Indications of Cefopen 1 gm/vial
Cefopen 1 gm/vial is indicated for the treatment of the following infections when caused by susceptible organisms: Respiratory Tract Infections, Peritonitis & Other Intra-abdominal Infections, Bacterial Septicemia, Skin and Skin Structures Infections, Pelvic Inflammatory Disease, Endometritis & Other Infections of the Female Genital Tract, Urinary Tract Infections, Enterococcal Infections etc.
Third generation Cephalosporins
Like all beta-lactam antibiotics, Cefopen 1 gm/vial binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins.
Dosage & Administration of Cefopen 1 gm/vial
Sterile Cefopen 1 gm/vial Sodium can be administered by IM or IV injection (following dilution).Adult: 2 to 4 grams per day administered in equally divided doses every 12 hours. In severe infections or infections caused by less sensitive organisms, the total daily dose and/or frequency may be increased. Patients have been successfully treated with a total daily dosage of 6-12 grams divided into 2,3, or 4 administrations ranging from 1.5 to 4 grams per dose. When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days
Cefopen 1 gm/vial is contraindicated in patients with known allergy to the Cephalosporin-class of antibiotics.
Side Effects of Cefopen 1 gm/vial
As with all Cephalosporins, hypersensitivity manifested by skin reactions (1 patient in 45), drug fever (1 in 260), or a change in Coombs' test (1 in 60) has been reported. These reactions are more likely to occur in patients with a history of allergies, particularly to Penicillin.
Pregnancy & Lactation
Pregnancy Category B.This drug should be used during pregnancy only if clearly needed. Only low concentrations of Cefopen 1 gm/vial is excreted in human milk. Although Cefopen 1 gm/vial passes poorly into breast milk of nursing mothers, caution should be exercised when Cefopen 1 gm/vial is administered to a nursing woman.
Precautions & Warnings
Cefopen 1 gm/vial is extensively excreted in bile. The serum half-life of Cefopen 1 gm/vial is increased 2-4 fold in patients with hepatic disease and/or biliary obstruction. In general, total daily dosage above 4 gm should not be necessary in such patients. If higher dosages are used, serum concentrations should be monitored.
Cefopen 1 gm/vial is to be stored in a dry place, below 25°C and protected from light prior to reconstitution. The reconstituted solution may be stored for 24 hours if kept in room temperature (below 25°C).
Use In Special Populations
Children use: Safety and effectiveness in children have not been established.Geriatric use: Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Cefopen 1 gm/vial for intravenous or intramuscular use may be initially reconstituted with compatible solution. Solutions should be allowed to stand after reconstitution to allow any foaming to dissipate to permit visual inspection for complete solubilization. Vigorous and prolonged agitation may be necessary to solubilize Cefopen 1 gm/vial in higher concentrations (above 333 mg Cefopen 1 gm/vial/ml). The maximum solubility of Cefopen 1 gm/vial is approximately 475 mg Cefopen 1 gm/vial/ml of compatible diluent.