Tablet: Each tablet contains Dexamethasone 0.5 mg.
Elixir: Each 5 ml contains Dexamethasone 0.5 mg.
Preservative: Sodium Benzoate 4.27 mg.
Pharmacology: Dexamethasone has the capacity to prevent or suppress the development of the local heat, redness, swelling and tenderness by which inflammation is recognized at the gross level of observation. At the microscopic level, they inhibit not only the early phenomena of the inflammatory process (edema, fibrin deposition, capillary dilatation, migration of phagocytes into the inflamed area, and phagocytic activity) but also the later manifestations (capillary proliferation, fibroblast proliferation, deposition of collagen and still later cicatrization). Naturally occurring glucocorticoids 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. It is among the most potent glucocorticoids, having about 25-30 times the anti-inflammatory activity of hydrocortisone. In contrast, its effect on electrolytes is slight.
Pharmacokinetics: Dexamethasone is effective when given by mouth and is absorbed from the gastrointestinal tract.The steroid exist in plasma in two forms: a protein bound form and a free form. The binding is accounted for by two protein fractions. One, corticosteroid-binding globulin is a glyco-protein and the other is plasma albumin. The globulin has high affinity but low total binding capacity; the albumin has low affinity but relatively large binding capacity. Consequently, at low or normal concentration of corticosteroids most of the hormone is bound to globulin. When the amount of corticosteroid is increased, concentration of both free and albumin-bound steroid increase with little change in the concentration of that bound to the globulin.
Tablet: It is indicated for primary or secondary adrenocortical insufficiency, rheumatic disorders, collagen diseases (systemic lupus erythematosus), dermatologic diseases (pemphigus, severe psoriasis, severe seborrheic dermatitis), bronchial asthma, ophthalmic diseases (eye inflammation, herpes zoster ophthalmicus, allergic conjunctivitis), hematologic disorders, neoplastic diseases (leukemias), edematous states and gastrointestinal diseases (ulcerative colitis).
Elixir: It is indicated in endocrine disorders, rheumatic disorder, collagen diseases, dermatologic diseases, allergic states, ophthalmic diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states and gastrointestinal diseases.
Tablet: The initial dosage varies from 0.75 to 9mg a day depending on the disease being treated. In less severe diseases, doses lower than 0.75mg may suffice, while in severe diseases, doses higher than 9mg may be required.
Elixir: 5ml to 90 ml daily in divided doses.
Dosage requirements are variable and must be individualized on the basis of the disease and the response of the patient.
Method of administration: Oral administration.
The toxic effects of overdosage should be treated symptomatically and dosages reduced or the drug slowly withdrawn. Sodium intake need to be reduced to less than 1g daily and potassium supplements may be necessary.
Systemic fungal infections.
Hypersensitivity to this product.
Administration of live virus vaccinations.
It should be used with caution in congestive heart failure, diabetes mellitus, chronic renal failure, hypertension, recent intestinal anastomoses, infectious diseases, myasthenia gravis, ocular herpes simplex, pregnancy and the elderly. Patients are warned to avoid exposure to chicken pox or measles. Patients with quiescent tuberculosis should be observed closely and should receive chemoprophylaxis if corticosteroid therapy is prolonged. Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. Prolonged use of corticosteroids may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves, and may enchance the establishment of secondary ocular infections due to fungi or viruses. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia and malaise. This may occur in patients even without evidence of adrenal insufficiency. There is an enchanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis.
Since 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.
Adverse reactions include fluid and electrolyte disturbance, muscle weakness, osteoporosis acute pancreatitis, cushingoid state, growth retardation, menstrual irregularities, increased intraocular pressure, visual disturbances, manifestations of latent diabetes mellitus, peptic ulcer with possible perforation and hemorrhage, impaired wound healing, convulsion and increased intracranial pressure with papilledema.
Elixir: Side effects include fluid and electrolyte disturbances, muscle weakness, edema, hypertension, osteoporosis, acute pancreatitis, amenorrhea, Cushingoid state, growth retardation, mental disturbances, increased intraocular pressure, visual disturbances, local atrophy and increased appetite.
Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. Phenytoin, phenobarbital, ephedrine and rifampicin may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests which should be interpreted with caution during administration of these drugs.
The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. It has been shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins.
When corticosteroids are administered concomitantly with potassium depleting diuretics, patients should be observed closely for development of hypokalaemia. Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweights the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic costicosteroid side-effects.
Store at temperature 25°C. Protect from light.
Shelf-Life: Tablet: 3 years.
Elixir: 1.5 years.
H02AB02 - dexamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Tab 0.5 mg (round, white, flat, plain with "S.W." debossed on one side only) x 10 x 10 x 10's. Elixir 0.5 mg/5 mL (clear, yellow with pineapple flavour) x 120 mL x 50's.