Unasyn IM/IV

Unasyn IM/IV

ampicillin + sulbactam

Manufacturer:

Pfizer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Sultamicillin (ampicillin & sulbactam). Per 375 mg powd for inj Sulbactam Na 125 mg, ampicillin Na 250 mg. Per 750 mg powd for inj Sulbactam Na 250 mg, ampicillin Na 500 mg. Per 1.5 g powd for inj Sulbactam Na 500 mg, ampicillin Na 1,000 mg
Indications/Uses
Upper & lower resp tract infections including sinusitis, otitis media & epiglottitis; bacterial pneumonias; UTI & pyelonephritis; intra-abdominal infections including peritonitis, cholecystitis, endometritis & pelvic cellulitis; bacterial septicemia; skin, soft tissue, bone & joint infections; gonococcal infections. Peri-op to reduce the incidence of post-op wound infections in patients undergoing abdominal or pelvic surgery in which peritoneal contamination may be present. As prophylaxis in termination of pregnancy or cesarean section to reduce post-op sepsis.
Dosage/Direction for Use
IM/IV Administer as bolus inj over a min of 3 min or as IV infusion over 15-30 min. Adult 1.5-12 g/day in divided doses every 6 or 8 hr, or every 12 hr for less severe infections. Max daily dose of sulbactam: 4 g/day. Severe infection Up to 12 g/day; moderate infection Up to 6 g/day; mild infection 1.5-3 g/day. Continued until 48 hr after pyrexia & other abnormal signs have resolved. Duration of treatment: 5-14 days. Prophylaxis of surgical infections 1.5-3 g at induction of anesth, may be repeated every 6-8 hr & stopped 24 hr after the majority of surgical procedures. Uncomplicated gonorrhea 1.5 g single dose + 1 g oral probenecid. Childn, infant & neonate 150 mg/kg/day every 6-8 hr. Neonate during 1st wk of life (especially preterm) 75 mg/kg/day in divided doses every 12 hr.
Contraindications
History of allergic reaction to penicillins.
Special Precautions
Previous hypersensitivity reactions to penicillins, cephalosporins & other allergens. Discontinue if severe skin reactions eg, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), dermatitis exfoliative, erythema multiforme, & acute generalized exanthematous pustulosis (AGEP) occurs. Constantly observe for signs of overgrowth of nonsusceptible organisms including fungi; discontinue if superinfection occurs. Consider Clostridium difficile associated diarrhea in patients who present w/ diarrhea following antibiotic use. Drug induced liver injury eg, cholestatic hepatitis & jaundice. Periodically check organ system dysfunction during extended therapy including renal, hepatic & hematopoietic systems, especially in premature neonates & other infants. Should not be used in infectious mononucleosis. Pregnancy & lactation.
Adverse Reactions
Agranulocytosis, neutropenia, leukopenia, hemolytic anemia, anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia; anaphylactic shock/reaction, anaphylactoid shock/reaction, hypersensitivity, Kounis syndrome, hypersensitivity; convulsion, headache, dizziness, somnolence, sedation; phlebitis; dyspnea; pseudomembranous colitis, enterocolitis, melena, abdominal pain, diarrhea, vomiting, nausea, dyspepsia, stomatitis, glossitis, tongue discoloration; cholestatic hepatitis, cholestasis, jaundice, hyperbilirubinemia, abnormal hepatic function; toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, erythema multiforme, acute generalized exanthematous pustulosis, angioedema, rash, pruritus, urticaria, dermatitis; tubulointerstitial nephritis; inj site reaction/pain, fatigue, malaise; increased ALT/AST.
Drug Interactions
Increased incidence of rashes w/ allopurinol. Substantial mutual inactivation w/ aminoglycosides (if mixed in vitro). May produce additive effects of alterations in platelet aggregation & coagulation tests w/ anticoagulants. May interfere bactericidal effect w/ bacteriostatic drugs (chloramphenicol, erythromycin, sulfonamides & tetracyclines). Reduced effectiveness of OCs (estrogen-containing). Decreased clearance & increased toxicity of methotrexate. Decreased renal tubular secretion w/ probenecid. False +ve glycosuria in urinalysis w/ Benedict's/Fehling's reagent & Clinitest. Transient decrease in plasma conc of total conjugated estriol, estriol-glucuronide, conjugated estrone & estradiol.
MIMS Class
Penicillins
ATC Classification
J01CR01 - ampicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Presentation/Packing
Form
Unasyn IM/IV 1.5 g powd for inj
Packing/Price
1's (P1,190.46/vial)
Form
Unasyn IM/IV 375 mg powd for inj
Packing/Price
1's (P446.15/vial)
Form
Unasyn IM/IV 750 mg powd for inj
Packing/Price
1's (P825.51/vial)
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