      Document 0020
 DOCN  DRG0020
 UNIQUE IDENTIFIER        DRG-0227
 NAME OF SUBSTANCE        Prednisone [USAN 1996]
 REGISTRY NUMBER          53-03-2
 STANDARD CHEMICAL NAME   Pregan-1,4-diene-3,11,20-trione,
                          17-21-dihydroxy- [USAN 1996]
 SYNONYMS                 Delta-Dome [USAN 1996]
 SYNONYMS                 Deltasone [USAN 1996]
 SYNONYMS                 Meticorten [USAN 1996]
 SYNONYMS                 Orasone [USAN 1996]
 SYNONYMS                 Paracort [USAN 1996]
 SYNONYMS                 Ancortone [CHEMLINE]
 SYNONYMS                 Bicortone [CHEMLINE]
 SYNONYMS                 Colisone [CHEMLINE]
 SYNONYMS                 Cortidelt [CHEMLINE]
 SYNONYMS                 Dacortin [CHEMLINE]
 SYNONYMS                 Decortancyl [CHEMLINE]
 SYNONYMS                 Decortisyl [CHEMLINE]
 SYNONYMS                 Dehydrocortisone [CHEMLINE]
 SYNONYMS                 Dekortin [CHEMLINE]
 SYNONYMS                 Delta E [CHEMLINE]
 SYNONYMS                 delta (1)-Cortisone [CHEMLINE]
 SYNONYMS                 delta (1)-Dehydrocortisone [CHEMLINE]
 SYNONYMS                 delta-Cortelan [CHEMLINE]
 SYNONYMS                 delta-Cortisone [CHEMLINE]
 SYNONYMS                 Deltacortisone [CHEMLINE]
 SYNONYMS                 Deltacortone [CHEMLINE]
 SYNONYMS                 Deltison [CHEMLINE]
 SYNONYMS                 Deltisone [CHEMLINE]
 SYNONYMS                 Deltra [CHEMLINE]
 SYNONYMS                 Di-adreson [CHEMLINE]
 SYNONYMS                 Encorton [CHEMLINE]
 SYNONYMS                 Encortone [CHEMLINE]
 SYNONYMS                 Enkorton [CHEMLINE]
 SYNONYMS                 Hostacortin [CHEMLINE]
 SYNONYMS                 Metacortandracin [CHEMLINE]
 SYNONYMS                 Prednison [CHEMLINE]
 SYNONYMS                 Prednisona [CHEMLINE]
 SYNONYMS                 Prednisonum [CHEMLINE]
 SYNONYMS                 Prednizon [CHEMLINE]
 SYNONYMS                 Rectodelt [CHEMLINE]
 SYNONYMS                 Supercortil [CHEMLINE]
 SYNONYMS                 Ultracorten [CHEMLINE]
 SYNONYMS                 Ultracortene [CHEMLINE]
 SYNONYMS                 1-Dehydrocortisone [CHEMLINE]
 SYNONYMS                 1,2-Dehydrocortisone [CHEMLINE]
 SYNONYMS                 17,21-Dihydroxypregna-1,4-diene-3,11,20-trion-
                          e [CHEMLINE]
 SYNONYMS                 Retrocortine [Merck Index 1989]
 SYNONYMS                 Juvason [Merck Index 1989]
 SYNONYMS                 Cortancyl [Merck Index 1989]
 SYNONYMS                 Delta Prenovis [Merck Index 1989]
 SYNONYMS                 Fernisone [Merck Index 1989]
 SYNONYMS                 Nurison [Merck Index 1989]
 SYNONYMS                 Prednilonga [Merck Index 1989]
 SYNONYMS                 Lisacort [Merck Index 1989]
 SYNONYMS                 Sone [Merck Index 1989]
 SYNONYMS                 Servisone [Merck Index 1989]
 SYNONYMS                 Pronison [Merck Index 1989]
 SYNONYMS                 Keteocort [Merck Index 1989]
 SYNONYMS                 Precortal [Merck Index 1989]
 PROTOCOL ID NUMBERS      NIAID ACTG 271
 SECONDARY SOURCE ID      NSC-10023 [USAN 1996]
 SECONDARY SOURCE ID      AI3-52939 [CHEMLINE]
 SECONDARY SOURCE ID      CCRIS 2646 [CHEMLINE]
 SECONDARY SOURCE ID      NCI-CO4897 [CHEMLINE]
 SECONDARY SOURCE ID      HSDB 3168 [CHEMLINE]
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Potent anti-inflammatory
                          effect. Readily absorbed from the
                          gastrointestinal system. Prednisone is
                          inactive until metabolized to prednisolone.
                          Its plasma half-life is 3.4 to 3.8 h and its
                          tissue half-life is 18-36 h. Protein binding
                          is high to very high. Oral doses have a peak
                          effect within 1-2 h and a duration of action
                          of 1.25 to 1.5 days. [PDR 1995] [USP DI 1995]
 DISEASES STUDIED/TREATED HIV-associated nephropathy [Am J Med 1994
                          Aug;97(2)]
 DISEASES STUDIED/TREATED HIV-associated idiopathic esophageal ulcer
                          [Am J Gastroenterol 1994 Dec;89(12)]
 CLASSIFICATION CODE      Glucocorticoid [USAN 1996]
 OTHER MAJOR USES         Adrenocortical insufficiency; congenital
                          adrenal hyperplasia; hypercalcemia associated
                          with cancer; nonsuppurative thyroiditis;
                          adjunct therapy for various rheumatic
                          disorders; selected collagen, dermatologic,
                          allergic, ophthalmic, respiratory, and
                          hematologic conditions; palliation for
                          leukemias and lymphomas in adults and acute
                          leukemia in childhood; nephrotic syndrome
                          [PDR 1995]
 SUBSTANCE INTERACTIONS   Possible interaction with drugs that induce
                          hepatic enzymes, such as phenobarbital,
                          phenytoin, and rifampin, and drugs that
                          inhibit corticosteroid metabolism, such as
                          troleandomycin and ketoconazole. [PDR 1995]
 ADVERSE EFFECTS          Adverse effects include sodium retention,
                          fluid retention, congestive heart failure in
                          susceptible patients, potassium loss,
                          hypokalemic alkalosis, hypertension, muscle
                          weakness, steroid myopathy, loss of muscle
                          mass, osteroporosis, vertebral compression
                          fractures, aseptic necrosis of femoral and
                          humeral heads, pathologic fracture of long
                          bones, peptic ulcer with possible perforation
                          and hemorrhage, pancreatitis, abdominal
                          distention, ulcerative esophagitis, increases
                          in transaminases and alkaline phosphatases,
                          impaired wound healing, thin fragile skin,
                          petechiae and ecchymoses, facial erythema,
                          increased sweating, suppression of skin test
                          reactions, negative nitrogen balance,
                          increased cranial pressure with papilledema
                          (pseudotumor cerebri), convulsions, vertigo,
                          headache, menstrual irregularities,
                          development of Cushingoid state, secondary
                          adrenocortical and pituitary unresponsiveness
                          in times of stress, growth suppression in
                          children, decreased carbohydrate intolerance,
                          manifestations of latent diabetes mellitus,
                          increased need for insulin or oral
                          hypoglycemic agents in diabetics, posterior
                          subcapsular cataracts, increased intraocular
                          pressure, glaucoma, exophthalmos, urticaria
                          and other allergic reactions. [PDR 1995]
 CONTRAINDICATIONS        Contraindicated in patients with systemic
                          fungal infections and with known
                          hypersensitivity to drug components. Patients
                          on corticosteroids should not be vaccinated
                          against smallpox. Patients on
                          immunosuppressant doses of corticosteroids
                          should avoid exposure to chicken pox or
                          measles. [PDR 1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Synthetic anti-inflammatory
                          glucocorticoid (adrenocortical steroid)
                          derived from cortisone [PDR 1995; CHEMLINE]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: White to practically
                          white, odorless, crystalline powder [PDR
                          1995]
 CHEMICAL/PHYSICAL DATA   MOLECULAR FORMUAL: C21H26O5 [USAN 1996]
 CHEMICAL/PHYSICAL DATA   MOLECULAR WEIGHT: 358.44 [USAN 1996]
 CHEMICAL/PHYSICAL DATA   ELEMENTAL COMP: C70.37%, H7.31%, O22.32%
                          [Merck Index 1989]
 CHEMICAL/PHYSICAL DATA   SOLUBILITY: Very slightly soluble in water;
                          slightly soluble in alcohol, chloroform,
                          dioxane, and methanol [PDR 1995]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: 2.5, 5, 10, 20, and 50 mg
                          tablets. [PDR 1995]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Oral [PDR 1995]
 SUBSTANCE DELIVERY DATA  STORAGE: Store at <40 C, preferably at 15-30
                          C. [NIAID ACTG 271]
 MANUFACTURERS            The Upjohn Company
 REFERENCES               Stasi R, Stipa E, Masi M, Cecconi M, Scimo
                          MT, Oliva F, Sciarra A, Perrotti AP, Adomo G,
                          Amadori S, et al. Long-term observation of
                          208 adults with chronic idiopathic
                          thrombocytopenic purpura. Am J Med.1995
                          May;98(5):436-42.
 REFERENCES               Levy R, Colonna P, Tourani JM, Gastaut JA,
                          Brice P, Raphael M, Taillan B, Andrieu JM.
                          Human immunodeficiency virus associated
                          Hodgkin's disease:report of 45 cases from the
                          French Registry of HIV-Associated Tumors.
                          Leuk Lymphoma. 1995 Feb;16(5-6):451-6.
 REFERENCES               Imrie KR, Sawka CA, Kutas G, Brandwein J,
                          Warner E, Burkes R, Quirt I, McGeer A,
                          Shepherd FA. HIV-associated lymphoma of the
                          gastrointestinal tract: the University of
                          Toronto AIDS-Lymphoma Study Group experience.
                          Leuk Lymphoma;VOL 16,ISS 3-4,1995,P343-9.
 REFERENCES               Godeau B, Coutant-Perronne V, Le Thi Huong D,
                          Guillevin L, Magadur G, De Bandt M, Dellion
                          S, Rossert J, Rostoker G, Piette JC, et al.
                          Pneumocystis carinii pneumonia in the course
                          of connective tissue disease: report of 34
                          cases. J Rheumatol;VOL 21,ISS 2,1994,P246-51.
 REFERENCES               Smith MC, Pawar R, Carey JT, Graham RC Jr,
                          Jacobs GH, Menon A, Salata RA, Seliga R,
                          Kalayjian RC. Effect of corticosteroid
                          therapy on human immunodeficiency
                          virus-associated nephropathy. Am J Med. 1994
                          Aug;97(2):145-51.
 REFERENCES               Wilcox CM and Schwartz DA. Comparison of two
                          corticosteroid regimens for the treatment of
                          HIV-associated idiopathic esophageal ulcer.
                          Am J Gastroenterol. 1994 Dec;89(12):2163-7.
 REFERENCES               Stein ME, Spencer D, Ruff P, Lakier R,
                          MacPhail P, Bezwoda WR. Endemic African
                          Kaposi's sarcoma: clinical and therapeutic
                          implications. 10-year experience in the
                          Johannesburg Hospital (1980-1990).
                          Oncology.1994 Jan-Feb:51(1):63-9.
 REFERENCES               Montaner JS, Guillemi S, Quieffin J, Lawson
                          L, Le T, O'Shaughnessy M, Ruedy J, Schechter
                          MT. Oral corticosteroids in patients with
                          mild Pneumocystis carinii pneumonia and the
                          acquired immune deficiency syndrome (AIDS).
                          Tuber Lung Dis. 1993 Jun;74(3):173-9.
 REFERENCES               Sawka Ca, Shepherd FA, Brandwein J, Burkes
                          RL, Sutton DM, Warner E. Treatment of
                          AIDS-related non-Hodgkin's lymphoma with a
                          twelve week chemotherapy program. Leuk
                          Lymphoma. 1992 Oct;8(3):213-20.
 REFERENCES               Casoli P, Tumiati B. Rheumatoid arthritis,
                          corticosteroid therapy and Kaposi's sarcoma:
                          a coincidence? A case and review of
                          literature. Clin Rheumatol;VOL 11,ISS 3,
                          1992,P432-5(REF:23).
 ENTRY MONTH              9511
 LAST REVISION DATE       960411
 

SOURCE: National Library of Medicine, Bethesda, MD.  Distributed by AEGIS.
