Sulbin
Broad Spectrum Antibiotic
Description:
Sulbactam sodium is a derivative 0f the basic penciillin nucleus. Chemically it is sodium penicillanate sulfone and is an off white crystalline powder highly soluble in water the molecular weight is 255.22 ampicillin sodium is derived from the penicillin nucleus 6 aminopenicillanic acid chemically it is D aminobenzyl penicillin sodum salt and has amolecular weight of 371.39
Sulbin im.iv.brand of sulbactam /ampicillin sodum combination is available as adry powder for reconstitution in vials containing the equivalent of 500 mg+1000mg , 250mg+500mg, 125mg+250mg of sulbactam and ampicillin respectively
Actions:
bichemical studies with cell free bacterial systems have shown sulbactam to be an irreversible inhibitor of most imprtant beta lactamases that occur in penicillin resistant organisms it possesses significant antibacterial activity only against neleseriaceae acinetobacter calcoaceticus bacteroides sp branhamella ,catarrhalls,and pseudomonas cepacla the potential for sulbactam sodum is preventing the destruction of penicillins and cephalosporins by resistant organisms was confirmed in whole organism studies using ressistant strains in which sulbactam sodum exhibited marked synergistic effects with penicillins and cephalosporins since sulbactam also binds to some penicillin binding proteins some sensitive strains are rendered mor susceptible to the combination than to the beta lactam antibiotic alone the bactericidal component of the combination is ampicillin which like benzyl penicillin acts against sensitive organisms during the stage of active multiplivation by the inhibition of biosynthesis of cell wall mucopeptide
INDICATIONS:
Sulbin im/iv is indicated for infections caused by susceptible microorganisms typical indications are upper and lower respiratory tract infections including sinusitis otitis media and epiglottitis ,bacterial peneumonias urinary tract infections and pyelonephritis intra abdominal infections including peritonitis cholecystitis endometttritis and pelvic cellulitis bacterial peneumonias urinary tract infections snd pyelonephritis intra abdominal infections including peritonitis cholecystitis endometritis and pelvic cellulitis bacterial septicemia skin soft tissue bone and joint infections and gonococcal infections sulbin im/iv may also be administered peri operatively to reduce the incidence of post operative wound infections in patients undergoing abdominal or pelvic surgery in which peritoneal contamination may by persent in termination of pregnancy or cesarean section sulbin im/iv may be used prophylactically to reduce post operative sepsis
CONTRAINDICATIONS:
The use of this combination is contraindicated in Individuals with a history of an allergic reaction to any 0f the penicillins
WARNINGS:
who have experienced serever reactions whe
Serious and occasionally latal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more apt to occur in individuals with ahistory of penicillin hypersensitivity and/or hypersensitivity reactions to multiple allergens there have been reports of individuals with ahistory of penicillin hypersensitivity who have experienced serever reactions when treated with cephalosporins before therapy with apenicillin careful inquiry should be made concerning previous hypersensitivity reactions to penicillin ,cephalosporins and other allergens if an allergic reactions occurs the drug should be discontinued and the appropriate therapy instituted
Use in Pregnancy and Lactation:
animal reproduction studies have revealed no evidence of impaired fertility or harm to the fetus due to sulbactam and ampicillin however safety for use in pregnancy and lactation has not been established
PRECAUTIONS :
As with any antabiotic Preparation. constant observation for Signs of overgrowth 0f nonsusceptible organisms Includinng fungi is essential Should superinfection occur, the drug should be discontinued and/or appropirate therapy instituted. As with any potent systems agent. it is advisable t0 check periodically for organ system dysfunction dUflr19 extended therapy; this includes renal. hepatiC, and hematopoietic systems This is periodically Important In neonates especially when premature and other infants
ADVERSE REACTIONS :
tsantbiobcs. the pnnapaJ side etfect obseNed IS If”It8C1IOI’I SIte palfl. espeaally assoaated WIth the I”Itramosc:utar route of adrrIInisb”allOO. A sma! number of patents may develop phIebIhS after intravenous adlTUfWStratlon Gastro-Intesllflal. the mosl common wee nausea vomillflg and oaetea Skwl I skI”IstnJclufe-lle IOClStcommon were rash ltchngandolher siI.Il reactIOnS Hematopoiett;andl~ IltSystems-ir*llIa,1hrOrrbocyIopen
arrIPIC*lsodun Thesereactms are rlM!fStlleon dlsaxltnJabonollherapyand8fe be!levedlObesens4Mtyreacbons Hepalic-transieflt eleYabonS 01alarWleandaspartJc lrat\SllTlll”la58haO’l! beenobseM!d beOCClS1Of”lllyobseMd
Sn::e1fl1ecooosmononuc::leostslSwaiIlDOgll”l. ampicIIin should noI be used 1″1 the Iteatment. A highpe:rcentageolpabentsW1thrnonortldeoSlSwt1o recewe
PACKING:
– 0.375 Vials contain 0 125 gm Sutbactam sodium 0,250 gm ampicillin sodium
– 750 Vials contain 250 gm Subactam sodium 0.500 gm ampicillin sodium
– 1,500 vials :is contain 0,500gm Subactam sodium I,000 gm ampicillin sodium
STORAGE:
Before reconstitution:
Keep at temperature not exceecing 30 C. in dry place
Keep out 0f the reach 0f children
produced by :
PHARCO PHARMACEUTICALS
