Dexamethasone Sodium Phosphate: Package Insert and Label Information (Page 2 of 2)

ADVERSE REACTIONS

Fluid and electrolyte disturbances:

Sodium retention

Fluid retention

Congestive heart failure in susceptible patients

Potassium loss

Hypokalemic alkalosis

Hypertension

Musculoskeletal:

Muscle weakness

Steroid myopathy

Loss of muscle mass

Osteoporosis

Vertebral compression fractures

Aseptic necrosis of femoral and humeral heads

Tendon rupture

Pathologic fracture of long bones

Gastrointestinal:

Peptic ulcer with possible subsequent perforation and hemorrhage

Perforation of the small and large bowel; particularly in patients with inflammatory

bowel disease

Pancreatitis

Abdominal distention

Ulcerative esophagitis

Dermatologic:

Impaired wound healing

Thin fragile skin

Petechiae and ecchymoses

Erythema

Increased sweating

May suppress reactions to skin tests

Burning or tingling, especially in the perineal area (after IV injection)

Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema

Neurologic:

Convulsions

Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after

treatment

Vertigo

Headache

Psychic disturbances

Endocrine:

Menstrual irregularities

Development of cushingoid state

Suppression of growth in pediatric patients

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 diabetics

Hirsutism

Ophthalmic:

Posterior subcapsular cataracts

Increased intraocular pressure

Glaucoma

Exophthalmos

Retinopathy of prematurity

Metabolic:

Negative nitrogen balance due to protein catabolism

Cardiovascular:

Myocardial rupture following recent myocardial infarction (see WARNINGS)

Hypertrophic cardiomyopathy in low birth weight infants

Other:

Anaphylactoid or hypersensitivity reactions

Thromboembolism

Weight gain

Increased appetite

Nausea

Malaise

Hiccups

The following additional adverse reactions are related to parenteral corticosteroid therapy:

Hyperpigmentation or hypopigmentation

Subcutaneous and cutaneous atrophy

Sterile abscess

Charcot-like arthropathy

OVERDOSAGE

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 LD 50 of dexamethasone in female mice was 6.5 g/kg. The intravenous LD 50 of dexamethasone sodium phosphate in female mice was 794 mg/kg.

DOSAGE AND ADMINISTRATION

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:

Author

Dosage

Cavanagh 1

3 mg/kg of body weight per 24 hours by constant intravenous infusion after an initial intravenous injection of 20 mg


Dietzman 2

2 to 6 mg/kg of body weight as a single intravenous injection


Frank 3

40 mg initially followed by repeat intravenous injection every 4 to 6 hours while shock persists


Oaks 4

40 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock persists


Schumer 5

1 mg/kg of body weight as a single intravenous injection

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 2 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, first day , 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

HOW SUPPLIED

Product: 50090-4567

NDC: 50090-4567-0 10 mL in a VIAL

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.; Lilleheir, 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.

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45955E

Revised: May 2014

DEXAMETHASONE SODIUM PHOSPHATE

Label ImageLabel Image
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4567(NDC:63323-516)
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE) DEXAMETHASONE PHOSPHATE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE, UNSPECIFIED FORM 13.5 mg in 1 mL
BENZYL ALCOHOL 10 mg in 1 mL
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4567-0 10 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040572 04/05/2005
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4567), REPACK (50090-4567)

Revised: 10/2019 A-S Medication Solutions

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