DOCSLIB.ORG

Oral Fluticasone Propionate in Active Distal Ulcerative Colitis

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Oral Fluticasone Propionate in Active Distal Ulcerative Colitis Gut, 1992, 33, 711-714 71 CLINICAL TRIAL Gut: first published as 10.1136/gut.33.5.711 on 1 May 1992. Downloaded from Oral fluticasone propionate in active distal ulcerative colitis P Angus, J A Snook, M Reid, D P Jewell Abstract Patients and methods Fluticasone propionate is a new corticosteroid As the study was placebo-controlled, entry was with low systemic bioavailability. This study restricted to patients (aged 18-65 years) with reports the outcome of a double blind clinical mild or moderately active ulcerative colitis that trial comparing oral fluticasone propionate (5 did not extend beyond the splenic flexure. mg four times daily) with placebo for the Patients had to be systemically well and to be treatment of active distal ulcerative colitis. passing more than three but less than seven Sixty patients were treated for four weeks, with motions daily. Before inclusion, the presence of assessments at two and four weeks. One active inflammation was confirmed by rigid patient was withdrawn when she was found to sigmoidoscopy. In all patients, the extent of the have amoebiasis. Thus, results are presented disease had been established within the previous for 29 patients who received placebo and 30 five years by either colonoscopy or barium who received fluticasone propionate. The two radiology. groups were weli matched for age, sex, length Pregnant or breastfeeding women and patients of history, and extent of disease. After four with significant cardiovascular, renal, hepatic, or weeks of therapy the clinical, sigmoidoscopic, metabolic diseases were ineligible for inclusion. and histological responses were similar in the The study was approved by the Central http://gut.bmj.com/ two groups. It is concluded that fluticasone Oxfordshire Research and Ethics Committee. propionate (5 mg four times daily) is not Written consent was obtained from each patient effective treatment for active distal ulcerative after a full explanation of the trial. colitis. DRUGS AND DOSAGES Corticosteroids have proved highly effective in Fluticasone propionate (5 mg tablets) and match- on September 30, 2021 by guest. Protected copyright. the treatment of acute attacks ofulcerative colitis ing placebo tablets were provided by Glaxo but their use is mitigated by side effects. Thus, Group Research Ltd. The active drug was used at the development of a corticoid with low systemic a dose of 20 mg daily. bioavailability would be a considerable advance. Several steroid compounds that have been shown to give very low blood concentrations and hence STUDY DESIGN have no effect on the hypothalamic-pituitary- Patients were randomly allocated to receive adrenal axis are available for topical use. These either fluticasone propionate (5 mg four times include betamethasone,' beclomethasone- 17 val- daily) or matching placebo tablets (one, four erate,2 and prednisolone metasulphobenzoate,3 times daily) for four weeks. The randomisation all of which are effective treatments for active code was generated using an in-house Glaxo distal ulcerative colitis. More recently, tixocortol program, PACT (Patient Allocation for Clinical pivalate4 and budesonide' have also proved as Trials). Patients were randomised in blocks of effective as a steroid enema. six. Fluticasone propionate is a new corticosteroid Concomitant treatment with systemic or topic- with low systemic bioavailability because of poor ally active steroids ofany kind was not permitted absorption from the gastrointestinal tract and during the study and patients who had received considerable first pass metabolism Group such medication within the 14 Gastroenterology Unit, (Glaxo previous days Radcliffe Infirmary, Research - personal communication). When were excluded. Patients were allowed to continue Oxford given in a single oral dose to patients with a well longterm treatment with sulphasalazine, P Angus established ileostomy, 72.7% of the drug was mesalazine, or olsalazine at the same dose pro- J A Snook M Reid recovered in the ileostomy effluent (J A Snook vided that therapy had already begun before the D P Jewell and D P Jewell; unpublished observations). relapse that brought the patient into the trial. Correspondence to: The purpose ofthis study was to evaluate, over At the beginning of the study, frequency of Dr D P Jewell, Gastroenterology Unit, a four week period, the efficacy and safety of 20 bowel actions, stool consistency, and severity of Radcliffe Infirmary, mg of fluticasone propionate given orally in rectal bleeding were noted. The macroscopic Woodstock Road, Oxford OX2 6HE. divided doses (5 mg four times daily) compared appearance of the rectal mucosa was graded 0-3 Accepted for publication with placebo for the treatment of active ulcera- according to the criteria of Baron et al.6 Based on 5 August 1991 tive colitis. the symptoms, clinical signs, and endoscopic 712 Oralfluticasone propionate in active distal ulcerative colitis findings, an overall physician's impression was noted improvement in their symptoms of colitis given as follows: 0-remission, 1-mild, 2-mode- (Table II). The physician's overall assessments rate, 3-severe, and 4-fulminant disease. A rectal showed that 14 of 30 patients (47%) treated with biopsy specimen was taken and the severity ofthe fluticasone propionate had improved or gone into Gut: first published as 10.1136/gut.33.5.711 on 1 May 1992. Downloaded from inflammation seen on histological sections remission by the end of the trial compared with stained with haematoxylin and eosin was graded 13 of 29 (45%) receiving placebo (p=0.888). according to the criteria of Powell-Tuck et al.7 Only four patients receiving fluticasone propio- The histopathologist (MR) was unaware of the nate and five on placebo were considered to be in patients' clinical findings. A full physical exami- remission as defined by the absence of symptoms nation was performed at entry and blood samples and quiescent disease on sigmoidoscopy. were taken for routine haematology, biochemis- The sigmoidoscopic gradings at four weeks (or try, and measurement of erythrocyte sedimenta- at the time of withdrawal) improved by at least tion rate, C-reactive protein, and orosomucoids. one grade in 13 in the fluticasone propionate Urine analysis was performed at each visit. group (43%) compared with 14 in the placebo Patients were seen in the outpatient clinic at group (48%) (p=0706). In one patient on two and four weeks after starting treatment. At fluticasone propionate and in four receiving both visits, symptom assessment, sigmoido- placebo the sigmoidoscopic appearances scopic and histological grading of disease returned to normal (grade 0). activity, general examination, and blood tests Forty eight of the 49 patients who completed were repeated. the study had adequate rectal biopsy specimens The effect of treatment on endogenous corti- taken at their last visit. The improvement in costeroid production was monitored by compar- histological scores was similar in the two groups - ing cortisol concentrations in saliva at 9.00 am on 11 showing improvement in the fluticasone pro- day 1 of the study (before entry) with the pionate group (48%) compared with nine in the concentrations on day 28 of treatment or at the placebo group (36%), p=0-411. Complete reso- time of withdrawal. The cortisol was measured lution of inflammation was noted in the biopsy by direct radioimmunoassay by BioClinical specimens of only one fluticasone propionate Services Ltd, Cardiff. patient and two placebo patients. STATISTICAL ANALYSIS TABLE I Patient characteristics The number of patients to be recruited was Group calculated assuming a remission rate of 80% with fluticasone propionate and 35% with placebo. Fluticasone http://gut.bmj.com/ Type 1 error, 2-tail, was set at 0.05 and type 2 propionate Placebo error, 1-tail, set at 0.1 to give a power of 90%. Sex: Male 18 12 Female 12 17 This gave a total sample size of 60 patients Age (years): 41 36 allowing for a proportion ofnon-assessable cases. Median (range) (25-64) (18-68) Weight (kg): 73-3 (13.9) 68-7 (11.8) Comparison of the changes in symptoms, Mean (SD) signs, and histological scores after four weeks Temperature ('C): 36-5 (0.2) 36-6 (0.2) was X2 test. t Mean (SD) performed using the The Student's Pulse (beats/min): 73 (6) 75 (8) on September 30, 2021 by guest. Protected copyright. test was used to compare mean salivary cortisol Mean (SD) Length ofhistory (months): 72 48 concentrations. Results were considered signifi- Median (range) (2-240) (2-240) cant if p was <0 05. Duration ofcurrent symptoms (weeks): 4 8 Median (range) (2-32) (1-24) Extent ofdisease: Rectum 14 12 Rectosigmoid 6 6 Results To splenic flexure 10 11 Sixty patients were recruited into the study. However, one patient was withdrawn after the biopsy report at 14 days which described amoe- TABLE II Percentage ofpatients completing the trial who biasis. She had been successfully treated for reported an improvement in symptoms ulcerative colitis during the previous two years Group but she was excluded from all subsequent analysis. Therefore, data from 59 patients have Fluticasone propionate Placebo been analysed on an intention to treat basis; 29 (n=23) (n =26) Significance received placebo and 30 received fluticasone Bowel frequency 54 58 p=0 804 propionate. The demographic and clinical Stool consistency 40 52 p=0.430 characteristics ofthe two groups were similar and Blood in stools* 36 39 p=0.850 are com- shown in Table I. Forty nine patients * Only 22 in the fluticasone propionate group and 23 in the placebo pleted the study.
Load more

Recommended publications
  • Steroid Use in Prednisone Allergy Abby Shuck, Pharmd Candidate
    Steroid Use in Prednisone Allergy Abby Shuck, PharmD candidate 2015 University of Findlay If a patient has an allergy to prednisone and methylprednisolone, what (if any) other corticosteroid can the patient use to avoid an allergic reaction? Corticosteroids very rarely cause allergic reactions in patients that receive them. Since corticosteroids are typically used to treat severe allergic reactions and anaphylaxis, it seems unlikely that these drugs could actually induce an allergic reaction of their own. However, between 0.5-5% of people have reported any sort of reaction to a corticosteroid that they have received.1 Corticosteroids can cause anything from minor skin irritations to full blown anaphylactic shock. Worsening of allergic symptoms during corticosteroid treatment may not always mean that the patient has failed treatment, although it may appear to be so.2,3 There are essentially four classes of corticosteroids: Class A, hydrocortisone-type, Class B, triamcinolone acetonide type, Class C, betamethasone type, and Class D, hydrocortisone-17-butyrate and clobetasone-17-butyrate type. Major* corticosteroids in Class A include cortisone, hydrocortisone, methylprednisolone, prednisolone, and prednisone. Major* corticosteroids in Class B include budesonide, fluocinolone, and triamcinolone. Major* corticosteroids in Class C include beclomethasone and dexamethasone. Finally, major* corticosteroids in Class D include betamethasone, fluticasone, and mometasone.4,5 Class D was later subdivided into Class D1 and D2 depending on the presence or 5,6 absence of a C16 methyl substitution and/or halogenation on C9 of the steroid B-ring. It is often hard to determine what exactly a patient is allergic to if they experience a reaction to a corticosteroid.
    [Show full text]
  • Contact Dermatitis to Medications and Skin Products
    Clinical Reviews in Allergy & Immunology (2019) 56:41–59 https://doi.org/10.1007/s12016-018-8705-0 Contact Dermatitis to Medications and Skin Products Henry L. Nguyen1 & James A. Yiannias2 Published online: 25 August 2018 # Springer Science+Business Media, LLC, part of Springer Nature 2018 Abstract Consumer products and topical medications today contain many allergens that can cause a reaction on the skin known as allergic contact dermatitis. This review looks at various allergens in these products and reports current allergic contact dermatitis incidence and trends in North America, Europe, and Asia. First, medication contact allergy to corticosteroids will be discussed along with its five structural classes (A, B, C, D1, D2) and their steroid test compounds (tixocortol-21-pivalate, triamcinolone acetonide, budesonide, clobetasol-17-propionate, hydrocortisone-17-butyrate). Cross-reactivities between the steroid classes will also be examined. Next, estrogen and testosterone transdermal therapeutic systems, local anesthetic (benzocaine, lidocaine, pramoxine, dyclonine) antihistamines (piperazine, ethanolamine, propylamine, phenothiazine, piperidine, and pyrrolidine), top- ical antibiotics (neomycin, spectinomycin, bacitracin, mupirocin), and sunscreen are evaluated for their potential to cause contact dermatitis and cross-reactivities. Finally, we examine the ingredients in the excipients of these products, such as the formaldehyde releasers (quaternium-15, 2-bromo-2-nitropropane-1,3 diol, diazolidinyl urea, imidazolidinyl urea, DMDM hydantoin), the non- formaldehyde releasers (isothiazolinones, parabens, methyldibromo glutaronitrile, iodopropynyl butylcarbamate, and thimero- sal), fragrance mixes, and Myroxylon pereirae (Balsam of Peru) for contact allergy incidence and prevalence. Furthermore, strategies, recommendations, and two online tools (SkinSAFE and the Contact Allergen Management Program) on how to avoid these allergens in commercial skin care products will be discussed at the end.
    [Show full text]
  • Rectal Corticosteroids Versus Alternative Treatments in Ulcerative Colitis: a Meta-Analysis Gut: First Published As 10.1136/Gut.40.6.775 on 1 June 1997
    Gut 1997; 40: 775-781 775 Rectal corticosteroids versus alternative treatments in ulcerative colitis: a meta-analysis Gut: first published as 10.1136/gut.40.6.775 on 1 June 1997. Downloaded from J K Marshall, E J Irvine Abstract medication consistently to the splenic Background-Clear strategies to optimise flexure,49 and a larger volume seems to allow the use of corticosteroids in ulcerative more proximal delivery.10 11 Rectal foam dis- colitis are lacking. seminates medication to the rectum and distal Aim-A meta-analysis was undertaken to descending colon,'2-16 whereas suppositories examine critically the role of rectal corti- coat only the rectum.'7 18 costeroids in the management of active Although studies of rectally administered distal ulcerative colitis. corticosteroids have reported fewer systemic Methods-AJl reported randomised con- adverse effects than with oral preparations, trolled trials were retrieved by searching plasma concentrations of prednisolone were the Medline and EMBASE databases and similar after administration of identical oral or the bibliographies of relevant studies. rectal doses.'9 20 Suppression of the hypo- Trials which met inclusion criteria were thalamic-pituitary-adrenal axis in association assessed for scientific rigour. Data were with rectal therapy has also been shown.2' 26 extracted by two independent observers Newer topically active corticosteroids such according to predetermined criteria. as tixocortol, beclomethasone, prednisolone Results-Of 83 trials retrieved, 33 met metasulphabenzoate, and budesonide, with inclusion criteria. Pooled odds ratios restricted absorption or rapid hepatic metab- (POR) showed conventional rectal corti- olism have been developed to reduce the costeroids and rectal budesonide to be adverse effects associated with conventional clearly superior to placebo.
    [Show full text]
  • Vr Meds Ex01 3B 0825S Coding Manual Supplement Page 1
    vr_meds_ex01_3b_0825s Coding Manual Supplement MEDNAME OTHER_CODE ATC_CODE SYSTEM THER_GP PHRM_GP CHEM_GP SODIUM FLUORIDE A12CD01 A01AA01 A A01 A01A A01AA SODIUM MONOFLUOROPHOSPHATE A12CD02 A01AA02 A A01 A01A A01AA HYDROGEN PEROXIDE D08AX01 A01AB02 A A01 A01A A01AB HYDROGEN PEROXIDE S02AA06 A01AB02 A A01 A01A A01AB CHLORHEXIDINE B05CA02 A01AB03 A A01 A01A A01AB CHLORHEXIDINE D08AC02 A01AB03 A A01 A01A A01AB CHLORHEXIDINE D09AA12 A01AB03 A A01 A01A A01AB CHLORHEXIDINE R02AA05 A01AB03 A A01 A01A A01AB CHLORHEXIDINE S01AX09 A01AB03 A A01 A01A A01AB CHLORHEXIDINE S02AA09 A01AB03 A A01 A01A A01AB CHLORHEXIDINE S03AA04 A01AB03 A A01 A01A A01AB AMPHOTERICIN B A07AA07 A01AB04 A A01 A01A A01AB AMPHOTERICIN B G01AA03 A01AB04 A A01 A01A A01AB AMPHOTERICIN B J02AA01 A01AB04 A A01 A01A A01AB POLYNOXYLIN D01AE05 A01AB05 A A01 A01A A01AB OXYQUINOLINE D08AH03 A01AB07 A A01 A01A A01AB OXYQUINOLINE G01AC30 A01AB07 A A01 A01A A01AB OXYQUINOLINE R02AA14 A01AB07 A A01 A01A A01AB NEOMYCIN A07AA01 A01AB08 A A01 A01A A01AB NEOMYCIN B05CA09 A01AB08 A A01 A01A A01AB NEOMYCIN D06AX04 A01AB08 A A01 A01A A01AB NEOMYCIN J01GB05 A01AB08 A A01 A01A A01AB NEOMYCIN R02AB01 A01AB08 A A01 A01A A01AB NEOMYCIN S01AA03 A01AB08 A A01 A01A A01AB NEOMYCIN S02AA07 A01AB08 A A01 A01A A01AB NEOMYCIN S03AA01 A01AB08 A A01 A01A A01AB MICONAZOLE A07AC01 A01AB09 A A01 A01A A01AB MICONAZOLE D01AC02 A01AB09 A A01 A01A A01AB MICONAZOLE G01AF04 A01AB09 A A01 A01A A01AB MICONAZOLE J02AB01 A01AB09 A A01 A01A A01AB MICONAZOLE S02AA13 A01AB09 A A01 A01A A01AB NATAMYCIN A07AA03 A01AB10 A A01
    [Show full text]
  • Practical Guidance for the Evaluation and Management of Drug Hypersensitivity: Specific Drugs
    Specific Drugs Practical Guidance for the Evaluation and Management of Drug Hypersensitivity: Specific Drugs Chief Editors: Ana Dioun Broyles, MD, Aleena Banerji, MD, and Mariana Castells, MD, PhD Ana Dioun Broyles, MDa, Aleena Banerji, MDb, Sara Barmettler, MDc, Catherine M. Biggs, MDd, Kimberly Blumenthal, MDe, Patrick J. Brennan, MD, PhDf, Rebecca G. Breslow, MDg, Knut Brockow, MDh, Kathleen M. Buchheit, MDi, Katherine N. Cahill, MDj, Josefina Cernadas, MD, iPhDk, Anca Mirela Chiriac, MDl, Elena Crestani, MD, MSm, Pascal Demoly, MD, PhDn, Pascale Dewachter, MD, PhDo, Meredith Dilley, MDp, Jocelyn R. Farmer, MD, PhDq, Dinah Foer, MDr, Ari J. Fried, MDs, Sarah L. Garon, MDt, Matthew P. Giannetti, MDu, David L. Hepner, MD, MPHv, David I. Hong, MDw, Joyce T. Hsu, MDx, Parul H. Kothari, MDy, Timothy Kyin, MDz, Timothy Lax, MDaa, Min Jung Lee, MDbb, Kathleen Lee-Sarwar, MD, MScc, Anne Liu, MDdd, Stephanie Logsdon, MDee, Margee Louisias, MD, MPHff, Andrew MacGinnitie, MD, PhDgg, Michelle Maciag, MDhh, Samantha Minnicozzi, MDii, Allison E. Norton, MDjj, Iris M. Otani, MDkk, Miguel Park, MDll, Sarita Patil, MDmm, Elizabeth J. Phillips, MDnn, Matthieu Picard, MDoo, Craig D. Platt, MD, PhDpp, Rima Rachid, MDqq, Tito Rodriguez, MDrr, Antonino Romano, MDss, Cosby A. Stone, Jr., MD, MPHtt, Maria Jose Torres, MD, PhDuu, Miriam Verdú,MDvv, Alberta L. Wang, MDww, Paige Wickner, MDxx, Anna R. Wolfson, MDyy, Johnson T. Wong, MDzz, Christina Yee, MD, PhDaaa, Joseph Zhou, MD, PhDbbb, and Mariana Castells, MD, PhDccc Boston, Mass; Vancouver and Montreal,
    [Show full text]
  • Wo 2008/127291 A2
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date PCT (10) International Publication Number 23 October 2008 (23.10.2008) WO 2008/127291 A2 (51) International Patent Classification: Jeffrey, J. [US/US]; 106 Glenview Drive, Los Alamos, GOlN 33/53 (2006.01) GOlN 33/68 (2006.01) NM 87544 (US). HARRIS, Michael, N. [US/US]; 295 GOlN 21/76 (2006.01) GOlN 23/223 (2006.01) Kilby Avenue, Los Alamos, NM 87544 (US). BURRELL, Anthony, K. [NZ/US]; 2431 Canyon Glen, Los Alamos, (21) International Application Number: NM 87544 (US). PCT/US2007/021888 (74) Agents: COTTRELL, Bruce, H. et al.; Los Alamos (22) International Filing Date: 10 October 2007 (10.10.2007) National Laboratory, LGTP, MS A187, Los Alamos, NM 87545 (US). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of national protection available): AE, AG, AL, AM, AT,AU, AZ, BA, BB, BG, BH, BR, BW, BY,BZ, CA, CH, (30) Priority Data: CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, 60/850,594 10 October 2006 (10.10.2006) US ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, (71) Applicants (for all designated States except US): LOS LR, LS, LT, LU, LY,MA, MD, ME, MG, MK, MN, MW, ALAMOS NATIONAL SECURITY,LLC [US/US]; Los MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, Alamos National Laboratory, Lc/ip, Ms A187, Los Alamos, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SV, SY, NM 87545 (US).
    [Show full text]
  • Pivalone Tixocortol Pivalate Nasal Suspension
    Pivalone Tixocortol Pivalate Nasal Suspension CAREFULLY SHAKE THE BOTTLE BEFORE USE COMPOSITION Tixocortol pivalate…………………………………………………………………… 1.000 g N-cetylpyridinium chloride……………………………………………………………0.020 g Excipient to………………………………………………………………………………100 g Bottle containing 10 ml of suspension. PHARMACEUTICAL FORM 1% tixocortol pivalate nasal suspension (10 ml nasal spray bottle) THERAPEUTIC PROPERTIES Tixocortol pivalate: local anti-inflammatory corticoid devoid of systemic effects. INDICATIONS Allergic rhinitis Seasonal rhinitis Acute congestive rhinitis Chronic congestive rhinitis Vasomotor rhinitis CONTRAINDICATIONS Antecedent allergy to the product. Epistaxis Existence of viral or fungal infections during treatment and existence of significant local superinfection DOSAGE AND ADMINISTRATION 1 to 2 pulverizations in each nostril 2 to 4 times a day. Do not exceed the prescribed dose. SPECIAL WARNINGS AND PRECAUTIONS FOR USE To be used after carefully blowing or cleaning the nose. In the event of systemic signs of bacterial infection, treatment with a systemic antibiotic must be considered. Events of epidural lipomatosis, central serous chorioretinopathy and pheochromocytoma crisis have been associated with systemic administration of corticosteroids. Long-term administration of inhaled or topical corticosteroid formulations may also be associated with these potential systemic effects. Page 1 of 6 Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES This medication would not be expected to impair the ability to drive or use machines.
    [Show full text]
  • Tixocortol, Chlorhexidine Gluconate / Tixocortol Pivalate, the Scientific Conclusions Are As Follows: Cumulatively, There Were 18 Non-Serious Medication Errors
    Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) 1 Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR(s) for tixocortol, chlorhexidine gluconate / tixocortol pivalate, the scientific conclusions are as follows: Cumulatively, there were 18 non-serious medication errors. Respectively, three cases of incorrect route of drug administration were identified during the reporting period and 9 cases cumulatively, two of whom were paediatric patients. For these cases, parents administrated nasal drops of tixocortol, chlorhexidine gluconate / tixocortol pivalate to the wrong administration site (eyes or throat). Based on the information reviewed in this PSUR, PRAC considered that sections 1 and 3 of the patient leaflet should be amended to better reflect the correct administration route of tixocortol, chlorhexidine gluconate / tixocortol pivalate for intranasal use in the product information. Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing tixocortol, chlorhexidine gluconate / tixocortol pivalate were warranted. The CMDh agrees with the scientific conclusions made by the PRAC. Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of the scientific conclusions for tixocortol, chlorhexidine gluconate / tixocortol pivalate the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) containing tixocortol, chlorhexidine gluconate / tixocortol pivalate is unchanged subject to the proposed changes to the product information. The CMDh reaches the position that the marketing authorisation(s) of products in the scope of this single PSUR assessment should be varied.
    [Show full text]
  • Intranasal Corticosteroid
    ReviewArticle Intranasal Corticosteroid Prapaporn Pornsuriyasak, M.D.*, Paraya Assanasen, M.D.** *Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, **Department of Otorhinolaryngology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand. Siriraj Med J 2008;60:90-95 E-journal: http://www.sirirajmedj.com apidly metabolized intranasal corticosteroid (INS), elastase, and plasminogen activator. Furthermore, lympho- with high topical potency and low systemic bioacti- cyte proliferation and delayed type hypersensitivity are R vity, was introduced for perennial rhinitis in 1974 also inhibited by corticosteroids in vitro. and found to be as effective as corticosteroids admini- The role of corticosteroids in the management of stered systemically.These second-generation INSs allergic rhinitis is influenced by their effect on the inflam- include beclomethasone dipropionate (BDP), budesonide matory cells and chemical mediators that are released in (BUD), flunisolide (FLU), fluticasone propionate (FP), the early- and late-phase allergic responses. The early- triamcinolone acetonide (TAA), mometasone furoate (MF), phase allergic response is characterized by an initial period and fluticasone furoate (FF). Although these INSs represent of sensitization to a specific allergen. Subsequent exposure improvements relative to earlier topical corticos-teroids, to the inciting allergen causes cross-linking of IgE antibodies they do vary from one to the other in potency and systemic located on the surface of mast cells residing in the nasal bioactivity. For example, MF is equal in potency to FP mucosa, which results in mast cell degranulation and the and is considered to be the most potent INS to date and release of various chemical mediators, such as histamine.
    [Show full text]
  • NA61: Tixocortol-21-Pivalate
    the art and science of smart patch testing® NA61: Tixocortol-21-Pivalate CAS#: 55560-96-8 Patient Information What are some products that may contain tixocortol-21-pivalate? Your patch test result indicates that you have a contact allergy to tixocortol-21- • Medications: pivalate. This contact allergy may cause your skin to react when it is exposed to – Creams this substance although it may take several days for the symptoms to appear. – Drops Typical symptoms include redness, swelling, itching, and fluid-filled blisters. – Lotions – Nasal sprays Where is tixocortol-21-pivalate found? – Ointments – Powders Tixocortol-21-pivalate is an anti-inflammatory topical corticosteroid used in – Rectal suspensions the treatment of rhinitis (as a nasal suspension or aerosols), pharyngitis (as • You May Also React to Products That Contain: lozenges), ulcerative colitis (as enema or rectal solution), and oral, inflammatory – Amcinonide conditions (as a suspension or a powder). It is also the principle screening – Budesonide substance for contact allergies to class A steroids. – Cloprednol – Desonide How can you avoid contact with tixocortol-21-pivalate? – Fludrocortisone acetate – Fluocinolone acetonide Avoid products that list any of the following names in the ingredients: – Fluocinonide • Tixocortol 21-pivalate – Flurandrenolide • Tixocortol pivalate – Halcinonide • 11beta,17-Dihydroxy-21-mercaptopregn-4-ene-3,20-dione 21-pivalate – Hydrocortisone • EINECS 259-706-4 – Hydrocortisone 17-butyrate – Hydrocortisone acetate • JO 1016 – Hydrocortisone
    [Show full text]
  • Chemotechnique Patch Test Products & Reference Manual
    Patch Test Products & Reference Manual 2018 7 Patch Test Products & Reference Manual 2018 DISTRIBUTOR MB Diagnostics AB Chemotechnique ©2017 Chemotechnique MB Diagnostics AB ©2017 Chemotechnique MB Diagnostics rev 20171128 Chemotechnique MB Diagnostics AB Modemgatan 9 | SE-235 39 | Vellinge | Sweden Tel +46 40 466 077 | www.chemotechnique.se President’s message With 2017 coming to an end, I look back at the past year with a sense of fulfillment. I reflect on the challenges overcome, the accomplishments achieved and the advancements made in the field of contact allergy. Entering 2018, our full hapten range is registered as pharmaceuticals in Canada following a lengthy regulatory process. The approved registration, the first in history, is a testament to the superior quality of the Chemotechnique products. This accomplishment has been achieved through the tireless work performed by our laboratory staff and from our North American distributor Dormer Laboratories and their consultants. I take this opportunity to extend my appreciation not only to the people involved but to all people fighting to overcome varying regulatory hurdles that are being imposed onto Patch Testing around the world, thereby limiting its beneficial expansion. The notion that an increasing number of patients previously undiagnosed are now experiencing an enhanced quality of life through the diagnosis of contact allergy assures me that Patch Testing remains as relevant as ever before, and I am of the firm belief that Patch Testing is, and will continue to be, a procedure
    [Show full text]
  • Customs Tariff - Schedule
    CUSTOMS TARIFF - SCHEDULE 99 - i Chapter 99 SPECIAL CLASSIFICATION PROVISIONS - COMMERCIAL Notes. 1. The provisions of this Chapter are not subject to the rule of specificity in General Interpretative Rule 3 (a). 2. Goods which may be classified under the provisions of Chapter 99, if also eligible for classification under the provisions of Chapter 98, shall be classified in Chapter 98. 3. Goods may be classified under a tariff item in this Chapter and be entitled to the Most-Favoured-Nation Tariff or a preferential tariff rate of customs duty under this Chapter that applies to those goods according to the tariff treatment applicable to their country of origin only after classification under a tariff item in Chapters 1 to 97 has been determined and the conditions of any Chapter 99 provision and any applicable regulations or orders in relation thereto have been met. 4. The words and expressions used in this Chapter have the same meaning as in Chapters 1 to 97. Issued January 1, 2018 99 - 1 CUSTOMS TARIFF - SCHEDULE Tariff Unit of MFN Applicable SS Description of Goods Item Meas. Tariff Preferential Tariffs 9901.00.00 Articles and materials for use in the manufacture or repair of the Free CCCT, LDCT, GPT, UST, following to be employed in commercial fishing or the commercial MT, MUST, CIAT, CT, harvesting of marine plants: CRT, IT, NT, SLT, PT, COLT, JT, PAT, HNT, Artificial bait; KRT, CEUT, UAT: Free Carapace measures; Cordage, fishing lines (including marlines), rope and twine, of a circumference not exceeding 38 mm; Devices for keeping nets open; Fish hooks; Fishing nets and netting; Jiggers; Line floats; Lobster traps; Lures; Marker buoys of any material excluding wood; Net floats; Scallop drag nets; Spat collectors and collector holders; Swivels.
    [Show full text]