Penodex Special Precautions

Undesirable effects may be minimized by using lowest effective dose for the minimum period. Frequent patient review is required to appropriately titrate the dose against disease activity. Where reduction in dosage is possible, the reduction should be gradual. (see Dosage & Administration)
Corticosteroids may exacerbate systemic fungal infections and therefore, should not be used in the presence of such infections unless they are needed to control drug reactions due to amphotericin.
Moreover, there have been cases reported in which concomitant use of amphotericin and hydrocortisone was followed by cardiac enlargement and congestive failure.
Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, retention of salt and water, and increased excretion of potassium, but these effects are less likely to occur with synthetic derivatives, except when in large dose. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
Administration of live virus vaccines is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained, however, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g. for Addison's disease.
Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction, therefore, therapy with corticosteroids should be used with great caution in these patients. The use of Dexamethasone sodium phosphate injection in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculosis regimen. If the corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation may occur. During prolonged corticosteroid therapy, these patients should receive prophylactic chemotherapy. Corticosteroids may mask some signs of infection and new infections may appear during their use.
Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical, and serious infections such as septicemia and tuberculosis may be masked and reach an advanced stage before being recognized. There may be decreased resistance, and inability to localize infection.
A report shows that the use of corticosteroids in cerebral malaria is associated with a prolonged coma and an increased incidence of pneumonia and gastro-intestinal bleeding. Chickenpox is of particular concern, since this normally minor illness may be fatal in immune suppressed patients. Patients (or parents of children) without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster, and if exposed they should seek urgent medical attention. Passive immunization with varicella/zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months, this should be given within 10 days of exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.
Measles can have a more serious or even fatal course in immune suppressed patients. In such children or adults particular care should be taken to avoid exposure to measles. If exposed, prophylaxis with intramuscular pooled immunoglobulin (IG) may be indicated. Exposed patients should be advised to seek medical advice without delay. Corticosteroids may activate latent amoebiasis or strongyloidiasis or exacerbate active disease. Therefore, it is recommended that latent or active amoebiasis and strongyloidiasis be ruled out before initiating corticosteroids therapy in any patient at risk or with symptoms of either condition. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Corticosteroids may increase or decrease motility and number of spermatozoa.
Special precautions: Particular care is required when considering use of systemic corticosteroids in patients with the following conditions, and frequent patient monitoring is necessary; renal insufficiency; hypertension, diabetes or in those with a family history of diabetes, congestive heart failure, osteoporosis, previous steroid myopathy, glaucoma (or family history of glaucoma), myasthenia gravis, non-specific ulcerative colitis, diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer existing or previous history of severe affective disorder (especially previous steroid psychosis), liver failure, and epilepsy. Signs of peritoneal irritation following gastro-intestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent.
Fat embolism has been reported as a possible complication of hypercortisonism.
There is an enhanced effect or corticosteroids in patients with hypothyroidism and in those with cirrhosis.
Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
Local steroid injection should be undertaken in an aseptic environment to reduce the particular risk of bacterial infection. Injection of a steroid into an infected site should be avoided.
Appropriate examination of joint fluid is necessary to exclude a septic process.
A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever and malaise are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted. Patients should understand the great importance of not overusing joints that are still diseased despite symptomatic improvement. Corticosteroids should not be injected into unstable joints.
Frequent intra-articular injections have been reported to cause development of Charcot-like arthropathies.
Use in pregnancy and lactation: There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intra-uterine growth retardation in the fetus; there is evidence of harmful effect on pregnancy in animals. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. When corticosteroids are essential however, patients with normal pregnancies may be treated as though they were in the non-gravid state. Patients with pre-eclampsia or fluid retention require close monitoring. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Mothers taking pharmacological doses of corticosteroids should be advised not to breast-feed.
Children: Corticosteroids cause growth retardation in infancy, childhood and adolescence, which may be irreversible. Treatment should be limited to the minimum dosage for the shortest possible time, in order to minimize suppression of the hypothalamic-pituitary adrenal axis and growth retardation, treatment should be limited, where possible, to a single dose on alternate days.
Growth and development of infants and children or prolonged corticosteroid therapy should be carefully monitored.