Comparison of Disinfection Effect Between Benzalkonium Chloride and Povidone Iodine in Nasotracheal Intubation

Total Page:16

File Type:pdf, Size:1020Kb

Comparison of Disinfection Effect Between Benzalkonium Chloride and Povidone Iodine in Nasotracheal Intubation Sato-Boku et al. BMC Anesthesiology (2019) 19:168 https://doi.org/10.1186/s12871-019-0839-y RESEARCHARTICLE Open Access Comparison of disinfection effect between benzalkonium chloride and povidone iodine in nasotracheal intubation: a randomized trial Aiji Sato-Boku1* , Keiji Nagano2, Yoshiaki Hasegawa3, Yuji Kamimura4, Yoshiki Sento4, MinHye So4, Eisuke Kako4, Masahiro Okuda1, Naoko Tachi1, Hidekazu Ito5, Yushi Adachi6 and Kazuya Sobue4 Abstract Background: Nasotracheal intubation can potentially result in microbial contamination from the upper respiratory tract to the lower respiratory tracts. However, an ideal nasotracheal disinfection method is yet to be determined. Therefore, we compared the disinfection effects between benzalkonium chloride and povidone iodine in nasotracheal intubation. Methods: Overall, this study enrolled 53 patients aged 20–70 years who were classified into classes 1 and 2 as per American Society of Anesthesiologists-physical status and were scheduled to undergo general anesthesia with NTI. Patients who did not give consent (n = 2) and who has an allergy for BZK or PVI were excluded from the study. The patients were randomly divided into two groups on the basis of the disinfection method: BZK (n = 26, one patient was discontinued intervention) and PVI (n = 25). 50 patients were assessed finally. The subjects’ nasal cavities were swabbed both before (A) and after disinfection (B), and the internal surface of the endotracheal tube was swabbed after extubation (C). The swabs were cultured on Brain heart infusion agar and Mannitol salt agar. The number of bacteria per swab was determined and the rates of change in bacterial count (B/A, C/B) were calculated. The growth inhibitory activity of the disinfectants on Staphylococcus aureus were also investigated in vitro. Results: Although the initial disinfection effects (B/A) were inferior for benzalkonium chloride compared with those for povidone iodine, the effects were sustained for benzalkonium chloride (C/B). In the in vitro growth inhibitory assay against S. aureus, benzalkonium chloride showed higher inhibitory activity than povidone iodine. Conclusion: Although both disinfectants were inactivated or diffused/diluted over time, benzalkonium chloride maintained the threshold concentration and displayed antimicrobial effects longer than povidone iodine; therefore, benzalkonium chloride appeared to show a better sustained effect. Benzalkonium chloride can be used for creating a hygienic nasotracheal intubation environment with sustained sterilizing effects. Trial registration: UMIN-CTR (Registration No. UMIN000029645). Registered 21 Oct 2017. Keywords: Nasotracheal intubation, Benzalkonium chloride, Povidone iodine, Bacteremia * Correspondence: [email protected] 1Department of Anesthesiology, Aichi Gakuin University School of Dentistry, 2-11 Suemori-dori, Chikusa-ku, Nagoya 464-8651, Japan Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Sato-Boku et al. BMC Anesthesiology (2019) 19:168 Page 2 of 8 Background Subjects Nasotracheal intubation (hereafter referred to as “NTI”) Overall, this study enrolled 53 patients aged 20–70 years is frequently necessary during dental, maxillofacial, and who were classified into classes 1 and 2 as per American oropharyngeal surgeries. This method is also useful Society of Anesthesiologists-physical status (hereafter re- while operating on patients with respiratory insuffi- ferred to as “ASA-PS”) and were scheduled to undergo ciency, patients who require long-term maintenance of general anesthesia with NTI. Patients who did not give the airway in the intensive care unit and patients in consent (n = 2) and who has an allergy for BZK or PVI whom orotracheal intubation is difficult because of tris- were excluded from the study. The patients were mus. However, some complications associated with NTI randomly divided into two groups on the basis of the include epistaxis [1, 2], bacteremia [3], retropharyngeal disinfection method: BZK (n = 26, one patient was dis- perforation [4], and partial or complete obstruction of continued intervention) and PVI (n = 25). 50 patients the tube [5, 6]. NTI complications are some of the many were assessed finally (Fig. 1). causes of anesthesia-related mortality [7]. Although several effective preventive measures against Anesthesia, sample collection, and microbial count epistaxis and retropharyngeal perforation have been re- The same method of anesthesia was employed for all pa- ported [8–10], an effective disinfection method during tients. No premedication was administered. After a pa- NTI is yet to be determined. In fact, dental procedures tient walked independently to the operating theater, the under general anesthesia with NTI demonstrate a higher standard vital monitors (electrocardiogram, blood pres- incidence of bacteremia compared with those conducted sure and oxygen saturation) were monitored. Anesthesia under local anesthesia [3]; moreover, patients with pros- was induced using propofol (1–2 mg/kg), remifentanil thetic heart valves, immunodeficient patients, diabetic (0.2 μg/kg/min.), and fentanyl (100 μg), with rocuronium patients, and patients taking steroids are at an increased (0.6 mg/kg) used as a neuromuscular blocking agent. risk of bacteremia, and such patients require antibiotic Until the effects of the neuromuscular blocking agent prophylaxis [11]. Reports describing the presence of became apparent, mask ventilation was implemented for NTI-related bacteremia also exist [11, 12]. Bacteremia is all patients using 100% oxygen. While mask ventilation likely caused by transferring intranasal bacteria into the was being performed, the subjects’ inferior nasal passage respiratory tract. Therefore, the disinfection of the nasal was swabbed with a sterile cotton swab before disinfec- mucosa before nasal intubation is crucial for avoiding tion (A). The subjects’ nasal cavities and inferior nasal the contamination of respiratory organs by nasal passages were adequately disinfected twice each using a microorganisms. sterile cotton swab with BZK (ZALKONIN® SOLUTION In Japan, benzalkonium chloride (hereafter referred to 0.025, Kenei Phamaceutical Co., Ltd., Osaka) or PVI as “BZK”) and povidone iodine (hereafter referred to as (POVIDONE-IDOINE SOLUTION 10% ⌈MEIJI⌋ Nitto “PVI”) are generally used as NTI disinfectants. A com- Medic Co., Ltd., Toyama). BZK and PVI were applied at prehensive literature search was performed using normal clinical concentrations of 0.025 and 5%, respect- PubMed, the Cochrane Central Register of Controlled ively. Next, the patients’ inferior nasal passages were Trials and EMBASE. However, to the best of our know- swabbed again with sterile cotton swabs after disinfec- ledge, the authors were unable to identify any previous tion (B). Then, tramazoline nasal drops were adminis- reports comparing the outcomes of disinfection effects tered to the nasal cavity and NTI was conducted after between these two disinfectants. Therefore, we investi- the muscle relaxant was observed to take effect. In all gated the disinfection effects of BZK and PVI when used cases, we maintained general anesthesia using Total for disinfection in NTI. Intra Venous Anesthesia. After the surgery, the internal surface of the endotracheal tube (inner surface 1 cm Methods from the tip of the tube) was swabbed immediately after Ethics approval and consent to participate extubation (C). We focused on how much bacteria that This study was approved by the Ethics Committee at the invaded from the upper airway to the lower airway School of Dentistry, Aichi Gakuin University (Approval during intubation was suppressed by long-term disinfec- No. 495) and was registered prospectively in the UMIN- tion effect. If we swabbed the outer surface of the endo- CTR as a clinical trial on 21 Oct 2017. (Registration No. tracheal tube, we could not avoid contamination by UMIN000029645). Our study adhered to CONSORT nasal bacteria during extubation. Therefore, we swabbed guidelines. The first patient was recruited and registered the the internal surface of the endotracheal tube. on 23 Oct 2017 (https://upload.umin.ac.jp/cgi-bin/ctr/ctr_ After collecting the specimens, only the swab head view_reg.cgi?recptno=R000033873). We obtained written was cut off. The samples from (A) and (C) were placed informed consent from all patients after providing them in 10 ml of sterile physiological saline and the samples with adequate explanation regarding the research aims. from (B) were placed in 40 ml of sterile physiological Sato-Boku et al. BMC Anesthesiology (2019) 19:168 Page 3 of 8 Fig. 1 Consolidated Standards of Reporting Trials (CONSORT) recommended description of patient recruitment saline to dilute the disinfectants (BZK or PVI) that were The evaluation of parameters absorbed by the swab. The samples were refrigerated The preoperative patient attributes of sex, age, and submitted for examination
Recommended publications
  • Evaluating Disinfectants for Use Against the COVID-19 Virus
    When it comes to choosing a disinfectant to combat the COVID-19 virus, research and health authorities suggest not all disinfectants are equally effective. The difference is in their active ingredient(s). HEALTH CANADA AND U.S. EPA ASSESSMENTS The work to evaluate disinfectants perhaps best starts with lists of approved disinfectants compiled by government health authorities. Health Canada has compiled a list of 85 hard surface disinfectant products (as of March 20, 2020) that meet their requirements for disinfection of emerging pathogens, including the virus that causes COVID-19. It can be accessed here. You can wade through the entire list. But if you locate the Drug Identification Number (DIN) on the disinfectant product label or the safety data sheet (SDS), then you can use the search function to quickly see if the product meets Health Canada requirements. A second list, updated on March 19, 2020, provides 287 products that meet the U.S. Environmental Protection Agency’s (EPA) criteria for use against SARS-CoV-2, the novel coronavirus that causes the disease COVID-19. This list can be found here. Like the Health Canada list, you can wade through this one too. However, to best use this list, you should locate the U.S. EPA registration number on the product label or SDS, and use that number to search the list. The U.S. EPA registration number of a product consists of two sets of numbers separated by a hyphen. The first set of numbers refers to the company identification number, and the second set of numbers following the hyphen represents the product number.
    [Show full text]
  • FDA-2015-N-0101; and FDA-2016-N-0124
    DE PARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 November 18, 2020 Docket Nos. FDA-1975-N-0012; FDA-2015-N-0101; and FDA-2016-N-0124 The American Cleaning Institute Attention: James Kim, PhD Vice President, Science and Regulatory Affairs 1401 H Street, N.W. Suite 700 Washington, D.C. 20005 Re: Benzalkonium Chloride, Benzethonium Chloride, Chloroxylenol, Ethanol, and Povidone-Iodine Dear Dr. Kim: This letter responds to The American Cleaning Institute’s (ACI’s) July 14, 2020 communication regarding the deferral from final rulemaking under the over-the-counter (OTC) Drug Review on benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, and povidone-iodine for use in nonprescription (often referred to as over-the-counter or OTC) consumer antiseptic wash, health care antiseptic, and consumer antiseptic rub drug products. In March 2016, FDA issued letters granting requests to defer three active ingredients— benzalkonium chloride, benzethonium chloride, and chloroxylenol—from inclusion in the final rulemaking for the December 2013 proposed rule for OTC consumer antiseptic washes (78 FR 76444). Similarly, in January 2017, FDA issued letters granting requests to defer six active ingredients—benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, povidone- iodine, and isopropyl alcohol—from inclusion in the final rulemaking for the May 2015 proposed rule for OTC health care antiseptics (80 FR 25166). In October 2017, FDA issued letters granting requests to defer three active
    [Show full text]
  • Which Disinfectants Work Best Against C. Difficile?
    Science at Your Doorstep WHICH DISINFECTANTS WORK BEST AGAINST C. DIFFICILE? Summary: In healthcare facilities, Clostridium difficile infections spread by transmission of bacterial spores. Appropriate sporicidal disinfectants are needed to prevent development of clusters and outbreaks. In this study, researchers in The Netherlands compared the effectiveness of 4 different disinfectant classes on killing distinctive C. difficile spores. They published their results in the respected journal, Antimicrobial Resistance & Infection Control. Hydrogen peroxide disinfectant wipes showed the highest bactericidal activity. Publication Description: According to the study, a dilution of sodium hypochlorite (chlorine bleach) has historically been used in hospitals to disinfect areas contaminated with C. difficile spores. But the authors state that “hypochlorite has to be used in excessive concentrations to be effective, thereby increasing its toxic and corrosive properties.” So the authors searched for alternative disinfectant types to eliminate C. difficile spores. The 4 different disinfectant compounds tested were: 1. Glucoprotamin 2. Hydrogen peroxide 3. Ethanol/propane/amino propyl glycine 4. Didecyldimonium chloride/benzalkonium chloride/biguanide (quat) Tiles were contaminated with a solution containing 5x106 CFU/ml spores of C. difficile. The tiles were left to dry for an hour and then wiped or sprayed with one of the sprays or wipes as intended by the manufacturers. After 5 minutes, microbiological cultures were performed. Conclusion: The authors concluded that for each active ingredient, the wipes performed better than the sprays. In general, impregnated cleaning/disinfection wipes performed better than ready-to-use sprays. Wipes with hydrogen peroxide showed the highest bactericidal activity. Reference: See article at: Antimicrobial Resistance & Infection Control; Volume 6, No.
    [Show full text]
  • Estonian Statistics on Medicines 2016 1/41
    Estonian Statistics on Medicines 2016 ATC code ATC group / Active substance (rout of admin.) Quantity sold Unit DDD Unit DDD/1000/ day A ALIMENTARY TRACT AND METABOLISM 167,8985 A01 STOMATOLOGICAL PREPARATIONS 0,0738 A01A STOMATOLOGICAL PREPARATIONS 0,0738 A01AB Antiinfectives and antiseptics for local oral treatment 0,0738 A01AB09 Miconazole (O) 7088 g 0,2 g 0,0738 A01AB12 Hexetidine (O) 1951200 ml A01AB81 Neomycin+ Benzocaine (dental) 30200 pieces A01AB82 Demeclocycline+ Triamcinolone (dental) 680 g A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+ Thymol (dental) 3094 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+ Cetylpyridinium chloride (gingival) 227150 g A01AD81 Lidocaine+ Cetrimide (O) 30900 g A01AD82 Choline salicylate (O) 864720 pieces A01AD83 Lidocaine+ Chamomille extract (O) 370080 g A01AD90 Lidocaine+ Paraformaldehyde (dental) 405 g A02 DRUGS FOR ACID RELATED DISORDERS 47,1312 A02A ANTACIDS 1,0133 Combinations and complexes of aluminium, calcium and A02AD 1,0133 magnesium compounds A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 811120 pieces 10 pieces 0,1689 A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 3101974 ml 50 ml 0,1292 A02AD83 Calcium carbonate+ Magnesium carbonate (O) 3434232 pieces 10 pieces 0,7152 DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 46,1179 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 2,3855 A02BA02 Ranitidine (O) 340327,5 g 0,3 g 2,3624 A02BA02 Ranitidine (P) 3318,25 g 0,3 g 0,0230 A02BC Proton pump inhibitors 43,7324 A02BC01 Omeprazole
    [Show full text]
  • Release of Antimicrobial Agents from Glass Ionomer Cements
    Y T E I C O S L BALKAN JOURNAL OF STOMATOLOGY A ISSN 1107 - 1141 IC G LO TO STOMA Release of Antimicrobial Agents from Glass Ionomer Cements SUMMARY Aleksandar Dimkov, Elizabeta Gjorgievska, The aim of this study was to determine the level of antimicrobial Aleksandar Fildishevski agents Benzalkonium Chloride and Cetylpyridinium Chloride released Faculty of Dentistry, Clinic for Pediatric and from ChemFlex, a conventional glass ionomer cement (GIC). The main null Preventive Dentistry, Skopje, FYROM hypothesis tested was that there is no release of antimicrobial agents into the surrounding medium. 3 groups of the conventional ChemFlex GIC of 5 samples each, with Benzalconium Chloride and CPC incorporated, were prepared - each group with a different percentage of the agents (1%, 2%, and 3%). The determination of the quantity of the antimicrobial agents was done by an UV- Spectrophotometer. The measurements were performed at 11 successive time intervals. The results of the statistical analysis point out that it is possible to incorporate these antimicrobial agents in conventional GIC, especially when the added percentage of the antimicrobial agents is 3%. ORIGINAL PAPERS (OP) Keywords: GIC; Antimicrobial Agents; UV-Spectrophotometry Balk J Stom, 2012; 16:84-89 Introduction application9. There are several studies dealing with the effect of incorporating chlorhexidine in different Because of the relatively frequent occurrence of concentrations and its combinations in GIC to improve recurrent caries after a restorative treatment, and because their antimicrobial properties10-14. of the huge number of cariogenic microorganisms There are only a few data in the literature referring existing in the oral cavity, which present a potential to the incorporation and release of other antimicrobial risk factor regarding the development of new carious components in GIC.
    [Show full text]
  • Australian Statistics on Medicines 1997 Commonwealth Department of Health and Family Services
    Australian Statistics on Medicines 1997 Commonwealth Department of Health and Family Services Australian Statistics on Medicines 1997 i © Commonwealth of Australia 1998 ISBN 0 642 36772 8 This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be repoduced by any process without written permission from AusInfo. Requests and enquiries concerning reproduction and rights should be directed to the Manager, Legislative Services, AusInfo, GPO Box 1920, Canberra, ACT 2601. Publication approval number 2446 ii FOREWORD The Australian Statistics on Medicines (ASM) is an annual publication produced by the Drug Utilisation Sub-Committee (DUSC) of the Pharmaceutical Benefits Advisory Committee. Comprehensive drug utilisation data are required for a number of purposes including pharmacosurveillance and the targeting and evaluation of quality use of medicines initiatives. It is also needed by regulatory and financing authorities and by the Pharmaceutical Industry. A major aim of the ASM has been to put comprehensive and valid statistics on the Australian use of medicines in the public domain to allow access by all interested parties. Publication of the Australian data facilitates international comparisons of drug utilisation profiles, and encourages international collaboration on drug utilisation research particularly in relation to enhancing the quality use of medicines and health outcomes. The data available in the ASM represent estimates of the aggregate community use (non public hospital) of prescription medicines in Australia. In 1997 the estimated number of prescriptions dispensed through community pharmacies was 179 million prescriptions, a level of increase over 1996 of only 0.4% which was less than the increase in population (1.2%).
    [Show full text]
  • Contact Sensitivity in Patients with Leg Ulcerations: a North American Study
    STUDY Contact Sensitivity in Patients With Leg Ulcerations A North American Study Liliana Saap, MD; Simone Fahim, MD; Emily Arsenault, MD; Melanie Pratt, MD; Tad Pierscianowski, MD; Vincent Falanga, MD; Anita Pedvis-Leftick, MD Objectives: (1) To determine the prevalence of aller- had no positive patch test result. The most common al- gen sensitivity in patients with past or present leg ulcers lergens were Myroxylon pereirae (balsam of Peru) (30% in 2 North American study centers vs European study [16/54]), bacitracin (24% [13/54]), fragrance mix (20% findings and the North American Contact Dermatitis [11/54]), wood tar mix (20% [11/54]), propylene glycol Group (NACDG) database and (2) to delineate a stan- (14% [7/52]), neomycin sulfate (13% [7/54]), benzal- dard battery of allergens for patch testing in North Ameri- konium chloride (13% [7/54]), carba mix (11% [6/54]), can patients that is representative of the newer dress- nickel sulfate (11% [6/54]), and control gel hydrocol- ings and wound care products. loid (11% [6/54]). Design: Fifty-four patients, with or without dermatitis, Conclusions: Comparable to European study findings, were prospectively entered in the study. The patients were there is a high incidence of positive patch test results in patch tested to the NACDG standard series and a com- patients with past or present leg ulcerations. The inci- prehensive supplemental series of 52 allergens. dences of the most common allergens in our patient popu- lation were higher than those seen in the NACDG, ex- Setting: Wound healing clinics at Boston University Roger cept for nickel.
    [Show full text]
  • Antiseptics in the Era of Bacterial Resistance: a Focus on Povidone Iodine
    Therapeutic Perspective Antiseptics in the era of bacterial resistance: a focus on povidone iodine Jean-Marie Lachapelle*1, Olivier Castel2, Alejandro Fueyo Casado3, Bernard Leroy1, Giuseppe Micali4, Dominique Tennstedt1 & Julien Lambert5 Practice Points Increasing bacterial resistance to antibiotics makes the management of superficial skin infections a major medical challenge. Antiseptics have broader spectrums of antimicrobial activity and a reduced potential for selection of bacterial resistance, relative to antibiotics. Consequently, antiseptics are appropriate alternatives to antibiotics for the prevention and treatment of superficial skin infections. Of four widely used antiseptics (povidone iodine, polihexanide, chlorhexidine and octenidine), povidone iodine has a particularly broad spectrum of antimicrobial activity that includes Gram-positive and Gram-negative bacteria, bacterial spores, fungi, protozoa and viruses. Widespread and extended use of povidone iodine is not associated with the selection of resistant bacterial strains. In contrast, bacterial resistance to chlorhexidine, quaternary ammonium salts, silver and triclosan has been documented. Regarding duration of effect on healthy skin, chlorhexidine is active for 1–4 h, whereas solutions of povidone iodine are active for 12–14 h. Aqueous and hydroalcoholic formulations of povidone iodine have good skin tolerance. Povidone iodine scrub has better skin tolerance than soap formulations of chlorhexidine and quaternary ammonium compounds (e.g., benzalkonium chloride and
    [Show full text]
  • Comparative Study of Bactericidal Activities of Six Different Disinfectants
    Nagoya J. Mod. Sci. 47. 101 ~ 112. 1985 COMPARATIVE STUDY OF BACTERICIDAL ACTIVITIES OF SIX DIFFERENT DISINFECTANTS YOSHIMICHI NAMBA*, ASAKATSU SUZUKI*, NOBORU TAKESHIMA** and NOBUO KATO*** * Department of Surgical Center, Nagoya Universi/y Hospital, and ** Deparlment of Anes/hesiology and *** Depar/ment of BaCieriology, Nagoya Universi/y School of Medicine Nagoya 466, Japan ABSTRACT Bactericidal activities of six commonly used disinfectants against scven different species of clinically isolatcd hacteria, mainly glucose-nonfermentative Gram-negative hacilli, were compared. In terms of mean values of the minimum hactericidal concentration (M BC), henzethonium chloride showed the highest efficacy, followed in order hy chlorhexidine gluconate, alkyldiaminoethylglycine hydrochloride, glutaraldehyde, povidone-iodine, and phenol. However, mean MBCs of henzethonium chloride, alkyldiaminoethylglycine hydrochloride and chlorhexidine gluconate against individual species covered a far wider range from species to species compared with those of the other three disinfectants. In addition, hactericidal activities of the ahove-mentioned three disinfectants against Pseudomonas cepacia and Achrolllohaetcr xrlosoxidans ranged more widely from strain to strain than against other species. When the minimum concentrations of individual disinfectants recommended for hospital use hy the manufacturers were used, chlorhexidine gluconate (0.02%), alkyldiaminoethylglycine hydrochloride (0.1%), henzethonium chloride (0.1%) and povidone-iodine (0.75%) were not hactericidal to definite numhers of hacterial strains tested. Among them, chlorhexidine gluconate at the concentration recommended was ineffective against many strains of all hacterial species tested, especially against strains of glucose-nonfermentative Gram-negative hacilli except for PseW/O/llOllaS aerugillosa. Alkyldiamino­ ethylglycine hydrochloride was also remarkahly ineffective against Staphylococcus aI/reus and P. cepacia. Among all the species tested, P.
    [Show full text]
  • Benzalkonium Chloride Used As an Excipient
    9 October 2017 EMA/CHMP/352187/2012 Committee for Human Medicinal Products (CHMP) Benzalkonium chloride used as an excipient Report published in support of the ‘Questions and answers on benzalkonium chloride used as an excipient in medicinal products for human use’ (EMA/CHMP/495737/2013) 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. Benzalkonium chloride used as an excipient Table of contents Executive summary ..................................................................................... 3 Introduction ................................................................................................ 3 Scientific discussion .................................................................................... 3 1. Characteristics......................................................................................... 3 1.1. Category (function) .............................................................................................. 3 1.2. Physico-chemical Properties ................................................................................... 3 1.3. Use in medicinal products ...................................................................................... 4 2. Pharmaco-toxicological data ..................................................................
    [Show full text]
  • Benzalkonium-Chloride-Summary-Report-Committee-Veterinary-Medicinal-Products En.Pdf
    The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/306/97-FINAL December 1997 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS BENZALKONIUM CHLORIDE SUMMARY REPORT 1. Benzalkonium chloride is a quaternary ammonium antiseptic and surfactant. It consists of a mixture of alkyldimethylammonium chlorides, the alkyl chains having chain lengths of C8 to C18. The European Pharmacopoeia requires that benzalkonium chloride should contain not less than 95 % and not more than 104 % of alkyldimethylammonium chlorides, calculated as C22H40NCl. 2. In veterinary medicine, benzalkonium chloride is used as an excipient in an injectable glycocorticoid formulation intended for use in cattle, pigs, horses, sheep, goats and pigs. When used as excipient, the concentration in the formulation is less than 0.05%, resulting in a dose approximately of 0.006 and 0.009 mg/kg bw. This application is restricted to its use as excipient in an injectable formulation. It may also be used as eye lotion or as dermal spray. It has also been approved for the cleansing and disinfecting of stablings and animal transport in 0.04% concentration. In human medicine, benzalkonium chloride is used primarily as a skin disinfectant at concentrations of 0.1 to 0.2 % and as preservative at concentrations of 0.01% for eye drops. It is also the active ingredient of vaginal spermicide ovules (0.35 mg/kg bw/application). 3. Benzalkonium chloride possesses depolarising muscle relaxant properties, and hypotensive effects. It has no other known pharmacological effects. No information on the pharmacokinetics and on the metabolism of benzalkonium chloride was provided. However, benzalkonium chloride belongs to the family of the quaternary ammonium compounds known to be poorly absorbed from the gastrointestinal tract after oral administration.
    [Show full text]
  • Estonian Statistics on Medicines 2013 1/44
    Estonian Statistics on Medicines 2013 DDD/1000/ ATC code ATC group / INN (rout of admin.) Quantity sold Unit DDD Unit day A ALIMENTARY TRACT AND METABOLISM 146,8152 A01 STOMATOLOGICAL PREPARATIONS 0,0760 A01A STOMATOLOGICAL PREPARATIONS 0,0760 A01AB Antiinfectives and antiseptics for local oral treatment 0,0760 A01AB09 Miconazole(O) 7139,2 g 0,2 g 0,0760 A01AB12 Hexetidine(O) 1541120 ml A01AB81 Neomycin+Benzocaine(C) 23900 pieces A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+Thymol(dental) 2639 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+Cetylpyridinium chloride(gingival) 179340 g A01AD81 Lidocaine+Cetrimide(O) 23565 g A01AD82 Choline salicylate(O) 824240 pieces A01AD83 Lidocaine+Chamomille extract(O) 317140 g A01AD86 Lidocaine+Eugenol(gingival) 1128 g A02 DRUGS FOR ACID RELATED DISORDERS 35,6598 A02A ANTACIDS 0,9596 Combinations and complexes of aluminium, calcium and A02AD 0,9596 magnesium compounds A02AD81 Aluminium hydroxide+Magnesium hydroxide(O) 591680 pieces 10 pieces 0,1261 A02AD81 Aluminium hydroxide+Magnesium hydroxide(O) 1998558 ml 50 ml 0,0852 A02AD82 Aluminium aminoacetate+Magnesium oxide(O) 463540 pieces 10 pieces 0,0988 A02AD83 Calcium carbonate+Magnesium carbonate(O) 3049560 pieces 10 pieces 0,6497 A02AF Antacids with antiflatulents Aluminium hydroxide+Magnesium A02AF80 1000790 ml hydroxide+Simeticone(O) DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 34,7001 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 3,5364 A02BA02 Ranitidine(O) 494352,3 g 0,3 g 3,5106 A02BA02 Ranitidine(P)
    [Show full text]