Metcort Special Precautions

Immunosuppressive Effects/Increased Susceptibility to Infections: Glucocorticoids (especially in large doses) suppress the inflammatory response and immune function and may increase susceptibility to and/or mask symptoms of infection (viral, bacterial and fungal). It is not known how the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known.
Corticosteroids 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 (at times fatal) and occur more frequently with increasing doses of corticosteroids.
Viral Infections: Viral infections eg, 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 (given within 10 days upon exposure), while prophylaxis with immunoglobulin (IG) may be indicated if exposed to measles. If a diagnosis of chicken pox is confirmed, the illness warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.
Special Pathogens: Corticosteroids may cause activation of latent diseases or exacerbation of intercurrent infections.
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.
Tuberculosis: Use methylprednisolone 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.
The role of corticosteroids in septic shock has been controversial with early studies reporting both beneficial and detrimental effects. Recent studies have shown that supplemental corticosteroids have been beneficial in patients with established septic shock who exhibit adrenal insufficiency. The routine use in septic shock however, is not recommended. A systematic review of short-course high-dose corticosteroids did not support their use. However, a meta-analyses and a review have suggested that longer courses (5-11 days) of low dose corticosteroids may reduce mortality especially in those with vasopressor-dependent septic shock.
Kaposi's sarcoma has been reported in patients receiving corticosteroids. Clinical improvement may be observed upon discontinuation of corticosteroids.
Vaccination: Do not administer live or live attenuated vaccines (including small pox vaccine) in patients receiving corticosteroids. This should be postponed until at least 3 months after stopping corticosteroid therapy. Although killed or inactivated vaccines may be administered in patients on corticosteroids, response to such vaccines cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving non-immunosuppressive doses of corticosteroids.
Hypersensitivity Reactions: Allergic reactions eg, angioedema may occur.
Anaphylactoid reactions (eg, bronchospasm) have occurred rarely in patients receiving parenteral corticosteroid therapy. Prior to methylprednisolone administration, appropriate precautionary measures should be taken especially when the patient has a history of allergy to any drug.
Endocrine Effects: Pharmacologic dose of corticosteroids administered for prolonged periods may result in HPA suppression (secondary adrenocortical insufficiency). Symptoms of adrenal insufficiency include malaise, muscle weakness, mental changes, muscle and joint pain, desquamation of the skin, dyspnea, anorexia, nausea and vomiting, fever, hypoglycemia, hypotension and dehydration. This effect is variable among patients and is dependent on dose and duration of treatment and may be minimized by the use of ADT.
In some cases, withdrawal symptoms may stimulate a clinical relapse of the disease for which the patient has been under treatment and therefore, clinical assessment of disease activity may be important. If the disease is unlikely to relapse on withdrawal of systemic corticosteroids, but there is uncertainty of HPA suppression, the dose of systemic corticosteroids may be reduced rapidly to physiologic doses. Dose reduction should be slower once a daily dose of methylprednisolone 6 mg is reached to allow the HPA-axis to recover.
Acute adrenal insufficiency leading to a fatal outcome may also occur if corticosteroids are abruptly withdrawn. Although abrupt withdrawal of doses up to 32 mg/day methylprednisolone for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression in majority of patients, consider gradual withdrawal of systemic corticosteroid therapy in the following patient groups even after courses lasting ≤3 weeks: Those who have had repeated courses of systemic corticosteroids, particularly if taken for >3 weeks. When a short course has been prescribed within 1 year of discontinuation of long-term therapy (months or years). Those who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy. Moreover, acute adrenal insufficiency leading to a fatal outcome may occur if glucocorticoids are withdrawn abruptly. Those receiving systemic corticosteroid doses of >32 mg daily of methylprednisolone. Those taking doses in the evening repeatedly.
Metabolic clearance of corticosteroids may be altered in hypothyroid (decreased clearance) or hyperthyroid (increased clearance) patients. Patient monitoring based on thyroid status may be necessary for these patients.
Glucocorticoids should be avoided in patients with Cushing's disease since the drug can produce or aggravate Cushing's syndrome.
Cardiovascular-Renal Effects: Use corticosteroids with caution and only if strictly necessary, in cases of congestive heart failure.
Particular care with frequent monitoring is required when considering the use of systemic corticosteroids in the following patients: Patients who have experienced a recent myocardial infarction (myocardial rupture has been reported); with hypertension; predisposed to thrombophlebitis and with renal insufficiency.
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 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.
Metabolism and Nutrition Disorders: Use with caution in patients with or a family history of diabetes mellitus since corticosteroids may cause an increase in blood glucose (steroid-induced diabetes), worsen preexisting diabetes and predispose those on long-term corticosteroid therapy to diabetes.
Gastrointestinal Effects: An increased risk of perforation has been shown in active or latent peptic ulcers, diverticulitis, abscess or other pyogenic infections, fresh intestinal anastomoses and nonspecific ulcerative colitis and therefore, caution in the use of steroids is recommended.
Hepatobiliary Effects: The effect of corticosteroids is enhanced in patients with cirrhosis. Particular care and frequent monitoring may be required when considering the use of systemic corticosteroids in patients with liver failure or cirrhosis.
Musculoskeletal Effects: Acute myopathy which occurs most frequently in patients with disorders of neuromuscular transmission eg, myasthenia gravis or in patients receiving therapy with neuromuscular blocking agents eg, 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 creatine kinase may also be observed. Clinical improvement or recovery after stopping corticosteroid therapy may need weeks to years.
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. Frequent patient monitoring is necessary.
Use corticosteroids with caution in patients with Duchenne's muscular dystrophy. Rhabdomyolysis and myoglobinuria have been reported after these patients have engaged in strenuous activity.
Patients with previous steroid myopathy must also use corticosteroids with caution.
Ophthalmic Effects: Prolonged use of corticosteroids may cause posterior subcapsular and nuclear cataracts (particularly in children), exophthalmos or increased intraocular pressure which may result in glaucoma or may occasionally damage the optic nerve. Development of secondary fungal and viral infections of the eye may be enhanced in patients receiving corticosteroids.
Use corticosteroids with caution in active ocular herpes simplex to avoid corneal scarring, loss of vision and corneal perforation.
Neuropsychiatric Effects: Corticosteroids should be used with caution in patients with seizure disorders or those with myasthenia gravis.
Although corticosteroids have been shown to be effective in speeding the resolution of 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.
Corticosteroids may lead to mental disturbances including euphoria, insomnia, mood swings, anxiety, personality changes and depression to frank psychoses. Corticosteroids may also aggravate emotional instability or psychotic tendencies. Particular care is required when considering the use of corticosteroids in patients with existing or previous history of severe affective disorders. Symptoms of potentially severe psychiatric adverse reactions associated with corticosteroid use typically emerge within a few days or weeks of starting treatment. Psychological effects have also been reported upon corticosteroid withdrawal; frequency is unknown.
Injury: High doses of systemic corticosteroids should not be used for the treatment of traumatic brain injury.
Effects on the Ability to Drive or Operate Machinery: The effect of corticosteroids on the ability to drive or use machinery has not been established. There is no evidence to suggest that methylprednisolone may affect the ability to drive and use machines. No deleterious effect of corticosteroids on driving and operating machinery ability is expected.
Use in pregnancy: Corticosteroids may cause fetal damage (ie, cleft palate, intrauterine growth retardation and adverse effects on brain growth and development) and abortion when administered to pregnant animals. Although there is no evidence that the use of corticosteroids result in an increased incidence of congenital abnormalities eg, cleft palate in man, corticosteroids may increase the risk of intrauterine growth retardation when administered for long periods or repeatedly during pregnancy.
Women who are pregnant or planning on becoming pregnant while receiving corticosteroids should inform their physician. Methylprednisolone should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
Methylprednisolone readily crosses the placenta. Carefully monitor infants born to women who received corticosteroids during pregnancy for symptoms of adrenal insufficiency.
There are no known effects of corticosteroids on labor and delivery.
Use in lactation: Corticosteroids are excreted in breast milk. Corticosteroid distributed into breast milk may suppress growth and interfere with endogenous glucocorticoid production in breastfeeding infants. Methylprednisolone should be administered to a breastfeeding mother only if the potential benefit outweighs the potential risk to the infant.
Use in children: The efficacy and safety of corticosteroids are considered to be similar in adults and children. Long-term administration of corticosteroids should be avoided in infancy, childhood and adolescence since this may cause growth retardation which may be irreversible.
Corticosteroid treatment should be administered where possible as a single dose on alternate days for the shortest possible duration in infants, children and adolescents.
Closely monitor growth and development of infants and children if prolonged therapy is necessary.
There are reports of increased intracranial pressure with papilledema in children (pseudomotor cerebri) usually after treatment withdrawal of methylprednisolone.
Use in the elderly: Methylprednisolone should be used with caution in the elderly especially in the long-term since 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 of concomitant disease or other drug therapy.