Dexamethasone Sodium Phosphate Injection
NDC Package 70069-021-25

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

25 ML

Dexamethasone Sodium Phosphate

Dexamethasone Sodium Phosphate

Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

A.    Intravenous or intramuscular administrationWhen 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 DisordersPrimary 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 hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer2.Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Post-traumatic osteoarthritisSynovitis of osteoarthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).Acute and subacute bursitis EpicondylitisAcute nonspecific tenosynovitisAcute gouty arthritisPsoriatic arthritisAnkylosing spondylitis3. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditis 4. Dermatologic Diseases Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitisBullous dermatitis herpetiformisSevere seborrheic dermatitisSevere psoriasisMycosis fungoides5. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:Bronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessSeasonal or perennial allergic rhinitisDrug hypersensitivity reactionsUrticarial transfusion reactionsAcute noninfectious laryngeal edema (epinephrine is the drug of first choice).6. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye, such as: Herpes zoster ophthalmicusIritis, iridocyclitisChorioretinitisDiffuse posterior uveitis and choroiditis Optic neuritisSympathetic ophthalmiaAnterior segment inflammation Allergic conjunctivitisAllergic corneal marginal ulcersKeratitis 7.  Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in: Ulcerative colitis (systemic therapy)  Regional enteritis (systemic therapy)8.Respiratory Diseases Symptomatic sarcoidosis  BerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculous chemotherapy. Loeffler's syndrome not manageable by other means. Aspiration pneumonitis9. Hematologic DisordersAcquired (autoimmune) hemolytic anemia.  Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated).  Secondary thrombocytopenia in adults  Erythroblastopenia (RBC anemia)  Congenital (erythroid) hypoplastic anemia10. Neoplastic DiseasesFor palliative management of:  Leukemias and lymphomas in adults Acute leukemia of childhood 11. Edematous StatesTo induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.12. Nervous SystemAcute exacerbations of multiple sclerosis13. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement.Diagnostic testing of adrenocortical hyperfunction.Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management.B. Intra-articular or soft tissue administrationWhen the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intra-articular or soft tissue administration are indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Synovitis of osteoarthritis.Rheumatoid arthritis.Acute and subacute bursitis.Acute gouty arthritis.Epicondylitis.Acute nonspecific tenosynovitis.Post-traumatic osteoarthritis.C. Intralesional administrationWhen the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intralesional administration are indicated for:Keloids.Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques,granuloma annulare, and lichen simplex chronicus (neurodermatitis).Discoid lupus erythematosus.Necrobiosis lipoidica diabeticorum.Alopecia areata.They also may be useful in cystic tumors of an aponeurosis tendon (ganglia).

Somerset Therapeutics, Llc

Human Prescription Drug

ANDA207442

ANDA - A product marketed under an approved Abbreviated New Drug Application.

04-19-2018

12-31-2026

N

No