“The Red Face” and More Clinical Pearls
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Ceftazidime for Injection) PHARMACY BULK PACKAGE – NOT for DIRECT INFUSION
PRESCRIBING INFORMATION FORTAZ® (ceftazidime for injection) PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION To reduce the development of drug-resistant bacteria and maintain the effectiveness of FORTAZ and other antibacterial drugs, FORTAZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4 thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1 azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β(Z)]]. It has the following structure: The molecular formula is C22H32N6O12S2, representing a molecular weight of 636.6. FORTAZ is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity. The Pharmacy Bulk Package vial contains 709 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3mEq) per gram of ceftazidime. FORTAZ in sterile crystalline form is supplied in Pharmacy Bulk Packages equivalent to 6g of anhydrous ceftazidime. The Pharmacy Bulk Package bottle is a container of sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous use. THE PHARMACY BULK PACKAGE IS NOT FOR DIRECT INFUSION, FURTHER DILUTION IS REQUIRED BEFORE USE. -
Hyperhidrosis: Sweating out the Details
Focus on CME at the Université de Montréal Hyperhidrosis: Sweating Out the Details Antranik Benohanian, MD, FRCPC; and Nowell Solish, MD, FRCPC Presented at the 250th meeting of the Montreal Dermatological Society, April 2003 yperhidrosis (HH) remains a relatively Table 1 Hunknown disorder to the general public Most commonly affected sites and health-care professionals. According to the literature, 0.5% to 1% of the population is Site Prevalence affected by HH. However, a recent survey held Facial 68.9% in the U.S. places that figure at 2.8%; thus, Axillary 50.8% revealing that the prevalence is underrated. Plantar 28.7% Among those affected, only 38% had discussed Palmar 24.8% the problem with a health professional.1 HH may be classified as primary or sec- ondary; either type can be localized or gen- Besides affecting quality of life, HH predis- eralized. Table 1 lists the most commonly poses its victims to a host of dermatologic dis- affected sites. orders (Table 2).3 The control of HH would also control the associated disease condition, as has Impact on quality of life been recently reported with the treatment of dyshidrotic hand dermatitis with intradermal HH is known to be a socially embarrassing and botulinum toxin.4 occupationally disabling disorder. Many patients suffer in silence. Figure 1 illustrates the How is HH treated? impact HH has on quality of life.2 Those with axillary HH often have to change Systemic approach clothing several times a day and throw out Minor sedatives, such as amitriptyline and clothing because of the damage caused to fabric hydroxyzine, produce an anticholinergic, as and leather. -
(CD-P-PH/PHO) Report Classification/Justifica
COMMITTEE OF EXPERTS ON THE CLASSIFICATION OF MEDICINES AS REGARDS THEIR SUPPLY (CD-P-PH/PHO) Report classification/justification of medicines belonging to the ATC group D07A (Corticosteroids, Plain) Table of Contents Page INTRODUCTION 4 DISCLAIMER 6 GLOSSARY OF TERMS USED IN THIS DOCUMENT 7 ACTIVE SUBSTANCES Methylprednisolone (ATC: D07AA01) 8 Hydrocortisone (ATC: D07AA02) 9 Prednisolone (ATC: D07AA03) 11 Clobetasone (ATC: D07AB01) 13 Hydrocortisone butyrate (ATC: D07AB02) 16 Flumetasone (ATC: D07AB03) 18 Fluocortin (ATC: D07AB04) 21 Fluperolone (ATC: D07AB05) 22 Fluorometholone (ATC: D07AB06) 23 Fluprednidene (ATC: D07AB07) 24 Desonide (ATC: D07AB08) 25 Triamcinolone (ATC: D07AB09) 27 Alclometasone (ATC: D07AB10) 29 Hydrocortisone buteprate (ATC: D07AB11) 31 Dexamethasone (ATC: D07AB19) 32 Clocortolone (ATC: D07AB21) 34 Combinations of Corticosteroids (ATC: D07AB30) 35 Betamethasone (ATC: D07AC01) 36 Fluclorolone (ATC: D07AC02) 39 Desoximetasone (ATC: D07AC03) 40 Fluocinolone Acetonide (ATC: D07AC04) 43 Fluocortolone (ATC: D07AC05) 46 2 Diflucortolone (ATC: D07AC06) 47 Fludroxycortide (ATC: D07AC07) 50 Fluocinonide (ATC: D07AC08) 51 Budesonide (ATC: D07AC09) 54 Diflorasone (ATC: D07AC10) 55 Amcinonide (ATC: D07AC11) 56 Halometasone (ATC: D07AC12) 57 Mometasone (ATC: D07AC13) 58 Methylprednisolone Aceponate (ATC: D07AC14) 62 Beclometasone (ATC: D07AC15) 65 Hydrocortisone Aceponate (ATC: D07AC16) 68 Fluticasone (ATC: D07AC17) 69 Prednicarbate (ATC: D07AC18) 73 Difluprednate (ATC: D07AC19) 76 Ulobetasol (ATC: D07AC21) 77 Clobetasol (ATC: D07AD01) 78 Halcinonide (ATC: D07AD02) 81 LIST OF AUTHORS 82 3 INTRODUCTION The availability of medicines with or without a medical prescription has implications on patient safety, accessibility of medicines to patients and responsible management of healthcare expenditure. The decision on prescription status and related supply conditions is a core competency of national health authorities. -
Fucidin H Cream Patient Leaflet
Scale Get-up Material No Sent by e-maiL l 100% GB 059516-XX Subject Date Date INS 175 x 280 mm 02/04/19 Colour Sign. Sign. Black RBE Preparation Place of production 213 Strength ® Packsize Fucidin H cream Ireland Comments: Page 1 of 2 Pharmacode 213 Font size: Heading: 9 pt, section: 8 pt, linespacing: 3 mm Mock-up for reg. purpose 175 mm IIE007-01 - 175 x 280 mm 175 x 280m Insert 100% PACKAGE LEAFLET: INFORMATION FOR THE USER Fucidin® H cream Fusidic acid and hydrocortisone acetate m Read all of this leaflet carefully before you start using this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. 20/01/2004 11/06/2018 IIE007-01 What is in this leaflet: Other medicines and Fucidin H cream 213 1. What Fucidin® H cream is and what it is used for Tell your doctor or pharmacist if you are taking, or have 2. Before you use Fucidin® H cream recently taken or might take any other medicines. 3. How to use Fucidin® H cream 4. Possible side effects Pregnancy and breast-feeding 5. -
Acute-Onset Alopecia
PHOTO CHALLENGE Acute-Onset Alopecia Justin P. Bandino, MD; Dirk M. Elston, MD A previously healthy 45-year-old man presented to the dermatology department with abrupt onset of patchy, progressively worsening alopecia of the scalp as well as nausea with emesis and blurry vision of a few weeks’ duration. All symptoms were temporally associated with a new demoli- tion job the patient had started at an industrial site. He reportedcopy 10 other contractors were simi- larly affected. The patient denied paresthesia or other skin changes. On physical examination, large patches of smooth alopecia without ery- thema,not scale, scarring, tenderness, or edema that coalesced to involve the majority of the scalp, eye- brows, and eyelashes (inset) were noted. Do WHAT’S THE DIAGNOSIS? a. alopecia areata b. dioxin-induced alopecia c. phosgene-induced alopecia d. syphilitic alopecia CUTIS e. thallium-induced alopecia PLEASE TURN TO PAGE E25 FOR THE DIAGNOSIS From the Department of Dermatology, Medical University of South Carolina, Charleston. The authors report no conflict of interest. Correspondence: Justin P. Bandino, MD, 171 Ashley Ave, MSC 908, Charleston, SC 29425 ([email protected]). E24 I CUTIS® WWW.MDEDGE.COM/DERMATOLOGY Copyright Cutis 2019. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher. PHOTO CHALLENGE DISCUSSION THE DIAGNOSIS: Thallium-Induced Alopecia t the time of presentation, a punch biopsy speci- pencil point–shaped fractures that shed approximately men of the scalp revealed nonscarring alopecia 1 to 2 months after injury. The 10% of scalp hairs in A with increased catagen hairs; follicular minia- the resting telogen phase have no matrix and thus are turization; peribulbar lymphoid infiltrates; and fibrous unaffected. -
209627Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209627Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review Reviewers of Multi-Disciplinary Review and Evaluation SECTIONS OFFICE/ AUTHORED/ ACKNOWLEDGED/ DISCIPLINE REVIEWER DIVISION APPROVED Mark Seggel, Ph.D. OPQ/ONDP/DNDP2 Authored: Section 4.2 Digitally signed by Mark R. Seggel -S CMC Lead DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Mark R. Signature: Mark R. Seggel -S Seggel -S, 0.9.2342.19200300.100.1.1=1300071539 Date: 2018.08.08 16:29:15 -04'00' Frederic Moulin, DVM, PhD OND/ODE3/DBRUP Authored: Section 5 Pharmacology/ Digitally signed by Frederic Moulin -S Toxicology DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Reviewer Signature: Frederic Moulin -S 0.9.2342.19200300.100.1.1=2001708658, cn=Frederic Moulin -S Date: 2018.08.08 15:26:57 -04'00' Kimberly Hatfield, PhD OND/ODE3/DBRUP Approved: Section 5 Pharmacology/ Toxicology Digitally signed by Kimberly P. Hatfield -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Team Leader Signature: Kimberly P. Hatfield -S 0.9.2342.19200300.100.1.1=1300387215, cn=Kimberly P. Hatfield -S Date: 2018.08.08 14:56:10 -04'00' Li Li, Ph.D. OCP/DCP3 Authored: Sections 6 and 17.3 Clinical Pharmacology Dig ta ly signed by Li Li S DN c=US o=U S Government ou=HHS ou=FDA ou=People Reviewer cn=Li Li S Signature: Li Li -S 0 9 2342 19200300 100 1 1=20005 08577 Date 2018 08 08 15 39 23 04'00' Doanh Tran, Ph.D. -
Antibiotic Use Guidelines for Companion Animal Practice (2Nd Edition) Iii
ii Antibiotic Use Guidelines for Companion Animal Practice (2nd edition) iii Antibiotic Use Guidelines for Companion Animal Practice, 2nd edition Publisher: Companion Animal Group, Danish Veterinary Association, Peter Bangs Vej 30, 2000 Frederiksberg Authors of the guidelines: Lisbeth Rem Jessen (University of Copenhagen) Peter Damborg (University of Copenhagen) Anette Spohr (Evidensia Faxe Animal Hospital) Sandra Goericke-Pesch (University of Veterinary Medicine, Hannover) Rebecca Langhorn (University of Copenhagen) Geoffrey Houser (University of Copenhagen) Jakob Willesen (University of Copenhagen) Mette Schjærff (University of Copenhagen) Thomas Eriksen (University of Copenhagen) Tina Møller Sørensen (University of Copenhagen) Vibeke Frøkjær Jensen (DTU-VET) Flemming Obling (Greve) Luca Guardabassi (University of Copenhagen) Reproduction of extracts from these guidelines is only permitted in accordance with the agreement between the Ministry of Education and Copy-Dan. Danish copyright law restricts all other use without written permission of the publisher. Exception is granted for short excerpts for review purposes. iv Foreword The first edition of the Antibiotic Use Guidelines for Companion Animal Practice was published in autumn of 2012. The aim of the guidelines was to prevent increased antibiotic resistance. A questionnaire circulated to Danish veterinarians in 2015 (Jessen et al., DVT 10, 2016) indicated that the guidelines were well received, and particularly that active users had followed the recommendations. Despite a positive reception and the results of this survey, the actual quantity of antibiotics used is probably a better indicator of the effect of the first guidelines. Chapter two of these updated guidelines therefore details the pattern of developments in antibiotic use, as reported in DANMAP 2016 (www.danmap.org). -
Dovobet Gel Patient Information Leaflet
L Scale Get-up Material No Sent by e-maiL l Scale Get-up Material No Sent by e-mail 100% Used for: GB 000000-XXComments: Insert, 2 columns Page 1 IIE015-02Subject Daivobet®, Dovobet®, Xamiol ® Date gel. SpaceDate for text: 2 X 67,5 x 580 mm. Subject Date Date INS 160 x 600 mm 05/05/20 Colour Sign. MaterialSign. number must be printed on both sides Colour Sign. Sign. 160 x 600 mm 08/09/2010 JUG Black RBE Material number on page 1, OCRB 8pt kerning+10(Quark)/ Preparation 100% 08/06/2018 OMA Place of productionOCRB MEDIUM 8pt kerning+50(Indesign) Preparation Place of production Strength ® Strength Packsize Dovobet gel Ireland Packsize Ireland Comments: Comments: Page 1 of 2 Font size: 9 pt Mock-up for reg. purpose 160 mm IIE015-02 - 160 x 600 mm - Page 1 of 2 2. 05/05/20 Package leaflet: Information for the user Dovobet® 50 micrograms/g + 0.5 mg/g gel RBE calcipotriol/betamethasone SOP_00867 SOP_003993 and SOP_000647, SOP_000962 Read all of this leaflet carefully before you start using this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. 6 • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. -
PSORCON® E Emollient Ointment (Diflorasone Diacetate Ointment) 0.05%
PSORCON® E Emollient Ointment (diflorasone diacetate ointment) 0.05% For Topical Use Not For Ophthalmic Use DESCRIPTION Each gram of Psorcon E Emollient Ointment contains 0.5 mg diflorasone diacetate in an ointment base. Chemically, diflorasone diacetate is: 6α,9-difluoro-11β,17,21-trihydroxy- 16β-methyl-pregna-1,4-diene-3,20-dione 17,21-diacetate. The structural formula is represented below: Psorcon E Emollient Ointment contains diflorasone diacetate in an emollient, occlusive base consisting of polyoxypropylene 15-stearyl ether, stearic acid, lanolin alcohol and white petrolatum. CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, 1 occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. They are metabolized primarily in the liver and are then excreted by the kidneys. -
NPTC-Formulary Brief Acne
Indian Health Service National Pharmacy and Therapeutics Committee Formulary Brief: Treatment of Acne vulgaris -January 2020- Background: The Indian Health Service (IHS) National Pharmacy and Therapeutics Committee (NPTC) reviewed the medical management of acne vulgaris at their January 2020 meeting. This review included topical therapies (retinoids, antibiotics, bactericidal and other anti-comedonal or anti-inflammatory agents) and oral therapies (antibiotics, isotretinoin, oral contraceptives, antiandrogens). Topical clindamycin, topical tretinoin, spironolactone, and combined estrogen-containing oral contraceptives are currently on the IHS National Core Formulary (NCF). Following clinical review, pharmacoeconomic evaluation and internal deliberation, the NPTC voted to ADD (1.) benzoyl peroxide (any topical formulation) and REPLACE topical clindamycin with (2.) combination clindamycin and benzoyl peroxide gel to the NCF. Discussion: Acne is the most common skin disorder in the United States (US), affecting 40-50 million persons of all ages. It can have significant sequelae from physical scarring, persistent hyperpigmentation, and psychological issues. Small studies focused on acne among American Indian/Alaska Native (AI/AN) populations suggest that the prevalence of acne is similar to other racial/ethnic groups in the US, but that the sequelae of scarring is significantly higher (55% in AI/AN vs. 3% among US white populations) and access to specialty care services is disproportionately low1. Acne is a chronic inflammatory disease of the pilosebaceous unit involving increased sebum production by sebaceous glands, hyperkeratinization of the follicle, colonization of the follicle by Propionobacterium acnes, and an inflammatory reaction. Acne is manifested with both non-inflammatory (open and closed comedones) and inflammatory lesions (papules, pustules, and nodules). Inflammatory acne is graded as mild, moderate, or severe based on the frequency of the various inflammatory lesions. -
Impact of Retreatment with an Artemisinin-Based Combination On
Muhindo Mavoko et al. Trials 2013, 14:307 http://www.trialsjournal.com/content/14/1/307 TRIALS STUDY PROTOCOL Open Access Impact of retreatment with an artemisinin-based combination on malaria incidence and its potential selection of resistant strains: study protocol for a randomized controlled clinical trial Hypolite Muhindo Mavoko1*, Carolyn Nabasumba2, Halidou Tinto3, Umberto D’Alessandro4,5, Martin Peter Grobusch6, Pascal Lutumba1 and Jean-Pierre Van Geertruyden7 Abstract Background: Artemisinin-based combination therapy is currently recommended by the World Health Organization as first-line treatment of uncomplicated malaria. Recommendations were adapted in 2010 regarding rescue treatment in case of treatment failure. Instead of quinine monotherapy, it should be combined with an antibiotic with antimalarial properties; alternatively, another artemisinin-based combination therapy may be used. However, for informing these policy changes, no clear evidence is yet available. The need to provide the policy makers with hard data on the appropriate rescue therapy is obvious. We hypothesize that the efficacy of the same artemisinin- based combination therapy used as rescue treatment is as efficacious as quinine + clindamycin or an alternative artemisinin-based combination therapy, without the risk of selecting drug resistant strains. Design: We embed a randomized, open label, three-arm clinical trial in a longitudinal cohort design following up children with uncomplicated malaria until they are malaria parasite free for 4 weeks. The study is conducted in both the Democratic Republic of Congo and Uganda and performed in three steps. In the first step, the pre-randomized controlled trial (RCT) phase, children aged 12 to 59 months with uncomplicated malaria are treated with the recommended first-line drug and constitute a cohort that is passively followed up for 42 days. -
Clindamycin Plus Quinine for Treating Uncomplicated Falciparum Malaria: a Systematic Review and Meta-Analysis Charles O Obonyo1* and Elizabeth a Juma1,2
Obonyo and Juma Malaria Journal 2012, 11:2 http://www.malariajournal.com/content/11/1/2 RESEARCH Open Access Clindamycin plus quinine for treating uncomplicated falciparum malaria: a systematic review and meta-analysis Charles O Obonyo1* and Elizabeth A Juma1,2 Abstract Background: Artemisinin-based combinations are recommended for treatment of uncomplicated falciparum malaria, but are costly and in limited supply. Clindamycin plus quinine is an alternative non-artemisinin-based combination recommended by World Health Organization. The efficacy and safety of clindamycin plus quinine is not known. This systematic review aims to assess the efficacy of clindamycin plus quinine versus other anti-malarial drugs in the treatment of uncomplicated falciparum malaria. Methods: All randomized controlled trials comparing clindamycin plus quinine with other anti-malarial drugs in treating uncomplicated malaria were included in this systematic review. Databases searched included: Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and LILACS. Two authors independently assessed study eligibility, extracted data and assessed methodological quality. The primary outcome measure was treatment failure by day 28. Dichotomous data was compared using risk ratio (RR), in a fixed effects model. Results: Seven trials with 929 participants were included. Clindamycin plus quinine significantly reduced the risk of day 28 treatment failure compared with quinine (RR 0.14 [95% CI 0.07 to 0.29]), quinine plus sulphadoxine- pyrimethamine (RR 0.17 [95% CI 0.06 to 0.44]), amodiaquine (RR 0.11 [95% CI 0.04 to 0.27]), or chloroquine (RR 0.11 [95% CI 0.04 to 0.29]), but had similar efficacy compared with quinine plus tetracycline (RR 0.33 [95% CI 0.01 to 8.04]), quinine plus doxycycline (RR 1.00 [95% CI 0.21 to 4.66]), artesunate plus clindamycin (RR 0.57 [95% CI 0.26 to 1.24]), or chloroquine plus clindamycin (RR 0.38 [95% CI 0.13 to 1.10]).