DEXAMETHASONE SODIUM PHOSPHATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

DEXAMETHASONE SODIUM PHOSPHATE

Composition:

DEXAMETHASONE PHOSPHATE 4 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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 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 administration. When 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 administration. When 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). Systemic fungal infections.

Product summary:

Dexamethasone Sodium Phosphate Injection, USP is available in the following package: 4 mg/mL 1 mL vials packaged in 25s (NDC 0641-6145-25) 5 mL vials packaged in 10s (NDC 0641-6146-10) 10 mg/mL 1 mL vials packaged in 25s (NDC 0641-0367-25) Protect from light: Keep covered in carton until time of use. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid freezing. Do not use if solution is hazy or has a precipitate. Do not autoclave. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 USA Revised February 2024 462-331-08

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP
RX ONLY
DESCRIPTION
Dexamethasone sodium phosphate injection, USP is a water-soluble
inorganic ester of
dexamethasone which produces a rapid response even when injected
intramuscularly.
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 molecular formula is: C
H
FNa O P and the structural formula is:
Dexamethasone Sodium Phosphate Injection is a sterile solution of
dexamethasone
sodium phosphate for intravenous and intramuscular use. The 4 mg/mL
strength may
also be used for intra-articular, intralesional and soft tissue
administration.
Each mL of Dexamethasone Sodium Phosphate Injection 4 mg/mL contains
dexamethasone sodium phosphate, equivalent to 4 mg dexamethasone
phosphate or
3.33 mg dexamethasone. Inactive ingredients per mL: 1 mg sodium
sulfite anhydrous,
19.4 mg sodium citrate anhydrous and 10.42 mg (0.01 mL) benzyl alcohol
(preservative) in Water for Injection.
Each mL of Dexamethasone Sodium Phosphate Injection 10 mg/mL contains
dexamethasone sodium phosphate, equivalent to 10 mg dexamethasone
phosphate or
8.33 mg dexamethasone. Inactive ingredients per mL: 1.5 mg sodium
sulfite anhydrous,
16.5 mg sodium citrate anhydrous and 10.42 mg (0.01 mL) benzyl alcohol
22
28
2
8
(preservative) in Water for Injection.
The pH of both concentrations is 7.0-8.5; sodium hydroxide and/or
citric acid used, if
needed, for pH adjustment. Sealed under nitrogen.
ACTIONS
Naturally occurring glucocorticoids (hydrocortisone), which also have
salt-retaining
properties, are used as replacement therapy in adrenocortical
deficiency states. Their
synthetic analogs are primarily used