Dexamethasone sodium phosphate injection 4mg/ml water-soluble
synthetic adrenocortical steroid anti-inflammatory drug
Each mL of the injection contains the following components:
Dexamethasone Sodium Phosphate
(equivalent to 4 mg of Dexamethasone Phosphate)...4.37 mg
pH adjusted between 7.5 and 10.5 with Citric Acid and/or Sodium
|molecular weight||chemical name|
21-(dihydrogen phosphate) disodium salt|
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 antiinflammatory 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.
Systemic fungal infections. (See WARNINGS regarding amphotericin B)
Hypersensitivity to any component of this product, including
sulfites (see WARNINGS).
Reports of acute toxicity and/or death following overdosage of
glucocorticoids are rare. In the event of overdosage, no specific
antidote is available; treatment is supportive and symptomatic.
The oral LD50 of dexamethasone in female mice was 6.5 g/kg. The
intravenous LD50 of dexamethasone sodium phosphate in female mice
was 794 mg/kg.
Dosage and Administration
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL -- For
intravenous, intramuscular, intra-articular, intralesional, and
soft tissue injection.
Dexamethasone Sodium Phosphate Injection, USP can be given directly
from the vial, or it can be added to Sodium Chloride Injection or
Dextrose Injection and administered by intravenous drip.
Solutions used for intravenous administration or further dilution
of this product should be preservative-free when used in the
neonate, especially the premature infant.
When it is mixed with an infusion solution, sterile precautions
should be observed. Since infusion solutions generally do not
contain preservatives, mixtures should be used within 24 hours.
DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE
BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT.
Intravenous and Intramuscular Injection
The initial dosage of Dexamethasone sodium phosphate injection
varies from 0.5 to 9 mg a day depending on the disease being
treated. In less severe diseases doses lower than 0.5 mg may
suffice, while in severe diseases doses higher than 9 mg may be
required. The initial dosage should be maintained or adjusted until
the patient's response is satisfactory. If a satisfactory clinical
response does not occur after a reasonable period of time,
discontinue Dexamethasone Sodium Phosphate Injection, USP and
transfer the patient to other therapy.
After a favorable initial response, the proper maintenance dosage
should be determined by decreasing the initial dosage in small
amounts to the lowest dosage that maintains an adequate clinical
response. Patients should be observed closely for signs that might
require dosage adjustment, including changes in clinical status
resulting from remissions or exacerbations of the disease,
individual drug responsiveness, and the effect of stress (e.g.,
surgery, infection, trauma). During stress it may be necessary to
increase dosage temporarily. If the drug is to be stopped after
more than a few days of treatment, it usually should be withdrawn
gradually. When the intravenous route of administration is used,
dosage usually should be the same as the oral dosage. In certain
overwhelming, acute, life-threatening situations, however,
administration in dosages exceeding the usual dosages may be
justified and may be in multiples of the oral dosages. The slower
rate of absorption by intramuscular administration should be
|Fluid and electrolyte disturbances||Musculoskeletal||Gastrointestinal||Dermatologic||Neurologic||Endocrine|
Congestive heart failure in susceptible patients
Loss of muscle mass
Vertebral compression fractures
Aseptic necrosis of femoral and humeral heads
Pathologic fracture of long bones Tendon rupture
|Peptic ulcer with possible subsequent perforation and hemorrhage|
Perforation of the small and large bowel, particularly in patients
with inflammatory bowel disease
|Impaired wound healing|
Thin fragile skin
Petechiae and ecchymoses
May suppress reactions to skin tests
Burning or tingling, especially in the perineal area (after I.V.
Other cutaneous reactions, such as allergic dermatitis, urticaria,
Increased intracranial pressure with papilledema (pseudotumor
cerebri) usually after treatment
|Menstrual irregularitiesDevelopment 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