Hycortil Special Precautions

Undesirable effects may be minimized by using the lowest effective dose for the minimum period. Frequent patient review is required to appropriately titrate the dose against disease activity (see Dosage & Administration). Adrenal cortical atrophy develops during prolonged therapy and may persist for months after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must, therefore, always be gradual to avoid acute adrenal insufficiency, being tapered off over weeks or months according to the dose and duration of treatment. During prolonged therapy any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage; if corticosteroids have been stopped following prolonged therapy, they may need to be temporarily re-introduced. Patients should carry "Steroid Treatment" cards which give clear guidance on the precautions to be taken to minimize risk and which provide details of prescriber, drug, dosage and the duration of treatment. 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 fungal, viral and bacterial infections and their severity. The clinical presentation may often be atypical and may reach an advanced stage before being recognized. Chickenpox is of serious concern since this normally minor illness may be fatal in immunosuppressed 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 a chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased. Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished. The use of Hydrocortisone sodium succinate for 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 corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Rarely, anaphylactoid reactions have been reported following parenteral Hydrocortisone sodium succinate for Injection therapy. Physicians using the drug should be prepared to deal with such a possibility. Appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of drug allergy. Care should be taken with patients receiving cardioactive drugs such as digoxin because of steroid induced electrolyte disturbance/potassium loss (see Adverse Reactions).
Special Precautions: Particular care is required when considering the use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary: osteoporosis (post-menopausal females are particularly at risk); hypertension or congestive heart failure; existing or previous history of severe affective disorders (especially previous steroid psychosis); diabetes mellitus (or a family history of diabetes). History of tuberculosis; glaucoma (or a family of glaucoma); previous corticosteroid-induced myopathy; liver failure or cirrhosis; renal insufficiency; epilepsy, peptic ulceration; fresh intestinal anastomoses; predisposition to thrombophlebitis; abscess or other pyogenic infections; ulcerative colitis; diverticulitis; myasthenia gravis; ocular herpes simplex for fear of corneal perforation; hypothyroidism.
Effects on ability to drive and use machines: None stated.
Interaction with other medicaments and other forms of interaction: Convulsions have been reported with concurrent use of corticosteroids and cyclosporin. Since concurrent administration of these agents results in a mutual inhibition of metabolism, it is possible that convulsions and other adverse effects associated with the individual use of either drug may be more apt to occur. Drugs that induce hepatic enzymes, such as rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone and aminoglutethimide enhance the metabolism of corticosteroids and its therapeutic effects may be reduced. Drugs such as erythromycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Steroids may reduce the effects of anticholinesterases in myasthenia gravis. The desired effects of hypoglycemic agents (including insulin), anti-hypertensives and diuretics are antagonized by corticosteroids and the hypokalemic effects of acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are enhanced. The efficacy of coumarin anticoagulants may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding. The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication. Salicylates and non-steroidal anti-inflammatory agents should be used cautiously in conjunction with corticosteroids in hypothrombinaemia. Steroids have been reported to interact with neuromuscular blocking agents such as pancuronium with partial reversal of the neuromuscular block.
Use in Pregnancy & Lactation: Corticosteroids cross the placenta. There may be a very small risk of cleft palate and intra-uterine growth retardation in the fetus; there is evidence of harmful effects on pregnancy in animals. Neonates of mothers who received such therapy during pregnancy should be observed for signs of hypoadrenalism and appropriate measures instituted if such signs exist. 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 of fluid retention require close monitoring. Because prednisolone is excreted in breast milk, it is reasonable to assume that all corticosteroids are. Infants of mothers taking pharmacological dose of steroids should be monitored carefully for signs of adrenal suppression.
Use in 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. The use of steroids should be restricted to the most serious indications.
Use in Elderly: The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.