DOSAGE AND ADMINISTRATION
Dexamethasone sodium phosphate injection, 4 mg per mL– For intravenous, intramuscular, intraarticular,
intralesional, and soft tissue injection.
Dexamethasone sodium phosphate injection 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 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If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn
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 recognized.
There is a tendency in current medical practice to use high (pharmacologic) doses of corticosteroids
for the treatment of unresponsive shock. The following dosages of dexamethasone sodium phosphate
injection have been suggested by various authors:
||3 mg/kg of body weight per 24 hours by constant intravenous infusion after an initial
intravenous injection of 20 mg
||2 to 6 mg/kg of bodyweight as a single intravenous injection
||40 mg initially followed by repeat
intravenous injection every 4 to 6 hours while shock persists
||40 mg initially followed by repeat
intravenous injection every 2 to 6 hours while shock persists
||1 mg/kg of body weight as a single intravenous injection
Administration of high dose corticosteroid therapy should be continued only until the patients condition
has stabilized and usually not longer than 48 to 72 hours.
Although adverse reactions associated with high dose, short term corticosteroid therapy are
uncommon, peptic ulceration may occur.
Dexamethasone sodium phosphate injection is generally administered initially in a dosage of 10 mg
intravenously followed by four mg every six hours intramuscularly until the symptoms of cerebral
edema subside. Response is usually noted within 12 to 24 hours and dosage may be reduced after two to
four days and gradually discontinued over a period of five to seven days. For palliative management of
patients with recurrent or inoperable brain tumors, maintenance therapy with two mg two or three times a
day may be effective.
Acute Allergic Disorders
In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, the
following dosage schedule combining parenteral and oral therapy is suggested:
Dexamethasone sodium phosphate injection, 4 mg per mL: first day, 1 or 2 mL (4 or 8 mg),
Dexamethasone tablets, 0.75 mg: second and third days, 4 tablets in two divided doses each day; fourth
day, 2 tablets in two divided doses; fifth and sixth days, 1 tablet each day; seventh day, no treatment;
eighth day, follow-up visit.
This schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk
of overdosage in chronic cases.
Intra-Articular, Intralesional And Soft Tissue Injection
Intra-articular, intralesional, and soft tissue injections are generally employed when the affected joints
or areas are limited to one or two sites. Dosage and frequency of injection varies depending on the
condition and the site of injection. The usual dose is from 0.2 to 6 mg. The frequency usually ranges
from once every three to five days to once every two to three weeks. Frequent intra-articular injection
may result in damage to joint tissues.
Some of the usual single doses are:
|Site of Injection
||Amount of Dexamethas one Phosphate (mg)
|2 to 4
|0.8 to 1
||2 to 3
||0.4 to 1
|Soft Tissue Infiltration
||2 to 6
||1 to 2
Dexamethasone sodium phosphate injection is particularly recommended for use in conjunction with one
of the less soluble, longer-acting steroids for intra-articular and soft tissue injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
administration, whenever the solution and container permit.
||Dexamethasone Sodium Phosphate Injection, USP (equivalent to 4 mg per mL
dexamethasone phosphate) 1 mL fill, in a 2 mL flip-top vial, packaged in 25.
20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from
freezing. Sensitive to heat. Do not autoclave.
Protect from light. Store container in carton until contents have been used.
Do not use if precipitate is present.
1. Cavanagh, D.; Singh, K.B.: Endotoxin shock in pregnancy and abortion, in: “Corticosteroids in the
Treatment of Shock”, Schumer, W.; Nyhus, L.M., Editors, Urbana, University of Illinois Press,
1970, pp. 86-96.
2. Dietzman, R.H.; Ersek, R.A.; Bloch, J.M.; Lillehei, R.C.: High-output, low-resistance gram-negative
septic shock in man, Angiology 20: 691-700, Dec. 1969.
3. Frank, E.: Clinical observations in shock and management (In: Shields, T.F., ed.: Symposium on
current concepts and management of shock), J. Maine Med. Ass. 59: 195-200, Oct. 1968.
4. Oaks, W. W.; Cohen, H.E.: Endotoxin shock in the geriatric patient, Geriat. 22: 120-130, Mar. 1967.
5. Schumer, W.; Nyhus, L.M.: Corticosteroid effect on biochemical parameters of human oligemic
shock, Arch. Surg. 100: 405-408, Apr. 1970.
Manufactured: Hospira, Inc., Lake Forest, IL 60045 USA. Revised: Nov 2017