Dr. Saltiel received his Pharm.D. from the University of California, San Francisco, in 1980, following undergraduate work at UCLA. At UCSF, he was the recipient of the Outstanding Service Award and the Bowl of Hygeia Award. He completed a residency in clinical pharmacy practice at the University of Illinois, in Chicago.
Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.
DRUG CLASS AND MECHANISM: Budesonide is a synthetic steroid of the glucocorticoid family. The naturally-occurring hormone whose actions budesonide mimics, is cortisol or hydrocortisone which is produced by the adrenal glands. Glucocorticoid steroids have potent anti-inflammatory actions. Crohn's disease is a chronic inflammatory bowel disease of unknown cause that results in diarrhea, crampy abdominal pain, fever and bleeding from the rectum. The active ingredient in Entocort EC, budesonide, is released from granules in the ileum of the small intestine and the right (proximal) colon, where the inflammation of Crohn's disease occurs. Budesonide acts directly by contact with the ileum and colon. The budesonide that is absorbed into the body travels to the liver where it is broken-down and eliminated from the body. This prevents the majority of the absorbed drug from being distributed to the rest of the body. As a result, budesonide causes fewer severe side effects throughout the body than other corticosteroids. The FDA approved Entocort EC in October of 2001.
PRESCRIPTION: Yes
GENERIC AVAILABLE: No
PREPARATIONS: Capsules: 3mg
STORAGE: Capsules should be stored between 15-30°C (59-86°F)
PRESCRIBED FOR: Budesonide
is used for the treatment of mild-to-moderately-active Crohn's disease involving
the ileum (the second half of the small intestine) and/or ascending colon (the beginning of the large intestine). It also is approved for maintaining remissions for up to three months.
DOSING: Budesonide usually is taken once daily for up to eight weeks.
DRUG INTERACTIONS: Medicines which block the liver enzymes that break down budesonide may lead to higher blood concentrations and more side effects. Such medications include ketoconazole (Nizoral), fluconazole (Diflucan), itraconazole (Sporanox), clarithromycin (Biaxin), erythromycin, verapamil (e.g. Calan; Isoptin; Covera HS), diltiazem (e.g. Cardizem; Dilacor), ritonavir (Norvir; Kaletra), indinavir (Crixivan), and saquinavir (Invirase, Fortovase). Grapefruit juice has the same effect and should not be drunk by patients taking budesonide.
PREGNANCY: Glucocorticoids taken orally that are similar to budesonide have been shown to cause fetal abnormalities in animals. It is not known if there is an increased risk of malformation in children born to mothers exposed to budesonide during pregnancy.
NURSING MOTHERS: Glucocorticosteroids are secreted in human milk. Because of the potential for adverse reactions in nursing infants from any corticosteroid, a decision should be made whether to discontinue nursing or discontinue the budesonide. The amount of budesonide secreted in breast milk has not been determined.
SIDE EFFECTS: Budesonide generally is well tolerated. The most common side effects are headache (1 in 5 patients), respiratory infection (1 in 10 patients), nausea (1 in 10 patients), and symptoms or signs of too much corticosteroid. In the latter case, acne occurs in about 1 in 6 patients, easy bruising in 1 in 6 patients, moon (rounded) faces in 1 in 10 patients, and swollen ankles in 1 in 14 patients.
High doses of glucocorticoids may decrease the formation and increase the breakdown of bone. Higher doses also may suppress the body's ability to make its own natural glucocorticoid, cortisol. It is possible that these effects are shared by budesonide. People with suppressed production of cortisol (which can be tested for by the doctor) need increased amounts of glucocorticoids, probably by the oral or intravenous route during periods of high physical stress.
Crohn's disease is a chronic inflammatory disease,
primarily involving the small and large intestine, but which can
affect other parts of the digestive system as well. Abdominal pain, diarrhea, vomiting, fever, and weight loss are
common symptoms.
Asthma is a common disorder in which
chronic inflammation of the bronchial tubes (bronchi) makes them swell, narrowing the airways. Signs and symptoms include shortness of breath, chest tightness,
cough and wheezing.
Emphysema is a progressive disease of the lungs. The primary cause of emphysema is smoking. Alpha 1-antitrypsin deficiency is a rare disorder that has a genetic predisposition to emphysema. Aging, IV drug use, immune deficiencies, and connect tissue illnesses are also risk factors for emphysema. Emphysema is a subtype of COPD (chronic obstructive pulmonary disease, COLD). Symptoms include shortness of breath and wheezing. Management of symptoms may be achieved with medications, quitting smoking, pulmonary rehabilitation, or surgery.
Microscopic colitis (lymphocytic colitis and collagenous colitis) is a disease of inflammation of the colon. Microscopic colitis is only visible when the colon's lining is examined under a microscope. The cause of microscopic colitis is not known. Symptoms of microscopic colitis are chronic watery diarrhea and abdominal pain or cramps. Microscopic colitis is diagnosed through biopsies of several areas of the colon. There is no standardized treatment for microscopic colitis; however, eliminating NSAIDs, and treatment medications such as Imodium, Lomotil, Petpo-Bismol, Entocort EC, and mesalamine (Asacol) have been helpful in some individuals.
Crohn's disease (also spelled Crohn disease) is a chronic inflammatory disease of the intestines. It
primarily causes ulcerations (breaks in the lining) of the small and large
intestines, but can affect the digestive system anywhere from the mouth to the
anus. It is named after the physician who described the disease in 1932. It also
is called granulomatous enteritis or colitis, regional enteritis, ileitis, or
terminal ileitis.
Crohn's disease is related closely to another chronic inflammatory condition that involves only the colon called
ulcerative colitis. Together, Crohn's disease and ulcerative colitis are frequently referred to as
inflammatory bowel disease (IBD). Ulcerative colitis and Crohn's disease have no medical cure. Once the diseases begin, they tend to fluctuate between periods of inactivity (remission) and activity (relapse).
Inflammatory bowel disease affects approximately 500,000 to two million peop...
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