CLAVULIN ® Amoxicillin + clavulanic acid

CLAVULIN ® is a drug based on Amoxicillin + clavulanic acid

THERAPEUTIC GROUP: General antimicrobials for systemic use - association of penicillins and beta-lactamase inhibitors

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

Indications CLAVULIN ® Amoxicillin + clavulanic acid

CLAVULIN ® is a medicine used in the treatment of bacterial infections of various organs and systems supported by microorganisms sensitive to amoxicillin.

Mechanism of action CLAVULIN ® Amoxicillin + clavulanic acid

The microbicide activity of CLAVULIN ® is guaranteed by the presence of amoxicillin, active ingredient belonging to the category of aminopenicillins, broad spectrum antibiotics able to inhibit the transpeptidation reaction blocking the synthesis of the bacterial wall and thus making the microorganism more sensitive to osmotic gradients, so as to determine its own lysis due to osmotic shock.

However the aforementioned activity is sustained in CLAVULIN ® also by the presence of clavulanic acid, a natural molecule extracted from some yeasts, able to counteract the resistance mechanisms put in place by the bacteria in order to reduce the microbicidal efficacy of the antibiotic.

More precisely the clavulanic acid, by binding the beta lactamases, resistance enzymes expressed by the various microorganisms, inhibits the inactivating antibiotic activity, normally carried out through the binding to amoxicillin and the opening of the beta lactam ring with consequent loss of structure -function.

The excellent efficacy of the treatment is also supported by the high stability of the active ingredients in aqueous solution, which makes the administration of the drug orally safe and easy.

Studies carried out and clinical efficacy

1.AMOXICILLIN / CLAVULANIC ACID IN THE DIVERTICULAR DISEASE MANAGEMENT

Int J Colorectal Dis. 2010 Nov; 25 (11): 1363-70. Epub 2010 Jun 5.

Interesting prospective study that shows how patients with diverticulitis could be effectively treated with amoxicillin / clavulanic acid, thus reducing the occurrence of any complications.

2 . HYPERSENSITIVITY TO AMOXICILLIN

Turk J Pediatr. 2011 Mar-Apr; 53 (2): 229-32.

Case report that reports the appearance of a generalized pustular rash, neutrophilia and high fever following the intake of amoxicillin and clavulanic acid. For these reasons it would be appropriate to carry out a careful medical history, useful to exclude any hypersensitivity to drugs, before starting the antibiotic treatment

3.AMOXICILLIN / CLAVULANIC ACID AS A FIRST-CHOICE TREATMENT IN MEDIUM OTITIS

Enferm Infecc Microbiol Clin. 2011 Mar; 29 (3): 167-73. Epub 2011 Feb 22.

Work demonstrating that treatment with amoxicillin / clavulanic acid still remains the first choice therapy for the treatment of otitis media with H.Influenzae overlap in children.

Method of use and dosage

CLAVULIN ®

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.

Although the standard dosage involves taking 2-3 tablets / sachets of 875 mg amoxicillin and 125 mg of clavulanic acid per day, the precise dosing schedule should be defined by your doctor after assessing a number of factors including:

Age of the patient;
Contextual presence of liver and kidney diseases;
Severity of the clinical picture;
Tolerability to therapy.

Treatment should be prolonged at least 2 days after the symptoms disappear in order to limit the occurrence of relapses.

Warnings CLAVULIN ® Amoxicillin + clavulanic acid

Antibiotic therapy with CLAVULIN ® should be prescribed by the doctor only after assessing the sensitivity of the organism responsible for the pathology to amoxicillin, and after considering the possible presence of conditions incompatible with the aforementioned therapy.

Particular caution should in fact be reserved for elderly patients or those suffering from liver and kidney diseases or with a history of hypersensitivity to drugs, given the greater susceptibility of these to adverse reactions related to antibiotic therapy.

In order to avoid the occurrence of serious side effects the doctor should monitor, especially in the initial stages of therapy, the state of liver and kidney function, suspending therapy at the onset of the first signs and symptoms.

CLAVULIN ® powder for oral suspension contains Aspartame, a source of phenylalanine, which is potentially dangerous for patients with phenylketonuria.

PREGNANCY AND BREASTFEEDING

The use of CLAVULIN ® during pregnancy and in the subsequent period of breastfeeding should only take place in cases of real need and always under strict specialist medical supervision.

These limitations are imposed by the absence of studies able to characterize the safety profile of amoxicillin on the fetus, when taken during the gestational period.

Interactions

In order to reduce the occurrence of potential side effects and at the same time maintain high therapeutic efficacy it would be advisable to pay particular attention to the simultaneous intake of CLAVULIN ® and:

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 CLAVULIN ® Amoxicillin + clavulanic acid

The use of CLAVULIN ® 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

CLAVULIN ® therapy is generally well tolerated and has no clinically relevant side effects.

Diarrhea, nausea and vomiting are the most frequently reported adverse reactions following intake of amoxicillin / clavulanic acid, while eczema, urticaria, angioedema, bronchospasm, laryngospasm, hypotension and in severe cases anaphylactic shock are the most worrying from the point of view clinical.

The aforementioned reactions are associated, exclusively in very rare cases, with leukopenia, thrombocytopenia, vertigo, headache, epigastric pain, hypertransaminasemia and hyperbilirubinemia.