Each 1ml solution contains 4mg Dexamethasone Phosphate (equivalent to 3.32mg dexamethasone base)
Or each 2ml solution contains 8mg Dexamethasone Phosphate (equivalent to 6.64mg dexamethasone base)
Edetate sodium, Sodium Hydroxide, Propylene glycol, water for injection
Mechanism of action:
Dexamethasone Sodium Phosphate 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.
A- 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. 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.
B. 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.
C. By intralesional injection:
Keloids, Localized hypertrophic, infiltrated, inflammatory lesions of lichen planus, psoriatic plaques, granuloma annulare and lichen simplex chronicus, Discoid lupus erythematosus, Necrobiosis lipoidica diabeticorum, Alopecia areata. May also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
Dosage and administration:
Dexamethasone Sodium Phosphate, 4mg/ml For intravenous, intramuscular, intraarticular, intralesional, and soft tissue injection.
Dexamethasone Sodium Phosphate ampule can be given directly from the ampule, 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 9mg a day depending on the disease being treated. In less severe diseases doses lower than 0.5mg may suffice, while in severe diseases doses higher than 9mg 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 ampule 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.
There is a tendency in current medical practice to use high (pharmacologic) doses of corticosteroids for the treatment of unresponsive shock.
Although adverse reactions associated with high dose, short term corticosteroid therapy are uncommon, peptic ulceration may occur.
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.
Dexamethasone Sodium Phosphate ampule is generally administered initially in a dosage of 10mg 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: first day, 1 or 2ml (4 or 8mg), intramuscularly.
This schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk of overdosage in chronic cases.
Dexamethasone tablets, 0.75mg: 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.
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 6mg. 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 Dexamethasone sodium Phosphate (mg)
Large Joints (e.g., Knee)
2 to 4
Small Joints (e.g., Interphalangeal,Temporomandibular)
0.8 to 1
2 to 3
0.4 to 1
Soft Tissue Infiltration
2 to 6
1 to 2
Dexamethasone Sodium Phosphate ampule 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.
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.
-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, Pathologic fracture of long bones-Tendon rupture.
-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 I.V. 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 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 diabetics, Hirsutism.
-Ophthalmic: Posterior subcapsular cataracts, Increased intraocular pressure, Glaucoma, Exophthalmos.
-Metabolic: Negative nitrogen balance due to protein catabolism.
-Cardiovascular: Myocardial rupture following recent myocardial infarction
-Other: Anaphylactoid or hypersensitivity reactions, Thromboembolism, Weight gain, Increased appetite, Nausea, Malaise, Hiccups.The following additional adverse reactions are related to parenteral corticosteroid therapy: Rare instances of blindness associated with intralesional therapy around the face and head- Hyperpigmentation or hypopigmentation, Subcutaneous and cutaneous atrophy, Sterile abscess, Post injection flare (following intra-articular use), Charcot-like arthropathy.
Systemic fungal infections, Hypersensitivity to any component of this product, including sulfites.
Information for Patients:
Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.
- Serious Neurologic Adverse Reactions with Epidural Administration: Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids has not been established, and corticosteroids are not approved for this use.
- Because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
- Dexamehasone ampule contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
- Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions due to amphotericin B. Moreover, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive failure.
- In patients on corticosteroid therapy subjected to any unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
- Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
- Corticosteroids may mask some signs of infection, and new infections may appear during their use.
There may be decreased resistance and inability to localize infection when corticosteroids are used. Moreover, corticosteroids may affect the nitroblue-tetrazolium test for bacterial infection and produce false negative results.
- Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
- Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
- Administration of live virus vaccines, including smallpox, is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained. However, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.
- Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. However the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.
- The use of Dexamethasone Sodium Phosphate ampule in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur.
Use in pregnancy or lactation:
Since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy or in women of childbearing potential requires that the anticipated benefits be weighed against the possible hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Mothers taking pharmacologic doses of corticosteroids should be advised not to nurse.