DOCSLIB.ORG

Sexually Transmitted Infections Treatment Guidelines, 2021

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Sexually Transmitted Infections Treatment Guidelines, 2021 Morbidity and Mortality Weekly Report Recommendations and Reports / Vol. 70 / No. 4 July 23, 2021 Sexually Transmitted Infections Treatment Guidelines, 2021 U.S. Department of Health and Human Services Centers for Disease Control and Prevention Recommendations and Reports CONTENTS Introduction ............................................................................................................1 Methods ....................................................................................................................1 Clinical Prevention Guidance ............................................................................2 STI Detection Among Special Populations ............................................... 11 HIV Infection ......................................................................................................... 24 Diseases Characterized by Genital, Anal, or Perianal Ulcers ............... 27 Syphilis ................................................................................................................... 39 Management of Persons Who Have a History of Penicillin Allergy .. 56 Diseases Characterized by Urethritis and Cervicitis ............................... 60 Chlamydial Infections ....................................................................................... 65 Gonococcal Infections ...................................................................................... 71 Mycoplasma genitalium .................................................................................... 80 Diseases Characterized by Vulvovaginal Itching, Burning, Irritation, Odor, or Discharge ........................................................................................... 82 Pelvic Inflammatory Disease .......................................................................... 94 Epididymitis .......................................................................................................... 98 Human Papillomavirus Infections ..............................................................100 Viral Hepatitis .....................................................................................................113 Proctitis, Proctocolitis, and Enteritis ..........................................................124 Ectoparasitic Infections ..................................................................................126 Sexual Assault and Abuse and STIs ............................................................128 References ...........................................................................................................135 The MMWR series of publications is published by the Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, Atlanta, GA 30329-4027. Suggested citation: [Author names; first three, then et al., if more than six.] [Title]. MMWR Recomm Rep 2021;70(No. RR-#):[inclusive page numbers]. Centers for Disease Control and Prevention Rochelle P. Walensky, MD, MPH, Director Debra Houry, MD, MPH, Acting Principal Deputy Director Daniel B. Jernigan, MD, MPH, Acting Deputy Director for Public Health Science and Surveillance Rebecca Bunnell, PhD, MEd, Director, Office of Science Jennifer Layden, MD, PhD, Deputy Director, Office of Science Michael F. Iademarco, MD, MPH, Director, Center for Surveillance, Epidemiology, and Laboratory Services MMWR Editorial and Production Staff (Serials) Charlotte K. Kent, PhD, MPH, Editor in Chief Martha F. Boyd, Lead Visual Information Specialist Ian Branam, MA, Acting Lead Christine G. Casey, MD, Editor Alexander J. Gottardy, Maureen A. Leahy, Health Communication Specialist Mary Dott, MD, MPH, Online Editor Julia C. Martinroe, Stephen R. Spriggs, Tong Yang, Shelton Bartley, MPH, Terisa F. Rutledge, Managing Editor Visual Information Specialists Lowery Johnson, Amanda Ray, David C. Johnson, Lead Technical Writer-Editor Quang M. Doan, MBA, Phyllis H. King, Jacqueline N. Sanchez, MS, Marella Meadows, Project Editor Terraye M. Starr, Moua Yang, Health Communication Specialists Information Technology Specialists Will Yang, MA, Visual Information Specialist MMWR Editorial Board Timothy F. Jones, MD, Chairman Matthew L. Boulton, MD, MPH William E. Halperin, MD, DrPH, MPH Carlos Roig, MS, MA Carolyn Brooks, ScD, MA Jewel Mullen, MD, MPH, MPA William Schaffner, MD Jay C. Butler, MD Jeff Niederdeppe, PhD Nathaniel Smith, MD, MPH Virginia A. Caine, MD Celeste Philip, MD, MPH Morgan Bobb Swanson, BS Jonathan E. Fielding, MD, MPH, MBA Patricia Quinlisk, MD, MPH Abbigail Tumpey, MPH David W. Fleming, MD Patrick L. Remington, MD, MPH Recommendations and Reports Sexually Transmitted Infections Treatment Guidelines, 2021 Kimberly A. Workowski, MD1,2; Laura H. Bachmann, MD1; Philip A. Chan, MD1,3; Christine M. Johnston, MD1,4; Christina A. Muzny, MD1,5; Ina Park, MD1,6; Hilary Reno, MD1,7; Jonathan M. Zenilman, MD1,8; Gail A. Bolan, MD1 1Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC, Atlanta, Georgia; 2Emory University, Atlanta, Georgia; 3Brown University, Providence, Rhode Island; 4University of Washington, Seattle, Washington; 5University of Alabama at Birmingham, Birmingham, Alabama; 6University of California San Francisco, San Francisco, California; 7Washington University, St. Louis, Missouri; 8Johns Hopkins University, Baltimore, Maryland Summary These guidelines for the treatment of persons who have or are at risk for sexually transmitted infections (STIs) were updated by CDC after consultation with professionals knowledgeable in the field of STIs who met in Atlanta, Georgia, June 11–14, 2019. The information in this report updates the 2015 guidelines. These guidelines discuss 1) updated recommendations for treatment of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis; 2) addition of metronidazole to the recommended treatment regimen for pelvic inflammatory disease; 3) alternative treatment options for bacterial vaginosis; 4) management of Mycoplasma genitalium; 5) human papillomavirus vaccine recommendations and counseling messages; 6) expanded risk factors for syphilis testing among pregnant women; 7) one-time testing for hepatitis C infection; 8) evaluation of men who have sex with men after sexual assault; and 9) two-step testing for serologic diagnosis of genital herpes simplex virus. Physicians and other health care providers can use these guidelines to assist in prevention and treatment of STIs. Introduction These STI treatment guidelines complement Recommendations for Providing Quality Sexually Transmitted Diseases Clinical The term “sexually transmitted infection” (STI) refers to Services, 2020 (2) regarding quality clinical services for STIs a pathogen that causes infection through sexual contact, in primary care and STD specialty care settings. This guidance whereas the term “sexually transmitted disease” (STD) refers specifies operational determinants of quality services in various to a recognizable disease state that has developed from an clinical settings, describes on-site treatment and partner infection. Physicians and other health care providers have a services, and indicates when STI-related conditions should be crucial role in preventing and treating STIs. These guidelines managed through consultation with or referral to a specialist. are intended to assist with that effort. Although the guidelines emphasize treatment, prevention strategies and diagnostic recommendations also are discussed. Methods This report updates Sexually Transmitted Diseases Treatment Guidelines, 2015 (1) and should be regarded as a source of These guidelines were developed by CDC staff who worked clinical guidance rather than prescriptive standards. Health care with subject matter experts with expertise in STI clinical providers should always consider the clinical circumstances of management from other federal agencies, nongovernmental each person in the context of local disease prevalence. These academic and research institutions, and professional medical guidelines are applicable to any patient care setting that serves organizations. CDC staff identified governmental and persons at risk for STIs, including family planning clinics, nongovernmental subject matter experts on the basis of their HIV care clinics, correctional health care settings, private expertise and assisted them in developing questions to guide physicians’ offices, Federally Qualified Health Centers, clinics individual literature reviews. CDC staff informed the subject for adolescent care, and other primary care facilities. These matter experts that they were being consulted to exchange guidelines are focused on treatment and counseling and do information and observations and to obtain their individual not address other community services and interventions that input. All subject matter experts disclosed potential conflicts are essential to STI and HIV prevention efforts. of interest. STI Treatment Guidelines, 2021, Work Group members are listed at the end of this report. In 2018, CDC staff identified key questions about treatment and clinical management to guide an update of the 2015 Corresponding preparer: Kimberly A. Workowski, MD, Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD treatment guidelines (1). To answer these questions STD, and TB Prevention, CDC. Telephone: 404-639-1898; Email: and synthesize new information available since publication [email protected]. of the 2015
Load more

Recommended publications
  • (12) United States Patent (10) Patent No.: US 8,993,581 B2 Perrine Et Al
    US00899.3581B2 (12) United States Patent (10) Patent No.: US 8,993,581 B2 Perrine et al. (45) Date of Patent: Mar. 31, 2015 (54) METHODS FOR TREATINGVIRAL (58) Field of Classification Search DSORDERS CPC ... A61K 31/00; A61K 31/166; A61K 31/185: A61K 31/233; A61K 31/522: A61K 38/12: (71) Applicant: Trustees of Boston University, Boston, A61K 38/15: A61K 45/06 MA (US) USPC ........... 514/263.38, 21.1, 557, 565, 575, 617; 424/2011 (72) Inventors: Susan Perrine, Weston, MA (US); Douglas Faller, Weston, MA (US) See application file for complete search history. (73) Assignee: Trustees of Boston University, Boston, (56) References Cited MA (US) U.S. PATENT DOCUMENTS (*) Notice: Subject to any disclaimer, the term of this 3,471,513 A 10, 1969 Chinn et al. patent is extended or adjusted under 35 3,904,612 A 9/1975 Nagasawa et al. U.S.C. 154(b) by 0 days. (Continued) (21) Appl. No.: 13/915,092 FOREIGN PATENT DOCUMENTS (22) Filed: Jun. 11, 2013 CA 1209037 A 8, 1986 CA 2303268 A1 4f1995 (65) Prior Publication Data (Continued) US 2014/OO45774 A1 Feb. 13, 2014 OTHER PUBLICATIONS Related U.S. Application Data (63) Continuation of application No. 12/890,042, filed on PCT/US 10/59584 Search Report and Written Opinion mailed Feb. Sep. 24, 2010, now abandoned. 11, 2011. (Continued) (60) Provisional application No. 61/245,529, filed on Sep. 24, 2009, provisional application No. 61/295,663, filed on Jan. 15, 2010. Primary Examiner — Savitha Rao (74) Attorney, Agent, or Firm — Nixon Peabody LLP (51) Int.
    [Show full text]
  • Figure 1: Etest Gradient Configuration When an Etest Gradient Strip Is
    Inoculum preparation Table 1. Recommended media, inoculum and To obtain reproducible MICs from a gradient based Use the inoculum guide in TABLE 1. Emulsify several incubation1). system, the stability of the gradient must be maintai- well-isolated colonies from an overnight agar plate in lêÖ~åáëã= ^Ö~ê= fåçÅìäìã fåÅìÄ~íáçå ned throughout the critical period when the position a suitable suspension medium to achieve the specifi ed Öêçìé ãÉÇá~ of the growth/inhibition edge for a particular bac- inoculum turbidity by comparing to a McFarland pìëéÉåëáçå qìêÄáÇáíó= qÉãéÉê~íìêÉ= ^íãçëéÜÉêÉ qáãÉ= Antimicrobial Susceptibility Testing terium/antibiotic combination is determined. Due turbidity standard. For fastidious organisms such as EjÅc~êä~åÇF Eœ=O=ø`F EÜçìêëF For In Vitro Diagnostic Use to the stability and precision of the Etest predefi ned pneumococci, streptococci, gonococci, anaerobes and gradient, MIC values have been shown to be repro- Haemophilus spp., use the suspension prepared in INTENDED USE ducible and equivalent to those of the CLSI reference broth within 15 minutes. ^ÉêçÄÉë jìÉääÉê= MKURB=k~`ä MKR================== PR=ø` ~ãÄáÉåí NSJOM Etest is a quantitative technique for determining dilution procedures. eáåíçå EN=áÑ=ãìÅçáÇF the antimicrobial susceptibility of Gram negative Inoculation and Gram positive aerobic bacteria such as En- REAGENTS Soak a sterile, non-toxic swab in the inoculum terobacteriaceae, Pseudomonas, Staphylococcus and Etest is supplied in a package of 100 or 30 (some suspension and remove excess fl uid by pressing it lop^L=lopb jìÉääÉê= MKURB=k~`ä MKR PR=ø` ~ãÄáÉåí OQ=lop^==== Enterococcus species and fastidious bacteria, such as reagents) test strips of one antimicrobial agent.
    [Show full text]
  • Novel Therapeutics for Epstein–Barr Virus
    molecules Review Novel Therapeutics for Epstein–Barr Virus Graciela Andrei *, Erika Trompet and Robert Snoeck Laboratory of Virology and Chemotherapy, Department of Microbiology and Immunology, Rega Institute for Medical Research, KU Leuven, 3000 Leuven, Belgium; [email protected] (E.T.); [email protected] (R.S.) * Correspondence: [email protected]; Tel.: +32-16-321-915 Academic Editor: Stefano Aquaro Received: 15 February 2019; Accepted: 4 March 2019; Published: 12 March 2019 Abstract: Epstein–Barr virus (EBV) is a human γ-herpesvirus that infects up to 95% of the adult population. Primary EBV infection usually occurs during childhood and is generally asymptomatic, though the virus can cause infectious mononucleosis in 35–50% of the cases when infection occurs later in life. EBV infects mainly B-cells and epithelial cells, establishing latency in resting memory B-cells and possibly also in epithelial cells. EBV is recognized as an oncogenic virus but in immunocompetent hosts, EBV reactivation is controlled by the immune response preventing transformation in vivo. Under immunosuppression, regardless of the cause, the immune system can lose control of EBV replication, which may result in the appearance of neoplasms. The primary malignancies related to EBV are B-cell lymphomas and nasopharyngeal carcinoma, which reflects the primary cell targets of viral infection in vivo. Although a number of antivirals were proven to inhibit EBV replication in vitro, they had limited success in the clinic and to date no antiviral drug has been approved for the treatment of EBV infections. We review here the antiviral drugs that have been evaluated in the clinic to treat EBV infections and discuss novel molecules with anti-EBV activity under investigation as well as new strategies to treat EBV-related diseases.
    [Show full text]
  • Qualitative Study to Explore the Knowledge and Attitude of Pregnant Women Regarding HIV/AIDS Testing in Kotayk Region and in Yerevan, Armenia
    Qualitative study to explore the knowledge and attitude of pregnant women regarding HIV/AIDS testing in Kotayk region and in Yerevan, Armenia Utilizing Professional Publication Framework Henrik Khachatryan, MD, MPH candidate, American University of Armenia Primary Adviser: M. Thompson, MS, DrPH Secondary Adviser: K. White, RN, PhD, CNAA October 2005 Table of Contents INTRODUCTION ...........................................................................................................................................................1 Background Information and Literature review....................................................................................................1 Rationale for the Research and Research Questions.............................................................................................4 METHODS AND MATERIALS........................................................................................................................................5 Study design...........................................................................................................................................................5 Study population ....................................................................................................................................................5 Sampling and Study Setting...................................................................................................................................6 Data collection Instrument.....................................................................................................................................6
    [Show full text]
  • Synthesis of Ribavirin, Tecadenoson, and Cladribine by Enzymatic Transglycosylation
    catalysts Article Synthesis of Ribavirin, Tecadenoson, and Cladribine by Enzymatic Transglycosylation 1, 2 2,3 2 Marco Rabuffetti y, Teodora Bavaro , Riccardo Semproli , Giulia Cattaneo , Michela Massone 1, Carlo F. Morelli 1 , Giovanna Speranza 1,* and Daniela Ubiali 2,* 1 Department of Chemistry, University of Milan, via Golgi 19, I-20133 Milano, Italy; marco.rabuff[email protected] (M.R.); [email protected] (M.M.); [email protected] (C.F.M.) 2 Department of Drug Sciences, University of Pavia, viale Taramelli 12, I-27100 Pavia, Italy; [email protected] (T.B.); [email protected] (R.S.); [email protected] (G.C.) 3 Consorzio Italbiotec, via Fantoli 15/16, c/o Polo Multimedica, I-20138 Milano, Italy * Correspondence: [email protected] (G.S.); [email protected] (D.U.); Tel.: +39-02-50314097 (G.S.); +39-0382-987889 (D.U.) Present address: Department of Food, Environmental and Nutritional Sciences, University of Milan, y via Mangiagalli 25, I-20133 Milano, Italy. Received: 7 March 2019; Accepted: 8 April 2019; Published: 12 April 2019 Abstract: Despite the impressive progress in nucleoside chemistry to date, the synthesis of nucleoside analogues is still a challenge. Chemoenzymatic synthesis has been proven to overcome most of the constraints of conventional nucleoside chemistry. A purine nucleoside phosphorylase from Aeromonas hydrophila (AhPNP) has been used herein to catalyze the synthesis of Ribavirin, Tecadenoson, and Cladribine, by a “one-pot, one-enzyme” transglycosylation, which is the transfer of the carbohydrate moiety from a nucleoside donor to a heterocyclic base. As the sugar donor, 7-methylguanosine iodide and its 20-deoxy counterpart were synthesized and incubated either with the “purine-like” base or the modified purine of the three selected APIs.
    [Show full text]
  • Laboratory Manual for Diagnosis of Sexually Transmitted And
    Department of AIDS Control LaborLaboraattororyy ManualManual fforor DiagnosisDiagnosis ofof SeSexxuallyually TTrransmitansmittteded andand RRepreproductivoductivee TTrractact InInffectionsections FOREWORD Sexually Transmitted Infections (STIs) and Reproductive Tract Infections (RTIs) are diseases of major global concern. About 6% of Indian population is reported to be having STIs. In addition to having high levels of morbidity, they also facilitate transmission of HIV infection. Thus control of STIs goes hand in hand with control of HIV/AIDS. Countrywide strengthening of laboratories by helping them to adopt uniform standardized protocols is very important not only for case detection and treatment, but also to have reliable epidemiological information which will help in evaluation and monitoring of control efforts. It is also essential to have good referral services between primary level of health facilities and higher levels. This manual aims to bring in standard testing practices among laboratories that serve health facilities involved in managing STIs and RTIs. While generic procedures such as staining, microscopy and culture have been dealt with in detail, procedures that employ specific manufacturer defined kits have been left to the laboratories to follow the respective protocols. An introduction to quality system essentials and quality control principles has also been included in the manual to sensitize the readers on the importance of quality assurance and quality management system, which is very much the need of the hour. Manual of Operating Procedures for Diagnosis of STIs/RTIs i PREFACE Sexually Transmitted Infections (STIs) are the most common infectious diseases worldwide, with over 350 million new cases occurring each year, and have far-reaching health, social, and economic consequences.
    [Show full text]
  • (Sporanox Capsules) 280-A
    PRIOR AUTHORIZATION CRITERIA BRAND NAME (generic) SPORANOX ORAL CAPSULES (itraconazole) Status: CVS Caremark Criteria Type: Initial Prior Authorization Policy FDA-APPROVED INDICATIONS Sporanox (itraconazole) Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. Blastomycosis, pulmonary and extrapulmonary 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. Sporanox Capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: 1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and 2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. Compendial Uses Coccidioidomycosis2,3
    [Show full text]
  • Partners with Mixed HIV Status
    Partners With Mixed HIV Status SERODISCORDANT RELATIONSHIPS Relationships in which one or more people has HIV and one or more people do not have HIV are sometimes called serodiscordant or mixed serostatus. The term serodiscordant is made up of two roots: 1. Sero—meaning blood 2. Discordant—meaning different or non-matching HIV isn’t the first topic that comes up when most people start dating. You may not know the HIV status of your partner(s). You might not even have been tested yourself. It can be very difficult to talk about HIV status. WHAT ARE THE SPECIAL ISSUES FOR SERODISCORDANT RELATIONSHIPS? People in mixed HIV status relationships face all the same things as other people in relationship. But there are some extra issues: The partner(s) with HIV might focus on not infecting their partner(s). The partner(s) who do not have HIV may concentrate on taking care of the person/people with HIV. This can cause a serious lack of balance in the relationship. HIV can cause changes in the body. Antiretroviral medications (ARVs) may have unpleasant side effects. This might give the partner(s) with HIV negative feelings about their body and their health. It may be difficult to feel attractive and have a normal romantic relationship. Fear of transmitting HIV can cause an excess of caution. This might even stop all sexual activity. Review the following fact sheets for more information: Stopping the Spread of HIV Safer Sex Guidelines Condoms Ways HIV is Transmitted Try to have open discussions about your desires, your fears, and your limits.
    [Show full text]
  • Penicillin Allergy Guidance Document
    Penicillin Allergy Guidance Document Key Points Background Careful evaluation of antibiotic allergy and prior tolerance history is essential to providing optimal treatment The true incidence of penicillin hypersensitivity amongst patients in the United States is less than 1% Alterations in antibiotic prescribing due to reported penicillin allergy has been shown to result in higher costs, increased risk of antibiotic resistance, and worse patient outcomes Cross-reactivity between truly penicillin allergic patients and later generation cephalosporins and/or carbapenems is rare Evaluation of Penicillin Allergy Obtain a detailed history of allergic reaction Classify the type and severity of the reaction paying particular attention to any IgE-mediated reactions (e.g., anaphylaxis, hives, angioedema, etc.) (Table 1) Evaluate prior tolerance of beta-lactam antibiotics utilizing patient interview or the electronic medical record Recommendations for Challenging Penicillin Allergic Patients See Figure 1 Follow-Up Document tolerance or intolerance in the patient’s allergy history Consider referring to allergy clinic for skin testing Created July 2017 by Macey Wolfe, PharmD; John Schoen, PharmD, BCPS; Scott Bergman, PharmD, BCPS; Sara May, MD; and Trevor Van Schooneveld, MD, FACP Disclaimer: This resource is intended for non-commercial educational and quality improvement purposes. Outside entities may utilize for these purposes, but must acknowledge the source. The guidance is intended to assist practitioners in managing a clinical situation but is not mandatory. The interprofessional group of authors have made considerable efforts to ensure the information upon which they are based is accurate and up to date. Any treatments have some inherent risk. Recommendations are meant to improve quality of patient care yet should not replace clinical judgment.
    [Show full text]
  • HIV Infection and AIDS
    G Maartens 12 HIV infection and AIDS Clinical examination in HIV disease 306 Prevention of opportunistic infections 323 Epidemiology 308 Preventing exposure 323 Global and regional epidemics 308 Chemoprophylaxis 323 Modes of transmission 308 Immunisation 324 Virology and immunology 309 Antiretroviral therapy 324 ART complications 325 Diagnosis and investigations 310 ART in special situations 326 Diagnosing HIV infection 310 Prevention of HIV 327 Viral load and CD4 counts 311 Clinical manifestations of HIV 311 Presenting problems in HIV infection 312 Lymphadenopathy 313 Weight loss 313 Fever 313 Mucocutaneous disease 314 Gastrointestinal disease 316 Hepatobiliary disease 317 Respiratory disease 318 Nervous system and eye disease 319 Rheumatological disease 321 Haematological abnormalities 322 Renal disease 322 Cardiac disease 322 HIV-related cancers 322 306 • HIV INFECTION AND AIDS Clinical examination in HIV disease 2 Oropharynx 34Neck Eyes Mucous membranes Lymph node enlargement Retina Tuberculosis Toxoplasmosis Lymphoma HIV retinopathy Kaposi’s sarcoma Progressive outer retinal Persistent generalised necrosis lymphadenopathy Parotidomegaly Oropharyngeal candidiasis Cytomegalovirus retinitis Cervical lymphadenopathy 3 Oral hairy leucoplakia 5 Central nervous system Herpes simplex Higher mental function Aphthous ulcers 4 HIV dementia Kaposi’s sarcoma Progressive multifocal leucoencephalopathy Teeth Focal signs 5 Toxoplasmosis Primary CNS lymphoma Neck stiffness Cryptococcal meningitis 2 Tuberculous meningitis Pneumococcal meningitis 6
    [Show full text]
  • UNASYN® (Ampicillin Sodium/Sulbactam Sodium)
    NDA 50-608/S-029 Page 3 UNASYN® (ampicillin sodium/sulbactam sodium) PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION To reduce the development of drug-resistant bacteria and maintain the effectiveness of UNASYN® and other antibacterial drugs, UNASYN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION UNASYN is an injectable antibacterial combination consisting of the semisynthetic antibiotic ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]- 3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is: COONa O CH3 N CH O 3 NH S NH2 Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia­ 1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is: NDA 50-608/S-029 Page 4 COONa CH3 O N CH3 S O O UNASYN, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. UNASYN dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL.
    [Show full text]
  • Annex I Summary of Product Characteristics
    ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 4 1. NAME OF THE MEDICINAL PRODUCT VISTIDE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cidofovir equivalent to 375 mg/5 ml (75 mg/ml) cidofovir anhydrous. The formulation is adjusted to pH 7.4. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion 4. CLINICAL PARTICULARS 4.1 Therapeutic Indication Cidofovir is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Until further experience is gained, cidofovir should be used only when other agents are considered unsuitable. 4.2 Posology and Method of Administration Before each administration of cidofovir, serum creatinine and urine protein levels should be investigated. The recommended dosage, frequency, or infusion rate must not be exceeded. Cidofovir must be diluted in 100 milliliters 0.9% (normal) saline prior to administration. To minimise potential nephrotoxicity, oral probenecid and intravenous saline prehydration must be administered with each cidofovir infusion. Dosage in Adults • Induction Treatment. The recommended dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hr) administered once weekly for two consecutive weeks. • Maintenance Treatment. Beginning two weeks after the completion of induction treatment, the recommended maintenance dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hr) administered once every two weeks. Cidofovir therapy should be discontinued and intravenous hydration is advised if serum creatinine increases by = 44 µmol/L (= 0.5 mg/dl), or if persistent proteinuria = 2+ develops. • Probenecid.
    [Show full text]