Laboratory Analysis Showed That Econazole and Miconazole
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Therapeutic Class Overview Antifungals, Topical
Therapeutic Class Overview Antifungals, Topical INTRODUCTION The topical antifungals are available in multiple dosage forms and are indicated for a number of fungal infections and related conditions. In general, these agents are Food and Drug Administration (FDA)-approved for the treatment of cutaneous candidiasis, onychomycosis, seborrheic dermatitis, tinea corporis, tinea cruris, tinea pedis, and tinea versicolor (Clinical Pharmacology 2018). The antifungals may be further classified into the following categories based upon their chemical structures: allylamines (naftifine, terbinafine [only available over the counter (OTC)]), azoles (clotrimazole, econazole, efinaconazole, ketoconazole, luliconazole, miconazole, oxiconazole, sertaconazole, sulconazole), benzylamines (butenafine), hydroxypyridones (ciclopirox), oxaborole (tavaborole), polyenes (nystatin), thiocarbamates (tolnaftate [no FDA-approved formulations]), and miscellaneous (undecylenic acid [no FDA-approved formulations]) (Micromedex 2018). The topical antifungals are available as single entity and/or combination products. Two combination products, nystatin/triamcinolone and Lotrisone (clotrimazole/betamethasone), contain an antifungal and a corticosteroid preparation. The corticosteroid helps to decrease inflammation and indirectly hasten healing time. The other combination product, Vusion (miconazole/zinc oxide/white petrolatum), contains an antifungal and zinc oxide. Zinc oxide acts as a skin protectant and mild astringent with weak antiseptic properties and helps to -
Abnormal Vaginal Discharge: What Does and Does Not Work in Treating Underlying Causes
AE_French.1104.final 10/18/04 11:03 AM Page 890 Applied Evidence N EW R ESEARCH F INDINGS T HAT A RE C HANGING C LINICAL P RACTICE Abnormal vaginal discharge: What does and does not work in treating underlying causes Linda French, MD Michigan State University, East Lansing, Mich Jennifer Horton, DO Genesys Regional Medical Center Family Practice Residency, Grand Blanc, Mich Michelle Matousek, DO Henry Ford Health System, Detroit, Mich Practice recommendations part of this article, “Abnormal vaginal discharge: Using office diagnostic testing more effectively” ■ Treat bacterial vaginosis with oral or intravagi- (JFP 2004; 53[10]:805–814), abnormal discharge nal metronidazole or with clindamycin (SOR: is more likely to be bacterial vaginosis or no A); recurrences are common (SOR: C). pathogen at all. Potential delay in diagnosis and treatment of a sexually transmitted disease is ■ Oral and intravaginal imidazoles are also a concern. Increasing resistance of Candida equally effective in the treatment of sp. to imidazoles is associated with indiscriminate candidiasis (SOR: A); alternate therapies use of over-the-counter products. for resistant cases have been little studied. ■ Oral metronidazole is the standard ■ BACTERIAL VAGINOSIS therapy for trichomoniasis (SOR: A). The standard treatment for bacterial vaginosis Oral tinidazole, newly available in the (BV) has been oral metronidazole (Flagyl) 500 mg US in 2004, should be used in resistant twice daily for 5 to 7 days. Intravaginal 0.75% cases (SOR: B). metronidazole gel (MetroGel) has been shown to be as effective as oral metronidazole (SOR: A).1,2 Oral metronidazole can cause nausea and ntifungal medications for intravaginal use abdominal pain in some patients; vaginal treat- have been available in the United States ment may be preferable for them. -
Topical Salicylic Acid and Lactic Acid Microemulsion
Organic and Medicinal Chemistry International Journal ISSN 2474-7610 Research Article Organic & Medicinal Chem IJ Volume 2 Issue 3 - May 2017 DOI: 10.19080/OMCIJ.2017.02.555587 Copyright © All rights are reserved by Maher Aljamal Topical Salicylic acid and Lactic acid Microemulsion Maher Aljamal1,2*, Ibrahim Kayali2 and Mohammad Abul-Haj2 1BeitJala Pharmaceutical Company / Research and Development department, Palestine 2Department of Chemistry, Palestine, Al- Quds university, Israel Submission: April 26, 2017; Published: May 02, 2017 *Corresponding author: Maher Aljamal, BeitJala Pharmaceutical Company / Research and Development department, Al- Quds university, Palestine, Tel: ; Email: Abstract Microemulsionsare used to solubilizing and improve an active pharmaceutical ingredientssolubility and permeability, such as those for topical absorption availability. The objective of this study was to prepare a microemulsion liquid composed of 12% salicylic acid and 4% of lactic acid using castor oil, Tween 80, propylene glycol, ethyl alcohol and purified water. Using the low energy emulsification technique; four andpseudo transparent/translucent ternary phase diagrams microemulsion. were constructed The Resultsand studied indicate for ata leastclear, 75thermodynamic days under a titrationmicroemulsion method liquid using obtainedpurified waterin each (with of the or without propylene glycol), each phase diagram was investigated at 25°C, 37°C and 45°C. The phases include conventional emulsion, viscous using low concentration of Tween 80. It was suggested that microemulsions of 12% Salicylic acid and 4% Lactic acid could be a suitable vehicleconstructed for topical phase treatment diagrams ofat psoriasis, all temperatures scaly patches, of study. ichthyoses, Using propylene dandruff, glycol corns, as calluses, a co-surfactant, and wartson lead the to handsmore orstable feet. -
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 -
Antifungal and Antibiotic Powders
ANTIFUNGAL AND ANTIBIOTIC POWDERS Antifungals: Econazole Powder, Ketoconazole Powder, Nyamyc (nystatin) Powder, Nystop (nystatin) Powder Antibiotics: Mupirocin Powder, Tobramycin Powder, Vancomycin Powder RATIONALE FOR INCLUSION IN PA PROGRAM Background Pharmacy compounding is an ancient practice in which pharmacists combine, mix or alter ingredients to create unique medications that meet specific needs of individual patients. Some examples of the need for compounding products would be: the dosage formulation must be changed to allow a person with dysphagia (trouble swallowing) to have a liquid formulation of a commercially available tablet only product, or to obtain the exact strength needed of the active ingredient, to avoid ingredients that a particular patient has an allergy to, or simply to add flavoring to medication to make it more palatable. The intent of the criteria is to provide coverage consistent with product labeling, FDA guidance, standards of medical practice, evidence-based drug information, and/or published guidelines. Pharmacy powder products have the potential for misuse. Misuse of these powder products is quite common and it is important to inform patients about the possible complications due to overuse of these drugs. Regulatory Status FDA approved indication: Antifungal agents kill fungi or inhibit their growth. Antifungals that kill fungi are called fungicidal while those that inhibit their growth are called fungistatic. Antibiotics, or antimicrobials, are medications that destroy or slow down the growth of bacteria. -
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) -
Evidence Studies for Tea Tree
Evidence Studies for Tea Tree Oil The Benefi ts of Cleansing with FungaSoap® Evidence Authors & Journal Article Title Area Instructions J Hosp Infect (England), Nov 2000, Tea tree oil as an alternative topical Caelli M, Porteous J, Carson Anti Bacterial 46(3) p236-7 decolonization agent for methicillin-resistant CF, et al. Staphylococcus aureus. J Antimicrob Chemother (England), Time-kill studies of tea tree oils on clinical May J, Chan CH, King A, et al. May 2000, 45(5)p639-43 isolates. J Appl Microbiol (England), Jan 2000, The mode of antimicrobial action of the Cox SD, Mann CM, Markham 88(1) p170-5 essential oil of Melaleuca alternafolia (tea JL, et al. tree oil). Oral Microbiol Immunol (Denmark), Susceptibility of oral bacteria to Melaleuca Hammer KA, Dry L, Johnson Dec 2003, 18(6)p389-92 alternifolia (tea tree) oil in vitro. M, et al. J Microbial Methods (Netherlands), Leakage of K+ ions from Staphylococcus Hada T, Inoue Y, Shiraishi A, Jun 2003, 53(3)p309-12 aureus in response to tea tree oil. et al. Antimicrob Agents Chemother Mechanism of action of Melaleuca alternifolia Carson CF, Mee BJ, Riley TV (United States), June 2002, 46(6) (tea tree) oil on Staphylococcus aureus p1914-20 determined by time-kill, lysis, leakage, and saltll tolerance assays and dl electron microscopy. J Am Podiatr Med Assoc (United 1998 William J. Stickel Bronze Award. Concha JM, Moore LS, States), Oct 1998, 88(10) p489-92 Antifungal activity of Melaleuca Alternifolia Holloway WJ Anti Fungal (tea tree) oil against various pathogenic organisms. Antimicrob Agents Chemother In vitro activities of ketoconazole, econazole, Hammer KA, Carson CF, (United States), Feb 2000, 44(2) miconazole, and Melaleuca alternafolia (tea Riley TV p467-9 tree) oil against Malassezia species. -
The Selection and Use of Essential Medicines
WHO Technical Report Series 958 THE SELECTION AND USE OF ESSENTIAL MEDICINES This report presents the recommendations of the WHO Expert THE SELECTION AND USE Committee responsible for updating the WHO Model List of Essential Medicines. The fi rst part contains a review of the OF ESSENTIAL MEDICINES report of the meeting of the Expert Subcommittee on the Selection and Use of Essential Medicines, held in October 2008. It also provides details of new applications for paediatric medicines and summarizes the Committee’s considerations and justifi cations for additions and changes to the Model List, including its recommendations. Part Two of the publication is the report of the second meeting of the Subcommittee of the Expert Committee on the Selection and Use of Essential Medicines. Annexes include the revised version of the WHO Model List of Essential Medicines (the 16th) and the revised version of the WHO Model List of Report of the WHO Expert Committee, 2009 Essential Medicines for Children (the 2nd). In addition there is a list of all the items on the Model List sorted according to their (including the 16th WHO Model List of Essential Medicines Anatomical Therapeutic Chemical (ATC) classifi cation codes. and the 2nd WHO Model List of Essential Medicines for Children) WHO Technical Report Series — 958 WHO Technical ISBN 978-92-4-120958-8 Geneva TTRS958cover.inddRS958cover.indd 1 110.06.100.06.10 008:328:32 The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for SELECTED WHO PUBLICATIONS OF RELATED INTEREST international health matters and public health. -
Candidiasis and Mechanisms of Antifungal Resistance
antibiotics Review Candidiasis and Mechanisms of Antifungal Resistance Somanon Bhattacharya 1,* , Sutthichai Sae-Tia 1 and Bettina C. Fries 1,2,3 1 Division of Infectious Diseases, Department of Medicine, Stony Brook University, Stony Brook, New York, NY 11794, USA; [email protected] (S.S.-T.); [email protected] (B.C.F.) 2 Department of Molecular Genetics and Microbiology, Stony Brook University, Stony Brook, New York, NY 11794, USA 3 Veterans Administration Medical Center, Northport, New York, NY 11768, USA * Correspondence: [email protected] Received: 4 May 2020; Accepted: 7 June 2020; Published: 9 June 2020 Abstract: Candidiasis can be present as a cutaneous, mucosal or deep-seated organ infection, which is caused by more than 20 types of Candida sp., with C. albicans being the most common. These are pathogenic yeast and are usually present in the normal microbiome. High-risk individuals are patients of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), organ transplant, and diabetes. During infection, pathogens can adhere to complement receptors and various extracellular matrix proteins in the oral and vaginal cavity. Oral and vaginal Candidiasis results from the overgrowth of Candida sp. in the hosts, causing penetration of the oral and vaginal tissues. Symptoms include white patches in the mouth, tongue, throat, and itchiness or burning of genitalia. Diagnosis involves visual examination, microscopic analysis, or culturing. These infections are treated with a variety of antifungals that target different biosynthetic pathways of the pathogen. For example, echinochandins target cell wall biosynthesis, while allylamines, azoles, and morpholines target ergosterol biosynthesis, and 5-Flucytosine (5FC) targets nucleic acid biosynthesis. -
Application Number
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205175Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 205-175 Priority or Standard Standard Submit Date(s) December 22, 2012 Received Date(s) December 24, 2012 PDUFA Goal Date October 24, 2013 Division / Office DDDP/ODE III Reviewer Name(s) Amy S. Woitach, D.O. Review Completion Date September 20, 2013 Established Name Econazole Nitrate Foam, 1% (Proposed) Trade Name Ecoza Therapeutic Class Antifungal Applicant Amderma Pharmaceuticals Formulation(s) Topical Foam Dosing Regimen Once daily for 4 weeks Indication(s) Interdigital tinea pedis Intended Population(s) Ages 12 years and older Template Version: March 6, 2009 Reference ID: 3376891 Clinical Review Amy S. Woitach, D.O. NDA 205-175 Econazole Nitrate Foam (Ecoza) 1% Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT......................................... 7 1.1 Recommendation on Regulatory Action ............................................................. 7 1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies ... 8 1.4 Recommendations for Postmarket Requirements and Commitments ................ 8 2 INTRODUCTION AND REGULATORY BACKGROUND ........................................ 9 2.1 Product Information .......................................................................................... 10 2.2 Tables of Currently Available Treatments for Tinea Pedis................................ 11 2.3 Availability of Proposed Active Ingredient in the United States -
Common Study Protocol for Observational Database Studies WP5 – Analytic Database Studies
Arrhythmogenic potential of drugs FP7-HEALTH-241679 http://www.aritmo-project.org/ Common Study Protocol for Observational Database Studies WP5 – Analytic Database Studies V 1.3 Draft Lead beneficiary: EMC Date: 03/01/2010 Nature: Report Dissemination level: D5.2 Report on Common Study Protocol for Observational Database Studies WP5: Conduct of Additional Observational Security: Studies. Author(s): Gianluca Trifiro’ (EMC), Giampiero Version: v1.1– 2/85 Mazzaglia (F-SIMG) Draft TABLE OF CONTENTS DOCUMENT INFOOMATION AND HISTORY ...........................................................................4 DEFINITIONS .................................................... ERRORE. IL SEGNALIBRO NON È DEFINITO. ABBREVIATIONS ......................................................................................................................6 1. BACKGROUND .................................................................................................................7 2. STUDY OBJECTIVES................................ ERRORE. IL SEGNALIBRO NON È DEFINITO. 3. METHODS ..........................................................................................................................8 3.1.STUDY DESIGN ....................................................................................................................8 3.2.DATA SOURCES ..................................................................................................................9 3.2.1. IPCI Database .....................................................................................................9 -
The Pleitropic Drug ABC Transporters from Saccharomyces Cerevisiae
J. Mol. Microbiol. Biotechnol. (2001) 3(2): 207-214. Drug ABC TransportersJMMB from S. Symposium cerevisiae 207 The Pleitropic Drug ABC Transporters from Saccharomyces cerevisiae Bruce Rogers1,3, Anabelle Decottignies2,4, The Discovery of the Yeast ABC Transporters and of Marcin Kolaczkowski2,5, Elvira Carvajal2,6, their Major Regulators Elisabetta Balzi2,7and André Goffeau2,8,* The first ABC transporter gene discovered in 1Phytera Inc, Worcester, MA, USA Saccharomyces cerevisiae was shown to encode the full- 2Unité de biochimie physiologique, Louvain-la-Neuve, size Ste6p plasma membrane protein exporting the a- Belgium mating pheromone (Mcgrath and Varshafsky, 1989; Kuchler 3Present address: Genetics Institute, Inc., Cambridge, MA, et al., 1989,). The first half-size ABC transporter gene, USA ADP1, was unravelled by the systematic sequencing of 4Present address: Imperial Cancer Research Fund, chromosome III (Purnelle et al., 1991). Adp1p belongs to London, U.K. the historic “white” family determining the eye color of 5Present address: University of Medicine Wroclaw, Drosophila. Its function in yeast is still unknown today. Department of Biophysics, Wroclaw, Poland During the next few “pregenomic” years, four additional 6Present address: State University of Rio de Janeiro, transporters were reported. The SNQ2 gene was Dept. Cell Biology and Genetics., Rio Janeiro, Brazil discovered in a screen for mutants resistant to 7Present address: European Commission, Research nitroxiquinoline oxides and other mutagens (Servos et al., Directorate, Brussels, Belgium 1993). The overexpressed PDR5 gene was found to confer 8Present address: Chaire Internationale de Recherche resistance to cycloheximide and many other drugs (Balzi Blaise Pascal, Laboratoire de Biologie Moléculaire, Ecole et al., 1994; Bissinger et al., 1994; Hirata et al., 1994).