 68382-0093-01 Zydus 100 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 68462-0163-01 Glenmark 100 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 72888-0035-00 Advagen 1000 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 72888-0500-01 Advagen 100 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 82009-0126-05 Quallent 500 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 00615-8388-30 NCS 5 tablets — AB Discontinued —
Carvedilol 6.25 mg 43063-0833-60 PD-Rx 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 50090-2175-00 A-S 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 50090-6742-00 A-S 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 50090-6865-00 A-S 90 tablets — AB FDA listed —
Carvedilol 6.25 mg 50090-7786-00 A-S 90 tablets — AB FDA listed —
Carvedilol 6.25 mg 51407-0040-01 Golden 100 tablets — AB FDA listed —
Carvedilol 6.25 mg 51655-0029-25 Northwind 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 51655-0943-18 Northwind 180 tablets — AB FDA listed —
Carvedilol 6.25 mg 55111-0253-01 Dr. 100 tablets — AB FDA listed —
Carvedilol 6.25 mg 55154-2649-00 Cardinal 1 tablet — AB FDA listed —
Carvedilol 6.25 mg 58657-0751-01 Method 100 tablets — AB FDA listed —
Carvedilol 6.25 mg 60760-0582-60 St. 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 63187-0424-60 Proficient 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 63187-0946-30 Proficient 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 65841-0617-01 Zydus 100 tablets — AB FDA listed —
Carvedilol 6.25 mg 67046-0336-03 Coupler 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 68071-2780-08 NuCare 180 tablets — AB FDA listed —
Carvedilol 6.25 mg 68071-4600-03 NuCare 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 68071-4816-03 NuCare 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 68071-5275-08 NuCare 180 tablets — AB FDA listed —
Carvedilol 6.25 mg 68788-9789-01 Preferred 100 tablets — AB FDA listed —
Carvedilol 6.25 mg 70518-0426-00 REMEDYREPACK 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 70518-0840-02 REMEDYREPACK 1 tablet — AB FDA listed —
Carvedilol 6.25 mgthis 71335-1457-02 Bryant 60 tablets — AB Discontinued —
Carvedilol 6.25 mg 71335-1937-01 Bryant 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 71335-2033-01 Bryant 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 71335-2101-01 Bryant 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 71610-0063-30 Aphena 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 72189-0664-60 Direct_Rx 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 72789-0431-60 PD-Rx 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 76385-0111-01 UNICHEM 100 tablets — AB FDA listed —
Coreg 6.25 mg 80725-0140-20 Waylis 100 tablets — AB FDA listed —
Carvedilol 6.25 mg 82804-0270-60 Proficient 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 68071-5311-08 NuCare 180 tablets — AB FDA listed —
Carvedilol 6.25 mg 67296-2298-06 Redpharm 60 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2016
On the market since
Oct 2016
📍
2026
Currently FDA-listed
10 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 Carvedilol — the program that covers self-administered drugs. 15 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 Carvedilol. 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
$36.64M
Claims incl. refills
3.9M
Beneficiaries
2.8M
Spend / beneficiary
$12.90
Spend / claim
$9.29
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 Carvedilol — the ingredient across all brands.

Top reported reactions

Fatigue9,141
Dyspnoea8,542
Diarrhoea7,250
Dizziness7,211
Nausea6,830
Death5,872
Hypotension5,784

Age at onset

Neonate73
Infant19
Child51
Adolescent46
Adult7,903
Elderly13,019

Reporter sex

0 reports
Male · 53%
Female · 47%
Unknown · 0%

Serious outcomes

Hospitalization54,875
Death16,481
Life-threatening5,862
Disabling2,892
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 10,422 3,417
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
71335-1457-01 30 TABLET, FILM COATED in 1 BOTTLE (71335-1457-1) 2022-02-09 Discontinued by firm
71335-1457-02 You're viewing this 60 TABLET, FILM COATED in 1 BOTTLE (71335-1457-2) 2022-02-09 Discontinued by firm
71335-1457-03 100 TABLET, FILM COATED in 1 BOTTLE (71335-1457-3) 2022-02-09 Discontinued by firm
71335-1457-04 180 TABLET, FILM COATED in 1 BOTTLE (71335-1457-4) 2022-02-09 Discontinued by firm
71335-1457-05 90 TABLET, FILM COATED in 1 BOTTLE (71335-1457-5) 2022-02-09 Discontinued by firm
71335-1457-06 120 TABLET, FILM COATED in 1 BOTTLE (71335-1457-6) 2022-02-09 Discontinued by firm
71335-1457-07 25 TABLET, FILM COATED in 1 BOTTLE (71335-1457-7) 2022-02-09 Active
71335-1457-08 10 TABLET, FILM COATED in 1 BOTTLE (71335-1457-8) 2022-02-09 Active

You're viewing one of 8 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-1457-02?
NDC 71335-1457-02 is a 60-count package — 60 tablet, film coated in 1 bottle.
What is the difference between NDC 71335-1457-02 and NDC 71335-1457-08?
Both are Carvedilol 6.25 mg Tablet, Film Coated — the drug itself is identical. NDC 71335-1457-02 is the 60-count package, while NDC 71335-1457-08 is the 10 tablets package.
What NDC number is used to bill for this package of Carvedilol 6.25 mg Tablet, Film Coated?
Bill NDC 71335-1457-02 — the 11-digit billing format is 71335145702. 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 No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 71335-1457-2, 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: 71335-1457-02, written without dashes as 71335145702. 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 71335-1457-02, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (1457) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 7 other package presentations of this same product, including 10 tablets (71335-1457-08), 25 tablets (71335-1457-07), 30 tablets (71335-1457-01). 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?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 193 words ▾

1 INDICATIONS AND USAGE Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: Mild to severe chronic heart failure ( 1.1 ) Left ventricular dysfunction following myocardial infarction in clinically stable patients ( 1.2 ) Hypertension ( 1.3 )

1.1Heart Failure Carvedilol Tablets is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4), Clinical Studies ( 14.1 )].

1.2Left Ventricular Dysfunction Following Myocardial Infarction Carvedilol Tablet is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [ see Clinical Studies ( 14.2 ) ].

1.3Hypertension Carvedilol Tablet is indicated for the management of essential hypertension [ see Clinical Studies ( 14.3 , 14.4 ) ]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [ see Drug Interactions ( 7.2 ) ].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Carvedilol Tablet should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects. Take with food. Individualize dosage and monitor during up-titration.

( 2 ) Heart failure: Start at 3.125 mg twice daily and increase to 6.25, 12.5, and then 25 mg twice daily over intervals of at least 2 weeks. Maintain lower doses if higher doses are not tolerated. ( 2.1 ) Left ventricular dysfunction following myocardial infarction: Start at 6.25 mg twice daily and increase to 12.5 mg then 25 mg twice daily after intervals of 3 to 10 days.

A lower starting dose or slower titration may be used. ( 2.2 ) Hypertension: Start at 6.25 mg twice daily and increase if needed for blood pressure control to 12.5 mg then 25 mg twice daily over intervals of 1 to 2 weeks. ( 2.3 )

2.1Heart Failure DOSAGE MUST BE INDIVIDUALIZED AND CLOSELY MONITORED BY A PHYSICIAN DURING UP-TITRATION. Prior to initiation of Carvedilol Tablets, it is recommended that fluid retention be minimized. The recommended starting dose of Carvedilol Tablets is 3.125 mg twice daily for 2 weeks.

If tolerated, patients may have their dose increased to 6.25, 12.5, and 25 mg twice daily over successive intervals of at least 2 weeks. Patients should be maintained on lower doses if higher doses are not tolerated. A maximum dose of 50 mg twice daily has been administered to patients with mild-to-moderate heart failure weighing over 85 kg (187 lbs.).

Patients should be advised that initiation of treatment and (to a lesser extent) dosage increases may be associated with transient symptoms of dizziness or lightheadedness (and rarely syncope) within the first hour after dosing. During these periods, patients should avoid situations such as driving or hazardous tasks, where symptoms could result in injury. Vasodilatory symptoms often do not require treatment, but it may be useful to separate the time of dosing of Carvedilol Tablets from that of the ACE inhibitor or to reduce temporarily the dose of the ACE inhibitor.

The dose of Carvedilol Tablets should not be increased until symptoms of worsening heart failure or vasodilation have been stabilized. Fluid retention (with or without transient worsening heart failure symptoms) should be treated by an increase in the dose of diuretics. The dose of Carvedilol Tablets should be reduced if patients experience bradycardia (heart rate <55 beats/minute).

Episodes of dizziness or fluid retention during initiation of Carvedilol Tablets can generally be managed without discontinuation of treatment and do not preclude subsequent successful titration of, or a favorable response to, carvedilol.

2.2Left Ventricular Dysfunction Following Myocardial Infarction DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with Carvedilol Tablet may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that Carvedilol Tablets be started at 6.25 mg twice daily and increased after 3 to 10 days, based on tolerability, to 12.5 mg twice daily, then again to the target dose of 25 mg twice daily.

A lower starting dose may be used (3.125 mg twice daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction.

2.3Hypertension DOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of Carvedilol Tablet is 6.25 mg twice daily. If this dose is tolerated, using standing systolic pressure measured about 1 hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 12.5 mg twice daily if needed, based on trough blood pressu…

💊 Dosage Forms and Strengths 107 words ▾

3 DOSAGE FORMS AND STRENGTHS The white, oval shaped, film-coated tablets are available in the following strengths: 3.125 mg – White, oval shaped, film-coated tablet engraved with 254 on one side and plain on the other side, 6.25 mg – White, oval shaped, film-coated tablet engraved with 255 on one side and plain on the other side, 12.5 mg – White, oval shaped, film-coated tablet engraved with 256 on one side and plain on the other side, and 25 mg – White, oval shaped, film-coated tablet engraved with 257 on one side and plain on the other side.

Tablets: 3.125, 6.25, 12.5, 25 mg ( 3 )

⛔ Contraindications 191 words ▾

4 CONTRAINDICATIONS Carvedilol Tablet is contraindicated in the following conditions: Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of Carvedilol Tablet. Second- or third-degree AV block Sick sinus syndrome Severe bradycardia (unless a permanent pacemaker is in place) Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy.

Such patients should first be weaned from intravenous therapy before initiating Carvedilol Tablet. Patients with severe hepatic impairment Patients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol. Bronchial asthma or related bronchospastic conditions ( 4 ) Second- or third-degree AV block ( 4 ) Sick sinus syndrome ( 4 ) Severe bradycardia (unless permanent pacemaker in place) ( 4 ) Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy.

( 4 ) Severe hepatic impairment ( 2.4 , 4 ) History of serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. ( 5.1 ) Bradycardia, hypotension, worsening heart failure/fluid retention may occur. Reduce the dose as needed.

( 5.2 , 5.3 , 5.4 ) Non-allergic bronchospasm (e.g., chronic bronchitis and emphysema): Avoid β-blockers. ( 4 ) However, if deemed necessary, use with caution and at lowest effective dose. ( 5.5 ) Diabetes: Monitor glucose as β-blockers may mask symptoms of hypoglycemia or worsen hyperglycemia.

( 5.6 )

5.1Cessation of Therapy Patients with coronary artery disease, who are being treated with Carvedilol Tablet should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in angina patients following the abrupt discontinuation of therapy with β-blockers. The last 2 complications may occur with or without preceding exacerbation of the angina pectoris.

As with other β-blockers, when discontinuation of Carvedilol Tablet is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. Carvedilol Tablet should be discontinued over 1 to 2 weeks whenever possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that Carvedilol Tablet be promptly reinstituted, at least temporarily.

Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue therapy with Carvedilol Tablet abruptly even in patients treated only for hypertension or heart failure.

5.2Bradycardia In clinical trials, Carvedilol Tablet caused bradycardia in about 2% of hypertensive patients, 9% of heart failure patients and 6.5% of myocardial infarction patients with left ventricular dysfunction. If pulse rate drops below 55 beats per minute, the dosage should be reduced.

5.3Hypotension In clinical trials of primarily mild-to-moderate heart failure, hypotension and postural hypotension occurred in 9.7% and syncope in 3.4% of subjects receiving Carvedilol Tablets compared with 3.6% and 2.5% of placebo subjects, respectively. The risk for these events was highest during the first 30 days of dosing, corresponding to the up-titration period and was a cause for discontinuation of therapy in 0.7% of subjects receiving Carvedilol Tablets, compared with 0.4% of placebo subjects. In a long-term, placebo-controlled trial in severe heart failure (COPERNICUS), hypotension and postural hypotension occurred in 15.1% and syncope in 2.9% of heart failure subjects receiving Carvedilol Tablets compared with 8.7% and 2.3% of placebo subjects, respectively.

These events were a cause for discontinuation of therapy in 1.1% of subjects receiving Carvedilol Tablets, compared with 0.8% of placebo subjects. Postural hypotension occurred in 1.8% and syncope in 0.1% of hypertensive patients, primarily following the initial dose or at the time of dose increase and was a cause for discontinuation of therapy in 1% of patients. In the CAPRICORN study of survivors of an acute myocardial infarction, hypotension or postural hypotension occurred in 20.2% of patients receiving Carvedilol Tablet compared to 12.6% of placebo patients.

Syncope was reported in 3.9% and 1.9% of patients, respectively. These events were a cause for discontinuation of therapy in 2.5% of patients receiving Carvedilol Tablet, compared to 0.2% of placebo patients. Starting with a low dose, administration with food, and gradual up-titration should decrease the likelihood of syncope or excessive hypotension [ see Dosage and Administration (2.1, 2.2 , 2.3 ) ].

During initiation of therapy, the patient should be cautioned to avoid situations such as driving or hazardous tasks, where injury could result should syncope occur.

5.4Heart Failure/Fluid Retention Worsening heart failure or fluid retention may occur during up-titration of Carvedilol Tablet. If such symptoms oc…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse events ( 6.1 ): Heart failure and Left ventricular dysfunction following myocardial infarction (≥10%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase. Hypertension (≥ 5%): Dizziness To report SUSPECTED ADVERSE REACTIONS, contact Beximco Pharmaceuticals USA Inc. at 877-372-6093 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Studies 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Carvedilol Tablet has been evaluated for safety in patients with heart failure (mild, moderate and severe), in patients with left ventricular dysfunction following myocardial infarction and in hypertensive patients. The observed adverse event profile was consistent with the pharmacology of the drug and the health status of the patients in the clinical trials.

Adverse events reported for each of these patient populations are provided below. Excluded are adverse events considered too general to be informative, and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population. Rates of adverse events were generally similar across demographic subsets (men and women, elderly and non-elderly, blacks and non-blacks).

Heart Failure Carvedilol Tablets has been evaluated for safety in heart failure in more than 4,500 subjects worldwide of whom more than 2,100 participated in placebo-controlled clinical trials. Approximately 60% of the total treated population in placebo-controlled clinical trials received Carvedilol Tablets for at least 6 months and 30% received Carvedilol Tablets for at least 12 months. In the COMET trial, 1,511 subjects with mild-to-moderate heart failure were treated with Carvedilol Tablets for up to 5.9 years (mean: 4.8 years).

Both in US clinical trials in mild-to-moderate heart failure that compared Carvedilol Tablets in daily doses up to 100 mg (n = 765) with placebo (n = 437), and in a multinational clinical trial in severe heart failure (COPERNICUS) that compared Carvedilol Tablets in daily doses up to 50 mg (n = 1,156) with placebo (n = 1,133), discontinuation rates for adverse experiences were similar in carvedilol and placebo subjects. In placebo-controlled clinical trials, the only cause of discontinuation >1%, and occurring more often on carvedilol was dizziness (1.3% on carvedilol, 0.6% on placebo in the COPERNICUS trial).

Table 1 shows adverse events reported in subjects with mild-to-moderate heart failure enrolled in US placebo-controlled clinical trials, and with severe heart failure enrolled in the COPERNICUS trial. Shown are adverse events that occurred more frequently in drug-treated subjects than placebo-treated subjects with an incidence of >3% in subjects treated with carvedilol regardless of causality. Median trial medication exposure was 6.3 months for both carvedilol and placebo subjects in the trials of mild-to-moderate heart failure, and 10.4 months in the trial of severe heart failure subjects.

The adverse event profile of Carvedilol Tablets observed in the long-term COMET trial was generally similar to that observed in the US Heart Failure Trials. Table 1. Adverse Events (%) Occurring More Frequently with Carvedilol Tablet than with Placebo in Subjects with Mild-to-Moderate Heart Failure (HF) Enrolled in US Heart Failure Trials or in Subjects with Severe Heart Failure in the COPERNICUS Trial (Incidence >3% in Subjects Treated with Carvedilol, Regardless of Causality) Body System/ Adverse Event Mild-to-Moderate HF Severe HF Carvedilol Tablets Placebo Carvedilol Tablets Placebo (n = 765) (n = 437) (n = 1,156) (n = 1,133) Body as a Whole Asthenia 7 7 11 9 Fatigue 24 22 - - Digoxin level incr…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS CYP P450 2D6 enzyme inhibitors may increase and rifampin may decrease Carvedilol Tablet levels. ( 7.1 , 7.5 ) Hypotensive agents (e.g., reserpine, MAO inhibitors, clonidine) may increase the risk of hypotension and/or severe bradycardia. ( 7.2 ) Cyclosporine or digoxin levels may increase.

( 7.3 , 7.4 ) Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. ( 7.4 ) Amiodarone may increase Carvedilol Tablet levels resulting in further slowing of the heart rate or cardiac conduction.

( 7.6 ) Verapamil- or diltiazem-type calcium channel blockers may affect ECG and/or blood pressure. ( 7.7 ) Insulin and oral hypoglycemics action may be enhanced. ( 7.8 )

7.1CYP2D6 Inhibitors and Poor Metabolizers Interactions of Carvedilol Tablet with potent inhibitors of CYP2D6 isoenzyme (such as quinidine, fluoxetine, paroxetine, and propafenone) have not been studied, but these drugs would be expected to increase blood levels of the R(+) enantiomer of Carvedilol Tablet [ see Clinical Pharmacology ( 12.3 ) ]. Retrospective analysis of side effects in clinical trials showed that poor 2D6 metabolizers had a higher rate of dizziness during uptitration, presumably resulting from vasodilating effects of the higher concentrations of the α-blocking R(+) enantiomer.

7.2Hypotensive Agents Patients taking both agents with β-blocking properties and a drug that can deplete catecholamines (e.g., reserpine and monoamine oxidase inhibitors) should be observed closely for signs of hypotension and/or severe bradycardia. Concomitant administration of clonidine with agents with β-blocking properties may may cause hypotension and bradycardia. When concomitant treatment with agents with β-blocking properties and clonidine is to be terminated, the β-blocking agent should be discontinued first.

Clonidine therapy can then be discontinued several days later by gradually decreasing the dosage.

7.3Cyclosporine Modest increases in mean trough cyclosporine concentrations were observed following initiation of Carvedilol Tablet treatment in 21 renal transplant patients suffering from chronic vascular rejection. In about 30% of patients, the dose of cyclosporine had to be reduced in order to maintain cyclosporine concentrations within the therapeutic range, while in the remainder no adjustment was needed. On the average for the group, the dose of cyclosporine was reduced about 20% in these patients.

Due to wide interindividual variability in the dose adjustment required, it is recommended that cyclosporine concentrations be monitored closely after initiation of Carvedilol Tablet therapy and that the dose of cyclosporine be adjusted as appropriate.

7.4Digitalis Glycosides Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Digoxin concentrations are increased by about 15% when digoxin and Carvedilol Tablet are administered concomitantly. Therefore, increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing Carvedilol Tablet [ see Clinical Pharmacology ( 12.5 ) ].

7.5Inducers/Inhibitors of Hepatic Metabolism Rifampin reduced plasma concentrations of Carvedilol Tablet by about 70% [ see Clinical Pharmacology ( 12.5 ) ]. Cimetidine increased AUC by about 30% but caused no change in C max [ see Clinical Pharmacology ( 12.5 ) ].

7.6Amiodarone Amiodarone, and its metabolite desethyl amiodarone, inhibitors of CYP2C9 and P-glycoprotein, increased concentrations of the S(-)-enantiomer of Carvedilol Tablet by at least 2-fold [ see Clinical Pharmacology ( 12.5 ) ]. The concomitant administration of amiodarone or other CYP2C9 inhibitors such as fluconazole with Carvedilol Tablet may enhance the β-blocking properties of Carvedilol Tablet resulting in further slowing of the heart rate or cardiac conduction. Patients should be observed for…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data regarding use of carvedilol in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. The use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and Respiratory depression in the neonate [see Clinical Considerations].

In animal reproduction studies, there was no evidence of adverse developmental outcomes at clinically relevant doses [see Data]. Oral administration of carvedilol to pregnant rats during organogenesis resulted in post-implantation loss, decreased fetal body weight, and an increased frequency of delayed fetal skeletal development at maternally toxic doses that were 50 times the maximum recommended human dose (MRHD). In addition, oral administration of carvedilol to pregnant rabbits during organogenesis resulted in increased post-implantation loss at doses 25 times the MRHD [see Data].

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 Disease-Associated Maternal and/or Embryo/Fetal Risk: Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.

Fetal/Neonatal Adverse Reactions: Neonates of women with hypertension who are treated with beta-blockers during the third trimester of pregnancy may be at increased risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. Observe newborns for symptoms of hypotension, bradycardia, hypoglycemia, and respiratory depression and manage accordingly. Data Animal Data: Studies performed in rats and rabbits given carvedilol during fetal organogenesis revealed increased post-implantation loss in rats at a maternally toxic dose of 300 mg per kg per day (50 times the MRHD as mg per m2) and in rabbits (in the absence of maternal toxicity) at doses of 75 mg per kg per day (25 times the MRHD as mg per m2).

In the rats, there was also a decrease in fetal body weight at 300 mg per kg per day (50 times the MRHD as mg per m’) accompanied by an increased incidence of fetuses with delayed skeletal development. In rats, the no-effect level for embryo-fetal toxicity was 60 mg per kg per day (10 times the MRHD as mg per m2; in rabbits, it was 15 mg per kg per day (5 times the MRHD as mg per m2). In a pre-and post-natal development study in rats administered carvedilol from late gestation through lactation, increased embryo-lethality was observed at a maternally toxic dose of 200 mg per kg per day (approximately 32 times the MRHD as mg per m2), and pup mortality and delays in physical growth/development were observed at 60 mg per kg per day (10 times the MRHD as mg per m2) in the absence of maternal toxicity.

The no-effect level was 12 mg per kg per day (2 times the MRHD as mg per m2). Carvedilol was present in fetal rat tissue.

8.2Lactation Risk Summary There are no data on the presence of carvedilol in human milk, the effects on the breastfed infant, or the effects on milk production. Carvedilol is present in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for carvedilol and any potential adverse effects on…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data regarding use of carvedilol in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. The use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and Respiratory depression in the neonate [see Clinical Considerations].

In animal reproduction studies, there was no evidence of adverse developmental outcomes at clinically relevant doses [see Data]. Oral administration of carvedilol to pregnant rats during organogenesis resulted in post-implantation loss, decreased fetal body weight, and an increased frequency of delayed fetal skeletal development at maternally toxic doses that were 50 times the maximum recommended human dose (MRHD). In addition, oral administration of carvedilol to pregnant rabbits during organogenesis resulted in increased post-implantation loss at doses 25 times the MRHD [see Data].

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 Disease-Associated Maternal and/or Embryo/Fetal Risk: Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.

Fetal/Neonatal Adverse Reactions: Neonates of women with hypertension who are treated with beta-blockers during the third trimester of pregnancy may be at increased risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. Observe newborns for symptoms of hypotension, bradycardia, hypoglycemia, and respiratory depression and manage accordingly. Data Animal Data: Studies performed in rats and rabbits given carvedilol during fetal organogenesis revealed increased post-implantation loss in rats at a maternally toxic dose of 300 mg per kg per day (50 times the MRHD as mg per m2) and in rabbits (in the absence of maternal toxicity) at doses of 75 mg per kg per day (25 times the MRHD as mg per m2).

In the rats, there was also a decrease in fetal body weight at 300 mg per kg per day (50 times the MRHD as mg per m’) accompanied by an increased incidence of fetuses with delayed skeletal development. In rats, the no-effect level for embryo-fetal toxicity was 60 mg per kg per day (10 times the MRHD as mg per m2; in rabbits, it was 15 mg per kg per day (5 times the MRHD as mg per m2). In a pre-and post-natal development study in rats administered carvedilol from late gestation through lactation, increased embryo-lethality was observed at a maternally toxic dose of 200 mg per kg per day (approximately 32 times the MRHD as mg per m2), and pup mortality and delays in physical growth/development were observed at 60 mg per kg per day (10 times the MRHD as mg per m2) in the absence of maternal toxicity.

The no-effect level was 12 mg per kg per day (2 times the MRHD as mg per m2). Carvedilol was present in fetal rat tissue.

🧒 Pediatric Use 186 words ▾

8.4Pediatric Use Effectiveness of Carvedilol Tablets in patients younger than 18 years of age has not been established. In a double-blind trial, 161 children (mean age 6 years, range 2 months to 17 years; 45% less than 2 years old) with chronic heart failure [NYHA class II to IV, left ventricular ejection fraction less than 40% for children with a systemic left ventricle (LV), and moderate-severe ventricular dysfunction qualitatively by echo for those with a systemic ventricle that was not an LV] who were receiving standard background treatment were randomized to placebo or to two dose levels of Carvedilol Tablet.

These dose levels produced placebo-corrected heart rate reduction of 4 to 6 heartbeats per minute, indicative of β- blockade activity. Exposure appeared to be lower in pediatric subjects than adults. After 8 months of follow-up, there was no significant effect of treatment on clinical outcomes.

Adverse reactions in this trial that occurred in greater than 10% of patients treated with Carvedilol Tablet and at twice the rate of placebo-treated patients included chest pain (17% versus 6%), dizziness (13% versus 2%), and dyspnea (11% versus 0%).

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Of the 765 subjects with heart failure randomized to Carvedilol Tablets in US clinical trials, 31% (235) were 65 years of age or older, and 7.3% (56) were 75 years of age or older. Of the 1,156 subjects randomized to Carvedilol Tablets in a long-term, placebo-controlled trial in severe heart failure, 47% (547) were 65 years of age or older, and 15% (174) were 75 years of age or older. Of 3,025 subjects receiving Carvedilol Tablets in heart failure trials worldwide, 42% were 65 years of age or older.

Of the 975 myocardial infarction patients randomized to Carvedilol Tablet in the CAPRICORN trial, 48% (468) were 65 years of age or older, and 11% (111) were 75 years of age or older. Of the 2,065 hypertensive patients in U.S. clinical trials of efficacy or safety who were treated with Carvedilol Tablet, 21% (436) were 65 years of age or older. Of 3,722 patients receiving Carvedilol Tablet in hypertension clinical trials conducted worldwide, 24% were 65 years of age or older.

With the exception of dizziness in hypertensive patients (incidence 8.8% in the elderly versus 6% in younger patients), no overall differences in the safety or effectiveness (see Figure 2 and 4) were observed between the older subjects and younger subjects in each of these populations. Similarly, other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Overdosage may cause severe hypotension, bradycardia, cardiac insufficiency, cardiogenic shock, and cardiac arrest. Respiratory problems, bronchospasms, vomiting, lapses of consciousness, and generalized seizures may also occur. The patient should be placed in a supine position and, where necessary, kept under observation and treated under intensive-care conditions.

The following agents may be administered: for excessive bradycardia: Atropine, 2 mg IV. to support cardiovascular function: Glucagon, 5 to 10 mg IV rapidly over 30 seconds, followed by a continuous infusion of 5 mg/hour; sympathomimetics (dobutamine, isoprenaline, adrenaline) at doses according to body weight and effect. If peripheral vasodilation dominates, it may be necessary to administer adrenaline or noradrenaline with continuous monitoring of circulatory conditions. For therapy-resistant bradycardia, pacemaker therapy should be performed.

For bronchospasm, β-sympathomimetics (as aerosol or IV) or aminophylline IV should be given. In the event of seizures, slow IV injection of diazepam or clonazepam is recommended. NOTE: In the event of severe intoxication where there are symptoms of shock, treatment with antidotes must be continued for a sufficiently long period of time consistent with the 7 to 10 hour half-life of carvedilol.

Cases of overdosage with Carvedilol Tablet alone or in combination with other drugs have been reported. Quantities ingested in some cases exceeded 1,000 milligrams. Symptoms experienced included low blood pressure and heart rate.

Standard supportive treatment was provided and individuals recovered.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Carvedilol Tablet is a racemic mixture in which nonselective β-adrenoreceptor blocking activity is present in the S(-) enantiomer and α 1 -adrenergic blocking activity is present in both R(+) and S(-) enantiomers at equal potency. Carvedilol Tablet has no intrinsic sympathomimetic activity.

12.2Pharmacodynamics Heart Failure The basis for the beneficial effects of Carvedilol Tablets in heart failure is not established. Two placebo-controlled trials compared the acute hemodynamic effects of Carvedilol Tablets with baseline measurements in 59 and 49 subjects with NYHA class II-IV heart failure receiving diuretics, ACE inhibitors, and digitalis. There were significant reductions in systemic blood pressure, pulmonary artery pressure, pulmonary capillary wedge pressure, and heart rate.

Initial effects on cardiac output, stroke volume index, and systemic vascular resistance were small and variable. These trials measured hemodynamic effects again at 12 to 14 weeks. Carvedilol Tablets significantly reduced systemic blood pressure, pulmonary artery pressure, right atrial pressure, systemic vascular resistance, and heart rate, while stroke volume index was increased.

Among 839 subjects with NYHA class II-III heart failure treated for 26 to 52 weeks in 4 US placebo-controlled trials, average left ventricular ejection fraction (EF) measured by radionuclide ventriculography increased by 9 EF units (%) in subjects receiving Carvedilol Tablets and by 2 EF units in placebo subjects at a target dose of 25 to 50 mg twice daily. The effects of carvedilol on ejection fraction were related to dose. Doses of 6.25 mg twice daily, 12.5 mg twice daily, and 25 mg twice daily were associated with placebo-corrected increases in EF of 5 EF units, 6 EF units, and 8 EF units, respectively; each of these effects were nominally statistically significant.

Left Ventricular Dysfunction Following Myocardial Infarction The basis for the beneficial effects of Carvedilol Tablet in patients with left ventricular dysfunction following an acute myocardial infarction is not established. Hypertension The mechanism by which β-blockade produces an antihypertensive effect has not been established. β-adrenoreceptor blocking activity has been demonstrated in animal and human studies showing that carvedilol (1) reduces cardiac output in normal subjects; (2) reduces exercise- and/or isoproterenol-induced tachycardia; and (3) reduces reflex orthostatic tachycardia.

Significant β-adrenoreceptor blocking effect is usually seen within 1 hour of drug administration. α1-adrenoreceptor blocking activity has been demonstrated in human and animal studies, showing that carvedilol (1) attenuates the pressor effects of phenylephrine; (2) causes vasodilation; and (3) reduces peripheral vascular resistance. These effects contribute to the reduction of blood pressure and usually are seen within 30 minutes of drug administration. Due to the α1-receptor blocking activity of carvedilol, blood pressure is lowered more in the standing than in the supine position, and symptoms of postural hypotension (1.8%), including rare instances of syncope, can occur.

Following oral administration, when postural hypotension has occurred, it has been transient and is uncommon when Carvedilol Tablet is administered with food at the recommended starting dose and titration increments are closely followed [see Dosage and Administration (2) ]. In hypertensive patients with normal renal function, therapeutic doses of Carvedilol Tablet decreased renal vascular resistance with no change in glomerular filtration rate or renal plasma flow. Changes in excretion of sodium, potassium, uric acid, and phosphorus in hypertensive patients with normal renal function were similar after Carvedilol Tablet and placebo.

Carvedilol Tablet has little effect on plasma catecholamines, plasma aldosterone, or electrolyte levels, but it does significantly reduce plasma renin activity when gi…

🧬 Mechanism of Action 46 words ▾

12.1Mechanism of Action Carvedilol Tablet is a racemic mixture in which nonselective β-adrenoreceptor blocking activity is present in the S(-) enantiomer and α 1 -adrenergic blocking activity is present in both R(+) and S(-) enantiomers at equal potency. Carvedilol Tablet has no intrinsic sympathomimetic activity.

📦 How Supplied / Storage and Handling 133 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Carvedilol Tablets are available as follows: 6.25 mg - White, oval shaped, film-coated tablet engraved with 255 on one side and plain on the other side contains 6.25 mg of Carvedilol. Tablets are supplied as follows: NDC 71335-1457-1: 30 Tablets in a BOTTLE NDC 71335-1457-2: 60 Tablets in a BOTTLE NDC 71335-1457-3: 100 Tablets in a BOTTLE NDC 71335-1457-4: 180 Tablets in a BOTTLE NDC 71335-1457-5: 90 Tablets in a BOTTLE NDC 71335-1457-6: 120 Tablets in a BOTTLE NDC 71335-1457-7: 25 Tablets in a BOTTLE NDC 71335-1457-8: 10 Tablets in a BOTTLE Store at 25°C (77°F); Excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 145 words ▾

11 DESCRIPTION Carvedilol is a nonselective β-adrenergic blocking agent with α 1 -blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-( o -methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure: Carvedilol is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet.

Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol Tablet is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C 24 H 26 N 2 O 4 . It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).

💬 Information for Patients 215 words ▾

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling ( Patient Information ). Advise the patient to read the FDA-approved patient labeling (Patient information). Patients taking Carvedilol Tablet should be advised of the following: • Patients should take Carvedilol Tablet with food. • Patients should not interrupt or discontinue using Carvedilol Tablet without a physician's advice. • Patients with heart failure should consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath. • Patients may experience a drop in blood pressure when standing, resulting in dizziness and, rarely, fainting.

Patients should sit or lie down when these symptoms of lowered blood pressure occur. • If experiencing dizziness or fatigue, patients should avoid driving or hazardous tasks. • Patients should consult a physician if they experience dizziness or faintness, in case the dosage should be adjusted. • Diabetic patients should report any changes in blood sugar levels to their physician. • Contact lens wearers may experience decreased lacrimation. Manufactured by: Beximco Pharmaceuticals Limited 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh Mfg.

Lic. No. 379 & 119 Manufactured for: Beximco Pharmaceuticals USA Inc.

4110 Regal Oaks Drive, P.0. Box 1060, Suwanee, GA 30024, USA Distributed by: Bayshore Pharmaceuticals LLC Short Hills, NJ 07078 3020009017 Revised - 07/2020

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-1456-01 · Bryant 71335-1459-01 · Bryant →
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.