Amoxi-Clav Augmentin (Amoxicillin Clavulanate): Side Effects, Interactions …

Amoxi-Clav Augmentin (Amoxicillin Clavulanate): Side Effects, Interactions …

Amoxicillin/clavulanic acid

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combination antibiotic drug

Amoxicillin/clavulanic acid
Clavulanic acid.svg 1.5x, // 2x” data-file-width=”512″ data-file-height=”360″ />
Combination of
Amoxicillin Penicillin antibiotic
Clavulanic acid Beta-lactamase inhibitor
Clinical data
Trade names Augmentin, Clavulin, other [2]
AHFS / Monograph
MedlinePlus a685024
License data
  • US  FDA :  Augmentin
  • AU: B1
  • US: B (No risk in non-human studies)
Routes of
by mouth, intravenous [1]
ATC code
  • J01CR02 ( WHO )
Legal status
Legal status
  • AU: S4 (Prescription only)
  • CA: ℞-only
  • UK: POM (Prescription only)
  • US: ℞-only
CAS Number
  • 74469-00-4  ☒N
PubChem CID
  • 6435923
  • 4940608  ☑Y
  • ChEMBL1697738  ☒N

 ☒N☑Y  (what is this?)    (verify)

Amoxicillin/clavulanic acid, also known as co-amoxiclav, is an antibiotic useful for the treatment of a number of bacterial infections . [3] It is a combination consisting of amoxicillin , a β-lactam antibiotic , and potassium clavulanate , a β-lactamase inhibitor . [3] It is specifically used for otitis media , strep throat , pneumonia , cellulitis , urinary tract infections , animal bites , and tuberculosis . [3] It is taken by mouth or by injection into a vein . [1]

Common side effects include diarrhea , vomiting, and allergic reactions . [3] It also increases the risk of yeast infections , headaches, and blood clotting problems . [1] [4] It is not recommended in people with a history of a penicillin allergy . [1] It is relatively safe for use during pregnancy. [3]

Amoxicillin/clavulanic acid was approved for medical use in the United States in 1984. [3] It is on the World Health Organization’s List of Essential Medicines , the most effective and safe medicines needed in a health system . [5] It is available as a generic medication. [3] The wholesale cost in the developing world is about US$0.18–1.14 per day. [6] In the United States a course of treatment costs $50–100. [2]


  • 1 Medical uses
  • 2 Adverse effects
  • 3 History
  • 4 Preparations
  • 5 Veterinary use
    • 5.1 Bacterial resistance
  • 6 References
  • 7 External links

Medical uses[ edit ]

Amoxicillin/clavulanic acid is widely used to treat or prevent many infections caused by susceptible bacteria, such as:

  • urinary tract infections
  • respiratory tract infections
  • skin and soft tissue infections
  • sinus infections
  • cat scratches
  • infections caused by the bacterial flora of the mouth , such as:
    • dental infections
    • infected animal bites
    • infected human bites (including uncomplicated “clenched-fist” or “reverse-bite” injuries ) [7] [8]

This combination results in an antibiotic with an increased spectrum of action and restored efficacy against amoxicillin-resistant bacteria that produce β-lactamase.

Adverse effects[ edit ]

Possible side effects include diarrhea , vomiting, nausea , thrush , and skin rash . These do not usually require medical attention. As with all antimicrobial agents, antibiotic-associated diarrhea due to Clostridium difficile infection—sometimes leading to pseudomembranous colitis —may occur during or after treatment with amoxicillin/clavulanic acid. [8]

Rarely, cholestatic jaundice (also referred to as cholestatic hepatitis, a form of liver toxicity ) has been associated with amoxicillin/clavulanic acid. The reaction may occur up to several weeks after treatment has stopped, and usually takes weeks to resolve. It is more frequent in men, older people, and those who have taken long courses of treatment; the estimated overall incidence is one in 100,000 exposures. [8] In the United Kingdom, co-amoxiclav carries a warning from the Committee on Safety of Medicines to this effect. [7]

As all aminopenicillins , amoxicillin has been associated with Stevens–Johnson syndrome / toxic epidermal necrolysis , although these reactions are very rare. [8] [9]

History[ edit ]

British scientists working at Beecham (now part of GlaxoSmithKline), filed for US patent protection for the drug combination in 1979.
They marketed it under the trade name Augmentin. [7] A patent was granted in 1985. [10]

Preparations[ edit ]

Amoxicillin/clavulanic acid is the International Nonproprietary Name (INN) and co-amoxiclav is the British Approved Name (BAN).

Many branded products indicate their strengths as the quantity of amoxicillin. Augmentin 250, for example, contains 250 mg of amoxicillin and 125 mg of clavulanic acid . [7] [11]

An intravenous preparation has been available in the UK since 1985, [12] but no parenteral preparation is available in the US; the nearest equivalent is ampicillin/sulbactam .

Suspensions of amoxicillin/clavulanic acid are available for use in children. They must be refrigerated to maintain effectiveness.

Veterinary use[ edit ]

Amoxicillin/clavulanic acid is used in numerous animals for a variety of conditions:

  • Dogs: periodontitis , kennel cough [13] [14]
  • Cats: urinary tract infections, skin and soft tissue infections
  • Calves: enteritis , navel ill
  • Cattle: respiratory tract infections, soft tissue infections, metritis , mastitis
  • Pigs: respiratory tract infections, colibacillosis , mastitis, metritis, agalactia

In combination with prednisolone , it is used for intramammary infusion for the treatment of mastitis in lactating cows. Trade names include Clavaseptin, Clavamox, and Synulox.

Amoxicillin/clavulanic acid is banned from use in domestic-food animals (cattle, swine, etc.) in both the US and Europe; in the UK, Synulox can be used in domestic-food animals as long as a specified withdrawal period is observed.

Bacterial resistance[ edit ]

Bacterial antibiotic resistance is a growing problem in veterinary medicine . Amoxicillin/clavulanic acid is reported to be effective against clinical Klebsiella infections, but is not efficacious against Pseudomonas infections. [15]

References[ edit ]

  1. ^ a b c d WHO Model Formulary 2008 (PDF). World Health Organization. 2009. p. 102. ISBN   9789241547659 . Archived (PDF) from the original on 13 December 2016. Retrieved 8 December 2016.

  2. ^ a b Hamilton, Richart (2015). Tarascon Pocket Pharmacopoeia 2015 Deluxe Lab-Coat Edition. Jones & Bartlett Learning. p. 97. ISBN   9781284057560 .
  3. ^ a b c d e f g “Amoxicillin and Clavulanate Potassium” . The American Society of Health-System Pharmacists. Archived from the original on 29 November 2016. Retrieved 8 December 2016.
  4. ^ Gillies, M; Ranakusuma, A; Hoffmann, T; Thorning, S; McGuire, T; Glasziou, P; Del Mar, C (17 November 2014). “Common harms from amoxicillin: a systematic review and meta-analysis of randomized placebo-controlled trials for any indication” . Canadian Medical Association Journal. 187: E21–31. doi : 10.1503/cmaj.140848 . PMC   4284189 . PMID   25404399 .
  5. ^ “WHO Model List of Essential Medicines (19th List)” (PDF). World Health Organization. April 2015. Archived (PDF) from the original on 13 December 2016. Retrieved 8 December 2016.
  6. ^ “Amoxicillin + Clavulanic Acid” . International Drug Price Indicator Guide. Retrieved 8 December 2016.
  7. ^ a b c d British National Formulary (57 ed.). March 2009.
  8. ^ a b c d Gordon D (2010). “Amoxicillin–Clavulanic Acid (Co-Amoxiclav)”. In Grayson ML; et al. Kucers’ the Use of Antibiotics: a Clinical Review of Antibacterial, Antifungal, Antiparasitic and Antiviral Drugs. London: Hodder Arnold/ASM Press. pp. 193–4. ISBN   0-340-92767-4 .
  9. ^ Harr T, French LE (2010). “Toxic epidermal necrolysis and Stevens-Johnson syndrome” . Orphanet Journal of Rare Diseases. 5: 39. doi : 10.1186/1750-1172-5-39 . PMC   3018455 . PMID   21162721 .
  10. ^ US 4441609  
  11. ^ “Augmentin — Prescribing Information” (PDF). December 2006. Archived (PDF) from the original on 20 December 2013.
  12. ^ Davies BE, Boon R, Horton R, Reubi FC, Descoeudres CE (October 1988). “Pharmacokinetics of amoxycillin and clavulanic acid in haemodialysis patients following intravenous administration of Augmentin” . British Journal of Clinical Pharmacology. 26 (4): 385–90. doi : 10.1111/j.1365-2125.1988.tb03395.x . PMC   1386558 . PMID   3190988 .
  13. ^ “Canine Infectious Tracheobronchitis (Kennel Cough)” . Archived from the original on 2006-05-21. Retrieved 2013-05-30.
  14. ^ “Kennel Cough – Symptoms and Treatment” . Archived from the original on 10 May 2013. Retrieved 30 May 2013.
  15. ^ Federation of Veterinarians in Europe Position Paper: “Antibiotic Resistance & Prudent Use of Antibiotics in Veterinary Medicine”

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      Antibiotic Class:

      Beta-lactam/beta-lactamase inhibitor


      Staphylococcus aureus (methicillin susceptible),
      Coagulase negative Staphylococci, Streptococcus pneumoniae (penicillin
      susceptible), Streptococcus spp., Haemophilus influenzae, Moraxella
      catarrhalis, Neisseria meningitides, Neisseria gonorrhoeae, Enterobacteriaceae,
      E. coli

      Mechanism of

      The beta-lactamase inhibitors are recognized as substrates
      for the beta-lactamases produced by bacteria. This allows the actual beta-lactams
      to attack the bacterial cell wall by binding to penicillin binding proteins


      Time dependent killer (Time > MIC)


      (of the clavulanic acid)

      Dose 200mg: Cmax: 8.5-14.3 mcg/L; Protein binding: 20%;
      Volume of distribution: 0.16-0.25L/kg;
      Table 5

      Adverse Effects:

      No new adverse effects are seen as a result of adding beta-lactamase
      inhibitors to beta-lactam antibiotics. The adverse reactions would remain the
      same for the parent compound


      PO: Complete listing on
      Table 6

      Dosing in adults:

      Mild/Moderate: 250mg q8h to 500mg q8h

      Severe: 875mg-2000mg q12h

      Dosing in pediatrics:

      Mild/Moderate: 20-25mg/kg/day divided q8h

      Severe: 40-45mg/kg/day divided q8h

      Table 8

      Disease state based dosing:

      Renal failure:  CrCl > 30mL/min: 500mg q8-12h or 875mg q12h

                             CrCl 10-30mL: 250-500mg q12h

                             CrCl < 10mL/min: 250-500mg q24h

      Hepatic failure:  No dosing changes recommended at this


      Precautions:  hypersensitivity to penicillins, history of
      gastrointestinal disease, particularly colitis, renal impairment


      Acenocoumarin � increased risk of bleeding; Allopurinol �
      higher probablility of amoxicillin rash; Contraceptives – decreased
      contraceptive effectiveness; Live
      Typhoid Vaccine –
      decreased immunological response to the
      typhoid vaccine; Methotrexate � methotrexate toxicity; Probenecid – increased
      amoxicillin levels; Warfarin � increased risk of bleeding


      Category B: No evidence of risk
      in humans but studies inadequate.

      Monitoring Requirements:

      Culture and sensitivities, serum levels, signs and symptoms of infection, white
      blood cell count

      Urinalysis, BUN, SCr, AST and ALT,
      skin rash, Neutropenia and

      Brand names/Manufacturer: 


      • Home
      • Drugs and Medications A-Z
      • A
      • Amoxi-Clav


      (amoxicillin – clavulanic acid)

      DIN (Drug Identification Number)
      02326507     AMOXI-CLAV 250/125 MG Tablet
      02326515     AMOXI-CLAV 500MG/125MG Tablet
      02326523     AMOXI-CLAV 875 MG/125 MG Tablet

      About this Medication
      • How does this medication work? What will it do for me?
      • What form(s) does this medication come in?
      • How should I use this medication?
      • Who should NOT take this medication?
      • What side effects are possible with this medication?
      • Are there any other precautions or warnings for this medication?
      • What other drugs could interact with this medication?
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      How does this medication work? What will it do for me?

      This combination product containing amoxicillin and clavulanic acid belongs to the group of medications known as antibiotics. It is used to treat infections caused by certain bacteria. Amoxicillin works by killing the bacteria that is causing the infection. Clavulanic acid helps make the amoxicillin more effective. This medication is most commonly used to treat infections of the sinus, ear, lung, skin, and bladder.

      This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

      Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

      Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

      Facts vs. Myths: Pneumococcal disease

      Facts vs. Myths: Pneumococcal disease

      You may be at higher risk than you think from bacteria that can lead to pneumonia, bacteremia, and meningitis.

      Get the facts

      What form(s) does this medication come in?

      250 mg/125 mg
      Each white, oval, biconvex, film-coated tablet engraved “250-125” on one side and plain on the other, contains 250 mg amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (in a ratio of 2:1). Nonmedicinal ingredients: magnesium stearate, croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, polyethylene glycol, and titanium dioxide.

      875 mg/125 mg
      Each white, oval, biconvex, film-coated tablet scored and engraved "AC" on one side and plain on the other, contains amoxicillin 875 mg as the trihydrate and clavulanic acid 125 mg as the potassium salt (in a ratio of 7:1). Nonmedicinal ingredients: magnesium stearate, croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide, and ethylcellullose.

      Your pneumococcal vaccine options

      Your pneumococcal vaccine options

      There are important differences between the two pneumococcal vaccines for adults available in Canada.

      Learn more

      How should I use this medication?

      The recommended adult dose of amoxicillin – clavulanic acid depends on the infection being treated. The usual recommended adult doses include 500 mg every 8 or 12 hours or 875 mg every 12 hours.

      The children’s dose of amoxicillin – clavulanic acid is based on body weight, as prescribed by the doctor. Depending on the infection being treated, the dose will range between 20 mg and 45 mg per kilogram of body weight per day, taken in divided doses.

      Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

      The medication may be taken with or without food, but taking it with food may reduce side effects such as upset stomach, nausea, diarrhea, and abdominal cramps. Amoxicillin – clavulanic acid is usually taken for a period of 7 to 10 days. In some cases, it may be necessary to take this medication for a longer period.

      If using the suspension form, use an oral syringe to measure each dose to get a more accurate measurement than household teaspoons.

      It is very important to take this medication exactly as prescribed by the doctor for the full duration of treatment, even though you may feel better before the medication is finished. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

      Store the tablets at room temperature, protect them from light and moisture, and keep them out of the reach of children.

      Store the suspension in the refrigerator and keep it out of the reach of children.

      Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

      Who should NOT take this medication?

      Do not take this medication if you:

      • are allergic to amoxicillin, penicillin, cephalosporins (e.g., cephalexin, ceftriaxone), clavulanic acid, or any ingredients of the medication
      • have had jaundice or liver problems with previous use of this medication
      • have or are suspected to have mononucleosis

      What side effects are possible with this medication?

      Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

      The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

      The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

      Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

      • abdominal and stomach cramps
      • bad taste in mouth
      • constipation
      • diaper rash (infant)
      • diarrhea (mild)
      • gas
      • headache
      • loss of appetite
      • nausea
      • tongue discolouration or “hairy” tongue
      • tooth discolouration
      • unusual tiredness or weakness
      • vomiting

      Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

      Check with your doctor as soon as possible if any of the following side effects occur:

      • signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
      • signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
      • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
      • vaginal itching and discharge
      • white patches in the mouth or on the tongue

      Stop taking the medication and seek immediate medical attention if any of the following occur:

      • diarrhea (watery and severe; may also be bloody)
      • fever that appears after starting the antibiotic
      • symptoms of a severe allergic reaction (severe skin rash; itching; hives; difficulty breathing; swelling of the mouth, throat, or tongue)
      • seizures
      • signs of a severe skin reaction (such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)
      • wheezing, difficulty breathing, or shortness of breath

      Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

      Are there any other precautions or warnings for this medication?

      Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

      Allergy: Amoxicillin, one of the ingredients in this medication, is a penicillin. If you have previously had an allergic reaction to antibiotics such as penicillin or cephalosporins (e.g., cephalexin, ceftriaxone), you should not take this medication. Before you take amoxicillin – clavulanic acid, inform your doctor about any previous adverse reactions you have had to medications, especially cephalosporins and penicillins.

      Get immediate medical attention if you experience symptoms of a severe allergic reaction (e.g., hives; swelling of the face, tongue, or throat; trouble breathing).

      Antibiotic-associated colitis: This medication, like other antibiotics, may cause a potentially dangerous condition called antibiotic-associated, or pseudomembranous, colitis. Symptoms include severe, watery diarrhea that may be bloody. If you notice these symptoms, stop taking amoxicillin – clavulanic acid and contact your doctor as soon as possible.

      Aspartame: The suspension forms of this medication contain aspartame. If you have phenylketonuria, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

      Birth control: This medication may decrease the effectiveness of birth control pills. Some doctors recommend adding another method of birth control for the rest of the cycle when amoxicillin-clavulanate is taken.

      Kidney Function: This medication is eliminated from the body mostly by the kidneys. If you have kidney disease or reduced kidney function, this medication may build up in your body and cause unwanted effects.

      If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

      Liver Function: If you have liver disease or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

      Clavulanic acid may cause a decrease in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

      Mononucleosis: When amoxicillin – clavulanic acid is used by a person who has mononucleosis, a widespread rash may occur. If you have or suspect you have mononucleosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

      This medication should not be used by anyone who has or is suspected to have mononucleosis.

      Overgrowth of organisms (super-infection): Prolonged or repeated use of this antibiotic may allow normal fungus or certain types of bacteria not killed by the antibiotic to overgrow, causing unwanted infections such as yeast infections. Contact your doctor if you notice white patches in the mouth (thrush), abnormal vaginal discharge, or itching.

      Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

      Breast-feeding: Amoxicillin passes into breast milk. It is not known if clavulanic acid passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

      What other drugs could interact with this medication?

      There may be an interaction between amoxicillin – clavulanic acid and any of the following:

      • allopurinol
      • anticoagulants (e.g., warfarin)
      • BCG
      • birth control pills
      • methotrexate
      • mycophenolate
      • probenecid
      • sodium picosulfate
      • tetracyclines (e.g., tetracycline, minocycline, doxycycline)
      • tuberculosis vaccine
      • typhoid vaccine

      If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

      • stop taking one of the medications,
      • change one of the medications to another,
      • change how you are taking one or both of the medications, or
      • leave everything as is.

      An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

      Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

      All material copyright MediResource Inc. 1996 – 2018. Terms and conditions of use . The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source:

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