HomeNDC LookupIngredientsDexamethasone › 10135-0795-71
Dexamethasone .5 mg/5mL Elixir, 237 mL — NDC 10135-0795-71 package photo

Dexamethasone .5 mg/5mL Elixir, 237 mL

by Marlex Pharmaceuticals, Inc · 237 mL in 1 BOTTLE, GLASS (10135-795-71)
NDC 10135-0795-71
🏷️ FDA NDC (as labeled) 10135-795-71 billing pads the product 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 →

🆔 Identity & classification

FDA NDC (as labeled) 10135-795-71
Product NDC 10135-795
11-digit billing NDC 10135079571
RxCUI 309686
UNII 7S5I7G3JQL
Application # ANDA084754
SPL Set ID 7b51ffce-ec64-4b49-8870-b9666537c541
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 1976-09-21
Route ORAL
Dosage form ELIXIR
Substance DEXAMETHASONE
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 10135-795-71 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 10135-0795-71. 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

LabelerMarlex Pharmaceuticals, Inc
Application holderKANCHAN HEALTHCARE INC
FDA applicationANDA084754 (ANDA)
Labeler code10135
First marketedSep 1976
Product typeHuman Prescription Drug
Portfolio10 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, a corticosteroid, is similar to a natural hormone produced by your adrenal glands. It often is used to replace this chemical when your body does not make enough of it. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain forms of arthritis; skin, blood, kidney, eye, thyroid, and intestinal disorders (e.g., colitis); severe allergies; and asthma. Dexamethasone is also used to treat certain types of cancer. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

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 →
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.

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 red
FlavorRaspberry
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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 4N14V5R27W
    A natural flavoring derived from raspberry fruit that gives medicines a pleasant taste. It helps mask bitter or unpleasant flavors to make medications easier to swallow.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

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

The official label also statesInactive Ingredients: Artificial raspberry flavor, citric acid, edetate disodium, FD&C Red #40, propylene glycol, purified water, saccharin sodium, sorbitol solution. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular weight is 392.47. 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:

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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 · Q2 2026 $0.0986 $23.37 / 237 ml
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 .5 mg/5mL 62135-0114-37 Chartwell 237 ml $0.101 AA Availability likely
Dexamethasone .5 mg/5mL 64980-0509-24 Rising 237 ml $0.101 AA Availability likely
Dexamethasone .5 mg/5mL 70954-0872-10 ANI 1 bottle $0.101 AA Availability likely
Dexamethasone .5 mg/5mL 85742-0004-03 Kanchan 237 ml $0.101 AA Availability likely
Dexamethasone .5 mg/5mL 00054-3177-57 Hikma 240 ml $0.165 Availability likely
Dexamethasone .5 mg/5mLthis 10135-0795-71 Marlex 237 ml AA FDA listed
Dexamethasone .5 mg/5mL 72162-2600-02 Bryant 237 ml AA FDA listed
Dexamethasone .5 mg/5mL 81033-0010-24 Kesin 20 cups AA 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

🏛️
1976
On the market since
Sep 1976
📍
2026
Currently FDA-listed
50 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 — 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
10135-0795-71 You're viewing this 237 mL in 1 BOTTLE, GLASS (10135-795-71) 1976-09-21 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 10135-795-71, 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: 10135-0795-71, written without dashes as 10135079571. 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 10135-0795-71, the first segment (10135) is the labeler code FDA assigned to Marlex Pharmaceuticals, Inc; the middle segment (0795) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (71) 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 Marlex Pharmaceuticals, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Marlex Pharmaceuticals, Inc 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 ~2 min read

INDICATIONS AND USAGE Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Atopic dermatitis, Bronchial asthma, Contact dermatitis, Drug hypersensitivity reactions, Seasonal or perennial allergic rhinitis, and Serum sickness. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus, and Acute rheumatic carditis. Dermatologic Diseases Bullous dermatitis herpetiformis, Exfoliative dermatitis, Mycosis fungoides, Pemphigus, Severe erythema multiforme (Stevens-Johnson syndrome), Severe psoriasis, and Severe seborrheic dermatitis.

Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids 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: Ulcerative colitis, and Regional enteritis. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults, Secondary thrombocytopenia in adults, Acquired (autoimmune) hemolytic anemia, Erythroblastopenia (RBC anemia), and Congenital (erythroid) hypoplastic anemia. Miscellaneous Diagnostic testing of adrenocortical hyperfunction, Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, and Trichinosis with neurologic or myocardial involvement.

Neoplastic Diseases For palliative management of: Leukemia and lymphomas in adults, and Acute leukemia of childhood. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: Allergic conjunctivitis, Keratitis, Allergic corneal marginal ulcers, Herpes zoster ophthalmicus, Iritis and iridocyclitis, Chorioretinitis, Anterior segment inflammation, Diffuse posterior uveitis and choroiditis, Optic neuritis, and Sympathetic ophthalmia. Respiratory Diseases Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, Berylliosis, Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, and Aspiration pneumonitis.

Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis, Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), Ankylosing spondylitis, Acute and subacute bursitis, Acute nonspecific tenosynovitis, Acute gouty arthritis, Post-traumatic osteoarthritis, Synovitis of osteoarthritis, and Epicondylitis.

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION For oral administration DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT. The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated. In less severe diseases doses lower than 0.75 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 satisfactory clinical response does not occur after a reasonable period of time, discontinue dexamethasone elixir 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.

The following milligram equivalents facilitate changing to dexamethasone elixir from other glucocorticoids: DEXAMETHASONE ELIXIR METHYLPREDNISOLONE AND TRIAMCINOLONE PREDNISOLONE AND PREDNISONE HYDROCORTISONE CORTISONE 0.75 mg = 4 mg = 5 mg = 20 mg = 25 mg 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. Test to distinguish Cushing's syndrome due to pituitary ACTH excess from Cushing's syndrome due to other causes. Give 2 mg of dexamethasone orally every 6 hours for 48 hours.

Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

Contraindications 24 words

CONTRAINDICATIONS Contraindicated in patients with known systemic fungal infections (See WARNINGS: Infections: Fungal Infections ) and patients with a known sensitivity to this drug.

⚠️ Warnings ~2 min read

WARNINGS In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Immunosuppression and Increased Risk of Infection Corticosteroids, including dexamethasone elixir, 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 elixir withdrawal or dosage reduction as needed. Tuberculosis If dexamethasone elixir 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 elixir 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 elixir. In corticosteroid-treated patients who have not had these diseases or are nonimmune, particular care should be taken to avoid exposure to varicella and measles: If a dexamethasone elixir-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 elixir-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 elixir.

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

Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating dexamethasone elixir in patients who have spent time in the tropics or patients with unexplained diarrhea. Strongyloides Infestation Corticosteroids, including dexamethasone elixir, 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 gram-negative septicemia.

Cerebral Malaria Avoid corticosteroids, including dexamethasone elixir, in patients with cerebral malaria. Kaposi’s Sarcoma Kaposi’s sarcoma has been reported to occur in patients receiving corticos…

🤒 Adverse Reactions 211 words

ADVERSE REACTIONS Fluid and Electrolyte Disturbances: Sodium retention, Fluid retention, Congestive heart failure in susceptible patients, Potassium loss, Hypokalemic alkalosis, and Hypertension. Musculoskeletal: Muscle weakness, Steroid myopathy, Loss of muscle mass, Osteoporosis, Vertebral compression fractures, Aseptic necrosis of femoral and humeral heads, Pathologic fracture of long bones, Tendon rupture. Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage, Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease, Pancreatitis, Abdominal distention, and Ulcerative esophagitis.

Dermatologic: Impaired wound healing, Thin fragile skin, Petechiae and ecchymoses, Erythema, Increased sweating, May suppress reactions to skin tests, Other cutaneous reactions, such as allergic dermatitis, urticaria, and angioneurotic edema. Neurologic: Convulsions, Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, Vertigo, Headache, and 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, and Hirsutism.

Ophthalmic: Posterior subcapsular cataracts, Increased intraocular pressure, Glaucoma, and Exophthalmos. Metabolic: Negative nitrogen balance due to protein catabolism Cardiovascular: Myocardial rupture following recent myocardial infarction (see WARNINGS ) Other: Hypersensitivity, Thromboembolism, Weight gain, Increased appetite, Nausea, Malaise, and Hiccups.

🤰 Pregnancy ~1 min read

Usage in Pregnancy: Since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy or in women of childbearing potential requires that the anticipated benefits be weighed against the possible hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects.

Mothers taking pharmacologic doses of corticosteroids should be advised not to nurse. Average and large doses of hydrocortisone or cortisone 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. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.

🆘 Overdosage 40 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 LD 50 of dexamethasone in female mice was 6.5 g/kg.

🧬 Clinical Pharmacology 78 words

CLINICAL PHARMACOLOGY 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 126 words

HOW SUPPLIED Dexamethasone Elixir, 0.5 mg dexamethasone per 5 mL, is a clear pink-red liquid supplied in the following size: 8 fl oz (No Dropper) (237 mL) RECOMMENDED STORAGE Store at 25ºC (77ºF); excursions permitted from 15º to 30º C (59º to 86ºF). [see USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED AVOID FREEZING Dispense in a tight, light-resistant container as defined in the USP. To report SUSPECTED ADVERSE REACTIONS, contact Marlex Pharmaceuticals, Inc. at 1-800-582-1953 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Rx Only Manufactured by: AptaPharma Inc.

1533 Union Avenue, Pennsauken, NJ 08110, USA Manufactured for: Kanchan Healthcare Inc. Suite No. 202; 1 Gatehall Drive Parsippany, NJ 07054 USA Distributed by: Marlex Pharmaceuticals, Inc.

65 Lukens Drive, New Castle, DE 19720, USA Revised 02/2025

📦 Storage and Handling 99 words

RECOMMENDED STORAGE Store at 25ºC (77ºF); excursions permitted from 15º to 30º C (59º to 86ºF). [see USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED AVOID FREEZING Dispense in a tight, light-resistant container as defined in the USP. To report SUSPECTED ADVERSE REACTIONS, contact Marlex Pharmaceuticals, Inc. at 1-800-582-1953 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Rx Only Manufactured by: AptaPharma Inc.

1533 Union Avenue, Pennsauken, NJ 08110, USA Manufactured for: Kanchan Healthcare Inc. Suite No. 202; 1 Gatehall Drive Parsippany, NJ 07054 USA Distributed by: Marlex Pharmaceuticals, Inc.

65 Lukens Drive, New Castle, DE 19720, USA Revised 02/2025

🧪 Inactive Ingredients 90 words

Inactive Ingredients: Artificial raspberry flavor, citric acid, edetate disodium, FD&C Red #40, propylene glycol, purified water, saccharin sodium, sorbitol solution. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder.

It is stable in air. It is practically insoluble in water. The molecular weight is 392.47.

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: structural formula

📋 Description 109 words

DESCRIPTION Each 5 mL (teaspoonful) contains: Dexamethasone, USP……………………………………0.5 mg Also Contains: Benzoic Acid, USP………………………………………. .0.1% (as a preservative) Alcohol………………………………………………………5% Inactive Ingredients: Artificial raspberry flavor, citric acid, edetate disodium, FD&C Red #40, propylene glycol, purified water, saccharin sodium, sorbitol solution. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder.

It is stable in air. It is practically insoluble in water. The molecular weight is 392.47.

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: structural formula

💬 Information for Patients 38 words

Information for Patients Persons 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 ↗
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.