Ampicillin and sulbactam: Pediatric drug information

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

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Unasyn

Therapeutic Category

Antibiotic, Beta-lactam and Beta-lactamase Combination;
Antibiotic, Penicillin

Dosing: Neonatal

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 (non-CNS), treatment: Limited data available:

Preterm neonates: IV: 100 mg ampicillin/kg/day divided every 12 hours; dosing based on a pharmacokinetic analysis of 15 premature neonates using a 1:1 formulation of ampicillin to sulbactam (GA ≤28 weeks: n=6; GA >28 weeks: n=9) (Ref).

Term neonates: IV: 100 mg ampicillin/kg/day divided every 8 hours; dosing based on a study in which 108 neonates (GA ≥37 weeks) received ampicillin/sulbactam in combination with amikacin for 3 to 8 days (Ref). Note: Higher dosing may be necessary for severe/resistant infections (eg, resistant Acinetobacter baumannii) (Ref).

Dosing: Pediatric

Dosage guidance:

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

General dosing:

Mild to moderate infection: 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).

Severe infection (eg, meningitis, resistant Streptococcus pneumoniae): Infants, Children, and Adolescents: IV: 200 to 400 mg ampicillin/kg/day divided every 6 hours; usual maximum dose: 2,000 mg ampicillin/dose (Ref). 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: Hepatic Impairment: Pediatric

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

Dosing: Adult

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

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).

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).

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

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.

Note: Renally adjusted dose recommendations are based on a usual recommended dose of 1.5 to 3 g every 6 hours and are expressed as total grams of ampicillin/sulbactam.

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 (Ref):

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 (Ref).

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

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

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

Peritoneal dialysis: IV: 1.5 g every 12 hours or 3 g every 24 hours (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.

CVVH/CVVHD/CVVHDF: IV: 3 g every 8 to 12 hours (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.

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

Dosing: Hepatic Impairment: Adult

There is no dosage adjustment 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: Hypersensitivity reaction (including anaphylaxis, angioedema, severe 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.

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): $3.60 - $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): $47.52 - $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: 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.

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).

Storage/Stability

Prior to reconstitution, store at 20°C to 25°C (68°F to 77°F).

IM: Concentration of 375 mg/mL (250 mg ampicillin/125 mg sulbactam) should be used within 1 hour after reconstitution.

Intermittent IV infusion: Refer to manufacturer's labeling for specific storage instructions after reconstitution and dilution (varies by concentration and diluent).

Use

Treatment of skin and soft tissue infections (FDA approved in ages ≥1 year and adults); treatment of intra-abdominal and gynecological infections (FDA approved in adults); has also been used for treatment of endocarditis, meningitis, and osteoarticular infection, and for surgical prophylaxis.

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.

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

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

Bacillus clausii: Antibiotics may diminish the therapeutic effect 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 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

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Khat: May decrease the 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 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: Antibiotics may decrease serum concentrations of the active metabolite(s) of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor therapy

Probenecid: May increase the 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 diminish the therapeutic effect of Sodium Benzoate. 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

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

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

Dietary Considerations

Some products may contain sodium.

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).

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).

Monitoring Parameters

SCr; CBC (with prolonged therapy), LFTs (with prolonged therapy or in patients with preexisting hepatic impairment). Observe for change in bowel frequency; monitor for signs of anaphylaxis during first dose.

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.

V_d:

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: C_max(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: C_max (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 | Ampicilina sulbactam norgreen | Ampicilina sulbactam pharmavial | Ampigen sb | Decilina compuesta | Prixin;
(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 | 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 | Sulbacsin | Unasyn s | Yucion-s | Yunasupin | Yunasupin chemix;
(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;
(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 | 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;
(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 | Visulin;
(ZM) Zambia: Sulbacin

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Topic 12695 Version 343.0

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Ampicillin and sulbactam: Pediatric drug information