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MEROCLAV

CEFUROXIME USP & CLAVULANIC ACID BP


NAME STRENGTH PACK SIZE DOSAGE FORM
MEROCLAV 250 MG & 62.5 MG 250 MG & 62.5 MG 20 S TABLET
MEROCLAV 500 MG & 125 MG 500 MG & 125 MG 20 S TABLET
MEROCLAV (125 MG+ 31.25MG)/5 ML (125 MG+ 31.25MG)/5 ML 70 ML POS

Meroclav 250: Each film coated tablet contains Cefuroxime 250 mg as Cefuroxime Axetil USP and Clavulanic Acid 62.5 mg as diluted Potassium Clavulanate BP.

Meroclav 500: Each film coated tablet contains Cefuroxime 500 mg as Cefuroxime Axetil USP and Clavulanic Acid 125 mg as diluted Potassium Clavulanate BP.

Meroclav 70 ml powder for suspension: After reconstitution, each 5 ml suspension contains Cefuroxime 125 mg as Cefuroxime Axetil USP and Clavulanic Acid 31.25 mg as diluted Potassium Clavulanate BP.

Cefuroxime is a broad spectrum second generation Cephalosporin active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-Iactamase 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 but binds irreversibly to the beta-lactamase enzymes. The presence of Clavulanic Acid protects Cefuroxime from degradation by beta-Iactamase enzymes and effectively extends the antibacterial spectrum of Cefuroxime to include many bacteria normally resistant to Cefuroxime and other Cephalosporins.

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 Meroclav may be administered without regard to meals. Direction for reconstitution of suspension: Shake the bottle well to loosen the powder. Add 35 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake the bottle well after each addition until all the powder is in suspension. Note: The reconstituted suspension must be stored at 2-8 °C temperature and should be used within 7 days after reconstitution. Shake the suspension well before each use. Keep the bottle tightly closed.

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

Meroclav 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.

During pregnancy: While all antibiotics should be avoided in the first trimester if possible. However, Meroclav can be safely used in later pregnancy to treat urinary and other infections. During lactation: Meroclav is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Concomitant administration of probenecid with Meroclav 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.

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

Meroclav tablet and powder for suspension should be kept in a cool (15°–25° C temperature) and dry place and protected from light.

Meroclav 250 : Each box contains 2x10 tablets in Alu-Alu blister pack.

Meroclav 500 : Each box contains 2x10 tablets in Alu-Alu blister pack.

Meroclav Suspension: Each bottle contains dry powder for 70 ml suspension with a measuring spoon.