Because of these side effects, doctors frequently choose safer medications, such as the 5-ASA drugs and antibiotics, as initial therapy. But there are a number of ways to reduce the risk of developing side effects. These include rapid but careful tapering off of steroids; alternate-day dosing; rectally applied corticosteroids; and rapidly metabolized corticosteroids such as budesonide (described above). To help prevent osteoporosis, many doctors routinely prescribe calcium supplements as well as multivitamins that contain vitamin D. Another option is the use of bisphosphonates, such as risedronate (Actonel®) and alendronate (Fosamax®). These compounds, which have been shown to help avert bone loss, are effective in treating and preventing steroid-induced osteoporosis.
Selection of treatment regimens depends on disease severity, disease location, and disease-associated complications. Various guidelines recommend that approaches be sequential - initially to induce clinical remission, and then to maintain remissions. Initial evidence of improvement should be seen within 2 to 4 weeks and maximal improvement should be seen in 12 to 16 weeks 3 . The classic approach to therapy in Crohn's disease has been a "step-up" approach starting with the least toxic agents for mild disease, and increasingly more aggressive treatment for more severe disease, or patients who have not responded to less toxic agents. More recently the field has been moving toward a "top-down" approach (early aggressive management) which might decrease exposure to anti-inflammatory agents and increase exposure to agents that enhance mucosal healing that might prevent future complications 4 .
Lactation studies have not been conducted with oral budesonide, including ENTOCORT EC, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. One published study reports that budesonide is present in human milk following maternal inhalation of budesonide [see Data]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ENTOCORT EC and any potential adverse effects on the breastfed infant from ENTOCORT EC, or from the underlying maternal condition.