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Ampicillin and sulbactam: Drug information

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

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Unasyn
Pharmacologic Category
  • Antibiotic, Penicillin
Dosing: Adult

Dosage guidance:

Dosing: Adult dosage recommendations are expressed as total grams of ampicillin/sulbactam.

Dosage forms information: Ampicillin/sulbactam is a combination product formulated in a 2:1 ratio.

Usual dosage range: IM, IV: 1.5 to 3 g every 6 hours (maximum: ampicillin/sulbactam 12 g daily) (Ref); for the treatment of infections caused by Acinetobacter spp., higher doses have been described (Ref).

Acinetobacter baumannii infection, multidrug resistant

Acinetobacter baumannii infection, multidrug resistant: IV: 9 g every 8 hours over 4 hours or 27 g/day over 24 hours as a continuous infusion; alternatively, may consider 3 g every 4 hours, especially if intolerance or toxicity precludes the use of higher doses. Use as part of an appropriate combination regimen whenever possible (Ref).

Anthrax, systemic, treatment

Anthrax, systemic (including meningitis), treatment (off-label use):

Note: Consult public health officials for event-specific recommendations.

IV: 3 g every 6 hours, in combination with other appropriate agents for ≥2 weeks; duration may be shortened and patient transitioned to oral therapy based on response and clinical judgement (Ref). Some experts suggest ≥3 weeks of IV combination therapy for patients with meningitis (Ref). After aerosol exposure, transition patients who are immunocompromised from treatment to postexposure prophylaxis; combined duration should total 60 days. Note: Administer antitoxin in addition to antibiotics for systemic anthrax (Ref).

Bite wound infection, treatment

Bite wound infection, treatment (animal or human bite) (off-label use): IV: 1.5 to 3 g every 6 hours (Ref); some experts prefer 3 g every 6 hours (Ref). Continue treatment for 1 to 2 days after resolution of infection; total duration is typically 5 to 14 days, although deep or complicated infections may require a longer duration (Ref).

Bloodstream infection

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

IV: 3 g every 6 hours (Ref). 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 (Ref).

Diabetic foot infection, moderate to severe

Diabetic foot infection, moderate to severe: IV: 3 g every 6 hours (Ref). Usual duration of therapy (including oral step-down therapy) is 2 to 4 weeks (in the absence of osteomyelitis) (Ref).

Endocarditis, treatment

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 (Ref). Some experts recommend gentamicin for the first 2 weeks of therapy (Ref).

Odontogenic soft tissue infection, pyogenic

Odontogenic soft tissue infection, pyogenic (off-label use): IV: 3 g every 6 hours; following clinical improvement, transition to oral step-down therapy and continue antibiotics until resolution, typically for a total of 7 to 14 days. Use in addition to appropriate surgical management (eg, drainage and/or extraction) (Ref).

Pelvic infections

Pelvic infections (alternative agent):

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 (Ref).

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

Peritonitis, treatment, peritoneal dialysis

Peritonitis, treatment, peritoneal dialysis (off-label route):

Note: Intraperitoneal administration is preferred to IV administration unless the patient has sepsis (Ref).

Continuous (with every CAPD exchange): Intraperitoneal: Loading dose: 1.5 g/L of dialysate added to first dialysate exchange; maintenance dose: 200 mg/L of dialysate with each subsequent dialysate exchange (Ref).

Duration: For patients with adequate clinical response, duration of therapy is ≥2 to 3 weeks depending on organism. For patients with no improvement after 5 days, remove catheter and treat with appropriate systemic antibiotics for 14 days after catheter removal (Ref).

Pneumonia

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) (Ref).

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 (Ref).

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 (Ref).

Surgical prophylaxis

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 (Ref). Postoperative prophylaxis is not recommended in clean and clean-contaminated surgeries (Ref).

Surgical site infection

Surgical site infection (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 (Ref).

Dosing: Kidney 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 A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: IV:

Note: Dosage recommendations are expressed as grams of ampicillin/sulbactam combination (Ref):

Ampicillin/Sulbactam Dosage Adjustment for Kidney Impairment (Usual Dosage Range 1.5 to 3 g IV Every 6 Hours)

Traditional intermittent infusion method (administered over ≤30 minutes)

CrCl

If the usual recommended dose is 1.5 g IV every 6 hours

If the usual recommended dose is 3 g IV every 6 hours

CrCl ≥30 mL/minute

No dosage adjustment necessary

No dosage adjustment necessary

CrCl 15 to 29 mL/minute

1.5 g IV every 12 hours

3 g IV every 12 hours

CrCl <15 mL/minute

1.5 g IV every 24 hours

3 g IV every 24 hours

Ampicillin/Sulbactam Dosage Adjustment Recommendations for Kidney Impairment when Treating Multidrug-resistant A. baumannii Infectiona

Traditional intermittent infusion method (administered over ≤30 minutes)

Extended infusion method (over 4 hours)

Continuous infusion method (over 24 hours)a

a The proposed renal dose adjustments are aimed at achieving pharmacokinetic/pharmacodynamic targets based on in-vitro or pharmacokinetic modeling. Clinical data are not available.

b Expert opinion derived from Yokoyama 2015. Note: Doses presented in Yokoyama 2015 are in grams of sulbactam; the doses listed above are multiplied by 3 to account for both the ampicillin and sulbactam components.

c Expert opinion derived from Jaruratanasirikul 2019. Note: Doses presented in Jaruratanasirikul 2019 are in grams of sulbactam; the doses listed above are multiplied by 3 to account for both the ampicillin and sulbactam components.

d Lower doses may be sufficient for patients with lower albumin concentrations (eg, 1.7 to 2.4 g/dL) and isolates with lower minimum inhibitory concentrations. See Jaruratanasirikul 2019 for more patient-specific recommendations.

e Expert opinion.

CrCl

If the usual recommended dose is 3 g IV every 4 hours administered over ≤30 minutes

If the usual recommended dose is 9 g IV every 8 hours administered over 4 hours

If the usual recommended dose is 27 g IV administered over 24 hours

CrCl ≥90 to 130 mL/minute

No dosage adjustment necessaryb

No dosage adjustment necessaryc,d

No dosage adjustment necessary

CrCl 60 to <90 mL/minute

No dosage adjustment necessaryb

6 g IV every 8 hours over 4 hoursc,d

18 g IV over 24 hoursc

CrCl 30 to <60 mL/minute

3 g IV every 6 hoursb

3 g IV every 6 hours over 4 hoursc,d

12 g IV over 24 hoursc

CrCl 15 to 29 mL/minute

3 g IV every 8 hoursb

3 g IV every 8 hours over 4 hoursc,d

9 g IV over 24 hoursc

CrCl <15 mL/minute

3 g IV every 12 hoursb

3 g IV every 12 hours over 4 hourse

6 g IV over 24 hourse

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 (Ref).

Standard dosage adjustment recommendations (usual dose 1.5 to 3 g IV every 6 hours):

IV: Traditional intermittent infusion (administered over ≤30 minutes): 1.5 to 3 g every 4 to 6 hours (Ref).

Dosage adjustment recommendations for multidrug-resistant A. baumannii infection:

IV: Continuous infusion (over 24 hours): 27 g IV administered over 24 hours.(Ref) Note: 36 g IV every 24 hours has also been modeled and may be necessary in cases with elevated minimum inhibitory concentrations; no clinical data available (Ref).

Hemodialysis, intermittent (thrice weekly): Dialyzable (39% to 63%) (Ref):

Standard dosage adjustment recommendations (usual dose 1.5 to 3 g IV every 6 hours):

IV: Traditional intermittent infusion (administered over ≤30 minutes): 1.5 to 3 g every 12 to 24 hours; administer after dialysis when scheduled dose falls on dialysis days (Ref).

Dosage adjustment recommendations for multidrug-resistant A. baumannii infection:

IV: Intermittent, extended or continuous infusion: Dose as for CrCl <15 mL/minute as presented in the A. baumannii dose adjustment table (Ref). On dialysis days, if possible, administer one of the doses after dialysis (Ref).

Peritoneal dialysis:

Standard dosage adjustment recommendations (usual dose 1.5 to 3 g IV every 6 hours):

IV: Traditional intermittent infusion (administered over ≤30 minutes): 1.5 g every 12 hours or 3 g every 24 hours (Ref).

Dosage adjustment recommendations for multidrug-resistant A. baumannii infection:

IV: Intermittent, extended or continuous infusion: Dose as for CrCl <15 mL/minute as presented in the A. baumannii dose adjustment table (Ref).

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.

Standard dosage adjustment recommendations (usual dose 1.5 to 3 g IV every 6 hours):

IV: Traditional intermittent infusion (administered over ≤30 minutes): 3 g every 8 to 12 hours (Ref).

Dosage adjustment recommendations for multidrug-resistant A. baumannii infection:

IV: Intermittent, extended or continuous infusion: Dose as for CrCl 30 to <60 mL/minute as presented in the A. baumannii dose adjustment table (Ref).

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.

Standard dosage adjustment recommendations (usual dose 1.5 to 3 g IV every 6 hours):

IV: Traditional intermittent infusion (administered over ≤30 minutes): Initial: 3 g followed by 1.5 to 3 g every 8 to 12 hours. Where possible, give one dose after PIRRT session (Ref).

Dosage adjustment recommendations for multidrug-resistant A. baumannii infection:

IV: Intermittent, extended or continuous infusion:

PIRRT days: Dose as for CrCl 30 to <60 mL/minute as presented in the A. baumannii dose adjustment table (Ref).

Non–PIRRT days: Dose as for CrCl <15 mL/minute as presented in the A. baumannii dose adjustment table (Ref).

Dosing: Liver Impairment: Adult

The liver dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Matt Harris, PharmD, MHS, BCPS, FAST, FCCP; Jeong Park, PharmD, MS, BCTXP, FCCP, FAST, Arun Jesudian, MD; Sasan Sakiani, MD.

Liver impairment prior to treatment initiation:

Child-Turcotte-Pugh class A through C: No dosage adjustment necessary (Ref).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

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

Dosage guidance:

Dosing: Dosage recommendations are expressed as mg of the ampicillin component.

Dosage forms information : 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.

General dosing:

Infants, Children, and Adolescents: IV, IM: 100 to 200 mg ampicillin/kg/day divided every 6 hours; usual maximum dose: 2,000 mg ampicillin/dose (Ref). Higher doses are necessary in some instances; see specific indications. Note: Higher dosing and alternative dosing strategies (eg, extended infusions, continuous infusions) have also been used to treat Acinetobacter baumannii infections in adults (Ref).

Endocarditis, treatment

Endocarditis, treatment: Limited data available: Children and Adolescents: IV: 200 to 300 mg ampicillin/kg/day divided every 4 to 6 hours; maximum dose: 2,000 mg ampicillin/dose. Recommended combination therapy and duration vary by causative pathogen; treatment duration is at least 4 to 6 weeks (Ref).

Intra-abdominal infection, complicated, treatment

Intra-abdominal infection, complicated, treatment: Note: Not recommended for empiric treatment due to high rates of Escherichia coli resistance (Ref).

Infants, Children, and Adolescents: IV: 200 mg ampicillin/kg/day divided every 6 hours (Ref).

Meningitis

Meningitis: Limited data available: Note: Experience is limited; not included in IDSA meningitis guidelines (Ref).

Infants, Children, and Adolescents: IV: 400 mg ampicillin/kg/day in divided doses every 4 to 6 hours; maximum dose: 2,000 mg ampicillin/dose (Ref).

Osteoarticular infection

Osteoarticular infection: Limited data available: Infants, Children, and Adolescents: IV: 200 mg ampicillin/kg/day in divided doses every 6 hours; maximum dose: 2,000 mg ampicillin/dose (Ref).

Pelvic inflammatory disease

Pelvic inflammatory disease (alternative agent): Adolescents: IV: 2,000 mg ampicillin 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 (Ref).

Rhinosinusitis, severe infection requiring hospitalization

Rhinosinusitis, severe infection requiring hospitalization: Limited data available: 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 (Ref).

Skin and soft tissue infection

Skin and soft tissue 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

Surgical prophylaxis: Limited data available: 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 (Ref).

Dosing: Kidney 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: Liver Impairment: Pediatric

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

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults. 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, pruritus

Gastrointestinal: Abdominal distention, flatulence, glossitis, mucous membrane bleeding, nausea, vomiting

Genitourinary: Dysuria, urinary retention

Hypersensitivity: Facial swelling

Infection: Candidiasis

Nervous system: Chills, fatigue, headache, malaise

Respiratory: Epistaxis, pharyngeal edema

Frequency not defined:

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

Genitourinary: Hematuria

Hematologic: Basophilia, decreased hematocrit, decreased hemoglobin, decreased neutrophils, decreased platelet count, decreased red blood cells, decreased white blood cell count, eosinophilia, lymphocytopenia, lymphocytosis, monocytosis, thrombocytosis

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

Renal: Casts in urine (hyaline), increased blood urea nitrogen, increased serum creatinine

Postmarketing:

Dermatologic: Acute generalized exanthematous pustulosis, bullous dermatitis (linear IgA), erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Gastrointestinal: Abdominal pain, cholestasis, Clostridioides difficile-associated diarrhea, dyspepsia, gastritis, melanoglossia, melena, stomatitis

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

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

Hypersensitivity: Drug reaction with eosinophilia and systemic symptoms, hypersensitivity reaction (including anaphylaxis, angioedema, severe hypersensitivity reaction)

Local: Injection-site reaction

Nervous system: Dizziness, seizure

Neuromuscular & skeletal: Arthralgia

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:

• 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.

Dosage Forms: US

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

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:

Generic: 15 g: Ampicillin 10 g and sulbactam 5 g (1 ea [DSC])

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

Pricing: US

Solution (reconstituted) (Ampicillin-Sulbactam Sodium Injection)

1.5 (1-0.5) g (per each): $2.81 - $9.54

3 (2-1) g (per each): $3.84 - $19.14

Solution (reconstituted) (Ampicillin-Sulbactam Sodium Intravenous)

1.5 (1-0.5) g (per each): $6.46

3 (2-1) g (per each): $11.08 - $11.09

15 (10-5) g (per each): $27.46 - $90.00

Solution (reconstituted) (Unasyn Injection)

1.5 (1-0.5) g (per each): $9.25

3 (2-1) g (per each): $17.47

Solution (reconstituted) (Unasyn Intravenous)

15 (10-5) g (per each): $87.37

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.

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. For some indications (eg, Acinetobacter infections), total daily dose may be administered over 24 hours as a continuous infusion (Ref). 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.

Intraperitoneal (off-label route): May administer continuously (with every exchange) (Ref).

Administration: Pediatric

Parenteral:

IM: Administer by deep IM injection.

IV: Administer by slow IV injection over 10 to 15 minutes or by intermittent IV infusion over 15 to 30 minutes. Avoid infusing concomitantly with aminoglycosides if feasible; consult drug interactions database for more information.

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

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

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

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

Allopurinol: May increase hypersensitivity effects of Ampicillin. Risk C: Monitor

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

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

Bacillus clausii: Antibiotics may decrease therapeutic effects of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider Therapy Modification

BCG (Intravesical): Antibiotics may decrease therapeutic effects of BCG (Intravesical). Risk X: Avoid

BCG Vaccine (Immunization): Antibiotics may decrease therapeutic effects of BCG Vaccine (Immunization). Risk C: Monitor

Chloroquine: May decrease 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 decrease therapeutic effects 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

Dichlorphenamide: Penicillins may increase hypokalemic effects of Dichlorphenamide. Risk C: Monitor

Fecal Microbiota (Live) (Oral): May decrease therapeutic effects of Antibiotics. Risk X: Avoid

Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor

Khat: May decrease serum concentration of Ampicillin. Management: Consider administering ampicillin 2 hours after khat chewing to avoid reductions in ampicillin bioavailability. Risk D: Consider Therapy Modification

Lactobacillus and Estriol: Antibiotics may decrease therapeutic effects of Lactobacillus and Estriol. Risk C: Monitor

Lanthanum: May decrease 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 serum concentration of Methotrexate. Risk C: Monitor

Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor

Probenecid: May increase serum concentration of Sulbactam. Management: Recommendations for management of this interaction vary by specific sulbactam-containing product. Coadministration of probenecid with sulbactam/durlobactam is not recommended, but no specific actions are recommended for ampicillin/sulbactam. Risk D: Consider Therapy Modification

Sodium Benzoate: Penicillins may decrease therapeutic effects of Sodium Benzoate. Risk C: Monitor

Sodium Picosulfate: Antibiotics may decrease therapeutic effects 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

Tegoprazan: May decrease serum concentration of Ampicillin. Risk C: Monitor

Tetracyclines: May decrease therapeutic effects of Penicillins. Risk C: Monitor

Typhoid Vaccine: Antibiotics may decrease therapeutic effects 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: Penicillins may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor

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 patients. 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).

Recommendations for using ampicillin/sulbactam in the management of Bacillus anthracis during pregnancy are available. Maternal infection with B. anthracis may cause preterm labor, fetal infection, fetal distress, or fetal loss. Maternal death may also occur. Ampicillin/sulbactam is a first line option for the treatment of systemic anthrax (with or without CNS involvement) during pregnancy. The dose of ampicillin/sulbactam in pregnant and postpartum patients is the same as in nonpregnant adults (CDC [Bower 2023]; Meaney-Delman 2014).

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 patient 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).

Breastfeeding 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).

Recommendations for using ampicillin/sulbactam in the management of B. anthracis in breastfeeding patients are the same as in pregnancy. Exposure to anthrax is not considered a contraindication to breastfeeding. However, if there are active cutaneous lesions on the breast, contact with the infant should be avoided and feeding from the affected breast should not occur until >48 hours of appropriate antibiotic therapy (CDC [Bower 2023]; Meaney-Delman 2014).

The manufacturer recommends that caution be used if administering to breastfeeding patients. 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.

Pharmacokinetics (Adult Data Unless Noted)

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:

Children ≤12 years: 0.34 ± 0.12 L/kg (Nahata 1999).

Adults: 0.36 L/kg (Foulds 1986).

Protein binding: 38%.

Half-life elimination: Children ≤12 years (normal renal function): Mean: 0.81 ± 0.12 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.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

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: Ampicillin 26.7 to 53.3 mg/kg/dose and sulbactam 13.3 to 26.7 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.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Unasyn;
  • (AR) Argentina: Aminoxidin sulbactam | Ampi bis plus | Ampicilina sulbactam drawer | Ampicilina sulbactam morgan | Ampicilina sulbactam norgreen | Ampicilina sulbactam pharmavial | Ampicilina sulbactam veinfar | Ampigen sb | Decilina compuesta | Decilina compuesto | Prixin | Trifacilina;
  • (AT) Austria: Ampicillin/Sulbactam AptaPharma | Ampicillin/sulbactam astro | Unasyn;
  • (BG) Bulgaria: Ampisulcillin | Unasyn;
  • (BR) Brazil: Ampicilina sodica + sulbactam sodica | Ampicilina sodica + sulbactam sodico | Libractan | Sulbacter | Unasyn;
  • (CL) Chile: Ampicilina+sulbactam | Unasyna;
  • (CN) China: Ampicillin sodium and sulbactam sodium | Ampicillin/sulbact | An te xian | Bei shu lin | Betamp | Er ye qiang | Er ye shu | Hai fu bo | Jia sai | Kai de lin | Kai lan xin | Lai qie li | Li an lin | Li tan | Pu shu | Qi sa | Qing tan wei | Rui an da | Shu an xin | Shu jia qing | Shu li wei | Shu sa lin | Shu ta bi tuo | Sulbactam/ampicil | Tian shu xin | Unasyn | Wei an xin | Xi di lin | Xin an lin | You pu lin | Zhen pai;
  • (CO) Colombia: AMPICILINA + SULBACTAM | Ampicilina sulbactam | Ampicilina y Sulbactam | Ampicilina+sulbactam | Ampidelt | Amplisul | Auropennz | Biosabactam | Fipexiam | Sulamp | Sulbactam + ampicilina | Sulpitam | Sultamicilina | Unasyn | Xilbac;
  • (CZ) Czech Republic: Ampicillin and Sulbactam IBI | Ampicillin/Sulbactam AptaPharma | Bitammon | Unasyn;
  • (DE) Germany: Ampicillin + Sulbactam DeltaSelect | Ampicillin comp | Ampicillin plus sulbactam eberth | Ampicillin Sulb. Teva | Ampicillin und Sulbactam IBI | Ampicillin/Sulbactam Actavis | Ampicillin/sulbactam aurobindo | Ampicillin/Sulbactam Kabi | Ampicillin/sulbactam puren | Unacid;
  • (DO) Dominican Republic: Ampibactam | Fipexiam | Unasyn;
  • (EC) Ecuador: AMPICILINA + SULBACTAM | Ampicilina sodica + sulbactam sodico | Ampicilina sulbactam | Ampicilina y Sulbactam | Ampicilina+sulbactam | Ampicilina/sulbactam biosano | Amplisul | Decilina | Sulbacilin | Sulbam | Sultamix | Unasyn | Xilbac;
  • (EE) Estonia: Alfasid | Ampicillin & sulbactam | Ampisulcillin | Unasyn;
  • (EG) Egypt: Ampictam | Sabect | Sulbin | Synerpen | Ultracillin | Unasyn | Unictam;
  • (ES) Spain: Unasyn;
  • (ET) Ethiopia: Ampicillin and sulbactam | Ampicillin/sulbactam | Sulbactam/ampicillin;
  • (FR) France: Unacim;
  • (GB) United Kingdom: Dicapen | Unasyn;
  • (GR) Greece: Begalin p | Demotine;
  • (HK) Hong Kong: Kintamvy | Unasyn;
  • (HU) Hungary: Ampicillin/Sulbactam AptaPharma | Unasyn;
  • (ID) Indonesia: Bactesyn | Cinam | Picyn | Unasyn | Viccillin SX;
  • (IN) India: Ampifect s | Ampirok | Ampitum | Cinclox s | Saltum | Sulbacin | Sulbact;
  • (IT) Italy: Ampicill+Sulb ibi | Bethacil;
  • (JO) Jordan: Unasyn;
  • (JP) Japan: Picillibacta | Pisulcin | Sulbac Ampicil | Sulbacillin | Sulbacsin | Unasyn s | Yucion-s | Yunasupin;
  • (KE) Kenya: Mahacillin s | Sulbacin;
  • (KR) Korea, Republic of: Aerbactam | Ambactam | Ampibactam | Ampitam | Baccillin | Bactacin | Bactamcillin | Lactacillin | Projin | Rukasyn | Ssulbacin | Sulbacillin | Sulbacin | Sulin | Sultam | Synertam | Ubacillin | Ubacsin | Ubactam | Ucilin | Ucillin | Unasyn | Unisulam | Upocin | Uposin;
  • (LT) Lithuania: Ampicillin & sulbactam | Ampicillin/sulbactam | Ampiplus | Ampisulcillin | Bestpen s | Bitammon | Unasyn;
  • (LV) Latvia: Ampisid | Sulbacin | Unasyn;
  • (MA) Morocco: Unasyne;
  • (MX) Mexico: Unasyna;
  • (MY) Malaysia: Ampicillin+sulbactam | Auropennz | Sulbacin | Sulbamp | Unasyn;
  • (NG) Nigeria: Unasyn;
  • (NO) Norway: Ampicillin plus sulbactam eberth;
  • (PA) Panama: AMPICILINA + SULBACTAM;
  • (PE) Peru: AMPICILINA + SULBACTAM | Ampisulkem | Fipexiam | Unasyn;
  • (PH) Philippines: Ambacitam | Ampibax | Ampicare | Ampico Sbt | Ampimax | Ampisul | Ampisultam | Amsucillin | Amsulvex | Amsutas | Bactacin | Biocillin plus | Ciltamin | Disulbac | Duobaclin | Gravitam | Linsul | Miasyn | Qualisultam | Sentram | Silgram | Sulbacin | Sultacillin | Sybactam | Unasan | Unasyn | Unathix | Unsin | Zulbactam;
  • (PK) Pakistan: Ambac | Ampitam | Sulbacin | Unasyn;
  • (PL) Poland: Ultraproct | Unasyn;
  • (PR) Puerto Rico: Ampicillin and sulbactam | Unasyn;
  • (PY) Paraguay: Aminoxidin sulbactam | Ampicilina sulbactam eticos | Ampicilina sulbactam gemepe | Ampicilina sulbactam interlabo | Ampicilina sulbactam nortelab | Ampicilina sulbactam vivele | Cilimpil bactam | Klafen | Libractam | Norake ibl;
  • (QA) Qatar: Unasyn;
  • (RO) Romania: Unasyn;
  • (RU) Russian Federation: Amibactam | Ampicillin sulbactam | Ampicillin+sulbactam | Ampisid | Complisan | Libakcil | Rampinam | Sulacillin | Sulbacin | Sultasin | Unasyn;
  • (SA) Saudi Arabia: Ampiplus | Unasyn | Unictam;
  • (SI) Slovenia: Ampicilin/sulbaktam aptapharma | Penactam | Unasyn;
  • (SK) Slovakia: Ampisulcillin | Bitammon | Unasyn;
  • (TH) Thailand: Ambacitam | Ampitam | Amsubac | Sulam | Sulbaccin | Unasyn;
  • (TR) Turkey: Devasid | Duobak | Duobaktam | Nobecid | Sulbaksit | Sultasid | Sultibac;
  • (TW) Taiwan: Ambacillin | Amsulber cyh | Ansullina | Subacillin | Sulampi | Unasyn;
  • (UA) Ukraine: Ampicillin+sulbactam | Ampiplus | Ampisid | Ampisulbin | Ampisulcillin | Unasyn;
  • (UG) Uganda: Unictam;
  • (UY) Uruguay: Aminoxidin sulbactam | Ampicilina sulbactam | Ampisul | Libractam | Maxicilina Sulbactam | Sulbampicin 1500 a+s | Sulbampicin 3000 a+s | Unasyn;
  • (VE) Venezuela, Bolivarian Republic of: Ampibactan | AMPICILINA + SULBACTAM | Ampicilina sulbactam | Ampicilina+sulbactam | Ampidelt | Ampilab | Ampitren | Ampiwell s | Amtacilyn | Fipexiam | Sentram | Sinif | Sulamp | Sulpexium | Sultamilan | Unacilyn | Unasyn;
  • (VN) Viet Nam: Ama power | Auropennz | Nerusyn | Visulin;
  • (ZM) Zambia: Sulbacin
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