ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد ایتم قابل مشاهده باقیمانده : 4 مورد

Ampicillin and sulbactam: Drug information

Ampicillin and sulbactam: Drug information
(For additional information see "Ampicillin and sulbactam: Patient drug information" and see "Ampicillin and sulbactam: Pediatric drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)
Brand Names: US
  • Unasyn
Pharmacologic Category
  • Antibiotic, Penicillin
Dosing: Adult

Note: Ampicillin/sulbactam is a combination product formulated in a 2:1 ratio. Adult dosage recommendations are expressed as total grams of ampicillin/sulbactam.

Usual dosage range: IM, IV: 1.5 to 3 g every 6 hours (maximum: ampicillin/sulbactam 12 g daily) (manufacturer's labeling); for the treatment of infections caused by Acinetobacter spp., higher doses have been described (Assimakopoulos 2019; Beganovic 2021; Betrosian 2008; Gilad 2008; Housman 2013; Levin 2003; Makris 2018; Mosaed 2018).

Bite wound infection, treatment (animal or human bite) (off-label use): IV: 1.5 to 3 g every 6 hours (IDSA [Stevens 2014]); some experts prefer 3 g every 6 hours (Baddour 2021a; Baddour 2021b). Duration of treatment for established infection is typically 5 to 14 days (including oral step-down therapy) (Baddour 2021a; Baddour 2021b; IDSA [Stevens 2014]).

Bloodstream infection (off-label use): For pathogen-directed therapy of susceptible organisms:

IV: 3 g every 6 hours (IDSA [Mermel 2009]; Jellison 2001; Murray 2019); for infections caused by Acinetobacter spp., higher doses (eg, 3 g every 4 hours or 9 g every 8 hours) have been described but comparative data are lacking (Gilad 2008; Housman 2013; Levin 2003). Usual duration is 7 to 14 days; individualize depending on organism, source of infection, and clinical response. A 7-day duration is recommended for patients with uncomplicated Enterobacteriaceae infection who respond appropriately to antibiotic therapy (Kanafani 2019; Moehring 2019; Yahav 2018).

Diabetic foot infection, moderate to severe: IV: 3 g every 6 hours (Harkless 2005). Usual duration of therapy (including oral step-down therapy) is 2 to 4 weeks (in the absence of osteomyelitis) (Harkless 2005; IDSA [Lipsky 2012]; Weintrob 2020).

Endocarditis, treatment (off-label use): Enterococcus (native or prosthetic valve; beta-lactamase–producing strains susceptible to aminoglycosides):

IV: 3 g every 6 hours in combination with gentamicin for 6 weeks (AHA [Baddour 2015]).

Odontogenic infection, pyogenic (off-label use): IV: 3 g every 6 hours; duration is 7 to 14 days (including oral step-down therapy) (Chow 2019).

Pelvic infections (alternative agent):

Intra-amniotic infection (chorioamnionitis): IV: 3 g every 6 hours. Continue until vaginal delivery or for 1 dose after cesarean delivery (ACOG 2017). Note: Some experts recommend 1 additional dose after vaginal delivery and extension of antibiotics after cesarean delivery until patient is afebrile and asymptomatic ≥48 hours (Tita 2019).

Pelvic inflammatory disease (including tubo-ovarian abscess): IV: 3 g every 6 hours in combination with doxycycline. After 24 to 48 hours of sustained clinical improvement, may transition to oral therapy to complete ≥14 days of treatment (CDC [Workowski 2015). Note: Some experts include this combination as a preferred regimen for tubo-ovarian abscess (Beigi 2020).

Postpartum endometritis: IV: 3 g every 6 hours; treat until patient is clinically improved (no fundal tenderness) and afebrile for 24 to 48 hours (Chen 2021; Gall 1996).

Peritonitis, treatment (peritoneal dialysis patients): Pathogen-directed therapy for susceptible organisms. Note: Intraperitoneal administration is preferred to IV administration. Duration of therapy is ≥2 weeks for patients with adequate clinical response (Burkart 2019; ISPD [Li 2016]). Consider a 25% dose increase in patients with significant residual renal function (urine output >100 mL/day) (ISPD [Li 2010]; ISPD [Li 2016]; Mancini 2018; Szeto 2018).

Intermittent (preferred): Intraperitoneal: 3 g per exchange every 12 hours; allow to dwell for ≥6 hours (Blackwell 1990; ISPD [Li 2016]).

Continuous (with every exchange) (dose is per liter of dialysate): Intraperitoneal: Loading dose: 750 mg/L to 1 g/L of dialysate with first exchange of dialysate; maintenance dose: 100 mg/L of dialysate with each subsequent exchange (ISPD [Li 2016]; Lam 2008).

Pneumonia (off-label use):

Aspiration pneumonia, community-acquired (nonsevere): IV: 1.5 to 3 g every 6 hours, generally for 5 days (including oral step-down therapy) (Klompas 2021).

Community-acquired pneumonia: Inpatients without risk factors for P. aeruginosa: IV: 3 g every 6 hours in combination with other agent(s) when appropriate. Total duration (including oral step-down therapy) is a minimum of 5 days; patients should be clinically stable with normal vital signs prior to discontinuation (ATS/IDSA [Metlay 2019]; Majcher-Peszynska 2014; Rossoff 1995).

Hospital-acquired or ventilator-associated pneumonia: IV: 3 g every 6 hours, as part of a combination regimen when appropriate. Duration of therapy varies based on disease severity and response to therapy; treatment is typically given for 7 days (Chan 2010; IDSA/ATS [Kalil 2016]; Ye 2016; Zalts 2016). Note: For infections caused by Acinetobacter spp., higher doses (eg, 3 g every 4 hours or 9 g every 8 hours) have been described but comparative data are lacking (Assimakopoulos 2019; Beganovic 2021; Betrosian 2008; Gilad 2008; Housman 2013; Levin 2003; Makris 2018; Mosaed 2018).

Surgical prophylaxis (off-label use): IV: 3 g within 60 minutes prior to surgical incision. Doses may be repeated in 2 hours if procedure is lengthy or if there is excessive blood loss. Note: Consider local susceptibility patterns prior to use (Anderson 2019; ASHP/IDSA/SIS/SHEA [Bratzler 2013]). In cases in which extension of prophylaxis is warranted postoperatively, total duration should be ≤24 hours (Anderson 2019). Postoperative prophylaxis is not recommended in clean and clean-contaminated surgeries (CDC [Berríos-Torres 2017]).

Surgical site infections (eg, intestinal, GU tract, abdominal wall) (off-label use): IV: 3 g every 6 hours. Duration depends on extent and severity of infection as well as response to therapy; may switch to oral treatment when clinically improved. Note: Consult local susceptibility patterns prior to empiric use (IDSA [Stevens 2014]; Mancino 2020).

Dosing: Renal Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: Renally adjusted dose recommendations are based on a usual recommended dose of 1.5 to 3 g every 6 hours.

Altered kidney function: IV:

Note: Estimation of renal function for the purpose of drug dosing should be done using the Cockcroft-Gault formula. Dosage recommendations are expressed as grams of ampicillin/sulbactam combination (Wright 1983; manufacturer's labeling):

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl 15 to 29 mL/minute: 1.5 to 3 g every 12 hours.

CrCl 5 to 14 mL/minute: 1.5 to 3 g every 24 hours.

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2): Augmented renal clearance (ARC) is a condition that occurs in certain critically-ill patients without organ dysfunction and with normal serum creatinine concentrations. Young patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Bilbao-Meseguer 2018; Udy 2010).

IV: 1.5 to 3 g every 4 to 6 hours (expert opinion).

Hemodialysis, intermittent (thrice weekly): Dialyzable (39% to 63% [Jusko 1973]):

IV: 1.5 to 3 g every 12 to 24 hours; administer after dialysis when scheduled dose falls on dialysis days (Heintz 2009).

Peritoneal dialysis: IV: 1.5 g every 12 hours or 3 g every 24 hours (Blackwell 1990; expert opinion).

CRRT: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection) and consideration of initial loading doses. Close monitoring of response and adverse reactions (eg, neurotoxicity) due to drug accumulation is important.

CVVH/CVVHD/CVVHDF: IV: 3 g every 8 to 12 hours (Heintz 2009; expert opinion).

PIRRT (eg, sustained, low-efficiency diafiltration): Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection) and consideration of initial loading doses. Close monitoring of response and adverse reactions (eg, neurotoxicity) due to drug accumulation is important.

IV: Initial: 3 g followed by 1.5 to 3 g every 8 to 12 hours. Where possible, give one dose after PIRRT session (Lorenzen 2012; expert opinion).

Dosing: Hepatic Impairment: Adult

There is no dosage adjustment provided in the manufacturer’s labeling.

Dosing: Pediatric

(For additional information see "Ampicillin and sulbactam: Pediatric drug information")

Note: Unasyn (ampicillin/sulbactam) is a combination product formulated in a 2:1 ratio (eg, each 3 g vial contains 2 g of ampicillin and 1 g of sulbactam); review dosing units carefully. Dosage recommendations are expressed as either mg of the ampicillin component or as total grams of the ampicillin/sulbactam combination within the dosing field; review dosing units in each indication carefully.

General dosing, susceptible infection: Infants, Children, and Adolescents:

Mild to moderate infection: IV: 100 to 200 mg ampicillin/kg/day divided every 6 hours; maximum dose: 2,000 mg ampicillin/dose (Red Book [AAP 2018]); may also be administered IM (Bradley 2018)

Severe infection (eg, meningitis, resistant Streptococcus pneumonia): IV: 200 to 400 mg ampicillin/kg/day divided every 6 hours; maximum dose: 2,000 mg ampicillin/dose (Bradley 2018; Red Book [AAP 2018]); may also be administered IM (Bradley 2018)

Endocarditis, treatment: Children and Adolescents: IV: 200 to 300 mg ampicillin/kg/day divided every 4 to 6 hours; maximum dose: 2,000 mg ampicillin/dose; may use in combination with gentamicin, vancomycin, and/or rifampin (optional; dependent upon organism) for at least 4 to 6 weeks; some organisms may require longer duration (AHA [Baltimore 2015])

Intra-abdominal infection, complicated: Infants, Children, and Adolescents: IV: 200 mg ampicillin/kg/day divided every 6 hours; Note: Due to high rates of E. coli resistance, not recommended for the treatment of community-acquired intra-abdominal infections (IDSA [Solomkin 2010])

Pelvic inflammatory disease: Adolescents: IV: 3 g ampicillin/sulbactam every 6 hours with doxycycline (CDC [Workowski 2015])

Rhinosinusitis, severe infection requiring hospitalization: Children and Adolescents: IV: 200 to 400 mg ampicillin/kg/day divided every 6 hours for 10 to 14 days; maximum dose: 2,000 mg ampicillin/dose (IDSA [Chow 2012])

Skin and skin structure infection: Children and Adolescents: IV: 200 mg ampicillin/kg/day divided every 6 hours for up to 14 days; maximum dose: 2,000 mg ampicillin/dose

Surgical prophylaxis: Children and Adolescents: IV: 50 mg ampicillin/kg/dose within 60 minutes prior to procedure; may repeat in 2 hours if lengthy procedure or excessive blood loss; maximum dose: 2,000 mg ampicillin/dose (Bratzler 2013)

Dosing: Renal Impairment: Pediatric

Children and Adolescents: IV:

CrCl ≥30 mL/minute/1.73 m2: No dosage adjustment required.

CrCl 15 to 29 mL/minute/1.73 m2: Administer every 12 hours.

CrCl 5 to 14 mL/minute/1.73 m2: Administer every 24 hours.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Geriatric

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Injection:

Generic: 3 g: Ampicillin 2 g and sulbactam 1 g (1 ea [DSC])

Solution Reconstituted, Injection [preservative free]:

Unasyn: 3 g: Ampicillin 2 g and sulbactam 1 g (1 ea); 1.5 g: Ampicillin 1 g and sulbactam 0.5 g (1 ea)

Generic: 1.5 g: Ampicillin 1 g and sulbactam 0.5 g (1 ea); 3 g: Ampicillin 2 g and sulbactam 1 g (1 ea)

Solution Reconstituted, Intravenous [preservative free]:

Unasyn: 15 g: Ampicillin 10 g and sulbactam 5 g (1 ea)

Generic: 1.5 g: Ampicillin 1 g and sulbactam 0.5 g (1 ea); 15 g: Ampicillin 10 g and sulbactam 5 g (1 ea); 3 g: Ampicillin 2 g and sulbactam 1 g (1 ea)

Generic Equivalent Available: US

Yes

Administration: Adult

Administer around-the-clock to promote less variation in peak and trough serum levels.

IV: Administer by slow injection over 10 to 15 minutes or as an IV infusion over 15 to 30 minutes. Ampicillin and gentamicin should not be mixed in the same IV tubing.

Some penicillins (eg, ampicillin, carbenicillin, ticarcillin, and piperacillin) have been shown to inactivate aminoglycosides in vitro. This has been observed to a greater extent with tobramycin and gentamicin, while amikacin has shown greater stability against inactivation. Concurrent Y-site administration should be avoided.

IM: Inject deep IM into large muscle mass; a concentration of 375 mg/mL ampicillin/sulbactam (250 mg ampicillin/125 mg sulbactam per mL) is recommended; may be diluted in sterile water or lidocaine 0.5% or lidocaine 2% for IM administration.

Administration: Pediatric

Parenteral:

IM: Administer by deep IM injection. Administer within 1 hour of preparation.

IV: Administered by slow IV injection over 10 to 15 minutes or by intermittent IV infusion over 15 to 30 minutes

Some penicillins (eg, carbenicillin, ticarcillin, and piperacillin) have been shown to inactivate aminoglycosides in vitro. This has been observed to a greater extent with tobramycin and gentamicin, while amikacin has shown greater stability against inactivation. Concomitant use of these agents may pose a risk of reduced antibacterial efficacy in vivo, particularly in the setting of profound renal impairment; however, definitive clinical evidence is lacking. If combination penicillin/aminoglycoside therapy is desired in a patient with renal dysfunction, separation of doses (if feasible), and routine monitoring of aminoglycoside concentrations, CBC, and clinical response should be considered.

Use: Labeled Indications

Bacterial infections: Treatment of skin and skin structure, intra-abdominal, and gynecological infections caused by susceptible bacteria; spectrum is that of ampicillin plus organisms producing beta-lactamases such as Staphylococcus aureus, Haemophilus influenzae, Escherichia coli, Klebsiella, Acinetobacter, Enterobacter, and anaerobes.

Use: Off-Label: Adult

Bite wound infection, treatment (animal or human bite); Bloodstream infection; Endocarditis, treatment; Odontogenic infection, pyogenic; Pneumonia; Surgical prophylaxis; Surgical site infections (eg, intestinal, GU tract, abdominal wall)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see Ampicillin.

>10%: Local: Pain at injection site (IM: 16%; IV: 3%)

1% to 10%:

Cardiovascular: Phlebitis (1%), thrombophlebitis (3%)

Dermatologic: Skin rash (<2%)

Gastrointestinal: Diarrhea (3%)

<1%:

Cardiovascular: Chest pain, edema, substernal pain

Dermatologic: Erythema of skin, facial swelling, pruritus

Gastrointestinal: Abdominal distention, flatulence, glossitis, nausea, vomiting

Genitourinary: Dysuria, urinary retention

Hematologic & oncologic: Lymphocytosis (atypical), mucous membrane bleeding

Infection: Candidiasis

Nervous system: Chills, fatigue, headache, malaise

Respiratory: Constriction of the pharynx, epistaxis

Frequency not defined:

Endocrine & metabolic: Decreased serum albumin, decreased serum total protein, increased lactate dehydrogenase

Genitourinary: Casts in urine (hyaline), finding of blood in urine

Hematologic: Basophilia, decreased hematocrit, decreased hemoglobin, decreased neutrophils, decreased red blood cells, eosinophilia, leukopenia, lymphocytopenia, monocytosis, thrombocythemia, thrombocytopenia

Hepatic: Increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase

Renal: Increased blood urea nitrogen, increased serum creatinine

Postmarketing:

Dermatologic: Acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Gastrointestinal: Abdominal pain, cholestasis, Clostridioides difficile associated diarrhea, dyspepsia, gastritis, hairy tongue, melena, stomatitis

Hematologic & oncologic: Agranulocytosis, hemolytic anemia, immune thrombocytopenia, positive direct Coombs test

Hepatic: Cholestatic hepatitis, cholestatic jaundice, hepatitis, hyperbilirubinemia, jaundice

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction

Local: Injection site reaction

Nervous system: Dizziness, seizure

Renal: Interstitial nephritis

Respiratory: Dyspnea

Contraindications

Hypersensitivity (eg, anaphylaxis or Stevens-Johnson syndrome) to ampicillin, sulbactam, or to other beta-lactam antibacterial drugs (eg, penicillins, cephalosporins), or any component of the formulations; history of cholestatic jaundice or hepatic dysfunction associated with ampicillin/sulbactam

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Serious and occasionally severe or fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy, especially with a history of beta-lactam hypersensitivity or a history of sensitivity to multiple allergens. Patients with a history of penicillin hypersensitivity have experienced severe reactions when treated with cephalosporins. Before initiating therapy, carefully investigate previous penicillin, cephalosporin, or other allergen hypersensitivity. If an allergic reaction occurs, discontinue and institute appropriate therapy.

• Hepatic dysfunction: Hepatitis and cholestatic jaundice have been reported (including fatalities). Toxicity is usually reversible. Monitor hepatic function at regular intervals in patients with hepatic impairment.

• Rash: Appearance of a rash should be carefully evaluated to differentiate a nonallergic ampicillin rash from a hypersensitivity reaction; rash occurs in 5% to 10% of children and is a generalized dull red, maculopapular rash, generally appearing 3-14 days after the start of therapy. It normally begins on the trunk and spreads over most of the body. It may be most intense at pressure areas, elbows, and knees.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Hepatic impairment: Hepatotoxicity has been reported. Monitor hepatic function at regular intervals in patients with hepatic impairment.

• Infectious mononucleosis: A high percentage of patients with infectious mononucleosis have developed rash during therapy; ampicillin-class antibacterials are not recommended in these patients.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment recommended.

Metabolism/Transport Effects

None known.

Drug Interactions

Acemetacin: May increase the serum concentration of Penicillins. Risk C: Monitor therapy

Allopurinol: May enhance the potential for allergic or hypersensitivity reactions to Ampicillin. Risk C: Monitor therapy

Aminoglycosides: Penicillins may decrease the serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Risk C: Monitor therapy

Atenolol: Ampicillin may decrease the bioavailability of Atenolol. Risk C: Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Chloroquine: May decrease the serum concentration of Ampicillin. Management: Separate the administration of ampicillin and chloroquine by at least 2 hours to minimize any potential negative impact of chloroquine on ampicillin bioavailability. Risk D: Consider therapy modification

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Dichlorphenamide: Penicillins may enhance the hypokalemic effect of Dichlorphenamide. Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Lanthanum: May decrease the serum concentration of Ampicillin. Management: Administer oral ampicillin at least two hours before or after lanthanum. Risk D: Consider therapy modification

Methotrexate: Penicillins may increase the serum concentration of Methotrexate. Risk C: Monitor therapy

Mycophenolate: Penicillins may decrease serum concentrations of the active metabolite(s) of Mycophenolate. This effect appears to be the result of impaired enterohepatic recirculation. Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Penicillins. Risk C: Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Tetracyclines: May diminish the therapeutic effect of Penicillins. Risk C: Monitor therapy

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Penicillins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Pregnancy Considerations

Both ampicillin and sulbactam cross the placenta (Foulds 1986; Maberry 1992).

Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of ampicillin/sulbactam may be altered (Chamberlain 1993; Foulds 1986).

As a class, penicillin antibiotics are widely used in pregnant women. Based on available data, penicillin antibiotics are generally considered compatible for use during pregnancy (Ailes 2016; Bookstaver 2015; Crider 2009; Damkier 2019; Lamont 2014; Muanda 2017a; Muanda 2017b).

Untreated intra-amniotic infection (chorioamnionitis) may lead to adverse pregnancy outcomes (including pneumonia, meningitis, and sepsis) in the newborn. Maternal complications may include postpartum uterine atony with hemorrhage, endometritis, peritonitis, sepsis, or adult respiratory distress syndrome. Ampicillin/sulbactam is an alternative option for the treatment of intra-amniotic infection (ACOG 2017).

Antibiotic prophylaxis is recommended prior to all cesarean deliveries unless the woman is already receiving an appropriate antibiotic. A single dose of a targeted antibiotic administered within 60 minutes prior to the delivery is recommended; ampicillin/sulbactam has been evaluated for this purpose, although other antibiotics may be preferred (consult current recommendations) (ACOG 2018).

Breast-Feeding Considerations

Ampicillin and sulbactam are present in breast milk.

A review article notes the exposure of ampicillin and sulbactam to a breastfeeding infant would be ~1% to 2% of a typical adult dose (Foulds 1986).

The manufacturer recommends that caution be used if administering to breastfeeding women. Ampicillin is considered compatible with breastfeeding when used in usual recommended doses. In general, antibiotics that are present in breast milk may cause nondose-related modification of bowel flora. Monitor infants for GI disturbances (WHO 2002).

Also refer to the Ampicillin monograph.

Dietary Considerations

Some products may contain sodium.

Monitoring Parameters

With prolonged therapy, monitor hematologic, renal, and hepatic function; monitor for signs of anaphylaxis during first dose. In patients with preexisting hepatic impairment, monitor hepatic function at regular intervals.

Mechanism of Action

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested. The addition of sulbactam, a beta-lactamase inhibitor, to ampicillin extends the spectrum of ampicillin to include some beta-lactamase-producing organisms.

Pharmacodynamics and Pharmacokinetics

Ampicillin: See Ampicillin monograph.

Sulbactam:

Distribution: Widely distributed to bile, blister, and tissue fluids; poor penetration into CSF with uninflamed meninges; higher concentrations attained with inflamed meninges; Vd (Nahata 1999):

Children 1 to 12 years: ~0.35 L/kg

Adults: 0.25 L/kg

Protein binding: 38%

Half-life elimination: Children 1 to 12 years (normal renal function): Mean range: ~0.7 to 0.9 hours (Nahata 1999); Adults (normal renal function): 1 to 1.3 hours; Note: Elimination kinetics of both ampicillin and sulbactam are similarly affected in patients with renal impairment, therefore, the blood concentration ratio is expected to remain constant regardless of renal function.

Excretion: Urine (~75% to 85% as unchanged drug) within 8 hours

Pharmacodynamics and Pharmacokinetics: Additional Considerations

Anti-infective considerations:

Parameters associated with efficacy:

Ampicillin: See Ampicillin monograph.

Sulbactam (in combination with ampicillin):

Time dependent; associated with time free drug concentration (fT) > minimum inhibitory concentration (MIC):

Acinetobacter baumannii: Goal: ≥40% to 60% fT > MIC (bactericidal) (Yokoyama 2014; Yokoyama 2015).

Expected drug exposure in patients with normal renal function:

Children <12 years of age: Cmax (peak): IV:

15- to 40-minute infusion, steady state: 40 to 80 mg/kg/dose every 6 hours: Ampicillin: 177 to 200 mg/L; sulbactam 81.9 to 102 mg/L (Nahata 1999).

Adults: Cmax (peak):

Note: Adult doses are expressed as the combined amount of ampicillin and sulbactam.

IV: 15-minute infusion, single dose:

1.5 g: Ampicillin: 40 to 71 mg/L; sulbactam: 21 to 40 mg/L.

3 g: Ampicillin: 109 to 150 mg/L; sulbactam: 48 to 88 mg/L.

IM:

1.5 g: Ampicillin: 8 to 37 mg/L; sulbactam: 6 to 24 mg/L.

Pricing: US

Solution (reconstituted) (Ampicillin-Sulbactam Sodium Injection)

1.5 (1-0.5) g (per each): $5.04 - $9.54

3 (2-1) g (per each): $7.62 - $19.14

Solution (reconstituted) (Ampicillin-Sulbactam Sodium Intravenous)

1.5 (1-0.5) g (per each): $6.39 - $6.40

3 (2-1) g (per each): $10.98

15 (10-5) g (per each): $47.52 - $90.00

Solution (reconstituted) (Unasyn Injection)

1.5 (1-0.5) g (per each): $9.16

3 (2-1) g (per each): $17.30

Solution (reconstituted) (Unasyn Intravenous)

15 (10-5) g (per each): $86.51

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Aepisul (PH);
  • Ambacitam (TH);
  • Aminoxidin Sulbactam (AR);
  • Ampi-Bis Plus (AR);
  • Ampictam (SY);
  • Ampigen SB (AR);
  • Ampisulcillin (EE);
  • Ampisulvenir (IL);
  • Amplisul (EC);
  • Amsubac (MY, TH);
  • Auropennz (MY);
  • Baccillin (KR);
  • Bactesyn (ID);
  • Begalin-P (GR);
  • Bethacil (IT);
  • Cinam (ID);
  • Demotine (GR);
  • Easyn (MY);
  • Kintamvy (HK);
  • Libractam (PY, UY);
  • Prixin (AR, PY);
  • Rexatam (TH);
  • Rukasyn (KR);
  • Shinasyn (MY);
  • Shu An Xin (CN);
  • Shudi (CN);
  • Sulbacin (KR, PH);
  • Ubacsin (KR);
  • Ubactam (KR);
  • Ultramox (PH);
  • Unacim (FR);
  • Unasyn (EG, IL, RO, UY);
  • Unasyna (CR, DO, GT, HN, NI, PA, SV);
  • Unictam (EG)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. Ailes EC, Gilboa SM, Gill SK, et al; The National Birth Defects Prevention Study. Association between antibiotic use among pregnant women with urinary tract infections in the first trimester and birth defects, National Birth Defects Prevention Study 1997 to 2011. Birth Defects Res A Clin Mol Teratol. 2016;106(11):940-949. doi:10.1002/bdra.23570 [PubMed 27891788]
  2. American Academy of Pediatrics (AAP). In: Kimberlin DW, Brady MT, Jackson MA, Long SA, eds. Red Book: 2018 Report of the Committee on Infectious Diseases. 31st ed. American Academy of Pediatrics; 2018.
  3. American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice. Committee opinion No. 712: Intrapartum management of intraamniotic infection. Obstet Gynecol. 2017;130(2):e95-e101. doi:10.1097/AOG.0000000000002236 [PubMed 28742677]
  4. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 199: Use of prophylactic antibiotics in labor and delivery. Obstet Gynecol. 2018;132(3):e103-e119. [PubMed 30134425]
  5. Anderson DJ, Sexton DJ. Overview of control measures for prevention of surgical site infection in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed April 29, 2019.
  6. Assimakopoulos SF, Karamouzos V, Lefkaditi A, et al. Triple combination therapy with high-dose ampicillin/sulbactam, high-dose tigecycline and colistin in the treatment of ventilator-associated pneumonia caused by pan-drug resistant Acinetobacter baumannii: a case series study. Infez Med. 2019;27(1):11-16. [PubMed 30882373]
  7. Baddour LM, Harper M. Animal bites (dogs, cats, and other animals): evaluation and management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 20, 2021a.
  8. Baddour LM, Harper M. Human bites: evaluation and management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 27, 2021b.
  9. Baddour LM, Wilson WR, Bayer AS, et al; American Heart Association Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and Stroke Council. Infective endocarditis in adults: diagnosis, antimicrobial therapy, and management of complications: a scientific statement for healthcare professionals from the American Heart Association [published correction appears in Circulation. 2015;132(17):e215]. Circulation. 2015;132(15):1435-1486. [PubMed 26373316]
  10. Baltimore RS, Gewitz M, Baddour LM, et al; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young and the Council on Cardiovascular and Stroke Nursing. Infective endocarditis in childhood: 2015 update: a scientific statement from the American Heart Association. Circulation. 2015;132(15):1487-1515. doi:10.1161/CIR.0000000000000298 [PubMed 26373317]
  11. Beigi RH. Management and complications of tubo-ovarian abscess. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 8, 2020.
  12. Beganovic M, Daffinee KE, Luther MK, LaPlante KL. Minocycline alone and in combination with polymyxin b, meropenem, and sulbactam against carbapenem-susceptible and -resistant Acinetobacter baumannii in an in vitro pharmacodynamic model. Antimicrob Agents Chemother. 2021;65(3):e01680-20. doi:10.1128/AAC.01680-20 [PubMed 33318006]
  13. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention guideline for the prevention of surgical site infection, 2017 [published correction appears in JAMA Surg. 2017;152(8):803]. JAMA Surg. 2017;152(8):784-791. doi:10.1001/jamasurg.2017.0904 [PubMed 28467526]
  14. Betrosian AP, Frantzeskaki F, Xanthaki A, Douzinas EE. Efficacy and safety of high-dose ampicillin/sulbactam vs. colistin as monotherapy for the treatment of multidrug resistant Acinetobacter baumannii ventilator-associated pneumonia. J Infect. 2008;56(6):432-436. doi:10.1016/j.jinf.2008.04.002 [PubMed 18501431]
  15. Bilbao-Meseguer I, Rodríguez-Gascón A, Barrasa H, Isla A, Solinís MÁ. Augmented renal clearance in critically ill patients: a systematic review. Clin Pharmacokinet. 2018;57(9):1107-1121. doi:10.1007/s40262-018-0636-7 [PubMed 29441476]
  16. Blackwell BG, Leggett JE, Johnson CA, Zimmerman SW, Craig WA. Ampicillin and sulbactam pharmacokinetics and pharmacodynamics in continuous ambulatory peritoneal dialysis (CAPD). Perit Dial Int. 1990;10(3):221-226. [PubMed 2099158]
  17. Bookstaver PB, Bland CM, Griffin B, Stover KR, Eiland LS, McLaughlin M. A review of antibiotic use in pregnancy. Pharmacotherapy. 2015 ;35(11):1052-1062. doi:10.1002/phar.1649 [PubMed 26598097]
  18. Bradley JS, Nelson JD, Barnett ED, Cantey JB, eds. Nelson's Pediatric Antimicrobial Therapy. 24th ed. American Academy of Pediatrics; 2018.
  19. Bratzler DW, Dellinger EP, Olsen KM, et al; American Society of Health-System Pharmacists; Infectious Diseases Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013;70(3):195-283. [PubMed 23327981]
  20. Burkart JM. Microbiology and therapy of peritonitis in peritoneal dialysis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 9, 2019.
  21. Chamberlain A, White S, Bawdon R, Thomas S, Larsen B. Pharmacokinetics of ampicillin and sulbactam in pregnancy. Am J Obstet Gynecol. 1993;168(2):667-673.
  22. Chan JD, Graves JA, Dellit TH. Antimicrobial treatment and clinical outcomes of carbapenem-resistant Acinetobacter baumannii ventilator-associated pneumonia. J Intensive Care Med. 2010;25(6):343-348. doi:10.1177/0885066610377975 [PubMed 20837632]
  23. Chen KT. Postpartum endometritis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed March 10, 2021.
  24. Chow AW. Complications, diagnosis, and treatment of odontogenic infections. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed April 29, 2019.
  25. Chow AW, Benninger MS, Brook I, et al; Infectious Diseases Society of America. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012;54(8):e72-e112. [PubMed 22438350]
  26. Cisneros JM, Reyes MJ, Pachón J, et al. Bacteremia due to Acinetobacter baumannii: epidemiology, clinical findings, and prognostic features. Clin Infect Dis. 1996;22(6):1026-1032. doi:10.1093/clinids/22.6.1026 [PubMed 8783704]
  27. Crider KS, Cleves MA, Reefhuis J, Berry RJ, Hobbs CA, Hu DJ. Antibacterial medication use during pregnancy and risk of birth defects: National Birth Defects Prevention Study. Arch Pediatr Adolesc Med. 2009 ;163(11):978-985. doi:10.1001/archpediatrics.2009.188 [PubMed 19884587]
  28. Dajani AS. Sulbactam/ampicillin in pediatric infections. Drugs. 1988;35(suppl 7):35-38.
  29. Daly JS, Dodge RA, Glew RH, et al. Effect of time and temperature on inactivation of aminoglycosides by ampicillin at neonatal dosages. J Perinatol. 1997;17(1):42-45. [PubMed 9069064]
  30. Damkier P, Brønniche LMS, Korch-Frandsen JFB, Broe A. In utero exposure to antibiotics and risk of congenital malformations: a population-based study. Am J Obstet Gynecol. 2019;221(6):648.e1-648.e15. doi:10.1016/j.ajog.2019.06.050 [PubMed 31260651]
  31. Foulds G. Pharmacokinetics of sulbactam/ampicillin in humans: a review. Rev Infect Dis. 1986;8(suppl 5):S503-S510. [PubMed 3025997]
  32. Gall S, Koukol DH. Ampicillin/sulbactam vs. clindamycin/gentamicin in the treatment of postpartum endometritis. J Reprod Med. 1996;41(8):575-580. [PubMed 8866384]
  33. Geckler RW. A comparison of ampicillin/sulbactam and cefuroxime in the treatment of patients with bacterial infections of the lower respiratory tract. Clin Ther. 1994;16(4):662-672. [PubMed 7982254]
  34. Gilad J, Carmeli Y. Treatment options for multidrug-resistant Acinetobacter species. Drugs. 2008;68(2):165-189. [PubMed 18197724]
  35. Goldfarb J, Aronoff SC, Jaffé A, et al. Sultamicillin in the treatment of superficial skin and soft tissue infections in children. Antimicrob Agents Chemother. 1987;31(4):663-664. [PubMed 3038003]
  36. Halstenson CE, Wong MO, Herman CS, et al. Effect of concomitant administration of piperacillin on the dispositions on isepamicin and gentamicin in patients with end-stage renal disease. Antimicrob Agents Chemother. 1992;36(9):1832-1836. [PubMed 1416875]
  37. Harkless L, Boghossian J, Pollak R, et al. An open-label, randomized study comparing efficacy and safety of intravenous piperacillin/tazobactam and ampicillin/sulbactam for infected diabetic foot ulcers. Surg Infect (Larchmt). 2005;6(1):27-40. doi:10.1089/sur.2005.6.27 [PubMed 15865549]
  38. Heintz BH, Matzke GR, Dager WE. Antimicrobial dosing concepts and recommendations for critically ill adult patients receiving continuous renal replacement therapy or intermittent hemodialysis. Pharmacotherapy. 2009;29(5):562-577. [PubMed 19397464]
  39. Housman ST, Hagihara M, Nicolau DP, Kuti JL. In vitro pharmacodynamics of human-simulated exposures of ampicillin/sulbactam, doripenem and tigecycline alone and in combination against multidrug-resistant Acinetobacter baumannii. J Antimicrob Chemother. 2013;68(10):2296-2304. doi:10.1093/jac/dkt197 [PubMed 23710070]
  40. Jellison TK, McKinnon PS, Rybak MJ. Epidemiology, resistance, and outcomes of Acinetobacter baumannii bacteremia treated with imipenem-cilastatin or ampicillin-sulbactam. Pharmacotherapy. 2001;21(2):142-148. [PubMed 11213849]
  41. Jusko WJ, Lewis GP, Schmitt GW. Ampicillin and hetacillin pharmacokinetics in normal and anephric subjects. Clin Pharmacol Ther. 1973;14(1):90-99. doi:10.1002/cpt197314190 [PubMed 4345622]
  42. Kalil AC, Metersky ML, Klompas M, et al. Executive summary: management of adults with hospital-acquired and ventilator-associated pneumonia: 2016 clinical practice guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016;63(5):575-582. [PubMed 27521441]
  43. Kanafani ZA, Kanj SS. Acinetobacter infection: treatment and prevention. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed May 14, 2019.
  44. Klompas M. Aspiration pneumonia in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed April 13, 2021.
  45. Kulhanjian J, Dunphy MG, Hamstra S, et al. Randomized comparative study of ampicillin/sulbactam vs ceftriaxone for treatment of soft tissue and skeletal infections in children. Pediatr Infect Dis J. 1989;8(9):605-610. [PubMed 2677956]
  46. Lam MF, Tang BS, Tse KC, Chan TM, Lai KN. Ampicillin-sulbactam and amikacin used as second-line antibiotics for patients with culture-negative peritonitis. Perit Dial Int. 2008;28(5):540-542. [PubMed 18708550]
  47. Lamont HF, Blogg HJ, Lamont RF. Safety of antimicrobial treatment during pregnancy: a current review of resistance, immunomodulation and teratogenicity. Expert Opin Drug Saf. 2014;13(12):1569-1581. doi:10.1517/14740338.2014.939580 [PubMed 25189188]
  48. Levin AS, Levy CE, Manrique AE, Medeiros EA, Costa SF. Severe nosocomial infections with imipenem-resistant Acinetobacter baumannii treated with ampicillin/sulbactam. Int J Antimicrob Agents. 2003;21(1):58-62. [PubMed 12507838]
  49. Li PK, Szeto CC, Piraino B, et al. ISPD peritonitis recommendations: 2016 update on prevention and treatment [published correction appears in Perit Dial Int. 2018;38(4):313]. Perit Dial Int. 2016;36(5):481-508. doi:10.3747/pdi.2016.00078 [PubMed 27282851]
  50. Li PK, Szeto CC, Piraino B, et al; International Society for Peritoneal Dialysis. Peritoneal dialysis-related infections recommendations: 2010 update [published correction appears in Perit Dial Int. 2011;31(5):512]. Perit Dial Int. 2010;30(4):393-423. doi:10.3747/pdi.2010.00049 [PubMed 20628102]
  51. Lipsky BA, Berendt AR, Cornia PB, et al. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012;54(12):e132-e173. [PubMed 22619242]
  52. Lorenzen JM, Broll M, Kaever V, et al. Pharmacokinetics of ampicillin/sulbactam in critically ill patients with acute kidney injury undergoing extended dialysis. Clin J Am Soc Nephrol. 2012;7(3):385-390. doi:10.2215/CJN.05690611 [PubMed 22223613]
  53. Maberry MC, Trimmer KJ, Bawdon RE, Sobhi S, Dax JB, Gilstrap LC 3rd. Antibiotic concentration in maternal blood, cord blood and placental tissue in women with chorioamnionitis. Gynecol Obstet Invest. 1992;33(3):185-186. doi:10.1159/000294878 [PubMed 1612532]
  54. Majcher-Peszynska J, Loebermann M, Klammt S, et al. CAPNETZ Study Group. Ampicillin/sulbactam in elderly patients with community-acquired pneumonia. Infection. 2014;42(1):79-87. [PubMed 23904004]
  55. Makris D, Petinaki E, Tsolaki V, et al. Colistin versus colistin combined with ampicillin-sulbactam for multiresistant Acinetobacter baumannii ventilator-associated pneumonia treatment: an open-label prospective study. Indian J Crit Care Med. 2018;22(2):67-77. doi:10.4103/ijccm.IJCCM_302_17 [PubMed 29531445]
  56. Mancini A, Todd L. Inconsistencies in ISPD peritonitis recommendations: 2016 update on prevention and treatment and the ISPD catheter-related infection recommendations: 2017 update. Perit Dial Int. 2018;38(4):309-310. doi:10.3747/pdi.2018.00026 [PubMed 29987068]
  57. Mancino AT, Lalani T. Wound infection following repair of abdominal wall hernia. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 12, 2020.
  58. Manzoni P, Esposito S, Gallo E, et al. Switch therapy in full-term neonates with presumed or proven bacterial infection. J Chemother. 2009;21(1):68-73. [PubMed 19297276]
  59. Mermel LA, Allon M, Bouza E, et al. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis. 2009;49(1):1-45. [PubMed 19489710]
  60. Metlay JP, Waterer GW, Long AC, et al. Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Resp Crit Care Med. 2019;200(7):e45-e67. doi:10.1164/rccm.201908-1581ST [PubMed 31573350]
  61. Meyers BR, Wilkinson P, Mendelson MH, et al. Pharmacokinetics of ampicillin-sulbactam in healthy elderly and young volunteers. Antimicrob Agents Chemother. 1991;35(10):2098-2101. [PubMed 1759832]
  62. Moehring R, Anderson DJ. Gram-negative bacillary bacteremia in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 12, 2019.
  63. Mosaed R, Haghighi M, Kouchak M, et al. Interim study: comparison of safety and efficacy of levofloxacin plus colistin regimen with levofloxacin plus high dose ampicillin/sulbactam infusion in treatment of ventilator-associated pneumonia due to multidrug resistant Acinetobacter. Iran J Pharm Res. 2018;17(suppl 2):206-213. [PubMed 31011353]
  64. Muanda FT, Sheehy O, Bérard A. Use of antibiotics during pregnancy and the risk of major congenital malformations: a population based cohort study. Br J Clin Pharmacol. 2017a;83(11):2557-2571. doi:10.1111/bcp.13364 [PubMed 28722171]
  65. Muanda FT, Sheehy O, Bérard A. Use of antibiotics during pregnancy and risk of spontaneous abortion. CMAJ. 2017b;189(17):E625-E633. doi:10.1503/cmaj.161020 [PubMed 28461374]
  66. Murray BE. Treatment of enterococcal infections. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed May 14, 2019.
  67. Nahata MC, Vashi VI, Swanson RN, Messig MA, Chung M. Pharmacokinetics of ampicillin and sulbactam in pediatric patients. Antimicrob Agents Chemother. 1999;43(5):1225-1229. doi:10.1128/AAC.43.5.1225 [PubMed 10223940]
  68. Rho SP, Jones A, Woo M, et al. Single dose pharmacokinetics of intravenous ampicillin plus sulbactam in healthy elderly and young subjects. J Antimicrob Chemother. 1989;24(4):573-580. [PubMed 2613605]
  69. Rossoff LJ, Hilton E, Smith C, Isenberg HD, Simme MM. Intravenous ampicillin/sulbactam versus cefuroxime axetil in the treatment of patients hospitalized with community-acquired lower respiratory tract infections. Curr Ther Res. 1995;56(9):852-862.
  70. Smolyakov R, Borer A, Riesenberg K, et al. Nosocomial multi-drug resistant Acinetobacter baumannii bloodstream infection: risk factors and outcome with ampicillin-sulbactam treatment. J Hosp Infect. 2003;54(1):32-38. [PubMed 12767844]
  71. Solomkin JS, Mazuski JE, Bradley JS, et al. Diagnosis and Management of Complicated Intra-Abdominal Infections in Adults and Children: Guidelines by the Surgical Infection Society and the Infectious Diseases Society of America. Clin Infect Dis. 2010;50(2):133-164. [PubMed 20034345]
  72. Stevens DL, Bisno AL, Chambers HF, et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59(2):e10-e52. doi: 10.1093/cid/ciu444. [PubMed 24973422]
  73. Sutton AM, Turner TL, Cockburn F, et al. Pharmacokinetic study of sulbactam and ampicillin administered concomitantly by intraarterial or intravenous infusion in the newborn. Rev Infect Dis. 1986;8(suppl 5):518-522. [PubMed 3025999]
  74. Syriopoulou V, Bitsi M, Theodoridis C, et al. Clinical Efficacy of Sulbactam/ampicillin in pediatric infections caused by ampicillin-resistant or penicillin-resistant organisms. Rev Infect Dis. 1986;8(suppl 5):630-633.
  75. Szeto CC, Li PK. Concerns regarding inconsistencies within and between ISPD recommendations for peritonitis and catheter-related infections-in reply. Perit Dial Int. 2018;38(4):311-312. doi:10.3747/pdi.2018.00046 [PubMed 29987069]
  76. Tita ATN. Intra-amniotic infections (clinical chorioamnionitis or triple I). Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed April 14, 2019.
  77. Trotman RL, Williamson JC, Shoemaker DM, Salzer WL. Antibiotic dosing in critically ill adult patients receiving continuous renal replacement therapy. Clin Infect Dis. 2005;41(8):1159-1166. [PubMed 16163635]
  78. Udy AA, Roberts JA, Boots RJ, Paterson DL, Lipman J. Augmented renal clearance: implications for antibacterial dosing in the critically ill. Clin Pharmacokinet. 2010;49(1):1-16. doi:10.2165/11318140-000000000-00000 [PubMed 20000886]
  79. Unasyn (ampicillin sodium and sulbactam sodium) [prescribing information]. New York, NY: Roerig; November 2018.
  80. Unasyn (ampicillin sodium and sulbactam sodium) [prescribing information]. New York, NY: Roerig; October 2020.
  81. Wald E, Reilly JS, Bluestone CD, et al. Sulbactam/ampicillin in the treatment of acute epiglottitis in children. Rev Infect Dis. 1986;8(suppl 5):617-619. [PubMed 3026014]
  82. Weintrob AC, Sexton DJ. Clinical manifestations, diagnosis, and management of diabetic infections of the lower extremities. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed November 24, 2020.
  83. Workowski KA, Bolan GA; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64(RR-03):1-137. [PubMed 26042815]
  84. World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. http://www.who.int/maternal_child_adolescent/documents/55732/en. Published 2002.
  85. Wright N, Wise R. The elimination of sulbactam alone and combined with ampicillin in patients with renal dysfunction. J Antimicrob Chemother. 1983;11(6):583-587. doi:10.1093/jac/11.6.583 [PubMed 6309731]
  86. Wynn RL, Bergman SA. Antibiotics and their use in the treatment of orofacial infections, part I and part II. Gen Dent. 1994;42(5):398-402, 498-502. [PubMed 7489869]
  87. Yahav D, Franceschini E, Koppel F, et al; Bacteremia Duration Study Group. Seven versus fourteen days of antibiotic therapy for uncomplicated gram-negative bacteremia: a noninferiority randomized controlled trial [published online December 11, 2018]. Clin Infect Dis. doi:10.1093/cid/ciy1054 [PubMed 30535100]
  88. Ye JJ, Lin HS, Yeh CF, et al. Tigecycline-based versus sulbactam-based treatment for pneumonia involving multidrug-resistant Acinetobacter calcoaceticus-Acinetobacter baumannii complex. BMC Infect Dis. 2016;16:374. doi:10.1186/s12879-016-1717-6 [PubMed 27496018]
  89. Yokoyama Y, Matsumoto K, Ikawa K, et al. Pharmacokinetic/pharmacodynamic evaluation of sulbactam against Acinetobacter baumannii in in vitro and murine thigh and lung infection models. Int J Antimicrob Agents. 2014;43(6):547-552. doi:10.1016/j.ijantimicag.2014.02.012 [PubMed 24796218]
  90. Yokoyama Y, Matsumoto K, Ikawa K, Watanabe E, Morikawa N, Takeda Y. Population pharmacokinetic-pharmacodynamic target attainment analysis of sulbactam in patients with impaired renal function: dosing considerations for Acinetobacter baumannii infections. J Infect Chemother. 2015;21(4):284-289. doi:10.1016/j.jiac.2014.12.005 [PubMed 25638291]
  91. Zalts R, Neuberger A, Hussein K, et al. Treatment of carbapenem-resistant Acinetobacter baumannii ventilator-associated pneumonia: retrospective comparison between intravenous colistin and intravenous ampicillin-sulbactam. Am J Ther. 2016;23(1):e78-e85. doi:10.1097/MJT.0b013e3182a32df3 [PubMed 24263165]
Topic 8745 Version 252.0