Dexamet

Dexamethasone sodium phosphate.

Colorless, transparent solution in colorless ampoule.
Each ampoule contains: Dexamethasone sodium phosphate (equivalent to Dexamethasone Phosphate), USP 5 mg.

Corticosteroid.

Corticosteroid: For use in certain endocrine and non-endocrine disorders responsive to corticosteroid therapy.
Systemic Administration: Dexamethasone Phosphate (Dexamet) Solution for Injection is recommended for systemic administration by intravenous or intramuscular injection when oral therapy is not feasible or desirable in the following conditions: Endocrine Disorders: Primary or secondary adrenocortical insufficiency (Hydrocortisone or Cortisone is the first choice, but synthetic analogues may be used with mineralocorticoids where applicable and in infancy, mineralocorticoid supplementation is particularly important).
Non-Endocrine Disorders: Dexamethasone Phosphate (Dexamet) solution for injection may be used in the treatment of non-endocrine corticosteroid responsive conditions including: Allergy and anaphylaxis: Angioneurotic edema and anaphylaxis.
Gastro-Intestinal: Crohn's disease and ulcerative colitis.
Infection (with appropriate chemotherapy): Miliary tuberculosis and endotoxic shock.
Neurological disorders: Raised intracranial pressure secondary to cerebral tumors and infantile spasms.
Respiratory: Bronchial asthma and aspiration pneumonitis.
Skin disorders: Toxic epidermal necrolysis.
Shock: Adjunctive treatment where high pharmacological doses are needed. Treatment is an adjunct to and not a substitute for specific and supportive measures the patient may require. Dexamethasone has been shown to be beneficial when used in the early treatment of shock, but it may not influence overall survival.
Local administration: Dexamethasone Phosphate (Dexamet) solution for injection is suitable for intra-articular or soft tissue injection as adjunctive therapy for short-term administration in: Soft tissue disorders such as carpal tunnel syndrome and tenosynovitis. Intra-articular disorders such as rheumatoid arthritis and osteoarthritis with inflammatory components.
Dexamethasone Phosphate (Dexamet) injection may be injected intralesional in selected skin disorders such as cystic acne vulgaris, localized lichen simplex and keloids.

Dexamethasone Phosphate (Dexamet) solution for injection can be given without mixing or dilution, but if preferred, can be added without loss of potency to sodium chloride or dextrose injection and given by intravenous drip. The infusion mixture must be used within 24 hours and the usual aseptic techniques for injections should be observed. Solutions used for intravenous administration or further dilution of this product should be preservative-free when used in the neonate, especially the premature infant.
All dosage recommendations are given in units of Dexamethasone Phosphate.
Intravenous and intramuscular injection: General considerations: Dosage must be individualized on the basis of the disease and the response of the patient. In order to minimize side effects, the lowest possible dosage adequate to control the disease process should be used. Usually, the parenteral dosage ranges are one-third to one-half the oral dose given every 12 hours.
The usual initial dosage is 0.5 mg-20 mg (0.125 mL-5 mL) a day. In situations of less severity, lower doses will generally suffice. However, in certain overwhelming, acute, life-threatening situations, administration in dosages exceeding the usual dosages may be justified. In these circumstances, the slower rate of absorption by intramuscular administration should be recognized.
Both the dose in the evening, which is useful in alleviating morning stiffness, and the divided dosage regimen are associated with greater suppression of the hypothalamic-pituitary-adrenal axis. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial dosage by small amounts at appropriate intervals to the lowest dosage which will maintain an adequate clinical response. Chronic dosage should preferably not exceed 500 micrograms of Dexamethasone daily. Close monitoring of the drug dosage is needed.
To avoid hypoadrenalism and/or a relapse of the underlying disease, it may be necessary to withdraw the drug gradually.
Whenever possible, the intravenous route should be used for the initial dose and for as many subsequent doses as are given while the patient is in shock (because of the irregular rate of absorption of any drug administered by any other route in such patients). When the blood pressure responds, use the intramuscular route until oral therapy can be substituted. For the comfort of the patient, not more than 2 mL should be injected intramuscularly at any one site.
In emergencies, the usual dose of Dexamethasone Phosphate (Dexamet) Injection by intravenous or intramuscular injection is 4 mg-20 mg (1 mL-5 mL) (in shock use only the I.V. route). This dose may be repeated until adequate response is noted.
After initial improvement, single doses of 2 mg-4 mg (0.5 mg-1 mL), repeated as necessary, should be sufficient. The total daily dosage usually need not exceed 80 mg (20 mL), even in severe conditions.
When constant maximal effect is desired, dosage must be repeated at three hour or four-hour intervals or maintained by slow intravenous drip.
Intravenous and intramuscular injections are advised in acute illness. When the acute stage has passed, oral steroid therapy should be substituted as soon as feasible.
Frequency of injection, once every three to five days to once every two to three weeks, depending on response.
Use in children: Dosage should be limited to a single dose on alternate days to lessen retardation of growth and minimize suppression of the hypothalamic-pituitary-adrenal axis.
Use in the Elderly: Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroid in old age, especially osteoporosis, diabetes, hypertension, hypokalemia, susceptibility to infection and thinning of the skin.
Close clinical supervision is required to avoid life threatening reactions.

Reports of acute toxicity and/or deaths following overdosage with glucocorticoids are rare. No antidote is available. Treatment is probably not indicated for reactions due to chronic poisoning, unless the patients have a condition that would render a patient unusually susceptible to ill effects from corticosteroids. In this case, symptomatic treatment should be instituted as necessary.
Anaphylactic and hypersensitivity reactions may be treated with adrenaline, positive pressure artificial respiration and aminophylline. The patient should be kept warm and quiet.
The biological half-life of Dexamethasone in plasma is about 190 minutes.

Systemic fungal infection: Systemic infection unless specific anti-infective therapy is employed; hypersensitivity to sulphites or any other component of this medication. Administration of live virus vaccines.

Effects on Ability to Drive and Use Machines: None reported.

The ability of corticosteroids to cross the placenta vanes between individual drugs, however, Dexamethasone readily crosses the placenta.
Administration of corticosteroid to pregnant animals can cause abnormalities of fetal development including cleft palate, intrauterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as deft palate/lip in man. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential however, patients with normal pregnancies may be treated as though they were in the non-gravid state.
Corticosteroids may pass into breast milk, although no data are available for Dexamethasone. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression.

The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal suppression, correlates with the relative potency of the drug, dosage timing of administration and the duration of treatment.
Fluid and electrolyte disturbances: Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension, increased calcium excretion.
Musculoskeletal: Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis (especially in post-menopausal females), vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathological fracture of long bones, tendon rupture, and post-injection flare (following intra-articular use).
Gastro-intestinal: Peptic ulcer with possible perforation and hemorrhage perforation of the small and the large bowel, particularly in patients with inflammatory bowel disease, pancreatitis, abdominal distension, ulcerative esophagitis, dyspepsia, esophageal candidiasis.
Dermatological: Impaired wound healing, thin fragile skin, petechiae and ecchymoses, erythema, striae, telangiectasia, acne, increased sweating, possible suppression of skin tests, burning or tingling especially in the perennial area (after intravenous injection), other cutaneous reactions such as allergic dermatitis, urticaria, angioneurotic edema and hypo- or hyper-pigmentation.
Neurological: Convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo, headache, psychic disturbances (e.g., euphoria, psychological dependence, depression, insomnia).
Endocrine: Menstrual irregularities, amenorrhea, development of Cushingoid state, suppression of growth in children and adolescents, secondary adrenocortical and pituitary unresponsiveness (particularly in time 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 diabetes, hirsutism.
Anti-inflammatory and immunosuppressive effects: Increased susceptibility and severity of infections with suppression of clinical symptoms and signs. Opportunistic infections, recurrence of dormant tuberculosis.
Ophthalmic: Posterior subcapsular cataracts, increased intra-ocular pressure, papilledema, corneal or scleral thinning, exacerbation or ophthalmic viral disease, glaucoma, exophthalmos, rare instances of blindness associated with intra-lesion therapy around the face and head, retinopathy of prematurity.
Metabolic: Negative nitrogen balance due to protein catabolism. Negative calcium balance.
Cardiovascular: Myocardial rupture following recent myocardial infarction. Hypertrophic cardiomyopathy in low birth-weight infants.
Others: Hypersensitivity, including anaphylaxis has been reported, leukocytosis, thrombo-embolism, weight gain, increased appetite, nausea, malaise, hiccups, a sterile abscess.
Withdrawal symptoms and signs: Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension, and death. In some instances, withdrawal symptoms may stimulate a clinical relapsed of the disease for which the patient has been undergoing treatment.

Aspirin should be used cautiously in conjunction with other corticosteroids in hypoprothrombinemia.
The renal clearance of salicylates is increased by corticosteroid and therefore, salicylate dosage should be reduced along with steroid withdrawal.
As Phenytoin, Barbiturates, Ephedrine, Rifabutin, Carbamazepine, Rifampicin, and Aminoglutethimide may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and reduced physiological activity, the dosage may have to be adjusted. These interactions may interfere with Dexamethasone suppression tests, which should be interpreted with caution during administration of these drugs.
False-negative results in the Dexamethasone suppression test in patients being treated with Indomethacin have been reported.
The efficacy of coumarin anticoagulants may be changed by concurrent corticosteroid treatment. The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time, in order to avoid spontaneous bleeding.
The desired effects of hypoglycemic agents (including insulin) are antagonized by corticosteroids.
When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia.
Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection and produce false-negative results.

Store at temperatures not exceeding 30°C.

Corticosteroid Hormones

H02AB02 - dexamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.

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