Unasyn

Unasyn

sultamicillin

ampicillin + sulbactam

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Sultamicillin (ampicillin & sulbactam). Per 750 mg tab Ampicillin 440 mg, sulbactam 294 mg. Per 1.5 g inj Ampicillin Na 1,000 mg, sulbactam Na 500 mg. Per 3 g inj Ampicillin Na 2,000 mg, sulbactam Na 1,000 mg
Indications/Uses
Susceptible infections eg, upper & lower resp tract infections including sinusitis, otitis media; bacterial pneumonia; UTI & pyelonephritis; skin & soft tissue & gonococcal infections. Tab: Tonsillitis; bronchitis. Patients requiring sulbactam/ampicillin therapy following initial IM/IV treatment. IM/IV: Epiglottitis; intra-abdominal infections including peritonitis, cholecystitis, endometritis & pelvic cellulitis; bacterial septicemia; bone & joint infections. Reduction of incidence of post-op wound infections in patients undergoing abdominal or pelvic surgery, in which peritoneal contamination may be present. Prophylaxis to reduce post-op sepsis in termination of pregnancy or cesarean section.
Dosage/Direction for Use
Tab Adult & childn Treatment duration: 5-14 days. Continued until 48 hr after pyrexia & other abnormal signs have resolved. Adult (including elderly) 375-750 mg bid daily. Uncomplicated gonorrhea 2.25 g (as three 750 mg tab) as single dose + probenecid 1 g. Infection caused by hemolytic Strep At least 10 days treatment. Childn weighing ≥30 kg Usual adult dose, <30 kg 25-50 mg/kg daily in 2 divided doses. IM/IV Administer as bolus inj over min of 3 min or as IV infusion over 15-30 min. May also be administered by deep IM inj. Adult 1.5-12 g daily in divided dose every 6-8 hr. Max daily dose of sulbactam: 4 g. Less severe infection Administer every 12 hr. Max daily dose: Mild infection 1.5-3 g, moderate infection Up to 6 g, severe infection Up to 12 g. Duration of treatment: 5-14 days. Surgical prophylaxis 1.5-3 g at induction of anesth, may be repeated every 6-8 hr. Uncomplicated gonorrhea 1.5 g as single dose + probenecid 1 g. Childn, infant & neonate 150 mg/kg daily every 6 or 8 hr. Neonate during 1st wk of life (especially pre-term) 75 mg/kg daily in divided doses every 12 hr.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. History of allergic reaction to any penicillins.
Special Precautions
Discontinue treatment if allergic reactions (eg, skin rash, irritation or swelling); severe skin reactions (eg, TEN, SJS, exfoliative dermatitis, erythema multiforme & acute generalized exanthematous pustulosis); superinfection occur. Not to be used in infectious mononucleosis. Serious & occasionally fatal hypersensitivity (anaphylactic) reactions. History of hypersensitivity reactions to penicillins, cephalosphorins & other allergens. Provide immediate emergency treatment w/ adrenaline; O2, IV steroids, airway management, including intubation during serious anaphylactic reactions. Sensitization. Clostridium difficile-associated diarrhea. Drug induced liver injury eg, cholestatic hepatitis & jaundice. Constantly observe for signs of overgrowth of non-susceptible organisms including fungi. Periodically check for organ system dysfunction during prolonged therapy, including renal, hepatic & hematopoietic systems. Severe renal impairment (CrCl ≤30 mL/min). Pregnancy. Not recommended during lactation. Neonates w/ undeveloped renal function. Tab: Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption.
Adverse Reactions
Anaemia, thrombocytopenia, eosinophilia; diarrhoea; hyperbilirubinaemia; increased ALT/AST. TEN, SJS, erythema multiforme. Tab: Pseudomembranous colitis, Candida infection; anaphylactic shock & reaction, Kounis syndrome, hypersensitivity; dizziness, somnolence, sedation, headache, convulsion; dyspnea; enterocolitis, melena, vomiting, abdominal pain, dyspepsia, nausea, stomatitis, dysgeusia, tongue discolouration, glossitis; jaundice, abnormal hepatic function, cholestatic hepatitis, cholestasis, hyperbilirubinaemia; angioedema, urticaria, dermatitis, rash, pruritus, exfoliative dermatitis, acute generalized exanthematous pustulosis; arthralgia; fatigue, malaise; abnormal platelet aggregation; agranulocytosis, hemolytic anemia, thrombocytopenic purpura, leukopenia, neutropenia; tubulointerstitial nephritis. IM/IV: Phlebitis; inj site pain.
Drug Interactions
Increased incidence of rashes w/ allopurinol. May produce additive effects w/ anticoagulants. Interference w/ bactericidal effects w/ bacteriostatics (chloramphenicol, erythromycin, sulfonamides & tetracyclines). Reduced effectiveness of estrogen-containing OCs. Decreased clearance & increased toxicity of MTX. Decreased renal tubular secretion & increased toxicity w/ probenecid. False +ve glycosuria in pregnant women w/ Benedict & Fehling reagent, & Clinitest. IM/IV: Substantial mutual inactivation w/ aminoglycosides.
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.
J01CR04 - sultamicillin ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
FC tab: D; Powd for inj: S
Presentation/Packing
Form
Unasyn FC tab 750 mg
Packing/Price
3 × 4's
Form
Unasyn powd for inj 1.5 g
Packing/Price
1's
Form
Unasyn powd for inj 3 g
Packing/Price
1's
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