Unasyn IM/IV Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

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.

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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 daily in divided doses every 6 or 8 hr, or every 12 hr for less severe infections. Max daily dose of sulbactam: 4 g daily. Severe infection Up to 12 g daily; moderate infection Up to 6 g daily; mild infection 1.5-3 g daily. 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 + oral probenecid 1 g. Childn, infant & neonate 150 mg/kg daily every 6-8 hr. Neonate during 1st wk of life (especially preterm) 75 mg/kg daily in divided doses every 12 hr.

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Overdosage

View Unasyn IM/IV overdosage for action to be taken in the event of an overdose.

Contraindications

History of allergic reaction to penicillins.

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Special Precautions

Previous hypersensitivity reactions to penicillins, cephalosporins & other allergens. Discontinue if severe skin reactions eg, TEN, 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.

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Use In Pregnancy & Lactation

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Adverse Reactions

Agranulocytosis, neutropenia, leukopenia, hemolytic anemia, anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia; anaphylactic shock/reaction, anaphylactoid shock/reaction, 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; TEN, SJS, exfoliative dermatitis, erythema multiforme, acute generalized exanthematous pustulosis, angioedema, rash, pruritus, urticaria, dermatitis; tubulointerstitial nephritis; inj site reaction/pain, fatigue, malaise; increased ALT/AST.

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Drug Interactions

Increased incidence of rashes w/ allopurinol. Substantial mutual inactivation w/ aminoglycosides (if mixed in vitro). May produce additive effects to alterations in platelet aggregation & coagulation tests w/ anticoagulants. Bactericidal effect may be interfered w/ bacteriostatic drugs (eg, chloramphenicol, erythromycin, sulfonamides & tetracyclines). Reduced effectiveness of OCs (estrogen-containing). Decreased clearance & increased toxicity of MTX. 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.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Unasyn IM/IV detailed prescribing information

Storage

View Unasyn IM/IV storage conditions for details to ensure optimal shelf-life.

Description

View Unasyn IM/IV description for details of the chemical structure and excipients (inactive components).

Action

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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.

Regulatory Classification

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)

Unasyn IM/IV

ampicillin + sulbactam

Manufacturer:

Pfizer

Distributor:

Zuellig