COMPOSITION

Mexclav 70 ml Powder for Suspension: Each 5 ml reconstituted suspension contains Cefuroxime Axetil USP equivalent to Cefuroxime 125 mg and Clavulanic Acid 31.25 mg as diluted Potassium Clavulanate BP.

DESCRIPTION

Cefuroxime is one of the bactericidal second-generation cephalosporin antibiotics, which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase-producing strains. It is indicated for the treatment of infections caused by sensitive bacteria.

Clavulanic Acid has a similar structure to the beta-lactam antibiotics but binds irreversibly to the beta-lactamase enzymes.

The presence of Clavulanic Acid in Mexclav formulations protects Cefuroxime from degradation by beta-lactamase enzymes and effectively extends the antibacterial spectrum of Cefuroxime to include many bacteria normally resistant to Cefuroxime and other cephalosporins.

INDICATIONS & USES

• Pharyngitis/tonsillitis caused by Streptococcus pyogenes
• Acute bacterial otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains) or Streptococcus pyogenes
• Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (nonbeta lactamase-producing strains only)
• Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pyogenes, Escherichia coli.
• Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilusparainfluenzae (beta-lactamase negative strains)
• Skin and Skin-Structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp.
• Urinary tract infections caused by Escherichia coli or Klebsiella pneumonia
• Bone and Joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase-producing strains)
• Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase and non-penicillinase-producing strains) in both males and females
• Early Lyme disease (erythema migrans) caused by Borrelia burgdorferi
• Septicemia caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp.
• Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitis and Staphylococcus aureus (penicillinase and non-penicillinase-producing strains)
• Switch therapy (injectable to oral) after surgery when the patient's condition is improved.

SIDE-EFFECTS

Generally, Cefuroxime and Clavulanic acid are 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 the overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash, and serum sickness-like urticaria may appear.

PRECAUTIONS

• Mexclav should be given with care to patients receiving concurrent treatment with potent diuretics & who have a history of colitis.

USE IN PREGNANCY & LACTATION

During pregnancy:

• All antibiotics should be avoided in the first trimester if possible. However, Mexclav can be safely used in later pregnancy to treat urinary and other infections.

During lactation:

• Mexclav is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

CONTRAINDICATIONS

• Patients with known allergy to cephalosporins & pseudomembranous colitis are contraindicated.

DRUG INTERACTIONS

Concomitant administration of probenecid with Mexclav increases the area under the serum concentration versus time curve by 50%. A drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

OVERDOSAGE

• Signs and symptoms: Overdosage of Mexclav can cause cerebral irritation leading to convulsions.
• Management: Serum levels of Mexclav can be reduced by hemodialysis and peritoneal dialysis.

STORAGE

• Store in a dry place at below 25OC, and protect from light. Keep out of reach of children. After reconstitution, keep the suspension in the refrigerator (20-80C) & use it within 7 days.

COMMERCIAL PACK

• Mexclav 70 ml PFS: Each amber-colored glass bottle contains dry powder to reconstituted 70 ml suspension.

Biopharma Ltd. Produces MEXCLAV PFS 70 ML it is a trusted product for alleviating various discomforts, and it's commonly found in pharmacies and stores.