Budesma Special Precautions

General: Proper Use of Drug: The patients should be instructed that Budesonide is a preventative agent which must be taken daily at the intervals recommended by their doctor and is not to be used as treatment for an acute asthmatic attack. Treatment with Budesonide inhalation aerosol should not be stopped abruptly, but tapered off gradually (as with other steroids). Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.
Steroid Replacement: The replacement of a systemic steroid with Budesonide has to be gradual and carefully supervised by the physician since upon withdrawal, systemic symptoms (e.g., joint and/or muscle pain, lassitude, depression) may occur despite maintenance or improvement of respiratory function. The guidelines under Dosage & Administration should be followed in all such cases.
Long-term Effects: The long-term effects of Budesonide in human subjects are still unknown. In particular, the local effects of the agent on developmental or immunologic processes in the mouth, pharynx, trachea and lungs are unknown. There is also no information about the possible long-term systemic effects of the agent. During long-term therapy, HPA axis function and hematological status should be assessed periodically.
Pulmonary Infiltration by Eosinophils: Pulmonary infiltrates with eosinophils may occur in patients on Budesonide therapy. Although, it is possible that in some patients this state may become manifest because of systemic steroid withdrawal when inhalational steroids are administered, a causative role for Budesonide and/or its vehicle cannot be ruled out.
Effect on Infection: Patients on immunosuppressant drugs are more susceptible to infections than healthy individuals. Illnesses like chickenpox and measles can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. The mechanism of modulation of the risk of developing a disseminated infection with respect to the dose, route, and duration of corticosteroid administration is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled I.V. immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.
Corticosteroids may mask some signs of infections and new infections may appear. A decreased resistance to localized infection has been observed during corticosteroid therapy. During long-term therapy, pituitary-adrenal function and hematological status should be periodically assessed. Exacerbation of asthma caused by infections is usually controlled by appropriate antibiotic treatment, by increasing the dose of inhaled Budesonide and if necessary, by giving a systemic steroid.
Hypothyroidism and Cirrhosis: There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.
Concomitant Aspirin: Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.
Use in Pregnancy: Pregnancy and Teratogenic Effects: Glucocorticoids are known teratogens in rodent species and Budesonide is no exception. Teratogenicity studies have been carried out by the inhaled and oral routes in mice, rats and rabbits. In mice and rabbits, Budesonide showed effects at high dose levels typical of a potent corticosteroid, e.g., retardation of fetal growth and cleft palate. Similarly in rats Budesonide induced early embryonic death and fetal growth retardation at very high dose levels; however, no fetus with cleft palate was detected. Well-controlled trials relating to fetal risk in humans are not available. Administration during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.