Sharpkil Plus

Cefuroxime+Clavulanic Acid

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 b-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 Sharpkil Plus 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

Sharpkil Plus 250/62.5 Tablet: Each tablet contains Cefuroxime Axetil USP equivalet to Cefuroxime 250 mg and diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 62.5 mg. Sharpkil Plus 500/125 Tablet: Each tablet contains Cefuroxime Axetil USP equivalet to Cefuroxime 500 mg and diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg
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 (non-beta-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 penumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (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 pneumoniae 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 meningitidis and Staphylococcus aureus (penicillinase and non-penicillinase producing strains) Switch therapy (injectable to oral) after surgery when patient’s condition is improved.
Adolescents & adults: Pharyngitis or Tonsillitis: 250 mg twice daily 5-10 days Acute bacterial maxillary sinusitis: 250 mg twice daily 10 days Acute bacterial exacerbation of chronic bronchitis: 250-500 mg twice daily 10 days Secondary bacterial infections of acute bronchitis: 250-500 mg twice daily 5-10 days Community acquired pneumonia: 250-500 mg twice daily 5-10 days Uncomplicated skin & skin-structure infections: 250-500 mg twice daily 10 days MDR Typhoid fever: 500 mg twice daily 10-14 days Uncomplicated urinary tract infection: 250 mg twice daily 7-10 days Uncomplicated gonorrhea: 1000 mg single dose Lyme disease: 500 mg twice daily 20 days Paediatric patients (3 months to 12 years) Pharyngitis or Tonsillitis: 20 mg/kg/day in two divided doses 5-10 days Acute otitis media: 30 mg/kg/day in two divided doses 10 days Acute bacterial maxillary sinusitis: 30 mg/kg/day in two divided doses 10 days Community acquired pneumonia: 30 mg/kg/day in two divided doses 5-10 days MDR Typhoid fever: 30 mg/kg/day in two divided doses 10-14 days Uncomplicated skin & skin-structure infections: 30 mg/kg/day in two divided doses 10 days Uncomplicated urinary tract infection: 20 mg/kg/day in two divided doses 7-10 days Cefaclav may be administered without regard to meals.
Patients with known allergy to cephalosporins & pseudomembranous colitis are contraindicated.
Cefuroxime Clavulanic Acid should be given with care to patients receiving concurrent treatment with potent diuretics & who have history of colitis.
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 overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.
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.
During pregnancy: While 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 and other infections. During lactation: Cefuroxime Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.
Signs and symptoms: Overdosage of Sharpkil Plus can cause cerebral irritation leading to convulsions. Management: Serum levels of Sharpkil Plus can be reduced by haemodialysis and peritoneal dialysis.
Sharpkil Plus 250/62.5 Tablet: Each box contains 2 Alu-Alu blister strips of 7 tablets. Sharpkil Plus 500/125 Tablet: Each box contains 1 Alu-Alu blister strips of 7 tablets.