Clavutil

Composition
Clavutil 250 Tablet: Each film coated tablet contains Cefuroxime Axetil USP equivalent to 250 mg Cefuroxime and diluted Potassium
Clavulanate BP equivalent to 62.5 mg Clavulanic Acid.
Clavutil 500 Tablet: Each film coated tablet contains Cefuroxime Axetil USP equivalent to 500 mg Cefuroxime and diluted Potassium
Clavulanate BP equivalent to 125 mg Clavulanic Acid.
Clavutil PFS: Each 5 ml suspension contains Cefuroxime Axetil USP equivalent to 125 mg Cefuroxime and diluted Potassium Clavulanate BP
equivalent to 31.25 mg Clavulanic Acid.
Pharmacology
Cefuroxime is a broad spectrum second generation Cephalosporin active against a wide range of Gram-positive and Gram-negative
susceptible organisms including many beta-lactamase producing strains. The bactericidal action of Cefuroxime results from inhibition of cell
wall synthesis by binding to essential target proteins. Cefuroxime has good stability to bacterial beta-lactamases.
Clavulanic Acid has a similar structure to the beta-lactam antibiotics which binds irreversibly to the beta-lactamase enzymes. The presence of
Clavulanic Acid 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.
Indication

• Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
• Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including betalactamase producing strains),
  Moraxella catarrhalis (including beta-lactamase producing strains) or Streptococcus pyogenes.
• Acute Bacterial Maxillary Sinusitis caused by Streptococcus pneumoniae or Haemophilus influenza.
• Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis caused by Streptococcus
  pneumoniae, Haemophilus influenzae or Haemophilus parainfluenzae.
• Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or
  Streptococcus pyogenes.
• Uncomplicated Urinary Tract Infections caused by Escherichia coli or Klebsiella pneumoniae.
• Uncomplicated Gonorrhea (urethral and endocervical) caused by Neisseria gonorrhoeae and Uncomplicated Gonorrhea (rectal in
  females) caused by non-penicillinase producing strains of Neisseria gonorrhoeae.
• Early Lyme disease (erythema migrans) caused by Borrelia burgdorferi.
• Septicemia caused by Staphylococcus aureus, 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 meningitidis
  and Staphylococcus aureus (penicillinase and non-penicillinase producing strains).

Dosage and Administration
Adults (13 years and older)
Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Pediatric Patients (who can swallow tablet whole)

Side Effect
Generally Cefuroxime-Clavulanic Acid is well tolerated. Major adverse reactions which may occur are diarrhea, nausea, vomiting, transient
elevation in AST, ALT, LDH and eosinophilia. Other adverse events that may occur are abdominal pain, abdominal cramps, flatulence,
indigestion, headache, vaginitis, rash, itch, dysuria, thirst, anorexia etc.
Contraindication
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to Cephalosporins & in patients with Pseudomonas Colitis.
Precautions
As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic Acid combination may result in overgrowth of
non-susceptible microorganisms.
Use in Special Group
Pregnancy & Lactation: All antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely
used in later pregnancy to treat Urinary Tract and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small
quantities and consequently caution should be exercised when it is administered to a nursing mother.
Drug Interaction
Concomitant administration of Probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time
curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial
absorption.
Overdoasge
Overdosage can cause cerebral irritation leading to convulsions. In this case, serum levels can be reduced by hemodialysis and peritoneal
dialysis.

Tablet: Keep away from light & moisture and store below 30^o C temperature.
Powder for Suspension: Keep away from light & moisture and store below 25^o C temperature. Reconstituted suspension should be stored in
a refrigerator (2-8) o C and used within 7 days. Keep out of reach of children.