CEFIXIME, AZITHROMYCIN & LACTIC ACID BACILLUS TABLETS-Manufacturers, Supplier, Third Party Contract Manufacturing & PCD Pharma Franchise


FYCEF-AZ LB – Cefixime, Azithromycin and Lactic Acid Bacillus Tablets

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FYCEF-AZ LB is the combination of three formulations: CEFIXIME, AZITHROMYCIN & LACTIC ACID BACILLUS TABLETS.

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.

Azithromycin is a semi-synthetic macrolide antibiotic of the azalide class. Like other macrolide antibiotics, azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of the bacterial 70S ribosome. Binding inhibits peptidyl transferase activity and interferes with amino acid translocation during the process of translation. Cefixime, Azithromycin and Lactic Acid Bacillus Tablet’s effects may be bacteriostatic or bactericidal depending of the organism and the drug concentration. Its long half life, which enables once daily dosing and shorter administration durations, is a property distinct from other macrolides.

Azithromycin, a semisynthetic antibiotic belonging to the macrolide subgroup of azalides, is used to treat STDs due to chlamydia and gonorrhea, community-acquired pneumonia, pelvic inflammatory disease, pediatric otitis media and pharyngitis, and Mycobacterium avium complex (MAC) in patients with advanced HIV disease. Similar in structure to erythromycin. Cefixime, Azithromycin and Lactic Acid Bacillus Tablets zithromycin reaches higher intracellular concentrations than erythromycin, increasing its efficacy and duration of action.


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.

Absorption: -Bioavailability is 37% following oral administration. Absorption is not affected by food. Azithromycin is extensively distributed in tissues with tissue concentrations reaching up to 50 times greater than plasma concentrations. Drug becomes concentrated within macrophages and polymorphonucleocytes giving it good activity against Chlamydia trachomatis.
Volume of distribution:-31.1 L/kg

Protein Binding: -Serum protein binding is variable in the concentration range approximating human exposure, decreasing from 51% at 0.02 µg/mL to 7% at 2 µg/mL.
Metabolism : -Hepatic. In vitro and in vivo studies to assess the metabolism of azithromycin have not been performed.

Route of elimination: – Biliary excretion of azithromycin, predominantly as unchanged drug, is a major route of elimination.
Half life: -68 hours

Clearance : –apparent plasma cl=630 mL/min [following single 500 mg oral and i.v. doses]
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).

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