Xilclav (Cefuroxime+Clavulanic Acid) 500 mg+125 mg

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Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

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    Indications of Xiclav 500 mg+125 mg

    Xiclav 500 mg+125 mg is indicated for treating infections caused by sensitive bacteria, including:

    • Pharyngitis/tonsillitis due to Streptococcus pyogenes
    • Acute bacterial otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains), or Streptococcus pyogenes
    • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
    • Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and E. coli
    • Acute bacterial exacerbation of chronic bronchitis and secondary bacterial infections of acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains)
    • Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes
    • Uncomplicated urinary tract infections caused by E.coli or Klebsiella pneumoniae
    • Bone and joint infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains)
    • Uncomplicated gonorrhea caused by penicillinase-producing and non-penicillinase-producing strains of Neisseria gonorrhoeae
    • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi
    • Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp
    • Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase and non-penicillinase-producing strains)
    • Switch therapy (injectable to oral)

    Theropeutic Class

    Second generation Cephalosporins

    Pharmacology

    Cefuroxime is a bactericidal second-generation cephalosporin antibiotic that effectively targets a wide range of susceptible Gram-positive and Gram-negative organisms, including numerous beta-lactamase producing strains. It works by disrupting bacterial cell wall synthesis through interference with the transpeptidation process.

    Clavulanic acid, a naturally derived beta-lactamase inhibitor produced by Streptomyces clavuligerus, shares a similar structure with beta-lactam antibiotics. It irreversibly binds to beta-lactamase enzymes, rendering them inactive. Clavulanic acid provides Cefuroxime with protection against degradation by beta-lactamase enzymes, offering a solution for treating bacterial infections caused by beta-lactam-resistant bacteria.

    Dosage of Xiclav 500 mg+125 mg

    Adolescents and adults (13 years and older)- Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days

    Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days

    Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days

    Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days

    Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days

    Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days

    Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose

    Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days

    MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days

    Early Lyme disease: 500 mg b.i.d. for 20 days

    Paediatric Patients (3 months to 12 years)- Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days

    Acute otitis media: 30 mg/kg/day b.i.d for 10 days

    Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days

    Impetigo: 30 mg/kg/day b.i.d for 10 days

    Administration of Xiclav 500 mg+125 mg

    Xiclav 500 mg+125 mg tablet may be taken without regard of food.

    Interaction of Xiclav 500 mg+125 mg

    When probenecid is administered concurrently with Cefuroxime-Clavulanic Acid, it significantly increases the area under the serum concentration-time curve by 50%. The use of medications that reduce gastric acidity may result in decreased bioavailability of Cefuroxime, potentially counteracting its postprandial absorption benefits.

    Contraindications

    Cefuroxime-Clavulanic Acid is contraindicated in patients with a known allergy to cephalosporins and in patients with Pseudomembranous Colitis.

    Side Effects of Xiclav 500 mg+125 mg

    Generally Xiclav 500 mg+125 mg is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

    Pregnancy & Lactation

    While it’s generally advisable to avoid antibiotics during the first trimester of pregnancy, Xiclav 500 mg+125 mg can be used safely in later stages to address urinary and other infections. It is excreted into breast milk in small amounts, but it’s essential to consider the potential for sensitizing the infant.

    Precautions & Warnings

    Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

    Storage Conditions

    Store in a cool, dry place (below 30o C), away from light and moisture. Keep out of the reach of children.

    Drug Classes

    Second generation Cephalosporins

    Mode Of Action

    Cefuroxime is a bactericidal second-generation cephalosporin antibiotic with activity against a wide range of susceptible Gram-positive and Gram-negative organisms, including many strains that produce beta-lactamase enzymes. Cefuroxime works by disrupting the bacterial cell wall synthesis through interference with the transpeptidation process.

    Clavulanic acid, a naturally derived beta-lactamase inhibitor produced by Streptomyces clavuligerus, shares a structural similarity with beta-lactam antibiotics. It irreversibly binds to beta-lactamase enzymes, rendering them inactive. This protective action of clavulanic acid shields Cefuroxime from degradation by beta-lactamase enzymes, making it an effective solution for treating bacterial infections caused by beta-lactam-resistant bacteria.

    Generic Name:

    Cefuroxime & Clavulanic Acid

    Theraputic Category:

    Antibiotic

    Pack Size:

    (250 mg + 62.5 mg : 2×7's), (500 mg + 125 mg : 2×7's)

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