Nuvista Pharma Ltd
Roxadex is indicated for Ulcerative colitis, Rheumatoid arthritis, Multiple sclerosis, Nausea and vomiting, Multiple myeloma, Cerebral oedema, Shock, Inflammatory joint diseases, Idiopathic thrombocytopenic purpura, Dental surgery, Allergic anaphylactic shock, Brain tumors, Status asthmaticus
Precautions and warnings
This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial.
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 enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis.
Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal perforation.
The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction must be gradual.
Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.
Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess, or other pyogenic infection, also in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis.
When large doses are given, some authorities advise that antacids be administered between meals to help to prevent peptic ulcer.
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed.
Steroids may increase or decrease motility and number of spermatozoa in some patients.
Phenytoin, phenobarbital, ephedrine, and rifampin 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.
When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia.
Intra-articular injection of a corticosteroid may produce systemic as well as local effects.
Fluid and electrolyte disturbances:
Congestive heart failure in susceptible patients
Loss of muscle mass
Pathologic fracture of long bones
Vertebral compression fractures
Aseptic necrosis of femoral and humeral heads
Peptic ulcer with possible subsequent perforation and hemorrhage
Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease
Impaired wound healing
Thin fragile skin
Petechiae and ecchymoses
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
Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment
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
Posterior subcapsular cataracts
Increased intraocular pressure
Negative nitrogen balance due to protein catabolism
Myocardial rupture following recent myocardial infarction.
Anaphylactoid or hypersensitivity reactions
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
Post-injection flare (following intra-articular use)
Increased risk of hypokalaemia when used concurrently with potassium-depleting drugs such as amphotericin B and loop diuretics. Reduces efficacy of isoniazid, salicylates, vaccines and toxoids. Increased activity of dexamethasone and cyclosporin when used together. Concurrent use with aspirin or ethanol may lead to increased GI side effects.
Potentially Fatal: Reduced efficacy in combination with ephedrine, cholestyramine, phenytoin, phenobarbital and rifampicin.
Systemic fungal infections . Hypersensitivity to any component of this product, including sulfites
Mode of actions
Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.
Dosage & Administration
Dexamethasone sodium phosphate injection, â€“ For intravenous, intramuscular, intra-articular, intralesional, and soft tissue injection.
Dexamethasone can be given parenterally at doses of 0.5-20 mg daily, either as a single IV/IM injection or by IV infusion.
Child: 200-500 mcg/kg daily.
Cerebral oedema: 10 mg IV initially, then 4 mg IM every 6 hours as required for 2-10 days. Large IV doses should be given slowly to reduce the possibility of cardiovascular collapse.
Shock: By intravenous or intramascular injection or infusion 2-6 mg/kg, repeated if necessary after 2-6 hours. The total daily intake of Dexamethasone, even in acute conditions should not exceed 80 mg except in certain very special circumstances.
Pregnancy & Lactation
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks