FYCEF-CV Tablets

CEFIXIME 200mg, CLAVUNIC ACID 125mg

Cefixime, an antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Cefixime is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall. PHARMACODYNAMICS: - Cefixime, an antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Cefixime is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall.

 

 

• Absorption: - About 40%-50% absorbed orally whether administered with or without food, however, time to maximal absorption is increased approximately 0.8 hours when administered with food.
• Protein binding: - 65% (concentration independent)
• Metabolism: - Hepatic. Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours.
• Half life : - 3-4 hours (may range up to 9 hours). In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours.

INDICATION For use in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:

(1) uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis,

(2) otitis media caused by Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella catarrhalis (most of which are beta-lactamase positive), and S. pyogenes,

(3) pharyngitis and tonsillitis caused by S. pyogenes,

(4) acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains), and

(5) uncomplicated gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains). CLAVULANIC ACID : -Clavulanic acid has a high affinity for and binds to certain ?-lactamases that generally inactivate amoxicillin by hydrolyzing its ?-lactam ring.

Combining clavulanate potassium with amoxicillin extends the antibacterial spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other penicillins and cephalosporins.

 

 

• Distribution Protein binding: About 25% (Clavulanic acid); about 18% (Amoxicillin). Amoxicillin distributes readily into most body tissues and fluids except the brain and spinal fluid.
• Excretion Half-life after oral admin: 1.3 hours (Amoxicillin); 1 hour (Clavulanic acid). About 50-70% of amoxicillin and 25-40% of clavulanic acid are excreted unchanged in urine during the 1st 6 hours after admin.