Dexamethasone Sodium Phosphate

DEXAMETHASONE SODIUM PHOSPHATE — dexamethasone sodium phosphate injection, solution
Fresenius Kabi USA, LLC

Dexamethasone Sodium Phosphate Injection, USP

For Intramuscular or Intravenous Use Only

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, USP chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α).

It occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula:

Structural Formula
(click image for full-size original)

Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.

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 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.

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 (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. 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).

CONTRAINDICATIONS

Systemic fungal infections.

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. 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.

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.

Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. In such children or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

Similarly, corticosteroids 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.

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