Cefixime / Clavulanic acid

Brand Names of Cefixime / Clavulanic acid in Kenya

C-Clav , Oriana Limited

Cef – Clave ,Syner-Med Pharmaceuticals (K) Ltd

Gramocef CV , Micro Labs Limited, India


Cefixime is a semisynthetic, third generation cephalosporin antibiotic, effective against a wide spectrum of sensitive Gram positive, Gram negative and anaerobic bacterial pathogens including beta-lactamase producing strains. It has high affinity for penicillin binding proteins with varying site of activity. It acts by inhibition of bacterial cell-wall synthesis. The elimination half-life is about 3 hours, with little variation over the usual therapeutic dosage range.

Clavulanic acid
is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. Clavulanic acid is an irreversible inhibitor of intracellular and extracellular β-lactamases, demonstrating concentration-dependent and competitive inhibition.

Rationale for combination: Although Clavulanic acid does have some degree of bacterial activity, its principal role is as a beta-lactamase inhibitor. Beta-lactam antibiotics, such as the penicillins and cephalosporins, act by disrupting the development of bacterial cells walls thus causing the disintegration of the bacteria. However, some bacteria acquire the genes to produce enzymes which inactivate this mode of action – so called beta-lactamases – drastically reducing the efficacy of this class of antibiotics.

Clavulanic acid has a similar structure to the beta-lactam antibiotics but binds irreversibly to the beta-lactamase enzymes. Used in combination with the beta-lactam antibiotics, it has become one of the most prescribed antibiotics prolonging the effective life of antibiotics.

Cefixime is found to be ineffective against bacteria which produces ESBL (Extended-Spectrum Beta-Lactamases) enzyme and resistance is seen in such types of bacteria. The combination of cefixime and clavulanic acid (ß-lactamase inhibitor) provides a solution for treatment of bacterial infections caused by beta lactam resistant pathogens.


Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis.

Otitis Media caused by Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis, (most of which are beta-lactamase positive) and S. pyogenes.

Pharyngitis and Tonsillitis, caused by S. pyogenes.

Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis, caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains).

Uncomplicated gonorrhea (cervical/urethral), caused by Neisseria gonorrhoeae (penicillinase-and non-penicillinase- producing strains).


Adults and Children over 10 Years: One tablet twice daily. The usual course of treatment is 7 days. This may be continued for up to 14 days if required.
The combination of cefixime and clavulanic acid (ß-lactamase inhibitor) provides a solution for treatment of bacterial infections caused by beta lactam resistant pathogens
Cefixime is used to treat multiple bacterial infections in different parts of the body
Cefixime and clavulanic acid can be used as a second line therapy where cefixime alone is not able to show its bacteriocidal activity
Clauvanic acid acts as ß-lactamase inhibitor, thus making cefixime effective against resistant becteria
Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature
Cefixime is absorbed slowly following oral administration and absorption is not significantly modified by the presence of food


Carbamazepine: Elevated carbamazepine levels have been reported when cefixime is administered concomitantly.

Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.

Oral Contraceptives: Cefixime may interfere with the effectiveness of birth control pills.

Glucose Test: A false positive reaction for glucose in the urine may occur with Benedict’s or Fehling’s solutions or with copper sulphate test tablets.

Coombs test: A false positive direct Coombs test has been reported during treatment with cephalosporin antibiotics.


The most frequent side effects seen with this combination are diarrhoea and stool changes. Events like nausea/vomiting, transient elevation in liver transaminases, alkaline phosphatase and jaundice can also occur.

Thrombocytosis, thrombocytopenia, leucopenia, hypereosinophilia, neutropenia and agranulocytosis may also occur.

Other adverse events that may occur are abdominal pain, abdominal cramps, flatulence, indigestion, headache, vaginitis, vulvar itch, rash, hives, itch, dysuria, chills, chest pain, shortness of breath, mouth ulcers, swollen tongue, sleepiness, thirst, anorexia.

Reporting of suspected adverse reactions:

The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:

Cefixime / Clavulanic acid in Kenya
Cefixime / Clavulanic acid in Kenya
Cefixime / Clavulanic acid in Kenya
Cefixime / Clavulanic acid in Kenya
Cefixime / Clavulanic acid in Kenya
Cefixime / Clavulanic acid in Kenya

Clinical | Pharmacokinetic data

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