Samarth Pharma

Purecef-S inj (cefoperazone sulbactam 1 gm) Descritption: It is unique combination of a third generation cephalosporin & beta-lactamase inhibitor. • Cefoperazone exerts its bactericidal effect by inhibiting the bacterial cell wall synthesis. • Sulbactam acts as a beta-lactamase inhibitor , (a derivative of basic penicillin nucleus) to increase the antibacterial activity of cefoperazone against beta-lactamase producing organisms. • Most of the remaining dose of cefoperazone is excreted in the bile. • After administration,the mean half life of sulbactam is about 1 hr while that for cefoperazone is 1.7 hrs. • After I.M administration, peak serum concentration are seen from 15 min to 2hrs. • Both sulbactam & cefoperazone ditribute into variety of tissue & fluids,bile,G.bladder,skin,appendix,fallopian tubes,ovary,uterus and others. Indications Monotherapy Sulbactam / cefoperazone is indicated for the treatment of the following infections when caused by susceptible organisms: • Respiratory tract infection ( Upper & Lower ) • UTI ( Upper & Lower ) • Peritonitis,Cholecystitis,Cholangitis & other intra-abdominal infections, Septicemia • Meningitis • Skin & soft tissue infections • Bone & joint infections • Pelvic inflammatory disease • Endometritis • Gonorrhoea & other genital tract infections Combination Therapy • Because of the broad spectrum of activity of sulbactam/cefoperazone, most infections can be treated adequately with this antibiotic alone. • However, sulbactam/cefoperazone may be used concomitantly with other antibiotics if such combinations are indicated. • If an aminoglycoside is used, renal function should be monitored during the course of therapy. ◊ Aminoglycosides are a group of antibiotics that are effective against certain types of bacteria. They include amikacin, gentamicin, kanamycin, neomycin, ... Dosage and Administration Daily dosage recommendations for sulbactam/cefoperazone in adults are as follow: Ratio of SBT&CPZ SBT/CPZ(g) Sulbactam(g) Cefoperazone(g) 1:1 2.0-4.0 1.0-2.0 1.0-2.0 • Dosage should be administered every 12 hours in equally divided doses. • In severe or refractory infections the daily dosage of sulbactam/cefoperazone may be increased up to 8 g of the 1:1 ratio (i.e., 4 g cefoperazone activity). • Doses should be administered every 12 hours in equally divided doses. • The recommended maximum daily dosage of sulbactam is 4 g. • Use in Children Daily dosage recommendations for sulbactam/cefoperazone in children are as follows: Ratio of SBT&CPZ SBT/CPZ ( mg/kg/d) Sulbactam ( mg/kg/d) Cefoperazone ( mg/kg/d) 1:1 40-80 20-40 20-40 • Doses should be administered every 6 to 12 hours in equally divided doses. • In serious or refractory infections, these dosages may be increased up to 160 mg/kg/day. • Doses should be administered in two to four equally divided doses. Use in Neonates For neonates in the first week of life, the drug should be given every 12 hours. The maximum daily dosage of sulbactam in pediatrics should not exceed 80 mg/kg/day. If more than 80 mg/kg/day of cefoperazone activity are necessary, additional cefoperazone should be administered. Reconstitution:Sulbactam/cefoperazone is available in 1.0 g vial. Total Dose(g) Equivalent dose SBT&CPZ (g) Vol of diluent conc.(ml) Maxi. Final dose of SBT&CPZ (mg/ml) 1.0 0.5 + 0.5 3.4 125 + 125 • Sulbactam/cefoperazone has been shown to be compatible with water for injection, 5% dextrose, normal saline, 5% dextrose in 0.225% saline, and 5% dextrose in normal saline.

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.