Pharmacort Special Precautions

General: Anaphylactoid reactions have occurred rarely in patients receiving corticosteroid therapy.
The lowest effective corticosteroid dose should be used to control the condition being treated. Gradual reduction of dosage is recommended whenever possible.
Complications of corticosteroid treatment are highly variable between patients as are durations of treatment. Dose and duration of treatment should be individually determined based on assessment of risk/benefit.
Kaposi's sarcoma has been seen mostly in patients receiving corticosteroids for chronic conditions. Clinical improvement may be observed upon discontinuation of corticosteroids.
Abrupt withdrawal of corticosteroids after prolonged therapy may result in corticosteroid withdrawal syndrome with symptoms such as fever, myalgia, arthralgia, and malaise.
Although recent studies have not been conducted with hydrocortisone or other­ corticosteroids, studies of methylprednisolone in septic shock suggest that increased mortality may occur in some subgroups of patients at higher risk (i.e., elevated creatinine­ greater than 2 mg/dL or with secondary infections).
Injection site reactions: Infection with hydrocortisone may result in demand and/or subdermal changes forming depression in the skin at the infection site. Care must be taken not be exceed the recommended doses in order to minimize the incidence of dermal and subdermal atrophy.
Cardio-Renal: Sodium retention resulting in edema, potassium loss, hypokalemic alkalosis, and hypertension may occur in patients receiving glucocorticoids. Congestive heart failure 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 corticosteroids. 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 corticosteroids increase calcium excretion which may result in hypocalcemia.
Use corticosteroid with caution in patients with hypertension, congestive heart failure, or renal insufficiency.
Use corticosteroid with caution in patients who have experienced a recent myocardial infarction since corticosteroid use is associated with ventricular free wall rupture in these patients.
Endocrine: Acute adrenal insufficiency may occur if corticosteroids are abruptly withdrawn since hypothalam1c-p1tu1tary adrenal (HPA) suppression 1s dependent on dose and duration of treatment. In some cases, withdrawal symptoms may stimulate a clinical relapse of the
disease for which the patient has been under treatment and therefore withdrawal of corticosteroids should be gradual.
Withdraw corticosteroids gradually following long-term (more than 3 weeks) use to minimize drug-induced secondary adrenocortical insufficiency. Since drug-induced adrenocortical insufficiency may persist for months after discontinuation of therapy, reinstitute hormone 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.
Use with caution in patients with diabetes mellitus since corticosteroids may cause an increase in blood sugar or steroid-induced diabetes. This usually resolves when the steroid is discontinued.
Gastrointestinal: An increase risk of perforation has been shown in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and non specific ulcerative colitis and therefore caution in the use of steroids is recommended. Manifestations of peritoneal irritation following gastrointestinal perforation may not be seen or is minimal in patients receiving corticosteroids.
Musculoskeletal: Hydrocortisone's effect in calcium regulation and its capacity to inhibit osteoblast formation may cause a decrease in bone formation and an increase in bone resorption. 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.
Vaccination: 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.
Infections: Glucocorticoids (especially in large doses) suppress the immune system and increase susceptibility to or mask symptoms of infection. Corticosteroid may cause decreased resistance and inability to localize infection. 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 occur more frequently with increasing doses of corticosteroid.
If corticosteroid have to be used in the presence of fungal or bacterial infections, administer appropriate anti-infective therapy.
Viral Infections: Viral infections such us chicken pox or measles can be more serious or even fatal in non-immunized children or adults on corticosteroid. Patients who have not had these diseases should particularly 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 congestive heart failure 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 intent 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 dissemination with widespread larval migration which is often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Use with great care in these patients.
Do not use corticosteroid in cerebral malaria.
Tuberculosis: Use hydrocortisone 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 lalent tuberculosis or tuberculin reactivity, observe these patients closely and administer chemoprophylaxis during prolonged corticosteroid therapy.
Ophthalmic: Prolonged use or corticosteroid may cause posterior subcapsular and nuclear cataracts (particularly in children), exophthalmus 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 weeks. 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.
Neuro-Psychiatric: Although corticosteroids have shown to be effective in speeding the resolution acute exacerbations of multiple sclerosis, data do not show that corticosteroids affect the ultimate outcome or natural history of the disease. Relatively high doses of corticosteroids are necessary to demonstrate a significant effect.
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 corticosteroid. 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 weeks to years of stopping corticosteroid therapy.
Corticosteroid 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.
Use in children: The efficacy and safety of corticosteroids are considered to be similar in adults and children.
Evidence of efficacy and safety in children for the treatment of nephrotic syndrome (>2 years old), and aggressive lymphomas and leukemias (>1 month old) have been in clinical studies
However, some of these conclusions and other indications for pediatric use of corticosteroid (e.g., severe asthma and wheezing) are based on adequate and well-controlled trials conducted in adults on the assumption that the course of the disease and their pathophysiology are considered to be substantially the same in both populations.
Periodically evaluate height, weight, ocular pressure, and blood pressure of children receiving corticosteroids. As in adults, children should undergo clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.
As much as possible, avoid long-term administration of pharmacologic doses of corticosteroids in children since these drugs may retard bone growth. Closely monitor growth and development of infants and children if prolonged therapy is necessary. Carefully weigh the potential effects on growth against the clinical benefits and the availability of alternative therapy. Minimize the potential effects of corticosteroids on by titrating to the lowest effective dose.
Use in elderly: There have been no clinical studies with sufficient number of patients (65 years old and above) to establish whether elderly patients respond differently from younger population. Although some reports have not seen any difference in responses between the elderly and younger patients, the incidence of corticosteroid-induced side effects may be increased since these patients have a greater frequency of decreased hepatic, renal, or cardiac function, and or concomitant disease or other drug therapy.
Use in pregnancy & lactation: During pregnancy the clinical benefit and possible risks of corticosteroid treatment should be considered.
Adverse effect is proven in animal experiments. Sufficient data is not available for a safe application in human pregnancy (possibility of cleft-palate formation and foetus growth retardation are low). Signs of hypo-adrenalism should be monitored in case of newborn whose mother has received corticosteroid treatment during pregnancy. In such case signs are observed, the appropriate treatment should be applied.
Prednisolone, is proven to be excreted in mother milk, which is most probably the case for other corticosteroids as well.
No data is available for hydrocortisone sodium succinate.
The benefit/risk ratio should be considered carefully, when treatment is to be applied during pregnancy and lactation and in case women in conceptive age.
Corticosteroids delay growth during infancy, childhood and adolescence. Treatment should be applied for the shortest possible time and for the most severe indications only.