AUGMENTIN ® Amoxicillin + clavulanic acid

AUGMENTIN ® is a drug based on Amoxicillin + clavulanic acid

THERAPEUTIC GROUP: General antimicrobials for systemic use - broad-spectrum penicillins

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications AUGMENTIN ® Amoxicillin + clavulanic acid

AUGMENTIN ® is indicated in the treatment of infectious diseases supported by micro-organisms sensitive to amoxicillin.

Community-acquired pneumonia, bacterial sinusitis, cystitis, pyelonephritis, soft tissue and skin infections, osteomyelitis and otitis represent only some of the pathologies for which the use of AUGMENTIN ® could be indicated.

Mechanism of action AUGMENTIN ® Amoxicillin + clavulanic acid

AUGMENTIN ® is a medicine that combines a natural beta lactamase inhibitor with an antibiotic belonging to the class of semi-synthetic penicillins and more precisely of aminopenicillins.

It is known in fact how amoxicillin, the active principle of AUGMENTIN ®, while carrying out an excellent broad-spectrum therapeutic action, by inhibiting the transpeptidation reaction and the consequent formation of the peptidoglycan, the main component of the bacterial wall, is particularly sensitive to the action of beta lactamase.

These last enzymes, generally expressed by bacterial cells as a mechanism of resistance to antibiotics, can in fact bind amoxicillin by opening the betalactam ring and neutralizing the therapeutic activity of the antibiotic.

In AUGMENTIN ® then:

Clavulanic acid, can bind beta lactamases through covalent bonds, inactivating the action of antibiotic resistance;
Amoxicillin can inhibit the formation of cross-linking, reducing the stability of the bacterial wall and facilitating the lysis of the pathogenic microorganism for osmotic shock.

Both active ingredients are stable in aqueous solutions and safe from a pharmacokinetic point of view, so that contextual intake in a single drug does not in any way alter the therapeutic properties of the drug.

Studies carried out and clinical efficacy

1. THE EFFECTIVENESS OF AMOXICILLIN / CLAVULANIC ACID IN THE TREATMENT OF THE PULMONITE ACQUIRED IN THE COMMUNITY

J Indian Med Assoc. 2011 Feb; 109 (2): 124-7.

Work demonstrating that clavulanic acid and amoxicillin therapy is effective in the treatment of community-acquired pneumonia, and well tolerated given the minimal side effects, characterized almost exclusively by diarrhea.

2 . AMOXICILLIN AND CLAVULANIC ACID IN APPENDICITIS CONTROL

BMJ Open. 2011 Feb 23;: 128-31.

Case report that reports the appearance of liver damage and subsequent cholestasis in an eight-year-old child undergoing treatment with amoxicillin and clavulanic acid. In these cases fortunately corticosteroid recovery therapy is generally well tolerated.

Method of use and dosage

AUGMENTIN ®

875 mg coated tablets of amoxicillin + 125 mg of clavulanic acid;

Powder for oral suspension of 875 mg of amoxicillin + 125 mg of clavulanic acid;

Powder for oral suspension of 400 mg amoxicillin + 57 mg of clavulanic acid.

The dosage and timing of the intake should be defined by your doctor after carefully assessing the patient's physio-pathological state, the severity of the clinical picture and the presence of contextual conditions such as advanced age or liver and kidney diseases, for which it would be necessary to further modulate the doses.

Generally the standard dosing schedule for adults would include the intake of 2 - 3 coated tablets of 1 g per day.

Warnings AUGMENTIN ® Amoxicillin + clavulanic acid

The use of AUGMENTIN ® should be supervised by your doctor and indicated after ascertaining the nature of the organism and its sensitivity to amoxicillin.

The inadequate use of this antibiotic could in fact determine the appearance of multi-drug resistant microorganisms such as to render antibiotic therapy ineffective.

Patients suffering from liver and kidney diseases or with a medical history characterized by hypersensitivity reactions to drugs, should immediately consult their doctor, with whom to evaluate the cost-benefit ratios deriving from antibiotic therapy with AUGMENTIN ®.

Instead, the doctor should periodically check the state of liver and kidney function of the patient undergoing therapy, suspending treatment following the appearance of undesirable side effects.

AUGMENTIN ® powder for oral suspension contains Aspartame, a source of phenylalanine, potentially dangerous for patients suffering from phenylketonuria.

PREGNANCY AND BREASTFEEDING

The absence of clinical trials able to test the safety of the fetus for clavulanic acid and amoxicillin does not allow the free use of AUGMENTIN ® during pregnancy.

Therefore, the use of this medicine would be indicated only in cases of real need and under strict specialist medical supervision.

The intake of AUGMENTIN ® during breastfeeding is contraindicated due to the tendency of the antibiotic to accumulate in breast milk.

Interactions

Despite also from the pharmacokinetic point the intake of amoxicillin and clavulanic acid proves to be safe and free of particular risks, the patient should pay particular attention in any case to the contextual consumption of:

Allopurinol, given the increased risk of developing allergic reactions;
Probenecid, responsible for the increase in blood concentrations and the hepatic and renal side effects of amoxicillin;
Warfarin, due to the increased risk of bleeding;
Methotrexate, given the increase in blood concentrations of this active ingredient induced by amoxicillin, responsible for an increase in the toxicity of the drug;
Ethanol and amiloride able to alter its intestinal absorption profile.

Contraindications AUGMENTIN ® Amoxicillin + clavulanic acid

The use of AUGMENTIN ® is contraindicated in patients who are hypersensitive to penicillins and cephalosporins or their excipients, in the course of infectious mononucleosis and drug-induced liver diseases.

Undesirable effects - Side effects

Different clinical trials and careful post-marketing monitoring have shown that the intake of amoxicillin / clavulanic acid is generally well tolerated and free of clinically relevant side effects.

However, in addition to the classic gastro-intestinal symptoms and potential hypersensitivity reactions, albeit rarely taking AUGMENTIN ® could lead to the appearance of leukopenia, thrombocytopenia, vertigo, headache, epigastric pain, hypertransaminasemia and hyperbilirubinemia.

Fortunately, these reactions are rare and present above all in patients predisposed or subjected to inadequate antibiotic therapies for dosages and times.