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Dexamethasone 4 mg Tablet, 12-count — NDC 80425-0515-01 package photo

Dexamethasone 4 mg Tablet, 12-count

by Advanced Rx of Tennessee, LLC · 12 TABLET in 1 BOTTLE (80425-0515-1)
NDC 80425-0515-01
🏷️ FDA NDC (as labeled) 80425-0515-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ 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

🆔 Identity & classification

FDA NDC (as labeled) 80425-0515-1
Product NDC 80425-0515
11-digit billing NDC 80425051501
NCPDP billing unit EA — each (per item)
RxCUI 197582
UNII 7S5I7G3JQL
Application # ANDA217001
SPL Set ID 348f5a56-978d-4272-e063-6294a90afdb6
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-07
Route ORAL
Dosage form TABLET
Substance DEXAMETHASONE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 80425-0515-1 — 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 → 80425-0515-01. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids for local oral treatment, Corticosteroids, Corticosteroids, moderately potent (group II)
How it works Corticosteroid Hormone Receptor Agonists
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

LabelerAdvanced Rx of Tennessee, LLC
Application holderBIONPHARMA INC
FDA applicationANDA217001 (ANDA)
Labeler code80425
First marketedMay 2025
Product typeHuman Prescription Drug
Portfolio280 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

📗 Our plain-language guide HelloPharmacist
  • You're right that it treats a lot of conditions, and that can feel confusing. Dexamethasone is a corticosteroid, which is a type of anti-inflammatory medicine. Whether it's calming...
  • Why has my doctor prescribed dexamethasone — it seems to be used for so many different things?
  • Please don't stop it abruptly without talking to your doctor first, especially if you've been on it for more than a few days. Your body adjusts to having this medication on board,...
  • Can I just stop taking dexamethasone if I feel better or if I'm worried about side effects?
📖 Read our full Dexamethasone guide →
8
Nutrient depletion considerations

Dexamethasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Dexamethasone 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 yellow
ShapeRound
ImprintS2
Size6 mm
ScoringScored — splits in 2
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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

4 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 $0.0986 $1.18 / 12 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
Dexamethasone 4 mg 00054-4184-25 Hikma 100 tablets $0.188 AB Availability likely —
Dexamethasone 4 mg 00054-8175-25 Hikma 100 tablets $0.188 AB Availability likely —
dexamethasone 4 mg 00904-7266-61 Major 100 tablets $0.188 AB Availability likely —
Dexamethasone 4 mg 47781-0914-01 Alvogen 100 tablets $0.188 BP Availability likely —
dexamethasone 4 mg 60219-2043-01 Amneal 100 tablets $0.188 AB Availability likely —
Dexamethasone 4 mg 60505-6254-01 Apotex 100 tablets $0.188 AB Availability likely —
Dexamethasone 4 mg 60687-0718-01 American 100 tablets $0.188 AB Availability likely —
Dexamethasone 4 mg 66993-0730-02 Prasco 100 tablets $0.188 — Availability likely —
Dexamethasone 4 mg 69452-0277-20 Bionpharma 100 tablets $0.188 AB Availability likely —
Dexamethasone 4 mg 70954-0403-10 ANI 100 tablets $0.188 AB Availability likely —
Dexamethasone 4 mg 72578-0171-01 Viona 100 tablets $0.188 AB Availability likely —
Dexamethasone 4 mg 72603-0189-01 NorthStar 100 tablets $0.188 AB Availability likely —
Dexamethasone 4 mg 72888-0240-01 Advagen 100 tablets $0.188 AB Availability likely —
Dexamethasone 4 mg 50090-6151-04 A-S 6 tablets — — FDA listed —
Dexamethasone 4 mg 50090-6152-00 A-S 28 tablets — — FDA listed —
Dexamethasone 4 mg 51407-0361-01 Golden 100 tablets — AB FDA listed —
Dexamethasone 4 mg 51655-0012-03 Northwind 3 tablets — AB FDA listed —
dexamethasone 4 mg 55154-4315-00 Cardinal 10 tablets — AB FDA listed —
Dexamethasone 4 mg 55154-4901-00 Cardinal 10 tablets — AB FDA listed —
Dexamethasone 4 mg 55289-0582-04 PD-Rx 4 tablets — AB FDA listed —
Dexamethasone 4 mg 63187-0561-00 Proficient 100 tablets — AB FDA listed —
Dexamethasone 4 mg 63629-3742-00 Bryant 4 tablets — AB FDA listed —
Dexamethasone 4 mg 67296-1837-01 Redpharm 10 tablets — BP Discontinued —
Dexamethasone 4 mg 68071-3588-01 NuCare 10 tablets — AB FDA listed —
Dexamethasone 4 mg 68071-3603-08 NuCare 8 tablets — AB FDA listed —
Dexamethasone 4 mg 68788-4113-01 Preferred 12 tablets — AB FDA listed —
Dexamethasone 4 mg 68788-8467-01 Preferred 12 tablets — AB FDA listed —
Dexamethasone 4 mg 68788-8824-01 Preferred 12 tablets — AB FDA listed —
Dexamethasone 4 mg 69306-0114-06 Doc 6 tablets — AB FDA listed —
Dexamethasone 4 mg 70518-1534-00 REMEDYREPACK 30 tablets — AB FDA listed —
Dexamethasone 4 mg 70518-4320-00 REMEDYREPACK 4 tablets — AB FDA listed —
Dexamethasone 4 mg 70771-1699-01 Zydus 100 tablets — AB FDA listed —
Dexamethasone 4 mg 71205-0703-20 Proficient 20 tablets — BP FDA listed —
Dexamethasone 4 mg 71335-2108-00 Bryant 4 tablets — BP FDA listed —
Dexamethasone 4 mg 71335-2227-00 Bryant 4 tablets — AB FDA listed —
Dexamethasone 4 mg 71335-2500-00 Bryant 4 tablets — AB FDA listed —
Dexamethasone 4 mg 71335-3054-00 Bryant 4 tablets — AB FDA listed —
Dexamethasone 4 mg 72189-0254-10 Direct 10 tablets — AB FDA listed —
Dexamethasone 4 mg 72189-0511-10 Direct_Rx 10 tablets — AB FDA listed —
Dexamethasone 4 mg 72789-0534-01 PD-Rx 100 tablets — AB FDA listed —
Dexamethasone 4 mg 80425-0328-01 Advanced 12 tablets — BP FDA listed —
Dexamethasone 4 mgthis 80425-0515-01 Advanced 12 tablets — AB FDA listed —
Dexamethasone 4 mg 82804-0157-04 Proficient 4 tablets — AB FDA listed —
Dexamethasone 4 mg 82804-0254-15 Proficient 15 tablets — AB FDA listed —
Dexamethasone 4 mg 85766-0246-01 Sportpharm 100 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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year 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 Dexamethasone — the program that covers self-administered drugs. 17 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 Dexamethasone. 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
$4.52M
Claims incl. refills
379.2K
Beneficiaries
287.4K
Spend / beneficiary
$15.74
Spend / claim
$11.92
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 Dexamethasone — the ingredient across all brands.

Top reported reactions

Fatigue17,772
Diarrhoea17,597
Nausea14,727
Plasma Cell Myeloma14,363
Pneumonia14,122
Death13,772
Neutropenia11,944

Age at onset

Neonate725
Infant410
Child1,670
Adolescent801
Adult25,864
Elderly28,087

Reporter sex

308,307 reports

Serious outcomes

Death49,539
Life-threatening22,963
Disabling6,508
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 30,273 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
80425-0515-01 You're viewing this 12 TABLET in 1 BOTTLE (80425-0515-1) 2025-05-07 Active

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 80425-0515-1, 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: 80425-0515-01, written without dashes as 80425051501. 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 80425-0515-01, the first segment (80425) is the labeler code FDA assigned to Advanced Rx of Tennessee, LLC; the middle segment (0515) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Advanced Rx of Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Advanced Rx of Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis.

Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.

Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.

Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).

For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION For Oral Administration The initial dosage varies from 0.75 mg to 9 mg a day depending on the disease being treated. It Should Be Emphasized That Dosage Requirements Are Variable and Must Be Individualized on The Basis of The Disease Under Treatment and The Response of The Patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that maintains an adequate clinical response is reached.

Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of dexamethasone for a week followed by 4 mg to 12 mg every other day for one month have been shown to be effective (see PRECAUTIONS , Neuro-psychiatric ). In pediatric patients, the initial dose of dexamethasone may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 mg/kg/day to 0.3 mg/kg/day in three or four divided doses (0.6 mg/m 2 bsa/day to 9 mg/m 2 bsa/day).

For the purpose of comparison, the following is the equivalent milligram dosage of the various corticosteroids: Cortisone, 25 mg Triamcinolone, 4 mg Hydrocortisone, 20 mg Paramethasone, 2 mg Prednisolone, 5 mg Betamethasone, 0.75 mg Prednisone, 5 mg Dexamethasone, 0.75 mg Methylprednisolone, 4 mg These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested: Dexamethasone sodium phosphate injection, 4 mg per mL First Day 1 mL or 2 mL, intramuscularly Dexamethasone tablets, 0.75 mg Second Day 4 tablets in two divided doses Third Day 4 tablets in two divided doses Fourth Day 2 tablets in two divided doses Fifth Day 1 tablet Sixth Day 1 tablet Seventh Day No treatment Eighth Day Follow-up visit This schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk of overdosage in chronic cases.

In cerebral edema , dexamethasone sodium phosphate injection is generally administered initially in a dosage of 10 mg intravenously followed by 4 mg every six hours intramuscularly until the symptoms of cerebral edema subside. Response is usually noted within 12 hours to 24 hours and dosage may be reduced after two to four days and gradually discontinued over a period of five to seven days. For palliative management of patients with recurrent or inoperable brain tumors, maintenance therapy with either dexamethasone sodium phosphate injection or dexamethasone tablets in a dosage of 2 mg two or three times daily may be effective.

Dexamethasone Suppression Tests Tests for Cushing's syndrome Give 1 mg of dexamethasone orally at 11:00 p.m. Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning. For greater accuracy, give 0.5 mg of dexamethasone orally every 6 hours for 48 hours.

Twenty‑four-hour urine collections are made for determination of 17-hydroxycorticosteroid excretion. 2. Test to distinguish Cushing's syndrome due to pituitary ACTH excess from Cushing's syndrome due to other causes.

Give 2 mg of dexamethas…

⛔ Contraindications 25 words ▾

CONTRAINDICATIONS Systemic fungal infections (see WARNINGS , Fungal infections ). Dexamethasone tablets are contraindicated in patients who are hypersensitive to any components of this product.

⚠️ Warnings ~2 min read ▾

WARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation. Immunosuppression and Increased Risk of Infection Corticosteroids, including dexamethasone, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens.

Corticosteroids can: Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider dexamethasone withdrawal or dosage reduction as needed.

Do not administer dexamethasone by an intraarticular, intrabursal, intratendinous, or intralesional route in the presence of acute local infection. Tuberculosis If dexamethasone is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur. Closely monitor such patients for reactivation.

During prolonged dexamethasone therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis. Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including dexamethasone. In corticosteroid treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles: If a dexamethasone-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated.

If varicella develops, treatment with antiviral agents may be considered. If a dexamethasone-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated. Hepatitis B Virus Reactivation Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including dexamethasone.

Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection. Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with dexamethasone. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.

Fungal Infections Corticosteroids, including dexamethasone, may exacerbate systemic fungal infections; therefore, avoid dexamethasone use in the presence of such infections unless dexamethasone is needed to control drug reactions. For patients on chronic dexamethasone therapy who develop systemic fungal infections, dexamethasone withdrawal or dosage reduction is recommended. Amebiasis Corticosteroids, including dexamethasone, may activate latent amebiasis.

Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating dexamethasone in patients who have spent time in the tropics or patients with unexplained diarrhea. Strongyloides Infestation Corticosteroids, including dexamethasone, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gramnegative septicemia.

Cerebral Malaria Avoid cortic…

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS (listed alphabetically, under each subsection) The following adverse reactions have been reported with dexamethasone or other corticosteroids: Allergic Reactions: Anaphylactoid reaction, anaphylaxis, angioedema. Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS, Cardio-renal ), edema, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

Dermatologic: Acne, allergic dermatitis, dry scaly skin, ecchymoses and petechiae, erythema, impaired wound healing, increased sweating, rash, striae, suppression of reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, hyperglycemia, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.

Fluid and Electrolyte Disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention, tumor lysis syndrome. Gastrointestinal: Abdominal distention, elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.

Metabolic: Negative nitrogen balance due to protein catabolism. Musculoskeletal: Aseptic necrosis of femoral and humeral heads, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures. Neurological/Psychiatric: Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.

Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, vision blurred. Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain. To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 29 words ▾

OVERDOSAGE Treatment of overdosage is by supportive and symptomatic therapy. In the case of acute overdosage, according to the patient’s condition, supportive therapy may include gastric lavage or emesis.

🧬 Clinical Pharmacology 91 words ▾

CLINICAL PHARMACOLOGY Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Glucocorticoids cause varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have sodium-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs including dexamethasone are primarily used for their anti-inflammatory effects in disorders of many organ systems. At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium‑retaining property of hydrocortisone and closely related derivatives of hydrocortisone.

📦 How Supplied / Storage and Handling 78 words ▾

HOW SUPPLIED Dexamethasone tablets, USP are available as follows: 4 mg: Pale yellow, round tablets with side notches, a functional score on one side and debossed ‘ S2 ’ on the other side of the tablet. Bottles of 12 Tablets NDC: 80425-0515-01 Storage Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.

Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF. Distributed by: Advanced Rx of Tennessee, LLC

📋 Description 114 words ▾

DESCRIPTION Dexamethasone tablets, USP, for oral administration, are supplied as 4 mg, and 6 mg. Inactive ingredients are corn starch, D&C yellow 10 (4 mg), FD&C blue 1 (6 mg), lactose monohydrate, and magnesium stearate. The molecular weight for dexamethasone is 392.5 g/mol.

It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The molecular formula is C 22 H 29 FO 5 and the structural formula is: Dexamethasone, USP a synthetic adrenocortical steroid, is a white to almost-white, crystalline powder. It is stable in air.

It is practically insoluble in water, very slightly soluble in ether, slightly soluble in methylene chloride and chloroform, and sparingly soluble in methanol, ethanol (96 %), acetone and 1,4 dioxane. image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80425-0514-01 · Advanced 80425-0516-01 · Advanced →
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.