Dexamethasone Sodium Phosphates

DEXAMETHASONE SODIUM PHOSPHATES- dexamethasone phosphate injection, solution
Cardinal Health

DESCRIPTION

Dexamethasone Sodium Phosphate Injection, USP is a water-soluble inorganic ester of dexamethasone.

It occurs as a yellow crystalline powder, is odorless or has a slight odor of alcohol, is exceedingly hygroscopic, and is freely soluble in water.

Dexamethasone Sodium Phosphate Injection, USP is a synthetic adrenocortical steroid anti-inflammatory drug.

It has the following structural formula:

Structural Formula

Dexamethasone Sodium Phosphate Injection, USP C22 H28 FNa2 O8 P, has a molecular weight of 516.41 and the chemical name 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-(dihydrogen phosphate) disodium salt.

Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL is a sterile solution for intravenous, intramuscular, intra-articular, intralesional and soft tissue administration.

Each mL of the injection contains the following components:

Dexamethasone Sodium Phosphate
(equivalent to 4 mg of Dexamethasone Phosphate)…4.37 mg
Sodium Sulfite…………………………………………………….1 mg
Benzyl Alcohol…………………………………………………….10 mg
Sodium Citrate…………………………………………………….for isotonicity
Water for Injection………………………………………………..q.s.
pH adjusted between 7 and 8.5 with Citric Acid and/or Sodium Hydroxide.

CLINICAL PHARMACOLOGY

Dexamethasone Sodium Phosphate Injection, USP has a rapid onset but short duration of action when compared with less soluble preparations. Because of this, it is suitable for the treatment of acute disorders responsive to adrenocortical steroid therapy.

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.

INDICATIONS AND USAGE

  1. By intravenous or intramuscular injection when oral therapy is not feasible:
    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
      Keratitis
      Allergic corneal marginal ulcers
    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 antituberculous 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) hypoplasticanemia
    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. Miscellaneous
      Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
      Trichinosis with neurologic or myocardial involvement
    13. Diagnostic testing of adrenocortical hyperfunction
    14. Cerebral Edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy.
  2. By intra-articular or soft tissue injection:
    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.
  3. By intralesional injection:
    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
    May also be useful in cystic tumors of an aponeurosis or tendon (ganglia).

CONTRAINDICATIONS

Systemic fungal infections. (See WARNINGS regarding amphotericin B)

Hypersensitivity to any component of this product, including sulfites (see WARNINGS).

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