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Augmentin safety information19
Contraindications
AUGMENTIN is contra-indicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins
AUGMENTIN is contra-indicated in patients with a previous history of AUGMENTIN-associated jaundice/hepatic dysfunction.
Warnings and precautions
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity
Adverse Events
Very Common: Diarrhoea (in adults)
Common: nausea, vomiting, mucocutaneous candidiasis, diarrhoea (in children)
References
- Marchisio P, et al. Pediatr Infect Dis J. 2019;38(12S Suppl):S10–21.
- Lieberthal A, et al. Pediatrics. 2013;131:e964–99.
- Suzuki HG, et al. BMJ Open 2020;10:e035343.
- World Health Organization. 22nd WHO Essential Medicines List, 2021. Available from: https://www.who.int/ publications/i/item/WHO-MHP-HPS-EML-2021.02. Accessed September 2023.
- Rosenfeld RM, et al. Head Neck Surg. 2015;152(Suppl 2):S1–39.
- Chow AW, et al. Clin Infect Dis 2012;54(8):e72–112.
- Orlandi RR, et al. Int Forum Allergy Rhinol. 2021;11(3):213–739.
- FDA Drug Safety Communication. FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together. Available from: https://www.fda.gov/Drugs/DrugSafety/ucm500143.htm. Accessed September 2023.
- Shulman ST, et al. Clin Infect Dis. 2012;55(10):e86–102.
- Munck H, et al. Eur J Clin Microbiol Infect Dis. 2018;37(7):1221–30.
- Metlay JP, et al. Am J Respir Crit Care Med. 2019;200(7):e45-67.
- Pneumonia (community acquired): antimicrobial prescribing. NICE guideline. 16 September 2019. Available from: https://www.nice.org.uk/guidance/ng138/resources/pneumonia-communityacquiredantimicrobialprescribingp df-66141726069445. Accessed September 2023.
- Bradley JS, et al. Clin Infect Dis. 2011;53(7):e25–76.
- Harris M, et al. Thorax. 2011;66 Suppl 2:ii1–23.
- Lim WS, et al. Thorax. 2009;64 Suppl 3:iii1–55.
- Stevens DL, et al. Clin Infect Dis 2014;1-43.
- Lipsky BA, et al. Clin Infect Dis 2012;54(12):132–73.
- Cellulitis and erysipelas: antimicrobial prescribing. NICE guideline. 27 September 2019. Available from: https://www.nice.org.uk/guidance/ng141/resources/cellulitis-and-erysipelas-antimicrobialprescribingp df-66141774778309. Accessed Se ptember2023.
- Augmentin prescribing information.
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Department of Pharmacovigilance & Drug Information |
دائرة التيقظ و المعلومات الدوائية المديرية العامة للصيدلة و الرقابة الدوائية وزارة الصحة, سلطنة عمان 0096822357687 / 0096822357686 :هاتف 0096822358489 :فاكس pharma-vigil@moh.gov.om :البريد الالكتروني www.moh.gov.om :الموقع الالكتروني |
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PM-RCH-ACA-WCNT-240003 Date of preparation: July 2024
