Drug reference

Cefixime + Clavulanic Acid

Cephalosporin · Antibiotic

Also known as Mahacef-CV, Cefolac-CV, Hhcefix-CV, Zifi CV, Xyfil-CV, Topcef CV

CephalosporinAntibioticATC J01DD08

CDSCO approvedSchedule HATC J01DD08

EXCRETION

—

not curated

INTERACTIONS

—

none in our sources

PREGNANCY

Pregnancy Category B (for both Cefixime and Clavulanic Acid individually). The FDC should be used during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.

FDA category + note

Mechanism

Cefixime, a third-generation cephalosporin, exerts its bactericidal action by inhibiting bacterial cell wall synthesis through binding to penicillin-binding proteins (PBPs), leading to osmotic lysis. Clavulanic acid is a beta-lactamase inhibitor that irreversibly binds to and inactivates a wide range of bacterial beta-lactamase enzymes. This protects cefixime from enzymatic degradation, thereby restoring and extending its spectrum of activity against beta-lactamase-producing strains. Combination rationale: Cefixime is a potent third-generation cephalosporin effective against a wide range of Gram-positive and Gram-negative bacteria. However, its efficacy can be compromised by bacterial resistance due to beta-lactamase production, particularly in community-acquired infections. The addition of clavulanic acid protects cefixime from hydrolysis by these enzymes, thereby expanding its spectrum of activity to include common beta-lactamase-producing pathogens, making it effective against a broader range of resistant infections and improving treatment outcomes.

Indications

Upper and lower respiratory tract infections (e.g., bronchitis, sinusitis, pharyngitis, tonsillitis)Urinary tract infections (e.g., cystitis, pyelonephritis)Otitis mediaSkin and soft tissue infectionsTyphoid fever (where Cefixime is indicated and resistance is suspected)

Dosing

Adult: Oral, Cefixime 200 mg + Clavulanic Acid 125 mg, twice daily (BD) for 7-14 days depending on infection severity. Also available as Cefixime 400 mg + Clavulanic Acid 125 mg once daily or BD for more severe infections. Common strengths available in India include 200mg/125mg and 400mg/125mg tablets.
Pediatric: Oral suspension, based on cefixime component, typically 8 mg/kg/day divided into two doses (BD). For children 6 months to 12 years: Cefixime 100 mg + Clavulanic Acid 62.5 mg per 5 mL suspension. Doses should not exceed adult doses.
Renal adjustment: For creatinine clearance (CrCl) 30-60 mL/min, monitor closely. For CrCl < 30 mL/min, reduce dose by 50% or increase dosing interval to every 24-48 hours. Not recommended in patients undergoing dialysis unless closely monitored.
Hepatic adjustment: No specific dose adjustment generally recommended for mild to moderate hepatic impairment; use with caution in severe impairment as clavulanic acid is metabolized in the liver.
Geriatric: No specific dose adjustment necessary based on age alone, but renal function should be assessed and dose adjusted accordingly for age-related decline in renal clearance.
Max dose: Cefixime: 400 mg/day. Clavulanic Acid: 250 mg/day.

Pharmacokinetics

Onset

Rapid absorption; antibacterial effect begins shortly after administration.

Peak effect

Cefixime: 2-6 hours. Clavulanic Acid: 1-2 hours.

Duration

Sufficient for twice-daily dosing due to antibacterial effects.

Half-life

Cefixime: 3-4 hours. Clavulanic Acid: ~1 hour.

Bioavailability

Cefixime: 40-50% (oral). Clavulanic Acid: ~70% (oral).

Protein binding

Cefixime: ~65%. Clavulanic Acid: ~25%.

Metabolism

Cefixime: Limited metabolism, primarily excreted unchanged. Clavulanic Acid: Extensively metabolized, forming inactive metabolites.

Excretion

Cefixime: Primarily renal (approximately 50% unchanged in urine). Clavulanic Acid: Renal (30-40% unchanged in urine) and non-renal elimination of metabolites.

Contraindications

Known hypersensitivity to cefixime, clavulanic acid, any penicillin, cephalosporin, or any component of the formulation
History of severe hypersensitivity reaction to any other beta-lactam antibiotic

Side effects

Common

DiarrheaNauseaVomitingAbdominal painHeadacheDizzinessFlatulence

Serious

Clostridium difficile-associated diarrhea (CDAD)
Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome)
Anaphylaxis and other severe hypersensitivity reactions
Hepatotoxicity (rare, primarily due to clavulanic acid)
Renal impairment (interstitial nephritis)
Hematologic disorders (e.g., thrombocytopenia, leukopenia, eosinophilia, hemolytic anemia)

Pregnancy & lactation

Pregnancy

Pregnancy Category B (for both Cefixime and Clavulanic Acid individually). The FDC should be used during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.

Lactation

Both Cefixime and Clavulanic Acid are excreted in breast milk in small amounts. Use with caution during breastfeeding; monitor infant for potential adverse effects such as diarrhea, rash, or oral candidiasis.