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Dexamethasone Sodium Phosphate 4 mg/mL Injection, Solution — NDC 71872-7157-01 package photo

Dexamethasone Sodium Phosphate 4 mg/mL Injection, Solution

by Medical Purchasing Solutions, LLC · 1 VIAL in 1 BAG (71872-7157-1) / 5 mL in 1 VIAL
NDC 71872-7157-01
🏷️ FDA NDC (as labeled) 71872-7157-1 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

⚠️
Other active recalls for Dexamethasone Sodium Phosphate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 4, 2026 — Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate. (SOMERSET THERAPEUTICS LLC) · FDA recall D-0398-2026
Class II · May 23, 2024 — Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. (Eugia US LLC) · FDA recall D-0555-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71872-7157-1
Product NDC 71872-7157
11-digit billing NDC 71872715701
RxCUI 1116927
UNII AI9376Y64P
Application # ANDA040803
SPL Set ID 86091483-2053-5da8-e053-2a91aa0a6f45
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 2011-05-11
Route INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE
Dosage form INJECTION, SOLUTION
Substance DEXAMETHASONE SODIUM PHOSPHATE
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 71872-7157-1 — 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 → 71872-7157-01. 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

LabelerMedical Purchasing Solutions, LLC
Application holderMYLAN LABORATORIES LTD
FDA applicationANDA040803 (ANDA)
Labeler code71872
First marketedMay 2011
Product typeHuman Prescription Drug
Portfolio250 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

Dexamethasone injection is used to treat severe allergic reactions. It is used in the management of certain types of edema (fluid retention and swelling; excess fluid held in body tissues,) gastrointestinal disease, and certain types of arthritis. Dexamethasone injection is also used for diagnostic testing. Dexamethasone injection is also used to treat certain conditions that affect the blood, skin, eyes, thyroid, kidneys, lungs, and nervous system. It is sometimes used in combination with other medications to treat symptoms of low corticosteroid levels (lack of certain substances that are usu...

Read the full MedlinePlus article ↗
📗 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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.

  • 10 mg / 1 mL UNII RS7A450LGA
    A sodium salt derived from citric acid that helps regulate acidity and maintain pH balance in the medicine. It also works as a binding agent to hold tablet ingredients together.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 0.11 mg / 1 mL UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 1.5 mg / 1 mL UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 0.2 mg / 1 mL UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 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 mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 Sodium Phosphate 4 mg/mL 67457-0418-05 Mylan 25 vials $0.238 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0422-54 Mylan 25 vials $0.238 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 25021-0052-01 Sagent 25 vials $0.672 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 63323-0165-16 Fresenius 25 vials $0.672 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 72572-0120-25 Civica, 25 vials $0.672 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0419-01 Mylan 25 vials $0.672 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 00641-6145-25 Hikma 25 vials $0.672 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0423-12 Mylan 25 vials $0.672 AP Availability likely —
Dexamethasone Sodium Phosphate 4 mg/mL 00404-9795-30 Henry 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 00404-9805-05 Henry 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 00641-6146-25 Hikma 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 50090-0414-00 A-S 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 50090-2313-02 A-S 2 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 50090-3300-00 A-S 25 vials — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 51662-1297-01 HF 5 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 51662-1370-01 HF 5 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 51662-1432-01 HF 30 ml — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 51662-1660-03 HF 10 pouches — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 55150-0238-05 Eugia 25 vials — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 55150-0239-30 Eugia 25 vials — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 55154-9364-05 Cardinal 5 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0421-30 Mylan 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 67457-0484-30 Mylan 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 68083-0474-25 Gland 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70069-0023-25 Somerset 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70069-0024-25 Somerset 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70121-1451-05 Amneal 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70121-1452-01 Amneal 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7021-01 Medical 1 vial — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7128-01 Medical 1 vial — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7147-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mLthis 71872-7157-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7164-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7171-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7347-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0397-05 Asclemed 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0398-30 Asclemed 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 84549-0421-30 ProPharma 30 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 84549-0422-54 ProPharma 5 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0077-01 Asclemed 1 ml — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0185-01 Asclemed 1 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7092-01 Medical 1 vial — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 71872-7153-01 Medical 1 vial — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0555-01 Asclemed 1 ml — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76045-0106-10 Fresenius 1 syringe — AP Discontinued —
Dexamethasone Sodium Phosphate 4 mg/mL 76420-0396-01 Asclemed 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 50090-1922-00 A-S 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 55150-0237-01 Eugia 25 vials — — FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 68083-0473-25 Gland 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70518-3724-00 REMEDYREPACK 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 76045-0210-10 Fresenius 1 syringe — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70069-0022-25 Somerset 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70121-1450-05 Amneal 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 70518-4372-00 REMEDYREPACK 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 85766-0215-25 Sportpharm 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 85766-0217-25 Sportpharm 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 85766-0216-25 Sportpharm 25 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 87063-0289-10 ASCLEMED 10 vials — AP FDA listed —
Dexamethasone Sodium Phosphate 4 mg/mL 87063-0290-25 ASCLEMED 25 vials — AP 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

🏛️
2011
On the market since
May 2011
📍
2026
Currently FDA-listed
15 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 Dexamethasone Sodium Phosphate — the program that covers self-administered drugs. 11 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 Sodium Phosphate. 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
$780.5K
Claims incl. refills
22.5K
Beneficiaries
17.3K
Spend / beneficiary
$45.01
Spend / claim
$34.65
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 SODIUM PHOSPHATE — the ingredient across all brands.

Top reported reactions

Nausea604
Pyrexia604
Anaemia495
Diarrhoea470
Platelet Count Decreased447
Myelosuppression440
Neutrophil Count Decreased439

Age at onset

Neonate15
Infant10
Child75
Adolescent40
Adult1,370
Elderly1,101

Reporter sex

0 reports
Male · 50%
Female · 49%
Unknown · 0%

Serious outcomes

Hospitalization4,574
Death1,762
Life-threatening1,212
Disabling361
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,299 452
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
71872-7157-01 You're viewing this 1 VIAL in 1 BAG (71872-7157-1) / 5 mL in 1 VIAL 2019-03-11 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 71872-7157-1, 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: 71872-7157-01, written without dashes as 71872715701. 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 71872-7157-01, the first segment (71872) is the labeler code FDA assigned to Medical Purchasing Solutions, LLC; the middle segment (7157) 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 Medical Purchasing Solutions, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Medical Purchasing Solutions, 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 💬 Information for Patients
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE A. By intravenous or intramuscular injection when oral therapy is not feasible: 1. Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance).

Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.

Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer.

2. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Post-traumatic osteoarthritis. Synovitis of osteoarthritis.

Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis.

Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis.

Ankylosing spondylitis. 3. Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus.

Acute rheumatic carditis. 4. Dermatologic Diseases: Pemphigus.

Severe erythema multiforme. (Stevens-Johnson Syndrome) Exfoliative dermatitis. Bullous dermatitis herpetiformis.

Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides.

5. Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: Bronchial asthma. Contact dermatitis.

Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis.

Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice).

6. Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye, such as: Herpes zoster ophthalmicus. Iritis, iridocyclitis.

Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis.

Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis.

Keratitis. Allergic corneal marginal ulcers. 7.

Gastrointestinal Diseases: To tide the patient over a critical period of the disease in: Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8.

Respiratory Diseases: Symptomatic sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.

Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9.

Hematologic Disorders: Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated). Secondary thrombocytopenia in adults.

Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10.

Neoplastic Diseases: For palliative management of: Leukemias and lymphomas in adults. Acute leukemia of childhood. 11.

Edematous States: To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Miscellaneous: Tuberculosis meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.

Trichinosis with neurologic or myocardial involvement. 13. Diagnostic testing of adrenocortical hyperfunction.

14. Cerebral Edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosur…

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Dexamethasone sodium phosphate injection, USP 4 mg/mL is for intravenous, intramuscular, intra-articular, intralesional and soft tissue injection. Dexamethasone sodium phosphate injection, USP 10 mg/mL is for intravenous or intramuscular use only. Dexamethasone sodium phosphate injection, USP can be given directly from the vial, or it can be added to sodium chloride injection or dextrose injection and administered by intravenous drip.

Solutions used for intravenous administration or further dilution of this product should be preservative-free when used in the neonate, especially the premature infant. When it is mixed with an infusion solution, sterile precautions should be observed. Since infusion solutions generally do not contain preservatives, mixtures should be used within 24 hours.

DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT. A. Intravenous and Intramuscular Injection: The initial dosage of dexamethasone sodium phosphate injection varies from 0.5 to 9 mg a day depending on the disease being treated.

In less severe diseases doses lower than 0.5 mg may suffice, while in severe diseases doses higher than 9 mg may be required. The initial dosage should be maintained or adjusted until the patient's response is satisfactory. If a satisfactory clinical response does not occur after a reasonable period of time, discontinue dexamethasone sodium phosphate injection and transfer the patient to other therapy.

After a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response. Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily.

If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually. When the intravenous route of administration is used, dosage usually should be the same as the oral dosage. In certain overwhelming, acute, life-threatening situations, however, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.

The slower rate of absorption by intramuscular administration should be recognized. Shock There is a tendency in current medical practice to use high (pharmacologic) doses of corticosteroids for the treatment of unresponsive shock. The following dosages of dexamethasone sodium phosphate injection have been suggested by various authors: Author* Dosage Cavanagh1 3 mg/kg of body weight per 24 hours by constant intravenous infusion after an initial intravenous injection of 20 mg Dietzman2 2 to 6 mg/kg of body weight as a single intravenous injection Frank3 40 mg initially followed by repeat intravenous injection every 4 to 6 hours while shock persists Oaks4 40 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock persists Schumer5 1 mg/kg of body weight as a single intravenous injection Administration of high dose corticosteroid therapy should be continued only until the patient's condition has stabilized and usually not longer than 48 to 72 hours.

Although adverse reactions associated with high dose, short term corticosteroid therapy are uncommon, peptic ulceration may occur. Cerebral Edema Dexamethasone sodium phosphate injection is generally administered initially in a dosage of 10 mg intravenously followed by four mg every six hours intramuscularly until the symptoms of cerebral edema subside. Response is usually noted within 12 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 m…

⛔ Contraindications 9 words ▾

CONTRAINDICATIONS Systemic fungal infections. (See WARNINGS regarding amphotericin B)

⚠️ Warnings ~2 min read ▾

WARNINGS Serious Neurologic Adverse Reactions with Epidural Administration Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy.

The safety and effectiveness of epidural administration of corticosteroids has not been established, and corticosteroids are not approved for this use. Because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug. Anaphylactoid and hypersensitivity reactions have been reported for dexamethasone sodium phosphate injection.

(See ADVERSE REACTIONS ). Corticosteroids may exacerbate systemic fungal infections and, therefore, should not be used in the presence of such infections unless they are needed to control drug reactions due to amphotericin B. Moreover, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive failure.

In patients on corticosteroid therapy subjected to any unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.

If the patient is receiving steroids already, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. Corticosteroids may mask some signs of infection, and new infections may appear during their use.

There may be decreased resistance and inability to localize infection when corticosteroids are used. Moreover, corticosteroids may affect the nitroblue-tetrazolium test for bacterial infection and produce false negative results. In cerebral malaria, a double-blind trial has shown that the use of corticosteroids is associated with prolongation of coma and a higher incidence of pneumonia and gastrointestinal bleeding.

Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary.

All corticosteroids increase calcium excretion. Administration of live virus vaccines, including smallpox, is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained.

However, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease. Patients who are on drugs which suppress the immune system are…

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Fluid and electrolyte disturbances: Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal: Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Tendon rupture Pathologic fracture of long bones Gastrointestinal: Peptic ulcer with possible subsequent perforation and hemorrhage Perforation of the small and large bowel; particularly in patients with inflammatory bowel disease Pancreatitis Abdominal distention Ulcerative esophagitis Dermatologic: Impaired wound healing Thin fragile skin Petechiae and ecchymoses Erythema Increased sweating May suppress reactions to skin tests Burning or tingling especially in the perineal area (after IV injection) other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema Neurologic: Convulsions Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment Vertigo Headache Psychic disturbances Endocrine: Menstrual irregularities Development of cushingoid state Suppression of growth in children Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness Decreased carbohydrate tolerance Manifestations of latent diabetes mellitus Increased requirements for insulin or oral hypoglycemic agents in diabetics Hirsutism Ophthalmic: Posterior subcapsular cataracts Increased intraocular pressure Glaucoma Exophthalmos Metabolic: Negative nitrogen balance due to protein catabolism Cardiovascular: Myocardial rupture following recent myocardial infarction.

(See WARNINGS ). Other: Anaphylactoid or hypersensitivity reactions Thromboembolism Weight gain Increased appetite Nausea Malaise Hiccups The following additional adverse reactions are related to parenteral corticosteroid therapy: Rare instances of blindness associated with intralesional therapy around the face and head Hyperpigmentation or hypopigmentation Subcutaneous and cutaneous atrophy Sterile abscess Post-injection flare (following intra-articular use) Charcot-like arthropathy

🆘 Overdosage 52 words ▾

OVERDOSAGE Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic. The oral LD50 of dexamethasone in female mice was 6.5 g/kg. The intravenous LD50 of dexamethasone sodium phosphate in female mice was 794 mg/kg.

🧬 Clinical Pharmacology 114 words ▾

CLINICAL PHARMACOLOGY Dexamethasone sodium phosphate injection has a rapid onset but short duration of action when compared with less soluble preparations. Because of this, it is suitable for the treatment of acute disorders responsive to adrenocortical steroid therapy. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.

Their synthetic analogs, including dexamethasone, are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

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 ~1 min read ▾

HOW SUPPLIED Dexamethasone sodium phosphate injection, USP 4 mg/mL is for-intravenous, intramuscular, intra-articular, intralesional and soft tissue administration available as follows: NDC Number Fill volume Pack size 67457-423-12 1 mL Single-Dose Vial 25’s 67457-422-54 5 mL Multi-Dose Vial 25’s 67457-421-30 30 mL Multi-Dose Vial 25’s Dexamethasone sodium phosphate injection, USP 10 mg/mL is for intravenous and intramuscular injection only available as follows: NDC Number Fill volume Pack size 67457-420-10 10 mL Multi-Dose Vial 10’s Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Sensitive to heat. Do not autoclave. Protect from freezing.

REFERENCES Cavanagh, D.; Singh, K. B.: Endotoxin shock in pregnancy and abortion, in: " Corticosteroids in the Treatment of Shock, " Schumer, W.; Nyhus, L. M., Editors, Urbana, University of Illinois Press, 1970, pp.

86–96. Dietzman, R. H.; Ersek, R.

A.; Bloch, J. M.; Lilleher, R. C.: High-output, low-resistance gram-negative septic shock in man, Angiology 20: 691–700, Dec.

1969. Frank, E.: Clinical observations in shock and management (in: Shields, T. F., ed.: Symposium on current concepts and management of shocks), J.

Maine Med. Ass . 59: 195 – 200, Oct.

1968. Oaks, W. W.; Cohen, H.

E.: Endotoxin shock in the geriatric patient, Geriat. 22: 120–130, Mar. 1967.

Schumer, W.; Nyhus, L. M.: Corticosteroid effect on biochemical parameters of human oligemic shock, Arch. Surg.

100: 405–408, Apr. 1970. Manufactured for: Mylan Institutional LLC Rockford, IL 61103 U.S.A.

Made in India DECEMBER 2015

📋 Description ~1 min read ▾

DESCRIPTION Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is a white or slightly yellow, crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. The molecular weight is 516.41.

It is designated chemically as 9-fluoro-11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt. The empirical formula is C 22 H 28 FNa 2 O 8 P and the structural formula is: Dexamethasone sodium phosphate injection, USP is a sterile solution of dexamethasone sodium phosphate, and is supplied in 4 mg/ mL and 10 mg /mL. Dexamethasone sodium phosphate injection, USP 4 mg/mL is a sterile solution for intravenous, intramuscular, intra-articular, intralesional and soft tissue administration.

Each mL contains: Active: Dexamethasone sodium phosphate 4.4 mg (equivalent to dexamethasone phosphate 4 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg. Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL.

Dexamethasone sodium phosphate injection, USP 10 mg/mL is a sterile solution for intravenous or intramuscular use only. Each mL contains: Actives: Dexamethasone sodium phosphate 11 mg (equivalent to dexamethasone phosphate 10 mg). Preservatives: Methylparaben 1.5 mg; Propylparaben 0.2 mg.

Inactives: Edetate Disodium 0.11 mg; Sodium Citrate Anhydrous 10 mg; Citric Acid and/or Sodium Hydroxide q.s to adjust pH 7.0 to 8.5 and Water for Injection q.s to 1 mL. structure

💬 Information for Patients 39 words ▾

Information for Patients Susceptible patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

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