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Amoxicillin

Klassificering: A

Preparat: Amimox®, Amoclav, Amoxicillin 2care4, Amoxicillin Aurobindo, Amoxicillin Ebb, Amoxicillin Mylan, Amoxicillin Sandoz, Amoxicillin/Clavulanic acid 2care4, Amoxicillin/Clavulanic acid Actavis, Amoxicillin/Clavulanic acid Aurobindo, Amoxicillin/Clavulanic acid BB, Amoxicillin/Klavulansyra 2care4, Amoxicillin/Klavulansyra Ebb, Amoxil Vials for Injection 500 mg, Augmentin, Augmentin i.v., Betaklav, Bioclavid, Co-amoxiclav, DAP-amoxicillin, Imacillin®, Klaximol, Nexium® HP, Spektramox®

ATC kod: A02BD06, J01CA04, J01CR02, V01AA20

Substanser: amoxicillin, amoxicillinnatrium, amoxicillintrihydrat

Sammanfattning

En stor studie har visat att känsligheten för amoxicillin var lika hos E. coli-positiva urinprov från kvinnor och män. Vissa studier har rapporterat mer resistens mot amoxicillin hos pojkar/män medan andra studier inte har påvisat någon könsskillnad.

Additional information

Pharmacokinetics and dosing

In a pharmacokinetic study (without significance calculations) in healthy volunteers (6 men, 6 women) amoxicillin mean half-life was shorter in men than in women (54 min vs. 73 min) after a single dose (500 mg). Higher concentration of amoxicillin was found in the men’s urine. However, no differences in exposure between men and women were shown [2].

A pharmacokinetic study (17 women) described significant changes in amoxicillin pharmacokinetics during pregnancy, in comparison to postpartum circumstances. Amoxicillin exposure was lower in the second and third trimesters of pregnancy than three months postpartum. On the contrary, creatinine clearance and amoxicillin renal clearance and secretion were higher during pregnancy. Plasma half-life of amoxicillin was shorter in the second and third trimesters than postpartum [3].

No sex differentiation in dosing has been recommended by the manufacturer [4].

Effects

Resistance patterns for pathogens often differ between populations. A Dutch study comparing resistance in urinary samples from 560 men with historic data from urinary samples from 917 women [5] found no difference between men and women in E.colisusceptibility to amoxicillin [6]. In contrast to this a Portuguese retrospective analysis of urinary samples (120 691 (78%) from women and 34 898 (22%) from men) amoxicillin resistance was more common in male urinary samples positive for E. coliandP. mirabilis[7].

Another study of urinary E. coliisolates (2 274 men, 32 265 women) has described age- and sex-specific antibiotic susceptibility patterns for ampicillin, amoxicillin clavulanate, ciprofloxacin, nitrofurantoin and trimethoprim-sulfamethoxazole. Amoxicillin/clavulanic acid susceptibility was similar in men and women (56.9% vs. 67.3%). Age-specific susceptibilities differed between men and women for all antibiotics studies except trimethoprim-sulfamethoxazole. However, the magnitude of the observed differences was generally less than 5% and the authors suggest that they may not represent clinically meaningful differences [8].

The benefit of antibiotic prophylaxis in preventing infections after craniotomy has been evaluated based on surveillance data of infections after craniotomy (one including 4 878 men and women, the other study 3134 men, 3109 women) [9,10]. In both studies, patients received cloxacillin or amoxicillin-clavulanate. Results showed that antibiotic prophylaxis decreased infections rates [9] but did not prevent meningitis [10]. Male sex was among risk factors for infection and meningitis.

Adverse effects

Amoxicillin/clavulanic acid can induce idiosyncratic drug-induced liver injury (DILI). Clinical studies have reported a higher incidence of DILI in women with certain drugs such as nitrofurantoin, flucloxacillin, erythromycin and isoniazid [11]. A study of amoxicillin/clavulanic acid induced DILI (35 men, 26 women) showed association with certain HLA I and II genotypes [12].

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Other information

A retrospective study, including 1921 patients (794 men, 1122 women, lack of access to 5 medical records), found a greater occurrence of positive penicillin skin test result in female patients than in male patients with self-reported penicillin allergy. The risk was calculated from the whole set of 64 positive results (11 men, 53 women), including different penicillins [1].A retrospective cohort study, analyzing data for antibiotic prescriptions in outpatient care in Belgium, revealed that girls/women were prescribed amoxicillin to a greater extent than boys/men, compared to broad-spectrum antibiotics. Also, female physicians (general practitioners and pediatricians) prescribed more amoxicillin, compared with broader spectrum alternatives, than male colleagues [13].

Försäljning på recept

Fler kvinnor än män hämtade ut läkemedel innehållande amoxicillin (ATC-kod J01CA04) på recept i Sverige år 2015, totalt 76 277 kvinnor och 66 376 män. Det motsvarar 16 respektive 14 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgrupperna 0-4 år och 70 år och äldre hos båda könen. I åldersgrupperna 0-4 år och 75 år och äldre var läkemedel innehållande amoxicillin i genomsnitt 1,4 gånger vanligare hos pojkar/män och i åldersgruppen 10-69 år i genomsnitt 1,5 gånger vanligare hos flickor/kvinnor [14].

Uppdaterat: 2019-02-26

Litteratursökningsdatum: 2014-09-17

Referenser

  1. Park MA, Matesic D, Markus PJ, Li JT. Female sex as a risk factor for penicillin allergy. Ann Allergy Asthma Immunol. 2007;99:54-8. PubMed
  2. Philipson A, Sabath LD, Rosner B. Sequence effect on ampicillin blood levels noted in an amoxicillin, ampicillin, and epicillin triple crossover study. Antimicrob Agents Chemother. 1975;8:311-20. PubMed
  3. Andrew MA, Easterling TR, Carr DB, Shen D, Buchanan ML, Rutherford T et al. Amoxicillin pharmacokinetics in pregnant women: modeling and simulations of dosage strategies. Clin Pharmacol Ther. 2007;81:547-56. PubMed
  4. Amimox (amoxicillin). Summary of Product Characteristics. Medical Products Agency - Sweden; 2016.
  5. den Heijer CD, Donker GA, Maes J, Stobberingh EE. Antibiotic susceptibility of unselected uropathogenic Escherichia coli from female Dutch general practice patients: a comparison of two surveys with a 5 year interval. J Antimicrob Chemother. 2010;65:2128-33. PubMed
  6. den Heijer CD, Penders J, Donker GA, Bruggeman CA, Stobberingh EE. The importance of gender-stratified antibiotic resistance surveillance of unselected uropathogens: a Dutch Nationwide Extramural Surveillance study. PLoS One. 2013;8:e60497. PubMed
  7. Linhares I, Raposo T, Rodrigues A, Almeida A. Frequency and antimicrobial resistance patterns of bacteria implicated in community urinary tract infections: a ten-year surveillance study (2000-2009). BMC Infect Dis. 2013;13:19. PubMed
  8. McGregor JC, Elman MR, Bearden DT, Smith DH. Sex- and age-specific trends in antibiotic resistance patterns of Escherichia coli urinary isolates from outpatients. BMC Fam Pract. 2013;14:25. PubMed
  9. Korinek AM, Golmard JL, Elcheick A, Bismuth R, van Effenterre R, Coriat P et al. Risk factors for neurosurgical site infections after craniotomy: a critical reappraisal of antibiotic prophylaxis on 4,578 patients. Br J Neurosurg. 2005;19:155-62. PubMed
  10. Korinek AM, Baugnon T, Golmard JL, van Effenterre R, Coriat P, Puybasset L. Risk factors for adult nosocomial meningitis after craniotomy: role of antibiotic prophylaxis. Neurosurgery. 2006;59:126-33; discussion 126-33. PubMed
  11. Leise MD, Poterucha JJ, Talwalkar JA. Drug-induced liver injury. Mayo Clin Proc. 2014;89:95-106. PubMed
  12. Donaldson PT, Daly AK, Henderson J, Graham J, Pirmohamed M, Bernal W et al. Human leucocyte antigen class II genotype in susceptibility and resistance to co-amoxiclav-induced liver injury. J Hepatol. 2010;53:1049-53. PubMed
  13. Blommaert A, Coenen S, Gielen B, Goossens H, Hens N, Beutels P. Patient and prescriber determinants for the choice between amoxicillin and broader-spectrum antibiotics: a nationwide prescription-level analysis. J Antimicrob Chemother. 2013;68:2383-92. PubMed
  14. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Författare: Anna Garmén, Desirée Loikas

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson