Cefuroxime + Clavulanic Acid

COMPOSITION Ceclav 250 Tablet:

Each film coated tablet contains 250 mg of Cefuroxime as Cefuroxime Axetil BP and 62.5 mg of Clavulanic Acid as Diluted Potassium Clavulanate BP. Ceclav 500 Tablet: Each film coated tablet contains 500 mg of Cefuroxime as Cefuroxime Axetil BP and 125 mg of Clavulanic Acid as Diluted Potassium Clavulanate BP. Ceclav PFS: After reconstitution, each 5 ml suspension contains 125 mg of Cefuroxime as Cefuroxime Axetil BP and 31.25 mg of Clavulanic Acid as Diluted Potassium Clavulanate BP

PHARMACOLOGY:

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. Cefuroxime has good stability to bacterial beta-lactamases. Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has poor intrinsic antimicrobial activity, but it is an irreversible binder of beta-lactamases produced by a wide range of gram positive and gram negative microorganism

INDICATIONS:

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 (nonbetalactamase-producing strains only). Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae,Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinaseand 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 Haemophilus parainfluenzae (beta-lactamase negative strains). Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinaseproducing strains), Streptococcus pyogenes, Escherichia coli,Klebsiella spp.,and Enterobacterspp. 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). Surgical Prophylaxis : Prophylaxis against infections in abdominal, pelvic, orthopedic, cardiac, pulmonary, esophageal and vascular surgery where there is increased risk for infection

CONTRAINDICATIONS:

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

SIDE EFFECTS:

Generally Cefuroxime and Clavulanic Acid is 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 may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis,rash and serum sickness like urticaria may appear.

DRUG INTERACTIONS:

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

USE IN PREGNANCY & LACTATION Pregnancy:

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

PRECAUTIONS Ceclav:

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

Tablets :

Store in a cool and dry place, away from light. Keep out of the reach of children. Suspension: The reconstituted suspension should be stored in a cool & dry place, preferably in a refrigerator and have to be used within 10 days after reconsititution. 

PACKAGING:

Ceclav 250 Tablet:Each box contains 3 pouches and each pouch contains 4 tablets in Alu-Alu blister strip. Ceclav 500 Tablet: Each box contains 2 pouches and each pouch contains 4 tablets in Alu-Alu blister strip. Ceclav PFS: Each box contains a glass bottle having dry powder to prepare 70 ml suspension