DOCSLIB.ORG

Package Leaflet: Information for the Patient Cloxacillin Villerton Nordic A

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Package Leaflet: Information for the Patient Cloxacillin Villerton Nordic A Package leaflet: Information for the patient Cloxacillin Villerton Nordic A/S 1 g powder for solution for injection/infusion Cloxacillin Villerton Nordic A/S 2 g powder for solution for injection/infusion cloxacillin Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have further questions, ask your doctor or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Cloxacillin Villerton Nordic A/S is and what it is used for 2. What you need to know before you use Cloxacillin Villerton Nordic A/S 3. How to use Cloxacillin Villerton Nordic A/S 4. Possible side effects 5. How to store Cloxacillin Villerton Nordic A/S 6. Contents of the pack and other information 1. What Cloxacillin Villerton Nordic A/S is and what it is used for Cloxacillin Villerton Nordic A/S contains the active substance cloxacillin, which is an antibiotic acting against bacterial infections. It prevents the bacteria to form normal cell wall. Without a cell wall the bacteria die quickly. Cloxacillin is used to treat infections caused by certain bacteria, particularly staphylococci, which creates an enzyme called beta-lactamase. This enzyme has the ability to break down penicillin. Cloxacillin is different respect to standard penicillin since it is not degraded by beta-lactamase. Cloxacillin Villerton Nordic A/S is used to treat infections of skin and soft tissue, heart inflammation, abscesses, inflammation of bone marrow and blood poisoning. 2. What you need to know before you use Cloxacillin Villerton Nordic A/S Do not use Cloxacillin Villerton Nordic A/S: - if you are allergic to cloxacillin, other penicillins or to cephalosporins. - if you are allergic to cephalosporins (another group of antibacterial medicines). Warnings and precautions Talk your doctor or pharmacist before using Cloxacillin Villerton Nordic A/S - if you have impaired kidney function. - if you have/get diarrhoea. Other medicines and Cloxacillin Villerton Nordic A/S Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. It is especially important for the doctor to know if you are taking any of the following: - methotrexate (a medicine used in treatment of cancer or rheumatism) - contraceptive pill 1 - probenecid (a medicine against gout) - warfarin (a blood-thinning medicine) Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy No known risks related to use of Cloxacillin Villerton Nordic A/S during pregnancy. Breast-feeding Cloxacillin is excreted in human milk, but at therapeutic doses the risk of an effect on the infant is considered to be unlikely. Driving and using machines Cloxacillin Villerton Nordic A/S is not considered to influence on the ability to drive and use machines. Each person must assess their ability to drive a car or perform hazardous work. Drugs can affect your ability to drive or perform hazardous work. Read the information in this leaflet carefully. If necessary, talk to your doctor or pharmacist. Cloxacillin Villerton Nordic A/S contains sodium The maximum recommended daily dose of this medicinal product contains 600 mg sodium (found in table salt). This is equivalent to 30% of the adult recommended maximum daily dietary intake for sodium. Talk to your doctor or pharmacist if you need Cloxacillin Villerton Nordic A/S on a daily basis for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet. 3. How to use Cloxacillin Villerton Nordic A/S Your doctor will decide the dose according to your needs. Cloxacillin Villerton Nordic A/S is a powder for solution to be dissolved in sterile water. The solution is injected intravenously or intramuscularly or administered by intravenous infusion. If you use more Cloxacillin Villerton Nordic A/S than you should As this medicine is given by a doctor or other healthcare professional, it is very unlikely that you will be given too much Cloxacillin Villerton Nordic A/S. However, if you have any concerns you should let your doctor, nurse or pharmacist know immediately. Symptoms of an overdose include nausea, vomiting, diarrhoea, reduced level of consciousness and cramps. If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor immediately if you get any of the following serious side effects: - Severe allergic reaction (anaphylactic reaction). This kind of side effect may be life-threatening. One or several of the following symptoms may occur: erythema, itchy hives-like eczema (urticaria), breathing difficulties and vertigo (rare, may affect up to 1 in 1,000 users). 2 - In rare cases, Cloxacillin Villerton Nordic A/S may affect white blood cells so that the immune response weakens. If you get an infection with symptoms like fever combined with a severely worsened general condition or fever combined with local signs of infection, for example, pain in the neck/throat/mouth, or difficulties in passing urine, you should see a doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be excluded by blood tests. In this case, it is important that you inform the doctor about your medication. Other possible side effects: Common side effects (may affect up to 1 in 10 users): - inflammation of a blood vessel (thrombophlebitis) - nausea, diarrhoea - skin rash Uncommon (may affect up to 1 in 100 users): - increased number of white blood cells - hives (urticaria) Rare (may affect up to 1 in 1,000 users): - acute infection of the colon (pseudomembranous colitis) - decreased number of white blood cells - lack of blood platelets, resulting in a tendency to bleed (thrombocytopenia) - effect on the liver - effect on kidneys A fungal infection of the oral cavity and the female organs may occur. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Cloxacillin Villerton Nordic A/S Keep this medicine out of the sight and reach of children. Do not store above 25 °C. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Cloxacillin Villerton Nordic A/S contains - The active substance is cloxacillin. Each vial contains 1 g or 2 g of cloxacillin (as cloxacillin sodium). - This medicine contains no excipients. What Cloxacillin Villerton Nordic A/S looks like and contents of the pack The medicine is a white or almost white crystalline powder. 3 Pack sizes: 10 vials of 1 g powder 10 vials of 2 g powder Marketing Authorisation Holder and Manufacturer <[To be completed nationally]> {Name and address} <{tel}> <{fax}> <{e-mail}> <This medicinal product is authorised in the Member States of the EEA under the following names: {Name of the Member State}{Name of the medicinal product} {Name of the Member State}{Name of the medicinal product}> This leaflet was last revised in <{MM/YYYY}> <--------------------------------------------------------------------------------------------------------------- The following information is intended for healthcare professionals only: INSTRUCTIONS FOR USE AND HANDLING: Intramuscular injection: Dilute 500 mg in 2 ml water for injections and 2 g in 4 ml water for injections. Intravenous injection: Dilute 500 mg in 10 ml water for injections, 1 g in 20 ml water for injection and 2 g in 40 ml water for injections. Intermittent infusion: Dilute 2 g in a 100 ml sodium chloride 9 mg/ml (0.9 %) solution for injection, or 100 ml water for injections. Reconstitution of the powder or preparation of solution for infusion must be performed under aseptic conditions. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. SHELF LIFE OF THE RECONSTITUTED SOLUTION: Chemical and physical stability is documented for 12 hours at 25 °C and 24 hours at 2 - 8 °C. From a microbiological point of view the medicinal product should be administered immediately. If reconstituted solution is not administered immediately, the storage time and storage conditions prior to use is the responsibility of the administrator and should normally not exceed 12 hours at 25 °C or 24 hours at 2 - 8 °C, if reconstitution does not take place under controlled and validated aseptic conditions. 4 .
Load more

Recommended publications
  • Synergistic Activity of Ampicillin and Cloxacillin
    144 THE JOURNAL OF ANTIBIOTICS APR. 1969 SYNERGISTIC ACTIVITY OF AMPICILLIN AND CLOXACILLIN PROTECTIVE EFFECT OF CLOXACILLIN ON ENZYMATIC DEGRADATION OF AMPICILLIN BY PENICILLINASE, AND THERAPEUTIC ACTIVITY OF MIXTURES OF AMPICILLIN AND CLOXACILLIN MlNORUNlSHIDA, YASUHIROMlNE Research Laboratories, Fujisawa Pharmaceutical Co., Ltd., Osaka, Japan and Shogo Kuwahara Department of Microbiology, Toho University School of Medicine, Tokyo, Japan (Received for publication February 15, 1969) A mixture of ampicillin (aminobenzyl penicillin, AB-PC) and cloxacillin (methylchlorophenylisoxazolyl penicillin, MCI-PC) showed an excellent bacteri- cidal activity even at low concentrations in which either of the penicillins alone did not have any activity against a clinically isolated strain of Escherichia colt, resistant to both of these penicillins. In this case, the microbial degrada- ion of AB-PC, caused by penicillinase (PC-ase), was strongly inhibited in the presence of MCI-PC. The enzymatic hydrolysis of AB-PC by extracellular nd cell-bound PC-ase, obtained from an AB-PC resistant strain of Staphylo- coccus aureus, was also inhibited in the presence of MCI-PC. Against that, t a under comparable conditions, penicillin G (PC-G) was almost completely destroyed by cell-bound PC-ase from this organism. An in vivo synergism was observed when mixtures of AB-PC and MCI-PC were applied for the treatment of mice challenged with a clinically isolated strain of E. coli resistant to both of these penicillins. Similar results were obtained in the treatment of mice experimentally infected with a strain of Staphylococcus aureus, which is highly resistant to AB-PC, but sensitive to MCI-PC. A decrease in the rate of hydrolysis of methicillin (dimethoxyphenyl penicillin, DMP-PC) by staphylococcal penicillinase (PC-ase) was first noted by Rolinson and his co-workers^.
    [Show full text]
  • Orbenin-DC® (Benzathine Cloxacillin)
    ORBENIN-DC- cloxacillin benzathine suspension Merck Sharp & Dohme Corp. ---------- Orbenin-DC® (benzathine cloxacillin) F-27865909 DRY COW (VACA SECA) Intramammary Infusion (Infusión intramamaria) LONG ACTING FORMULA (FÓRMULA DE LARGA ACCIÓN) CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: Orbenin-DC (benzathine cloxacillin) is a stable, nonirritating suspension of benzathine cloxacillin containing the equivalent of 500 mg of cloxacillin per disposable syringe. Orbenin-DC is manufactured by a nonsterilizing process. Benzathine cloxacillin is a semisynthetic penicillin derived from the penicillin nucleus, 6-amino- penicillanic acid. Benzathine cloxacillin is the benzathine salt of 6-[3-(2-chlorophenyl)-5- methylisoxazolyl-4-carboxamido] penicillanic acid. The low solubility of Orbenin-DC results in an extended period of activity. Therefore, directions for use should be followed explicitly. ACTION: Benzathine cloxacillin is bactericidal in action against susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide. It is active against gram-positive organisms associated with mastitis such as Staphylococcus aureus and Streptococcus agalactiae and, because of its resistance to penicillinase, penicillin G-resistant staphylococci which may be the cause of mastitis. Appropriate laboratory tests should be conducted, including in vitro culturing and susceptibility tests on pretreatment milk samples collected aseptically. SUSCEPTIBILITY TEST: The Kirby-Bauer1 procedure, utilizing antibiotic susceptibility disks, is a quantitative method that may be adapted to determining the sensitivity of bacteria in milk to Orbenin-DC. For testing the effectiveness of Orbenin-DC in milk, follow the Kirby-Bauer procedure using the 1 mcg oxacillin susceptibility disk.
    [Show full text]
  • Management of Penicillin and Beta-Lactam Allergy
    Management of Penicillin and Beta-Lactam Allergy (NB Provincial Health Authorities Anti-Infective Stewardship Committee, September 2017) Key Points • Beta-lactams are generally safe; allergic and adverse drug reactions are over diagnosed and over reported • Nonpruritic, nonurticarial rashes occur in up to 10% of patients receiving penicillins. These rashes are usually not allergic and are not a contraindication to the use of a different beta-lactam • The frequently cited risk of 8 to 10% cross-reactivity between penicillins and cephalosporins is an overestimate based on studies from the 1970’s that are now considered flawed • Expect new intolerances (i.e. any allergy or adverse reaction reported in a drug allergy field) to be reported after 0.5 to 4% of all antimicrobial courses depending on the gender and specific antimicrobial. Expect a higher incidence of new intolerances in patients with three or more prior medication intolerances1 • For type-1 immediate hypersensitivity reactions (IgE-mediated), cross-reactivity among penicillins (table 1) is expected due to similar core structure and/or major/minor antigenic determinants, use not recommended without desensitization • For type-1 immediate hypersensitivity reactions, cross-reactivity between penicillins (table 1) and cephalosporins is due to similarities in the side chains; risk of cross-reactivity will only be significant between penicillins and cephalosporins with similar side chains • Only type-1 immediate hypersensitivity to a penicillin manifesting as anaphylaxis, bronchospasm,
    [Show full text]
  • Antibiotic Use for Sepsis in Neonates and Children: 2016 Evidence Update
    Antibiotic Use for Sepsis in Neonates and Children: 2016 Evidence Update Aline Fuchsa, Julia Bielickia,b, Shrey Mathurb, Mike Sharlandb, Johannes N. Van Den Ankera,c a Paediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, Basel, Switzerland b Paediatric Infectious Disease Research Group, Institute for Infection and Immunity, St George's University of London, London, United Kingdom c Division of Clinical Pharmacology, Children’s National Health System, Washington, DC, USA WHO-Reviews 1 TABLE OF CONTENTS 1. INTRODUCTION ............................................................................................................................... 3 1.1. Aims ......................................................................................................................................... 3 1.2. Background ............................................................................................................................. 3 1.2.1. Definition and diagnosis ................................................................................................. 3 Neonatal Sepsis ............................................................................................................................... 3 Paediatric Sepsis ............................................................................................................................. 4 Community versus hospital acquired sepsis .................................................................................. 5 1.2.2. Microbiology ..................................................................................................................
    [Show full text]
  • Antibiotic Dosing for Children: Draft Expert Recommendations for the 2017 Essential Medicines List for Children (Emlc)
    Antibiotic Dosing for Children: Draft expert Recommendations for the 2017 Essential Medicines List for Children (EMLc) Purpose and Scope of Recommendations Expert recommendations for antibiotic dosing in the EMLc have been developed to address the lack of harmony in currently available international formularies. In many instances, recommendations are historical practise-based and not strongly evidence-based. Limited evidence is available from studies of effectiveness and safety as well as all age pharmacokinetics for children. National preferences for weight-based (US), age-banded (UK) and weight-banded (WHO) dosing strategies have resulted in quite widely varying recommendations. The rationale of this dosing guidance has been to provide simple recommendations which are feasible in the LMIC context. Dosing guidance has been given as a single total daily dose (mg/kg/day) with options for acceptable frequency of dosing which can be adapted to local context. A maximum upper dose has been provided, largely based on available adult dosing. These recommendations have been developed for children ages 2 months to 12 years. In general, the aim was to produce a simple dosing guidance that covered all clinical infection syndromes, except severe infections such as meningitis, where significantly higher doses are recommended. Dosing recommendations have not been adjusted for children with renal or liver impairment. The recommendations have not accounted for global variation in rates of antimicrobial resistance. Using a single dose in this overall guidance does not reflect the range of doses that are actually required to translate the guidance into practical weight/age based formulations for children. Methods For the development of these recommendations, the expert group comprised paediatricians, paediatric clinical pharmacologists and pharmacists based in the UK and Europe.
    [Show full text]
  • Guide Cellulite Adulte WEB EN.Pdf
    OCTOBER 2017 DRUG ANTIBIOTICS CELLULITIS IN ADULTS This optimal usage guide is mainly intended for primary care health professionnals. It is provided for information purposes only and should not replace the clinician’s judgement. The recommendations were developed using a systematic approach and are supported by the scientific literature and the knowledge and experience of Quebec clinicians and experts. For more details, go to inesss.qc.ca. GENERAL INFORMATION IMPORTANT CONSIDERATIONS Cellulitis can be observed on all skin surfaces, but most cases are found on the legs. CELLULITIS IN ADULTS Cellulitis is typically caused by β-hemolytic streptococci or Staphylococcus aureus, although a pathogen is isolated in less than 20 % of cases. Differential diagnosis is a major issue, since some skin conditions – that do not require antibiotic therapy – can present similar symptoms/signs. RISK FACTORS FOR DEVELOPING CELLULITIS Portal of entry or potential reservoir Comorbidities and other factors • Injury • Venous or arterial insufficiency • Skin problem (e.g., eczema) • Lymphedema • Toe web abnormalities (e.g., tinea pedis) • Uncontrolled diabetes • Hygiene or neglect issues • Immunosuppression • Uncorrected dental problem • History of cellulitis DIAGNOSIS SIGNS AND SYMPTOMS Photos available to help with diagnosis Cellulitis diagnosis is generally characterized by the acute appearance of a continuous erythematous area (without an area of healthy skin inside) that’s edematous, warm and painful. The patient may also have systemic symptoms (fever, nausea, vomiting, chills, malaise, lack of appetite). Cellulitis generally does not cause any epidermal changes (scales, scabs, vesicles, etc.). If such changes are present, suspect a different or related pathology (e.g., eczema). CLINICAL ASSESSMENT Assess the general condition of the patient.
    [Show full text]
  • ABX-2 Newslet: Cystitis & Skin
    Antibiotics & Common Infections ABX-2: Uncomplicated Cystitis & Skin Stewardship, Effectiveness, Safety & Clinical Pearls- April 2017 ABX-2 RELATED LINKS RxFILES ACADEMIC DETAILING ON ABX CANADIAN GUIDELINES/REFERENCES We are excited to bring out the ABX-2 topic on the treatment of uncomplicated cystitis Bugs & Drugs: and skin & soft tissue (SSTI) infections. The new charts in this newsletter will support http://www.bugsanddrugs.ca/ our spring academic detailing discussions with providers in Saskatchewan. Our MUMS Guidelines: discussions on ABX-1 were very well received and we know many of you made use of the http://www.mumshealth.com extra support tools such as the “Gone Viral?” office/clinic posters and the patient friendly “Viral Prescription Pad”. These are all available at www.RxFiles.ca/abx. CYSTITIS / UTI U.S. IDSA 2010: ABX-2: A FEW PEARLS FROM INSIDE THAT CAUGHT OUR EYE... Acute Uncomplicated Cystitis and Pylonephritis (UTI) UNCOMPLICATED CYSTISIS - Page 2 - 3 > 60 YEARS https://academic.oup.com/cid/article- lookup/52/5/e103 1) Staying Power: > 60 years & still 96% or better! Susceptibility of E. coli, the most common urinary pathogen, to nitrofurantoin SK MOH 2013: (MACROBID) remains at 96% or better in Saskatchewan (per recent antibiograms). UTI in Continuing Care Settings “I used to be https://saskpic.ipac-canada.org/ so strong...” STAYING POWER photos/custom/UTI%20Guidelines%20 2) 60% - Are you kidding?! 19April2013.pdf In some institutional settings, like long-term care, E. coli resistance to ciprofloxacin can be as high as ~60%. No wonder antimicrobial SOGC 2010: stewardship messaging suggests “Reserve to Preserve” for when we really Recurrent UTI C IPROFLOXAC I N need it! http://www.jogc.com/article/S1701- 2163(16)34717-X/pdf 3) Urine cultures are not required - for most Skip the Urine Req.
    [Show full text]
  • Effectiveness of Antibiotic Infusion at Drying-Off in Preventing New
    Effectiveness of Antibiotic Infusion Association Practitioners; Bovine open ofaccess distribution. American Copyright © at Drying-Off in Preventing New Mastitis Infections in Cows* M. G. Sinkevich, M.S., P. B. Barto, V.M.D., M.S., Ph.D., L. J. Bush, M.S., Ph.D. M. E. Wells, M.S., Ph.D. and G. D. Adams, M.S. Agricultural Experiment Station Oklahoma State University Stillwater, Oklahoma 74074 Bovine mastitis is responsible for greater Ayrshire, 13 Guernseys, 23 Jerseys, and 77 economic loss than any other single disease Holsteins) were blocked on the basis of number of affecting dairy cattle. Losses may be attributed to lactations completed (one, two, three or more) and reduced milk yield, altered milk composition, randomly assigned to treatment groups. Micro­ veterinary fees, cost of drugs, increased culling rate cocci, diphtheroids, and Staph, epidermidis were and cost of replacement cows (8). recorded as nonpathogens. Cows having quarters Most mastitis causing bacteria (Staphylococcus with these organisms were regarded as negative and aureus, Streptococcus uberis, Strep, dysgalactiae, were included in the experiment. Pseudomonas aeruginosa, Escherichia coli, Kleb­ The treatments were: (a) control, no infusion siella species, and Cory neb acterium pyogenes) are and (b) intramammary infusion of 500 mg. widely distributed in the environment, so that benzathine cloxacillina into each quarter after the complete eradication appears to be impossible last milking of the lactation period. All cows in (1,7,5). Strep, agalactiae is limited to the mam­ both groups were teat dipped with an iodine mary gland with many opportunities existing for solution15 (10,000 ppm available iodine) once a day transfer from cow to cow.
    [Show full text]
  • Antibiotics & Common Infections
    Antibiotics & Common Infections Stewardship, Effectiveness, Safety & Clinical Pearls October 2016 ANTIMICROBIAL RELATED LINKS ANTIMICROBIAL STEWARDSHIP GETTING STRATEGIES TO WORK - REAL WORLD CANADIAN GUIDELINES There are world-wide efforts that look • Public, patient & provider education for strategies to deal with the challenge of over time to change expectations Bugs & Drugs (Alberta/BC): growing antimicrobial resistance. How can • Realistic appreciation for viral versus http://www.bugsanddrugs.ca/ we all work together to be stewards of this bacterial etiologies important, but limited resource? • Delayed prescriptions for select MUMS Guidelines – “Orange Book” conditions with instructions to fill only (Anti-infective Review Panel): SELECT ANTIBIOTIC RESISTANT if symptoms do not resolve or condition http://www.mumshealth.com PATHOGENS OF MAJOR CONCERN worsens. (Offer to those who value convenience.) PATIENT RESOURCES • methicillin-resistant Staphylococcus aureus (MRSA) • “It’s easy to prescribe antibiotics. It i Canadian Antibiotic Awareness: • multi-drug resistant Streptococcus takes time, energy & trust not to do so.” http://www.antibioticawareness.ca pneumonia (MRSP) Success lies in changing the culture & the which includes: • vancomycin-resistant enterococci (VRE) understanding of antibiotic limitations, • multi-drug resistant Escherichia coli & benefits & harms. 1. Viral Prescription Pad for respiratory other gram negative bacteria (e.g. ESBL) infections (download or order for free); ANTIBIOTIC HARMS – UNDERAPPRECIATED provides information about symptomatic KEY STRATEGIES FOR REDUCING ANTIBIOTICS Q To the Patient relief for viral infections and indicates when • vaccinations to prevent infections and • 1 in 5 emergency room visits for adverse patients should consider a return visit. decrease antibiotic use drug events (ADEs) are from antibiotics. • practice and educate on infection • Antibiotics are the most common cause of 2.
    [Show full text]
  • Summary Report
    European Medicines Agency Veterinary Medicines and Inspections Revision 11 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS PENICILLINS SUMMARY REPORT 1. Penicillins (and their salts including the benzatine, procaine and sodium salts) have been widely used in veterinary medicine for more than 30 years and today form the most important group of antibiotics. 2. Penicillins have a low toxicity in the normal sense of the word; the therapeutic index is more than 100, and toxic effect have only been seen after extremely high doses. No teratogenic effects have been recorded. In connection with therapeutic use of penicillins hypersensitivity reactions are by far the most commonly encountered side-effects. The amount of penicillin haptene necessary to sensitize a subject is several orders of magnitude higher than the quantity needed to trigger an allergic reaction in an already sensitized individual. Furthermore, it takes a much higher oral dose to induce an allergic reaction than if the drug is administered parenterally. Against this background it can be concluded that the small amounts of penicillins which may be present in food products of animal origin are not able to sensitize the consumer, but will, at the most, trigger a reaction in already sensitized subjects. Literature contains only very few references reporting allergic reactions traceable to penicillin residues in foods. At least 6 µg penicillin (equivalent to 10 IU penicillin) seems normally necessary to provoke an allergic reaction. Penicillins are strong inhibitors of the bacteria used in production processes employed by the dairy industry. Concentrations as low as 0.006 µg (0.01 IU) penicillin per gram milk considerably inhibit starter cultures and delay acid production.
    [Show full text]
  • Efficacy of Cloxacillin Versus Cefazolin for Methicillin
    Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2018-023151 on 1 September 2018. Downloaded from Efficacy of cloxacillin versus cefazolin for methicillin-susceptible Staphylococcus aureus bacteraemia (CloCeBa): study protocol for a randomised, controlled, non- inferiority trial Charles Burdet,1,2 Paul Loubet,1,3 Vincent Le Moing,4 William Vindrios,3 Marina Esposito-Farèse,5,6 Morgane Linard,2 Tristan Ferry,7 Laurent Massias,1,8 Pierre Tattevin,9 Michel Wolff,1,10 François Vandenesch,11 Nathalie Grall,1,12 Caroline Quintin,5 France Mentré,1,2 Xavier Duval,1,6 François-Xavier Lescure,1,3 for the CloCeBa study group To cite: Burdet C, Loubet P, ABSTRACT Strengths and limitations of this study Le Moing V, et al. Efficacy of Introduction Methicillin-susceptible Staphylococcus cloxacillin versus cefazolin aureus (MSSA) bacteraemia is a common and severe for methicillin-susceptible ► First randomised controlled trial to compare the disease responsible for approximately 65 000 deaths every Staphylococcus aureus safety and efficacy of cefazolin and cloxacillin for year in Europe. Intravenous antistaphylococcal penicillins bacteraemia (CloCeBa): treatment of methicillin-susceptible Staphylococcus (ASP) such as cloxacillin are the current recommended study protocol for a aureus bacteraemia. antibiotics. However, increasing reports of toxicity and randomised, controlled, non- ► Pragmatic trial designed to interfere as little as pos- recurrent stock-outs of ASP prompted healthcare providers inferiority trial. BMJ Open sible with usual care. 2018;8:e023151. doi:10.1136/ to seek for alternative antibiotic treatment. Based on ► Investigation of the potential impact of different bmjopen-2018-023151 retrospective studies, cefazolin, a first-generation types of S.
    [Show full text]
  • Cloxacillin Drug Class1 Antibiotic – Penicillin
    Monographs for Commonly Administered Intravenous Medications in Home and Community Care Cloxacillin Drug Class1 Antibiotic – Penicillin Spectrum1,2 Refer to product monograph for complete spectrum Staphylococcal species and Streptococcal species Cross Sensitivities / Allergies1 Cross sensitivities with penicillins and possibly cephalosporins Indications1,3 Skin and skin structure Osteomyelitis Septicemia Endocarditis Other conditions based on culture and sensitivity results Outpatient Considerations3 Must be able to access laboratory monitoring (either at outpatient laboratory or by arranging in-home lab) if using an interacting oral medication (see Potential Drug Interactions section) or receiving long term therapy. Administration via central venous access device is preferred, as cloxacillin is an irritant. If treatment duration is greater than 7 days, prescriber to arrange order central line access. Oral cloxacillin may an option, and step down from IV to oral should be considered after 3-5 days, based on indication, gastrointestinal absorption and clinical status. IM dosing is also an option. Prescribing Considerations Usual dose is 500 mg – 2 g IV q6h and Dosage in Adults1,3 Maximum dose is 8 - 12 g IV per day (e.g., 2 g IV q4h) No renal dose adjustment is necessary Administration Dispensed in an ambulatory cassette/multi-dose bag intended for an infusion pump, programmed to deliver the total daily dose via preprogrammed boluses over 24 hours. Prior to connecting the patient to therapy, double check the pump programming versus the order. Recheck after each order change. Contact pharmacy infusion provider for specific questions pertaining to administration. Stability / Compatibilities1 Compatible with: Follow the stability as specified by the infusion 0.9% Sodium chloride (NS) provider (as it is based on the dilution).
    [Show full text]