      Document 0234
 DOCN  DRG0234
 UNIQUE IDENTIFIER        DRG-0013
 NAME OF SUBSTANCE        Dexamethasone [USAN 1995]
 REGISTRY NUMBER          50-02-2
 STANDARD CHEMICAL NAME   Pregna-1,4-diene-3,20-dione,
                          9-fluoro-11,17,21- trihydroxy-16-methyl-, (11
                          beta, 16 alpha)- [USAN 1995]
 SYNONYMS                 Hexadecadrol [Merck Index 1989]
 SYNONYMS                 Calonat [Merck Index 1989]
 SYNONYMS                 Decasone [Merck Index 1989]
 SYNONYMS                 Decacortin [Merck Index 1989]
 SYNONYMS                 Deronil [Merck Index 1989]
 SYNONYMS                 Decadron [PDR 1995]
 SYNONYMS                 Fluormone [Merck Index 1989]
 SYNONYMS                 Dekacort [Merck Index 1989]
 SYNONYMS                 Dexa-Cortisyl [Merck Index 1983]
 SYNONYMS                 Dinormon [Merck Index 1989]
 SYNONYMS                 Millicorten [Merck Index 1989]
 SYNONYMS                 Fortecortin [Merck Index 1989]
 SYNONYMS                 Anaflogistico [Merck Index 1989]
 SYNONYMS                 Spoloven [Merck Index 1989]
 SYNONYMS                 Luxazone [Merck Index 1989]
 SYNONYMS                 Dectancyl [Merck Index 1989]
 SYNONYMS                 Dexameth [Merck Index 1989]
 SYNONYMS                 Dexapos [Merck Index 1989]
 SYNONYMS                 Dexasone [Merck Index 1989]
 SYNONYMS                 Dexinoral [Merck Index 1989]
 SYNONYMS                 Gammacorten [Merck Index 1989]
 SYNONYMS                 Dextelan [Merck Index 1989]
 SYNONYMS                 Policort [Merck Index 1989]
 SYNONYMS                 Dexacortal [Merck Index 1989]
 SYNONYMS                 Dexa-Mamallet [Merck Index 1989]
 SYNONYMS                 Decalix [Merck Index 1989]
 SYNONYMS                 Dexacortin [Merck Index 1989]
 SYNONYMS                 Deseronil [Merck Index 1989]
 SYNONYMS                 Corson [Merck Index 1989]
 SYNONYMS                 Hexadrol [USAN 1995]
 SYNONYMS                 Deltafluorene [Merck Index 1989]
 SYNONYMS                 Oradexon [Merck Index 1989]
 SYNONYMS                 Dexa-Cortidelt [Merck Index 1989]
 SYNONYMS                 Aeroseb-D [Merck Index 1989]
 SYNONYMS                 Dexinolon [Merck Index 1989]
 SYNONYMS                 Decaderm  [Merck Index 1989]
 SYNONYMS                 Dexafarma [Merck Index 1989]
 SYNONYMS                 Cortissumman [Merck Index 1989]
 SYNONYMS                 Dexa-sine [Merck Index 1989]
 SYNONYMS                 Loverine [Merck Index 1989]
 SYNONYMS                 Maxidex  [USAN 1995]
 SYNONYMS                 Dexa-Scheroson [Merck Index 1989]
 SYNONYMS                 Pet Derm III [Merck Index 1989]
 SYNONYMS                 Isopto-Dex [Merck Index 1989]
 SYNONYMS                 9-alpha-Fluoro-16-alpha-methylprednisolone
                          [Merck Index 1989]
 SYNONYMS                 16-alpha-Methyl-9-alpha-fluoro-1,4-pregnadien-
                          e-11-beta,17-alpha,21-triol-3,20-dione [Merck
                          Index 1989]
 SYNONYMS                 16-alpha-Methyl-9-alpha-fluoroprednisolone
                          [Merck Index 1989]
 SYNONYMS                 1-Dehydro-16-alpha-methyl-9-alpha-fluorohydro-
                          cortisone [Merck Index 1989]
 SYNONYMS                 16-alpha-Methyl-9-alpha-fluoro-delta-1-hydroc-
                          ortisone [Merck Index 1989]
 SYNONYMS                 Dexamethasone acefurate [USAN 1995]
 SYNONYMS                 Dexamethasone acetate [USAN 1995]
 SYNONYMS                 Dexamethasone dipropionate [USAN 1995]
 SYNONYMS                 Dexamethasone sodium phosphate [USAN 1995]
 SYNONYMS                 Lokalison F [Merck Index 1989]
 PROTOCOL ID NUMBERS      NIAID ACTG 008
 PROTOCOL ID NUMBERS      NIAID ACTG 009
 PROTOCOL ID NUMBERS      NIAID ACTG 074
 PROTOCOL ID NUMBERS      NIAID ACTG 142
 PROTOCOL ID NUMBERS      NIAID ACTG 252
 PROTOCOL ID NUMBERS      NIAID ACTG 202
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Glucocorticoids cause
                          profound and varied metabolic effects and
                          modify the body's immune responsiveness to
                          varied stimuli; dexamethasone exhibits potent
                          anti-inflammatory effects in disorders of
                          many organ systems. Oral dosing produces a
                          plasma peak concentration in 1-2 hours, with
                          a duration of action of 2.75 days (respective
                          intramuscular injection values for
                          dexamethasone acetate are 8 hours and 6
                          days); dexamethasone exhibits high protein
                          binding and plasma and tissue half-lives of
                          3-4.5 and 36-54 hours, respectively. [PDR
                          1993]
 DISEASES STUDIED/TREATED Acquired autoimmune hemolytic anemia [PDR
                          1995]
 CLASSIFICATION CODE      Anti-inflammatory [PDR 1995]
 CLASSIFICATION CODE      Immunomodulator [PDR 1995]
 CLASSIFICATION CODE      Antineoplastic [NIAID ACTG 252]
 OTHER MAJOR USES         Treatment inflammation in disorders of many
                          organ systems, including the treatment of
                          adrenocortical function abnormalities,
                          allergic disorders, collagen disorders, and
                          various other disorders (dermatologic,
                          gastrointestinal, hematologic, nonrheumatic
                          inflammation, neurologic, ophthalmic, oral,
                          respiratory, rheumatic), hepatitis, and
                          certain neoplastic diseases [PDR 1995]
 SUBSTANCE INTERACTIONS   Concurrent chronic use with antacids may
                          decrease dexamethasone absorption, lowering
                          its effectiveness at low dose levels;
                          inhibition of the growth response to somatrem
                          or somatropin may occur with daily doses of
                          375 or 188 mcg/square meter of dexamethasone,
                          respectively. [USP DI 1989]  Phenytoin,
                          phenobarbital, ephedrine, and rifampin may
                          enhance metabolic clearance of
                          corticosteroids, resulting in decreased blood
                          levels and lessened physiologic activity.
                          False-negative results in the dexamethasone
                          suppression test in patients treated with
                          indomethacin have been reported.
                          Corticosteroids have been reported to alter
                          prothrombin time in patients also receiving
                          anticoagulants. When corticosteroids are
                          given concomitantly with potassium-depleting
                          diuretics, patients should be observed for
                          hypokalemia. [PDR 1995]
 ADVERSE EFFECTS          May cause sodium and fluid retention,
                          congestive heart failure, potassium loss,
                          hypokalemic alkalosis, hypertension, muscle
                          weakness, steroid myopathy, osteoporosis,
                          muscle mass loss, vertebral compression
                          fractures, aseptic necrosis of femoral and
                          humeral heads, long bone fracture, tendon
                          rupture, peptic ulcer with possible
                          hemorrhage, small/large bowel perforation,
                          pancreatitis, abdominal distention,
                          ulcerative esophagitis, impaired wound
                          healing, thin fragile skin, petechiae and
                          ecchymoses, erythema, increased sweating,
                          cutaneous reactions, convulsions, increased
                          intracranial pressure with papilledema,
                          vertigo, headache, menstrual  irregularities,
                          development of cushingoid state, growth
                          suppression in children, secondary
                          adrenocortical and pituitary
                          unresponsiveness, decreased carbohydrate
                          tolerance, latent diabetes manifestations,
                          increased need for insulin/oral hypoglycemic
                          agents in diabetics, hirsutism, posterior
                          subcapsular cataracts, increased intraocular
                          pressure, glaucoma, exophthalmos, negative
                          nitrogen balance due to protein catabolism,
                          hypersensitivity, thromboembolism, weight
                          gain, increased appetite, nausea, malaise,
                          psychic disturbances. [PDR 1995]
 CONTRAINDICATIONS        Contraindicated in patients with systemic
                          fungal infections or hypersensitivity to
                          dexamethasone. [PDR 1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Glucocorticoid; synthetic
                          adrenocortical steroid [PDR 1995]
 CHEMICAL/PHYSICAL DATA   MOLECULAR FORMULA: C22H29FO5 [USAN 1995]
 CHEMICAL/PHYSICAL DATA   MOLECULAR WEIGHT: 392.47 [USAN 1995]
 CHEMICAL/PHYSICAL DATA   PERCENT ELEMENTAL COMPOSITION: C67.32%;
                          H7.45%; F4.84%; O20.38% [Merck Index 1989]
 CHEMICAL/PHYSICAL DATA   MELTING POINT: 262-264 C; 268-271 C [Merck
                          Index 1989]
 CHEMICAL/PHYSICAL DATA   SOLUBILITY: Soluble in water (25C): 10 mg/100
                          ml. Soluble in acetone, ethanol, chloroform.
                          [Merck Index 1989]
 CHEMICAL/PHYSICAL DATA   STABILITY: Stable in air [PDR 1993]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: White crystalline
                          powder [PDR 1995]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Elixir (0.1 mg/ml); oral
                          solution (0.5-1 mg/ml); tablets (4-6 mg);
                          solution for injection (4 mg/ml); 0.05%
                          ophthalmic ointment; aerosol for inhalation;
                          0.1% topical cream. [PDR 1993]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Intranasal aerosol. [PDR 1995]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Oral (dexamethasone);
                          intra-articular or soft-tissue injection
                          (dexamethasone acetate or dexamethasone
                          sodium phosphate); inhalation; topical;
                          intranasal administration. [PDR 1995]
 SUBSTANCE DELIVERY DATA  STORAGE: Store elixir, oral solution, and
                          parenteral dosage forms in tight container at
                          15-30 C (59-86 F) and protect from freezing
                          and from light. [PDR 1995]
 SUBSTANCE DELIVERY DATA  STORAGE: Store tablets in well-closed
                          container at 15-30 C (59-86 F). [PDR 1995]
 MANUFACTURERS            Merck Sharpe & Dohme
 REFERENCES               Kaplan L, Straus D, Testa M, Levine AM.
                          Randomized trial of standard dose mBACOD with
                          GM-CSF vs reduced dose mBACOD for systemic
                          HIV-associated lymphoma: ACTG 142 (Meeting
                          abstract). Proc Annu Meet Am Assoc Cancer
                          Res; 14:A818 1995.
 REFERENCES               Guo WX, Antakly T. AIDS-related Kaposi's
                          sarcoma evidence for direct stimulatory
                          effect of glucocorticoid on cell
                          proliferation. Am J Pathol; VOL 146, ISS 3,
                          1995, P727-34.
 REFERENCES               Wormser GP, Horowitz H, Dworkin B. Low-dose
                          dexamethasone as adjunctive therapy for
                          disseminated Mycobacterium avium complex
                          infections in AIDS patients. Antimicrob
                          Agents Chemother. 1994 Sep;38(9):2215-7.
 REFERENCES               Holsboer F, Grasser A, Friess E, Wiedemann K.
                          Steroid effects on central neurons and
                          implications for psychiatric and neurological
                          disorders. Ann N Y Acad Sci. 1994 Nov
                          30;746:345-59; discussion 359-61.
 REFERENCES               Walsh C, Wernz JC, Levine A, Rarick M,
                          Willson E, Melendez D, Bonnem E, Thompson J,
                          Shelton B. Phase I trial of m-BACOD and
                          granulocyte macrophage colony stimulating
                          factor in HIV-associated non-Hodgkin's
                          lymphoma. J Acquir Immune Defic Syndr. 1993
                          Mar;6(3):265-71.
 REFERENCES               O'Brien JF, Meade JL, Falk JL. Dexamethasone
                          as adjuvant therapy for severe acute
                          pharyngitis. Ann Emerg Med. 1993
                          Feb;22(2):212-5.
 REFERENCES               Nelson M, Daniels D, Erskine D, Hawkins D,
                          Gazzard BG. Steroid treatment--an association
                          with overt cytomegalovirus infection (CMV) in
                          patients with AIDS. Int Conf AIDS. 1992 Jul
                          19-24;8(2):B125 (abstract no. PoB 3228).
 REFERENCES               MacPhail LA, Greenspan D, Greenspan JS.
                          Recurrent aphthous ulcers in association with
                          HIV infection. Diagnosis and treatment. Oral
                          Surg Oral Med Oral Pathol. 1992
                          Mar;73(3):283-8.
 REFERENCES               Levine AM, Wernz JC, Kaplan L, Rodman N,
                          Cohen P, Metroka C, Bennett JM, Rarick MU,
                          Walsh C, Kahn J, et al. Low-dose chemotherapy
                          with central nervous system prophylaxis and
                          zidovudine maintenance in AIDS-related
                          lymphoma. A prospective multi-institutional
                          trial [see comments]. JAMA. 1991 Jul
                          3;266(1):84-8.
 REFERENCES               Chavanet P, Bouyssou H, Solary E, Caillot D,
                          Grapin M, Gilles A, Waldner A, Portier H.
                          Advantages of vincristine (V), adriamycine(A)
                          and dexamethasone (D) (VAD) in a 4-day
                          infusion in the management of multiply
                          resistant Kaposi sarcoma (KS). Int Conf AIDS.
                          1991 Jun 16-21;7(2):274 (abstract no.
                          W.B.2371).
 ENTRY MONTH              8906
 LAST REVISION DATE       960501
 

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