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Brand Name, Dosage Format and Strength
Drenex 3 mg Tablet
Corticosteroid, Recombinant Growth Hormone
WARNINGS AND PRECAUTIONS
Increased corticosteroid dosage is required in patients with adrenal insufficiency who are subjected to stress (e.g., infection, surgery, trauma).
Withdrawal of corticosteroids after prolonged therapy may result in corticosteroid withdrawal syndrome which includes symptoms such as fever, myalgia, arthralgia, and malaise which may occur even in patients without evidence of adrenal insufficiency.
The lowest possible corticosteroid dose should be used to control the condition being treated. Gradual reduction of dosage is recommended whenever possible.
Corticosteroid effects are exaggerated in patients with hypothyroidism and cirrhosis.
Kaposi`s sarcoma has been seen mostly in patients receiving corticosteroids for chronic conditions. Clinical improvement may be observed upon discontinuation of corticosteroids.
Minimize drug-induced secondary adrenocortical insufficiency caused by rapid withdrawal of corticosteroids by gradual reduction of dosage. Since drug-induced adrenocortical insufficiency may persist for months after discontinuation of therapy, reinstitute corticosteroid therapy in any situation of stress occurring during that period. Dosage may have to be increased in patients already receiving corticosteroid therapy. Administer a salt and/or mineralocorticoid concurrently since mineralocorticoid secretion may also be impaired.
Metabolic clearance of corticosteroids may be altered in hypothyroid (decreased clearance) or hyperthyroid (increased clearance) patients. Dosage adjustment based on thyroid status may be necessary for these patients.
Glucocorticoids suppress the immune system and increase susceptibility to or mask symptoms of infection. Corticosteroids may cause decreased resistance and inability to localize infection and may also produce false negative results with nitroblue-tetrazolium test for bacterial infections. Infections caused by any pathogen including viral, bacterial, fungal, protozoan, or helminthic infections in any location of the body may be associated with corticosteroids alone or in combination with other immunosuppressive agents. These infections may be mild to severe and occurs more frequently with increasing doses of corticosteroids.
- Viral Infections: Viral infections such as chicken pox or measles can be more serious or even fatal in non-immunized children or adults on corticosteroids. Patients who have not had these diseases, should take particular care to avoid exposure. Prophylaxis with varicella zoster immune globulin (VZIG) may be indicated if exposed to chicken pox, while prophylaxis with immunoglobulin (IG) may be indicated if exposed to measles. Consider treatment with antiviral agents if chicken pox develops.
- Fungal Infections: Systemic fungal infections may be exacerbated by corticosteroids. Do not use corticosteroids in the presence of such infections unless they are needed to control life-threatening drug reactions. Cardiac enlargement and CHF have been reported with concomitant use of amphotericin B and hydrocortisone.
- Special Pathogens: Corticosteroids may cause activation of latent diseases or exacerbation of intercurrent infections due to pathogens including Candida, Mycobacterium, Amoeba, Toxoplasma, Pneumocystis, Cryptococcus, Nocardia, etc.
As corticosteroids may also activate latent amoebiasis, rule out latent or active amoebiasis before initiating corticosteroid therapy in patients who have spent time in the tropics or with unexplained diarrhea.
In patients with known or suspected Strongyloides (threadworm) infestation, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration which is often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Use corticosteroids with great care in these patients.
Do not use corticosteroids in cerebral malaria since it is associated with prolongation of coma and higher incidence of pneumonia and GI bleeding.
- Tuberculosis: Use dexamethasone in active tuberculosis only in fulminating or disseminated cases in which corticosteroids are used with appropriate antituberculous regimen.
Since reactivity to the disease may occur in patients with latent tuberculosis or tuberculin reactivity, observe these patients closely and administer chemoprophylaxis during prolonged corticosteroid therapy.
Do not administer live or live attenuated vaccines (including small pox vaccine) in patients receiving corticosteroids. Although killed or inactivated vaccines may be administered in patients on corticosteroids, response to such vaccines cannot be predicted.
Patients who are receiving corticosteroids as replacement therapy, e.g., for Addison`s disease, may be immunized.
Prolonged use of corticosteroids may cause posterior subcapsular and nuclear cataracts (particularly in children), exopthalmos, or increased intraocular pressure which may result in glaucoma or may occasionally damage the optic nerve. Monitor intraocular pressure if steroid therapy is continued for more than 6 wks. Development of secondary fungal and viral infections of the eye may be enhanced in patients receiving corticosteroids.
Do not use corticosteroids in active ocular herpes simplex to avoid corneal perforation.
Sodium retention resulting in edema, potassium loss, hypokalemic alkalosis, and HTN may occur in patients receiving glucocorticoids. CHF may occur in susceptible patients. These mineralocorticoid effects occur mostly with average and large doses of hydrocortisone or cortisone and occur less frequently with synthetic corticosteroid s such as dexamethasone. However, these effects may occur when synthetic corticosteroids are used in high dosage for prolonged periods. Dietary salt restriction and potassium supplementation may be advised when necessary. All corticosteroid s increase calcium excretion which may result in hypocalcemia.
Use corticosteroids with caution in patients with HTN, CHF, or renal insufficiency.
Use corticosteroids with caution in patients who have experienced a recent MI since corticosteroid use is associated with left ventricular free wall rupture in these patients.
Acute myopathy which occurs most frequently in patients with disorders of neuromuscular transmission such as myasthenia gravis, or in patients receiving therapy with neuromuscular blocking agents such as pancuronium, has been observed with use of high doses of corticosteroids. Acute myopathy, which may result in quadriparesis, is generalized and may involve ocular and respiratory muscles. Elevation of creatinine kinase may also be observed. Clinical improvement or recovery may need wks to yrs of stopping corticosteroid therapy.
Corticosteroids may lead to mental disturbances including euphoria, mood swings, depression and anxiety, personality changes, and frank psychoses. Corticosteroids may also aggravate emotional instability or psychotic tendencies.
Corticosteroids have been implicated in the development, reactivation, perforation, hemorrhage, and delayed healing of peptic ulcers and should therefore not be used in patients with peptic ulcers except in life-threatening situations.
Use corticosteroids with caution in patients with diverticulitis, recent intestinal anastomoses, or nonspecific ulcerative colitis especially if there is risk of impending perforation, abscess, or other pyogenic infection.
Manifestations of peritoneal irritation following GI perforation may not be seen or is minimal in patients receiving corticosteroids.
Manifestations of protein catabolism which may occur during prolonged corticosteroid therapy include muscle wasting, muscle pain or weakness, delayed wound healing, and atrophy of the protein matrix of the bone resulting to osteoporosis, vertebral compression of fractures, aseptic necrosis of femoral or humeral heads, or pathologic fractures of long bones. These catabolic effects may lead to osteoporosis at any age and inhibition of bone growth in children and adolescents. Since postmenopausal women and geriatric or debilitated patients are especially prone to osteoporosis, special consideration must be given to these patients prior to initiation of corticosteroid therapy.