Dexamethasone

Dexamethasone - Decadron ®

Usual Diluents

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

Stability / Miscellaneous

Spinal cord compression: 10 to 100mg (usually 10 mg) iv stat; followed by 4 to 24 mg iv q6h. Use larger doses (eg up to 100mg initially) in patients with profound or rapidly progressive neurologic injury, and lower doses in patients with mild or equivocal signs.

DOSAGE AND ADMINISTRATION
Dexamethasone Sodium Phosphate Injection, 4 mg/mL-For intravenous, intramuscular, intra-articular, intralesional and soft tissue injection.

Dexamethasone Sodium Phosphate Injection, 10 mg/mL-For intravenous and intramuscular injection only.

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 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 recognized.

Shock
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:

REFERENCES
*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.

Administration of high dose corticosteroid therapy should be continued only until the patient's 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.

Cerebral Edema
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/mL -First day, 1 or 2 mL (4 or 8 mg) intramuscularly.

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:

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.

HOW SUPPLIED
Dexamethasone Sodium Phosphate Injection, USP is available in the following package:
10 mg/mL
1 mL DOSETTE vials packaged in 25s (NDC 0641-0367-25)

Storage
Protect from light: Keep covered in carton until time of use. Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Avoid freezing. Do not use if solution is hazy or has a precipitate. Do not autoclave.

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Stability
Injection solution: Store at room temperature; protect from light and freezing.
Stability of injection of parenteral admixture at room temperature (25°C): 24 hours.

Stability of injection of parenteral admixture at refrigeration temperature (4°C): 2 days; protect from light and freezing.

Injection should be diluted in 50-100 mL NS or D5W.