      Document 0089
 DOCN  DRG0089
 UNIQUE IDENTIFIER        DRG-0158
 NAME OF SUBSTANCE        Beclomethasone dipropionate [PDR 1995]
 REGISTRY NUMBER          5534-09-8
 STANDARD CHEMICAL NAME   Pregna-1,4-diene-3,20-dione,9-chloro-11-hydro-
                          xy-16-methyl- 17,21-bis(1-oxopropoxy)-,
                          (11beta,16beta)- [USAN 1996]
 SYNONYMS                 Beclovent [USAN 1996]
 SYNONYMS                 Beconase [USAN 1996]
 SYNONYMS                 Becotide [CHEMLINE]
 SYNONYMS                 Dipropionate beclomethasone [CHEMLINE]
 SYNONYMS                 Entyderma [CHEMLINE]
 SYNONYMS                 Propaderm [CHEMLINE]
 SYNONYMS                 Propaderm forte [CHEMLINE]
 SYNONYMS                 Sanasthyml [CHEMLINE]
 SYNONYMS                 Sch 18020W [USAN 1996]
 SYNONYMS                 Vancenase [USAN 1996]
 SYNONYMS                 Vanceril [USAN 1996]
 SYNONYMS                 9-Chloro-11 beta,17,21-trihydroxy-16
                          beta-methylpregna-1, 4-diene-3, -20-dione
                          17,21-dipropionate [CHEMLINE]
 SYNONYMS                 Aldecin [Merck Index 1989]
 SYNONYMS                 Anceron [Merck Index 1989]
 SYNONYMS                 Andion [Merck Index 1989]
 SYNONYMS                 Beclacin [Merck Index 1989]
 SYNONYMS                 Becloforte [Merck Index 1989]
 SYNONYMS                 Beclomet [Merck Index 1989]
 SYNONYMS                 Beclorhinol [Merck Index 1989]
 SYNONYMS                 Becloval [Merck Index 1989]
 SYNONYMS                 Becodisks [Merck Index 1989]
 SYNONYMS                 Beconasol [Merck Index 1989]
 SYNONYMS                 Clenil-A [Merck Index 1989]
 SYNONYMS                 Inalone O [Merck Index 1989]
 SYNONYMS                 Inalone R [Merck Index 1989]
 SYNONYMS                 Korbutone [Merck Index 1989]
 SYNONYMS                 Rino-Clenil [Merck Index 1989]
 SYNONYMS                 Beclometasone 17,21-dipropionate [CHEMLINE]
 SYNONYMS                 Viarex [Merck Index 1989]
 SYNONYMS                 Viarox [Merck Index 1989]
 SYNONYMS                 Sanasthmax [Merck Index 1989]
 SYNONYMS                 Beclometasone [USAN 1996]
 PROTOCOL ID NUMBERS      NIAID ACTG 186
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Mechanism of
                          anti-inflammatory action is unknown. The
                          precise mechanism of the aerosolized drug's
                          action in the nose is also unknown. The
                          effects of beclomethasone dipropionate on
                          hypothalamic-pituitary adrenal (HPA) function
                          have been evaluated in adult volunteers by
                          other routes of administration. There was no
                          suppression of early morning plasma cortisol
                          concentrations when beclomethasone was
                          administered in a dose of 1000 mcg/day for a
                          month as an oral aerosol or for 3 days by
                          intramuscular injection. However, partial
                          suppression of plasma cortisol concentration
                          was observed when beclomethasone dipropionate
                          was administered in doses of 2000 mcg per day
                          either by aerosol or intramuscularly.
                          Immediate suppression of plasma cortisol
                          concentrations was observed after single
                          doses of 4000 mcg of the drug. Suppression of
                          HPA function has been reported in adult
                          patients who received 1600 mcg daily doses.
                          Absorption of the drug occurs rapidly from
                          all respiratory and gastrointestinal tissues.
                          The principal route of excretion of the drug
                          and its metabolites is the feces; less than
                          10% is excreted in the urine. Studies have
                          shown that the degree of binding to plasma
                          proteins is 87%. [PDR 1995]
 DISEASES STUDIED/TREATED Prevention of recurrent HIV-associated
                          sinusitis [NIAID ACTG 186]
 CLASSIFICATION CODE      Anti-inflammatory [PDR 1995]
 OTHER MAJOR USES         Indicated for the relief of the symptoms of
                          seasonal or perennial rhinitis in those cases
                          poorly responsive to conventional treatment
                          [PDR 1995]
 ADVERSE EFFECTS          Adverse effects include hypersensitivity,
                          mild nasopharyngeal irritation, sneezing,
                          headache, nausea, lightheadedness, nasal
                          stuffiness, nosebleeds, rhinorrhea, or
                          tearing eyes. Localized infections of the
                          nose and pharynx with Candida albicans have
                          occurred rarely. [PDR 1995] [NIAID ACTG 186]
 CONTRAINDICATIONS        Contraindicated in the primary treatment of
                          status asthmaticus or other acute episodes of
                          asthma where intensive measures are required,
                          or if there is hypersensitivity to any
                          ingredients of the preparation. [PDR 1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Anti-inflammatory
                          corticosteroid; diester of beclomethasone
                          [PDR 1995]
 CHEMICAL/PHYSICAL DATA   MOLECULAR FORMULA: C28H37ClO7 [USAN 1996]
 CHEMICAL/PHYSICAL DATA   MOLECULAR WEIGHT: 521.05 [USAN 1996]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: White to creamy-white,
                          odorless powder. [PDR 1995]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: 16.8 g cannisters. [PDR 1995]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Inhalation of nasal spray.
                          [PDR 1995]
 SUBSTANCE DELIVERY DATA  STORAGE: Store at 2-30 C (36-86 F). [PDR
                          1995]
 MANUFACTURERS            Glaxo Wellcome
 REFERENCES               Lopez J, Rosello X, Jane E. Stomatitis
                          aphthous in patients HIV+, treatment. Int
                          Conf AIDS. 1994 Aug 7-12;10(1):183 (abstract
                          no. PBO159).
 REFERENCES               Davies RJ, Lund VJ, Harten-Ash VJ. The effect
                          of intranasal azelastine and beclomethasone
                          on the symptoms and signs of nasal allergy in
                          patients with perennial allergic rhinitis.
                          Rhinology 1993 Dec;31(4):159-64.
 REFERENCES               Woodman K, Bremner P, Burgess C, Crane J,
                          Pearce N, Beasley R. A comparative study of
                          the efficacy of beclomethasone dipropionate
                          delivered from a breath activated and
                          conventional metered dose inhaler in
                          asthmatic patients. Curr Med Res Opin
                          1993;13(2):61-9.
 REFERENCES               Davies B. A comparison of beclomethasone
                          dipropionate and budesonide in the treatment
                          of asthma [see comments]. Br J Clin Pract
                          1993 Mar-Apr;47(2):87-93.
 REFERENCES               Abzug MJ, Cotton MF. Severe chickenpox after
                          intranasal use of corticosteroids [see
                          comments]. J Pediatr 1993 Oct;123(4):577-9.
 ENTRY MONTH              9212
 LAST REVISION DATE       960614
 

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