Augmentin drug Uses, Dosage, Side Effects

what is augmentin
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augmentin drug category >> Generic drug of the therapeutic class: Otorhinolaryngology Medicines  – Pneumonology Medicines
active principles: Amoxicillinclavulanic acid

what is augmentin used for  and indication?

Augmentin is indicated for the treatment of the following infections in adults and children ( see Posology and method of administration , Warnings and Precautions , Pharmacodynamics ):

  • severe ENT infections (such as mastoiditis, peritonsillar infections, epiglottitis and sinusitis, when accompanied by severe systemic signs and symptoms),
  • exacerbation of chronic bronchitis (diagnosed appropriately),
  • acute community pneumonia,
  • cystitis,
  • pyelonephritis,
  • skin and soft tissue infections, especially cellulitis, animal bites, severe tooth abscesses with spread of cellulite,
  • infections of bones and joints, especially osteomyelitis,
  • intra-abdominal infections,
  • female genital infections.

Prophylaxis of postoperative infections in adults involving:

  • the digestive system,
  • the pelvic cavity,
  • head and neck,
  • the biliary system.

Official recommendations concerning the appropriate use of antibacterials should be taken into account.

what’s Augmentin Dosage?


As an indication, in adults with normal renal function, the usual dosage is 1 g, 2 to 4 times per day.

In severe infections it can be increased up to 12 g / day, without ever exceeding 200 mg of clavulanic acid per injection and 1200 mg of clavulanic acid per day:

  • up to 6 g / day, use the dosage 1 g / 200 mg,
  • from 6 g to 12 g / day, use the 2 g / 200 mg dosage.

The dosage should be appropriate for the prevention of infections during certain surgical procedures.

The dosage should be adjusted in case of renal failure.


Hypersensitivity to the active substances, to penicillins or to any of the excipients.

  • History of severe immediate hypersensitivity reaction (eg, anaphylaxis) to another beta-lactam (eg, cephalosporin, carbapenem or monobactam).
  • History of jaundice / hepatic impairment related to amoxicillin / clavulanic acid .

how does augmentin work

Pharmacotherapeutic group: Association of penicillins, including beta-lactamase inhibitors; ATC code: J01CR02

Mode of action

  • Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins or PLPs) in the biosynthetic pathway of bacterial peptidoglycans, structural components of the cell wall. bacterial. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, often followed by cell lysis and death.
  • Since amoxicillin is subject to degradation by beta-lactamases produced by resistant bacteria, its spectrum of activity when administered alone does not include the organisms producing these enzymes.
  • Clavulanic acid is a beta-lactam structurally related to penicillins. It inhibits certain beta-lactamase enzymes and thus prevents the inactivation of amoxicillin. Clavulanic acid alone does not have a clinically relevant antibacterial effect.

Pharmacokinetic / pharmacodynamic relationship

The time above the minimum inhibitory concentration (T> MIC) is considered to be the major parameter of amoxicillin efficacy.

Mechanisms of resistance

The two main mechanisms of resistance to amoxicillin / clavulanic acid are:

  • Inactivation by bacterial beta-lactamases not inhibited by clavulanic acid, including classes B, C and D;
  • Modification of PLPs, which reduces the affinity of the antibacterial agent for the target.

Bacterial impermeability or efflux pump mechanisms can lead to bacterial resistance, particularly in Gram-negative bacteria.

Critical values

The critical concentrations for amoxicillin / clavulanic acid are derived from EUCAST (European Committee on Antimicrobial Susceptibility Testing).

What are the side effects of taking Augmentin?

The most common side effects are:

  1. diarrhea.
  2. nausea.
  3. vomiting.

Adverse reactions identified in clinical studies and since the commercialization of Augmentin are listed below according to the MedDRA system organ classification.

The following terminology is used to classify adverse reactions according to their frequency:

  • Very common (³ 1/10)
  • Frequent (³ 1/100 to <1/10)
  • Uncommon (1/1000 to <1/100)
  • Rare (1/10 000 to <1/1000)
  • Very rare (<1 / 10,000)

Not known (can not be estimated from the available data)

Infections and infestations
Cutaneous and mucosal candidiasis Frequent
Excessive development of non-susceptible organisms Not known frequency
Blood and lymphatic system disorders
Reversible leukopenia (including neutropenia) Rare
thrombocytopenia Rare
Reversible agranulocytosis Not known frequency
Hemolytic anemia Not known frequency
Prolongation of bleeding time and Quick 1 time Not known frequency
Immune system disorders 10
Angioedema Not known frequency
anaphylaxis Not known frequency
Serum sickness Not known frequency
Hypersensitivity vasculitis Not known frequency
Nervous system disorders
dizziness Rare
headaches Rare
Convulsions 2 Not known frequency
Aseptic meningitis Not known frequency
Vascular disorders
Thrombophlebitis 3 Rare
Gastrointestinal disorders
Diarrhea Frequent
Nausea Rare
vomiting Rare
Indigestion Rare
Colitis associated with antibiotics 4 Not known frequency
Hepatobiliary disorders
Elevations of ASAT and / or ALAT 5 rates Rare
Hepatitis 6 Not known frequency
Cholestatic jaundice 6 Not known frequency
Skin and subcutaneous tissue disorders 7
Skin rash Rare
itching Rare
Urticaria Rare
Erythema multiforme Rare
Stevens-Johnson Syndrome Not known frequency
Epidermolysis necrotizing hyperacute Not known frequency
Bullous dermatitis or exfoliator Not known frequency
Generalized acute exanthematous pustulosis (PEAG) 9 Not known frequency
Renal and urinary disorders
Interstitial nephritis Not known frequency
Crystalline 8 Not known frequency
1 See section Warnings and precautions for use

2 See section Warnings and precautions for use

3 At the injection site

4 Including pseudomembranous colitis and haemorrhagic colitis (see Warnings and precautions for use )

5 A moderate rise in AST and / or ALT has been noted in patients treated with antibiotics of the family of beta-lactam antibiotics, but the significance of these increases is unknown.

6 These effects have been observed with other penicillins and cephalosporins (see Warnings and Precautions ).

7 If hypersensitivity dermatitis occurs, treatment should be discontinued (see Warnings and Precautions section ).

8 See Overdose section

9 See warnings and precautions for use

10 See sections Contraindications and Warnings and precautions for use

augmentin drug interactions

Oral anticoagulants

  • Oral anticoagulants are often administered simultaneously with penicillin antibiotics and no interaction has been reported. However, cases of increased INR have been reported in patients maintained with acenocoumarol or warfarin during amoxicillin administration.
  • If co-administration is necessary, the time of Quick or INR should be carefully monitored when adding or removing amoxicillin. In addition, dosage adjustment of oral anticoagulants may be necessary (see sections Warnings and Precautions and Adverse Reactions ).


  • Penicillins can reduce the excretion of methotrexate and increase its toxicity.


  • Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin.
  • Concomitant use of probenecid may lead to a prolonged increase in blood levels of amoxicillin, but not clavulanic acid.

Mycophenolate mofetil

  • In patients treated with mycophenolate mofetil, a decrease of approximately 50% in the residual concentrations of the active metabolite, mycophenolic acid (MPA), has been reported in the days following the start of oral treatment with amoxicillin and clavulanic acid.
  • The change in residual concentration does not necessarily imply a change in the overall exposure to the MPA. Therefore, a dose modification of mycophenolate mofetil is not expected to be necessary in the absence of clinical evidence of graft dysfunction.
  • However, close clinical monitoring is required during administration of the combination, as well as shortly after the completion of antibiotic therapy.

Augmentin Warnings and Precautions

Before opening :

  1. Store at a temperature not exceeding 25 ° C.
  2. Store in the original package, at the humidity level.
  3. For storage conditions of the medicinal product after reconstitution, see section 6.3.

Drive and use machines

  • The effects on the ability to drive vehicles or use machines have not been studied.
  • However, the occurrence of adverse effects (eg allergic reactions, dizziness, convulsions) that may affect the ability to drive or use machines is possible.


augmentin pregnancy

  • Animal studies have not shown any direct or indirect harmful effects with respect to pregnancy and / or embryonal / fetal development and / or delivery and / or postnatal development).
  • Limited data on the use of amoxicillin / clavulanic acid in pregnant women do not indicate an increased risk of congenital malformations.
  • A single study in women with premature premature rupture of fetal membranes indicated that prophylactic treatment with amoxicillin / clavulanic acid may be associated with an increased risk of necrotizing enterocolitis in neonates. Use should be avoided during pregnancy,

augmentin and feeding

  • Both substances are excreted in breast milk (the effects of clavulanic acid on breastfed infants are not known).
  • As a result, diarrhea and fungal infection of the mucous membranes are possible in the breastfed infant and may require cessation of breastfeeding.
  • The combination of amoxicillin and clavulanic acid may only be used during breastfeeding after the benefit / risk ratio has been assessed by the attending physician.

what is an overdose of augmentin

Overdose signs and symptoms

  1. Gastrointestinal symptoms and disturbances in water and electrolyte balance are possible.
  2. Cases of crystalluria leading in some cases to renal insufficiency have been observed with amoxicillin (see section Warnings and precautions for use).
  3. Convulsions are possible in patients with renal impairment or those receiving high doses.
  4. Amoxicillin precipitation has been observed in bladder catheters, particularly after intravenous administration of large doses. The permeability of the probe should be checked regularly (see section Warnings and precautions for use).

Treatment of intoxication

  1. The treatment of gastrointestinal signs is symptomatic and involves special monitoring of the electrolyte balance.
  2. Amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis.

What is  Forms and Composition Augmentin?

  • Powder and solvent for solution for injection or infusion (IV) at 1 g / 200 mg:  Bottle * + 20 ml solvent ampoule, unitary box.
  • Powder for solution for injection or infusion (IV) at 1g / 200mg:   Vials * , pack of 10.
  • Powder for solution for infusion (IV) at 2g / 200mg adult:   Vials * , pack of 10.
  • Powder for solution for injection or infusion (IV) at 500 mg / 50 mg:   Vials * , box of 10. *   Vials contain a sterile white to off-white powder.
Pdre and solvent p sol inj or perf (IV) 1 g / 200 mg: p bottle
Amoxicillin (INN) sodium salt expressed as amoxicillin 1 g
Clavulanic acid (INN) Potassium salt expressed as clavulanic acid 200mg
  • Solvent: water for injections.

Excipients with known effect :

  1. Sodium content: 62.9 mg (2.7 mmol) per vial.
  2. Potassium content: 39.3 mg (1.0 mmol) per vial.
Injection or perf (IV) 1 g / 200 mg: p bottle
Amoxicillin (INN) sodium salt expressed as amoxicillin 1 g
Clavulanic acid (INN) Potassium salt expressed as clavulanic acid 200mg

Excipients with known effect :

  1. Sodium content: 62.9 mg (2.7 mmol) per vial.
  2. Potassium content: 39.3 mg (1.0 mmol) per vial.
Lice p sol p perf 2 g / 200 mg ad: p bottle
Amoxicillin (INN) sodium salt expressed as amoxicillin 2 g
Clavulanic acid (INN) Potassium salt expressed as clavulanic acid 200mg

Excipients with known effect :

  1. Sodium content: 125.9 mg (5.5 mmol) per vial.
  2. Potassium content: 39.3 mg (1.0 mmol) per vial.
Pdre p sol inj or perf (IV) 500 mg / 50 mg: p bottle
Amoxicillin (INN) sodium salt expressed as amoxicillin 500 mg
Clavulanic acid (INN) Potassium salt expressed as clavulanic acid 50 mg

Excipients with known effect :

  1. Sodium content: 31.5 mg (1.4 mmol) per vial.
  2. Potassium content: 9.8 mg (0.3 mmol) per vial.


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Additional information:

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Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

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  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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