Samarth Pharma

THERAPEUTIC CLASSIFICATION ANTIBIOTIC ACTION AND CLINICAL PHARMACOLOGY Plugfix(cefixime) exerts its bactericidal effect by attaching to penicillin-binding proteins and inhibiting peptidoglycan synthesis, thus causing damage to the bacterial cell wall. Following oral dosing, Plugfix attains peak serum levels in approximately 4 hours. The half-life is about 3 to 4 hours and is not dose dependent. Cefixime is excreted by renal and biliary mechanisms. About 50% of the absorbed dose is excreted unchanged in the urine within 24 hours. There is no evidence of metabolism of cefixime in vivo. INDICATIONS AND USAGE: Plugfix(cefixime) is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms: 1.Upper Respiratory Tract: Pharyngitis and tonsillitis caused by S. pyogenes. 2. Middle Ear: Otitis media caused by S. pneumoniae, H. influenzae (beta-lactamase positive and negative strains), M. catarrhalis (former B. catarrhalis) (beta-lactamase positive and negative strains) and S. pyogenes. Paranasal sinuses: Sinusitis caused by S. pneumoniae, H. influenzae (beta-lactamase positive and negative strains), and M. catarrhalis (former B. catarrhalis) (beta-lactamase positive and negative strains). 3.Lower Respiratory Tract: Acute bronchitis caused by S. pneumoniae, M. catarrhalis (former B. catarrhalis) (beta-lactamase positive and negative strains) and H. influenzae (beta-lactamase positive and negative strains). 4.Urinary Tract: Acute uncomplicated cystitis and urethritis caused by E. coli, P. mirabilis, and Klebsiella species. 5.Uncomplicated Gonorrhea: Uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase (beta-lactamase-positive) and nonpenicillinase (beta-lactamase-negative) producing strains. Usage in Children: Safety and effectiveness of PLUGFIX ( Cifixime) in children less than six months old have not been established.