Dexamethasone Sodium Phosphate 10 mg/mL Injection, Solution, 25 vials — NDC 72485-118-25 (Billing 72485-0118-25)
This is a package of 25 vials of Dexamethasone Sodium Phosphate 10 mg/mL Injection, Solution from Armas Pharmaceuticals, marketed since Apr 2025 and currently FDA-listed; retail pharmacies pay about $1.16 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 72485-118-25 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 72485 labeler · 118 product · 25 package
- Package marketed since
- Apr 22, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0372485118014
- Medicaid fills, this package
- 1,036 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Dexamethasone Sodium Phosphate (different manufacturers) — 2 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 062053
- GCN: 97837
- GPI-14 (Medi-Span): 22100020202011
- HICL (First Databank): 034381
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 1812079
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It's a steroid that calms inflammation and immune overreaction. Depending on the product, it treats allergic conditions, skin diseases, hormone disorders and eye conditions. Hemady...
- Follow your prescription label exactly. Tablets and liquid are swallowed, and your prescriber sets the amount based on your condition. Please don't stop suddenly after long use, be...
- Increased appetite, weight gain, trouble sleeping, mood swings, nausea and fluid retention are common. Call your doctor for signs of infection, black stools, vision changes, or sev...
- Some medicines interact with it, including certain antifungals, blood thinners, diabetes medicines, aspirin or NSAIDs, and estrogen products. Check with me before adding anything n...
Patient education
Supplement & herbal interactions
Dexamethasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.157 | $28.92 / 25 ml |
| Medicaid paysCMS SDUD · 12 mo | $61.01 | $1,525.18 / 25 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J1100 | $0.085 / J1100 unit | — |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 72485-0118-25 You're viewing this Main listing | 25 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE | 2025-04-22 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dexamethasone Sodium Phosphate 10 mg/mL 70069-0025-10 | Somerset | 10 vials | $0.510 | AP | Availability likely | save 56% |
| Dexamethasone Sodium Phosphate 10 mg/mL 63323-0516-10 | Fresenius | 10 vials | $0.510 | AP | Availability likely | save 56% |
| Dexamethasone Sodium Phosphate 10 mg/mL 67457-0420-10 | Mylan | 10 vials | $0.510 | AP | Availability likely | save 56% |
| Dexamethasone Sodium Phosphate 10 mg/mL 67457-0483-10 | Mylan | 10 vials | $0.510 | AP | Availability likely | save 56% |
| Dexamethasone Sodium Phosphate 10 mg/mL 25021-0053-01 | Sagent | 25 vials | $1.157 | AP | Availability likely | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 55150-0304-25 | Eugia | 25 vials | $1.157 | AP | Availability likely | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 63323-0506-16 | Fresenius | 25 vials | $1.157 | AP | Availability likely | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 70069-0021-25 | Somerset | 25 vials | $1.157 | AP | Availability likely | — |
| Dexamethasone Sodium Phosphate 10 mg/mLthis 72485-0118-25 | Armas | 25 vials | $1.157 | AP | Availability likely | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 00641-0367-25 | Hikma | 25 vials | $1.236 | AP | Availability likely | +7% |
| Dexamethasone Sodium Phosphate 10 mg/mL 72572-0122-25 | Civica, | 25 vials | $1.236 | AP | Availability likely | +7% |
| Dexamethasone sodium phosphate 10 mg/mL 42571-0432-79 | Micro | 25 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 50090-3541-00 | A-S | 25 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 68083-0607-25 | Gland | 25 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 70121-1399-05 | Amneal | 25 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 71872-7091-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 80425-0261-01 | Advanced | 25 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 85766-0071-01 | Sportpharm | 1 ml | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 85766-0186-25 | Sportpharm | 25 vials | — | AP | FDA listed | — |
| Dmt Suik 10 mg/mL 76420-0270-01 | Asclemed | 1 vial | — | — | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 51662-1343-01 | HF | 1 ml | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 71872-7090-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 71872-7205-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 76045-0212-10 | Fresenius | 1 syringe | — | AP | FDA listed | — |
| Dmt Suik 10 mg/mL 80425-0556-01 | Advanced | 1 vial | — | — | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 51662-1391-01 | HF | 10 ml | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 55154-5118-05 | Cardinal | 5 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 70518-0532-01 | REMEDYREPACK | 25 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 76420-0399-10 | Asclemed | 10 vials | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 00404-9842-10 | Henry | 1 vial | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 76045-0109-10 | Fresenius | 1 syringe | — | AP | FDA listed | — |
| Dexamethasone Sodium Phosphate 10 mg/mL 85766-0214-10 | Sportpharm | 10 vials | — | AP | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Armas Pharmaceuticals labeler code 72485
- Verapamil Hydrochloride 10 mg/4mL Injection NDC 72485-109-05
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- Lincomycin 600 mg/2mL Injection, Solution NDC 72485-114-01
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- Nicardipine Hydrochloride 25 mg/10mL Injection NDC 72485-116-10
- Azacitidine 100 mg Injection, Powder, Lyophilized, For Solution NDC 72485-201-01
- Imatinib mesylate 100 mg Tablet, Film Coated NDC 72485-202-90
- Imatinib mesylate 400 mg 400 mg Tablet, Film Coated NDC 72485-203-30
- Capecitabine 150mg 150 mg Tablet, Film Coated NDC 72485-204-60
- Capecitabine 500mg 500 mg Tablet, Film Coated NDC 72485-205-12
- Erlotinib 25 mg Tablet, Film Coated NDC 72485-217-30
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS A. Intravenous or intramuscular administration . When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 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. Allergic corneal marginal ulcers. Keratitis.
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 anti-tuberculosis chemotherapy. Loeffler's syndrome not manageable by other means.
Aspiration pneumonitis. 9. Hematologic disorders: Acquired (autoimmune) hemolytic anemia.
Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. 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.
Nervous system. Acute exacerbations of multiple sclerosis. 13.
Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy. Trichinosis with neurologic or myocard… [Excerpted — this section continues on DailyMed.]
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION A. Intravenous or intramuscular administration. The initial dosage of dexamethasone sodium phosphate injection may vary from 0.50 mg/day to 9 mg/day depending on the specific disease entity being treated.
In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. Usually the parenteral dosage ranges are one-third to one-half the oral dose given every 12 hours. However, in certain overwhelming, acute, life-threatening situations, administration of dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.
For the treatment of unresponsive shock high pharmacologic doses of this product are currently recommended. Reported regimens range from 1 to 6 mg/kg of body weight as a single intravenous injection to 40 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock persists. For the treatment of cerebral edema in adults an initial intravenous dose of 10 mg is recommended followed by 4 mg intramuscularly every six hours until maximum response has been noted.
This regimen may be continued for several days postoperatively in patients requiring brain surgery. Oral dexamethasone, 1 to 3 mg t.i.d., should be given as soon as possible and dosage tapered off over a period of five to seven days. Nonoperative cases may require continuous therapy to remain free of symptoms of increased intracranial pressure.
The smallest effective dose should be used in children, preferably orally. This may approximate 0.2 mg/kg/24 hours in divided doses. In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day or 4 to 8 mg dexamethasone every other day for 1 month have been shown to be effective.
The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, dexamethasone sodium phosphate injection should be discontinued and the patient transferred to other appropriate therapy. 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 which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the 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 later situation it may be necessary to increase the dosage of dexamethasone sodium phosphate injection for a period of time consistent with the patient’s condition. If after a long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. B.
Intra-articular, soft tissue or intralesional administration . The dose for instrasynovial administration is usually 2 to 4 mg for large joints and 0.8 to 1 mg for small joints. For soft tissue and bursal injections a dose of 2 to 4 mg is recommended.
Ganglia require a dose of 1 to 2 mg. A dose of 0.4 to 1 mg is used for injection into tendon sheaths. Injection into intervertebral joints should not be attempted at any time and hip joint injection cannot be recommended as an office procedure.
Intrasynovial and soft tissue injections should be employed only when affected areas are limited to 1 or 2 sites. It should be remembered that corticoids provide palliation only and that other conventional or… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Systemic fungal infections.
⚠️ Warnings ▾
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 have not been established, and corticosteroids are not approved for this use. In patients on corticosteroid therapy subject to any unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. 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.
Immunosuppression and Increased Risk of Infection Corticosteroids, including dexamethasone sodium phosphate injection, 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 sodium phosphate injection withdrawal or dosage reduction as needed. Do not administer dexamethasone sodium phosphate injection by an intraarticular, intrabursal, intratendinous, or intralesional route in the presence of acute local infection.
Tuberculosis If dexamethasone sodium phosphate injection is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of the disease may occur. Closely monitor such patients for reactivation. During prolonged dexamethasone sodium phosphate injection 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 sodium phosphate injection. 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 sodium phosphate injection-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated.
If varicella develops, treatment with antiviral agents may be considered. If a dexamethasone sodium phosphate injection-treated patient is exposed to measles, prophylaxis with immunoglobulin (IG) 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 sodium phosphate injection.
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 sodium phosphate injection. 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 sodium phosphate injection, may exacerbate systemic fungal infections; therefore, avoid dexamethasone sodium phosphate injec… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
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 Pathologic fracture of long bones Gastrointestinal: Peptic ulcer with possible subsequent perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitis Dermatological: Impaired wound healing Thin fragile skin Facial erythema Increased sweating May suppress reactions to skin tests Petechiae and ecchymoses Neurological: Convulsions Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment Vertigo Headache Ophthalmic: Posterior subcapsular cataracts Increased intraocular pressure Glaucoma 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 Metabolic: Negative nitrogen balance due to protein catabolism Miscellaneous: Hyperpigmentation or hypopigmentation Subcutaneous and cutaneous atrophy Sterile abscess Postinjection flare, following intra-articular use Charcot-like arthropathy Itching, burning, tingling in the ano-genital region To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc., at 1-855-839-8195 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Dexamethasone Sodium Phosphate Injection USP, 10 mg/mL (Preservative Free) is supplied as a clear, colorless solution, in a single-dose vials as follows: 1 mL, 25 Single-Dose Vials in a Carton NDC 72485-118-25 This container closure is not made with natural rubber latex. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Sensitive to heat.
Do not autoclave. Protect from freezing. Protect from light.
Store in container until time of use. Discard unused portion. CAUTION: Federal law prohibits dispensing without a prescription.
Manufactured by: Micro Labs Limited INDIA. Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728 (USA) Rev.
10/2024
📋 Description ▾
DESCRIPTION Dexamethasone sodium phosphate injection, USP is a sterile, water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone sodium phosphate, C 22 H 28 FNa 2 O 8 P, has a molecular weight of 516.40 and chemically is Pregna-1,4-diene-3, 20- dione, 9-fluoro-11, 17-dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11β, 16α). It occurs as a white or almost white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 10.5.
It has the following structural formula: Dexamethasone sodium phosphate injection, USP is available in 10 mg/mL concentration. Each mL of dexamethasone sodium phosphate injection USP, 10 mg/mL (Preservative Free) , contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg trisodium citrate, dihydrate for tonicity adjustment; and water for injection, q.s. pH adjusted with citric acid monohydrate or sodium hydroxide, if necessary. pH: 7.4 to 8.2. DexamethasoneFor
⚠️ Precautions ▾
PRECAUTIONS Drug-induced secondary adrenocortical insufficiency 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. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal perforation. The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction must be gradual.
Psychic derangements may appear when corticosteroids are used ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.
Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection, also in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed. Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice.
Intra-articular injection of a corticosteroid may produce systemic as well as local effects. Appropriate examination of any joint fluid present is necessary to exclude a septic process. A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis.
If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted. Local injection of a steroid into a previously infected joint is to be avoided. Corticosteroids should not be injected into unstable joints.
Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See Dosage and Administration Section).
Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.
📄 Package Label / Principal Display Panel ▾
Packaging DexamethasoneSodPhosInj-1