WHO Model Prescribing Information: Drugs used in Bacterial Infections
(2001; 179 pages) View the PDF document
Table of Contents
View the documentPreface
View the documentIntroduction
Open this folder and view contentsUpper respiratory tract infections
Open this folder and view contentsLower respiratory tract infections
Open this folder and view contentsOther respiratory tract infections
Open this folder and view contentsPerioral and dental infections
Open this folder and view contentsGastrointestinal tract infections
Open this folder and view contentsUrinary tract infections
Open this folder and view contentsSkin and soft tissue infections
Open this folder and view contentsBone and joint infections
Open this folder and view contentsSexually transmitted diseases
Open this folder and view contentsCardiovascular infections
Open this folder and view contentsCentral nervous system infections
Open this folder and view contentsMiscellaneous infections
Open this folder and view contentsSepticaemia
Close this folderDrugs (for details of contraindications, etc., see individual drug entries)
View the documentAmoxicillin
View the documentAmoxicillin + clavulanic acid
View the documentAmpicillin
View the documentBenzylpenicillin
View the documentBenzathine benzylpenicillin
View the documentProcaine benzylpenicillin
View the documentCefalexin
View the documentCefazolin
View the documentCefotaxime
View the documentCeftazidime
View the documentCeftriaxone
View the documentCefuroxime
View the documentChloramphenicol
View the documentCiprofloxacin
View the documentClindamycin
View the documentCloxacillin1
View the documentDoxycycline
View the documentErythromycin
View the documentGentamicin
View the documentImipenem + cilastatin
View the documentMetronidazole
View the documentNalidixic acid
View the documentNitrofurantoin
View the documentNystatin
View the documentPhenoxymethylpenicillin
View the documentRifampicin
View the documentSpectinomycin
View the documentStreptomycin
View the documentSulfadiazine
View the documentSulfamethoxazole + trimethoprim
View the documentTetracycline
View the documentTinidazole
View the documentTrimethoprim
View the documentVancomycin
 

Amoxicillin + clavulanic acid

Tablet, 500 mg of amoxicillin +125mg of clavulanic acid

General information

The two components of this combination product operate synergistically because clavulanic acid binds to β-lactamases and thereby competitively protects the amoxicillin against resistant β-lactamase-producing strains. Both components are well absorbed after oral administration and are distributed into the lungs, pleural fluid and peritoneal fluid. They are largely excreted unchanged in the urine.

Clinical information

Uses

Treatment of:

• infections caused by susceptible β-lactamase- producing strains of Escherichia coli, Haemophilus influenzae, Klebsiella spp. and Staphylococcus aureus (where amoxicillin alone is not appropriate)

• acute otitis media and acute sinusitis

• acute exacerbations of chronic bronchitis in adults

• aspiration pneumonia and lung abscesses

• human and animal bites and clenched-fist injuries, together with procaine benzylpenicillin

• urinary tract infections in children

• osteomyelitis due to Haemophilus influenzae or unknown pathogen in children ≤ 5 years, together with cloxacillin and either ceftriaxone or cefotaxime.


Prophylaxis in contaminated surgery.

Dosage and administration

The dosage for amoxicillin + clavulanic acid is expressed in terms of the amoxicillin component.

Acute otitis media

Adults: amoxicillin 500mg + clavulanic acid orally every 8 hours for 5 days.

Children: amoxicillin 7.5 - 15mg/kg + clavulanic acid (maximum 500mg) orally every 8 hours for 5 days.

Acute sinusitis

Adults: amoxicillin 500mg + clavulanic acid orally every 8 hours for 7 - 10 days.

Children: amoxicillin 7.5 - 15mg/kg + clavulanic acid (maximum 500mg) orally every 8 hours for 7 - 10 days.

Acute exacerbations of chronic bronchitis in adults

Amoxicillin 500mg + clavulanic acid orally every 8 hours for 5 days.

Aspiration pneumonia and lung abscesses

Adults: amoxicillin 500mg + clavulanic acid orally every 8 hours for 14 days.

Children: amoxicillin 15mg/kg + clavulanic acid (maximum 500mg) orally every 8 hours for 14 days.

Human and animal bites and clenched-fist injuries

Adults: amoxicillin 500mg + clavulanic acid orally every 8 hours for 5 days, following initial therapy with procaine benzylpenicillin 1.5 million IU i.m. every 24 hours for 5 days.

Children: amoxicillin 15mg/kg + clavulanic acid (maximum 500mg) orally every 8 hours for 5 days, following initial therapy with procaine benzylpenicillin 50 000IU/kg (maximum 1.5 million IU) i.m. every 24 hours for 5 days.

Urinary tract infections in children

Amoxicillin 7.5mg/kg + clavulanic acid (maximum 250mg) orally every 8 hours for 5 - 10 days.

Osteomyelitis due to Haemophilus influenzae or unknown pathogen in children5 years

Children aged from 2 months to 5 years: amoxicillin 15mg/kg + clavulanic acid (maximum 500mg) orally every 8 hours to complete the treatment course of 3 - 4 weeks, following initial therapy with cloxacillin 25 - 50mg/kg (maximum 2g) i.v. or i.m. every 4 - 6 hours and ceftriaxone 50 - 75mg/kg (maximum 1g) i.v. or i.m. every 24 hours for 4 - 6 days (or until clinical improvement occurs).

Neonates: amoxicillin 15mg/kg + clavulanic acid (maximum 500mg) orally every 8 hours to complete the treatment course of 3 - 4 weeks, following initial therapy with cloxacillin 25 - 50mg/kg (maximum 2g) i.v. or i.m. every 4 - 6 hours and cefotaxime 50 - 75mg/kg (maximum 2g) i.v. every 8 hours for 4 - 6 days (or until clinical improvement occurs).

Prophylaxis in contaminated surgery

Adults: amoxicillin 500mg + clavulanic acid i.v. at induction of anaesthesia.

Children: amoxicillin 125mg + clavulanic acid i.v. at induction of anaesthesia.

Contraindications

Known hypersensitivity to penicillins.

Precautions

Facilities should be available for treating anaphylaxis whenever penicillins are used. Patients should be questioned carefully about previous allergic reactions before the first dose is administered. If a skin rash develops during treatment or no improvement occurs within 2 days, the patient should be transferred to a different class of antimicrobial.

Use in pregnancy

There is no evidence that amoxicillin + clavulanic acid is teratogenic. It may be used during pregnancy.

Adverse effects

Hypersensitivity reactions range in severity from skin rashes to immediate anaphylaxis. Erythematous maculopapular rashes are common and usually occur within 3 - 14 days after the start of treatment, initially appearing on the trunk and thereafter spreading peripherally to involve most of the body. In most instances the rash is mild and subsides after 6 - 14 days despite continuation of therapy.

Hepatotoxicity is more frequent than with amoxicillin.

Diarrhoea can occur. Interstitial nephritis, neutropenia and thrombocytopenia have been reported.

Overdosage

Overdosage can cause convulsions, paralysis and even death.

Excessive blood concentrations can be lowered by haemodialysis.

Storage

Preparations should be stored in tightly closed containers, protected from light.

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