Neoclav

Composition

Neoclav 250 tablet: Each film coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 250 mg and Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 62.5 mg.

Neoclav 500 tablet: Each film coated tablet contains Cefuroxime Axetil USP equivalent to Cefuroxime 500 mg and Diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.

 

Description

Cefuroxime has bactericidal activity against a wide range of common pathogens, including beta-lactamase producing strains. The bactericidal action of cefuroxime results from inhibition of cell wall synthesis by binding to essential target proteins. Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. Clavulanic acid binds to and inactivates them thus preventing the destruction of cefuroxime that is a substrate for this enzyme.

 

Indication

• 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.

• 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).

• Switch therapy (injectable to oral).

 

Dosage and administration

Adults (13 years and older)

• Pharyngitis or Tonsillitis: 250 mg twice daily for 5-10 days.

• Acute bacterial maxillary sinusitis: 250 mg twice daily for 10 days.

• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg twice daily for 10 days.

• Secondary bacterial infections of acute bronchitis: 250-500 mg twice daily for 5-10 days.

• Community acquired pneumonia: 250-500 mg twice daily for 5-10 days.

• Uncomplicated skin & skin-structure infections: 250-500 mg twice daily for 10 days

• Typhoid fever: 500 mg twice daily for 10-14 days.

• Uncomplicated urinary tract infection: 250 mg twice daily for 7-10 days.

• Uncomplicated gonorrhea: 1000 mg single dose.

• Lyme disease: 500 mg twice daily for 20 days

 

Contraindication

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to Cephalosporins & in patients with Pseudomembranous Colitis.

 

Adverse 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, sleepiness, thirst, anorexia etc.

 

Use in special group

All antibiotics should be avoided in the first trimester if possible. 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.

 

Precaution

As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic Acid combination may result in overgrowth of nonsusceptible microorganisms.

 

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.

 

Storage

Keep out of the reach of children. Keep below 300C, protect from light.

 

Prescribing Information


How supplied

Neoclav 250 tablet: Each box contains 2X6’s tablet in blister pack.

Neoclav 500 tablet: Each box contains 1X6’s tablet in blister pack.