Pill Identifier App

Ampicillin Sodium and Sulbactam Sodium

Class: Aminopenicillins
VA Class: AM111
Chemical Name: 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, [2S-[2α,5α,6β(S*)]]-6-[(Aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-, mixt. with (2S-cis)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid 4,4-dioxide
CAS Number: 94935-63-4
Brands: Unasyn

Introduction

Antibacterial; β-lactam antibiotic; fixed combination of ampicillin (an aminopenicillin) and sulbactam (a β-lactamase inhibitor).1 3 29 30 64 69

Uses for Ampicillin Sodium and Sulbactam Sodium

Bone and Joint Infections

Treatment of bone and joint infections (including osteomyelitis and/or septic arthritis) caused by susceptible β-lactamase-producing bacteria.30 58 62 64 90

Intra-abdominal Infections

Treatment of intra-abdominal infections caused by susceptible β-lactamase-producing Escherichia coli, Klebsiella (including K. pneumoniae), Bacteroides (including B. fragilis), or Enterobacter.1 4 29 30 47 53 64 82 85

May be as effective as multiple-drug regimens for treatment of less severe intra-abdominal infections, but an aminoglycoside probably should be used concomitantly for empiric therapy in more serious intra-abdominal infections, including hospital-acquired infections, pending results of in vitro susceptibility tests.64 101 102

Gynecologic Infections

Treatment of serious gynecologic infections (e.g., endometritis, postpartum endomyometritis, posthysterectomy pelvic cellulitis, vaginal cuff abscess, salpingitis, tubo-ovarian abscess, pelvic peritonitis or abscess, surgical wound sepsis) caused by susceptible β-lactamase-producing E. coli or Bacteroides (including B. fragilis).1 49 50 52 54 55 56 74 75 76 83 91

Treatment of pelvic inflammatory disease (PID).6 7 When a parenteral regimen is indicated for PID, CDC and others recommend a regimen of IV ampicillin and sulbactam and IV doxycycline as an alternative6 7 since it provides good coverage against C. trachomatis, N. gonorrhoeae, and anaerobes and is effective for tubo-ovarian abscess.6

Slideshow: Flashback: FDA Drug Approvals 2013

Respiratory Tract Infections

Treatment of lower respiratory tract infections (including pneumonia,57 77 84 87 89 bronchitis,29 57 61 84 87 89 acute exacerbations of chronic bronchitis,84 87 bronchiectasis)84 87 caused by susceptible Staphylococcus, Streptococcus, Haemophilus influenzae, H. parainfluenzae, Moraxella catarrhalis, E. coli, Klebsiella, or Proteus mirabilis.77 81 84 87 89

Has been used for treatment of respiratory tract infections (e.g., pneumonia, tracheobronchitis) or bacteremia caused by Acinetobacter resistant to imipenem and other anti-infectives.93 Imipenem or meropenem with or without an aminoglycoside usually are recommended for treatment of infections caused by susceptible Acinetobacter.4 101

Skin and Skin Structure Infections

Treatment of skin and skin structure infections (e.g., wound infections, cellulitis, ulcers, abscesses, furunculosis) caused by susceptible β-lactamase-producing S. aureus,1 58 71 87 90 Enterobacter,1 E. coli,1 58 71 87 90 Klebsiella (including K. pneumoniae),1 71 P. mirabilis,1 58 71 90 Bacteroides (including B. fragilis),1 or Acinetobacter.1 29 30 48 58 61 64 86 87 90

Also has been used for treatment of skin and skin structure infections caused by susceptible S. epidermidis,58 71 87 90 S. warneri,58 90 Enterococcus faecalis,58 71 90 Citrobacter,71 or Morganella morganii.58 90

Bite Wounds

Empiric treatment of animal or human bites.4 5 Active against most likely bite pathogens, including anaerobes, Staphylococcus, Eikenella corrodens, Pasteurella multocida.5

Alternative for treatment of infections caused by P. multocida or E. corrodens.4 5

Gonorrhea and Associated Infections

Has been used for treatment of uncomplicated gonorrhea caused by susceptible Neisseria gonorrhoeae.29 30 47 79 80 94 95 However, penicillins, including ampicillin sodium and sulbactam sodium, are not included in current CDC recommendations for treatment of gonorrhea.6

Meningitis

Alternative for treatment of meningitis caused by susceptible N. meningitidis, H. influenzae, or S. pneumoniae.78 59 87 Other drugs generally preferred and some clinicians strongly discourage use of ampicillin and sulbactam in CNS infections.101 Treatment failures reported when used for treatment of meningitis caused by K. pneumoniae.35

Perioperative Prophylaxis

Perioperative prophylaxis to reduce the incidence of infections in patients undergoing contaminated or potentially contaminated surgery (e.g., GI or biliary tract surgery, vaginal or abdominal hysterectomy, transurethral prostatectomy).29 30 51 60 98 99 100 Other anti-infectives with narrower spectra of activity (e.g., cephalosporins) generally preferred when prophylaxis is indicated in such procedures.96 97

Ampicillin Sodium and Sulbactam Sodium Dosage and Administration

Administration

Administer by slow IV injection or IV infusion or by IM injection.1

Dosage is the same for IM and IV administration;1 higher serum concentrations usually are attained with IV administration1 30 33 46 63 67 and IV route generally preferred, especially for severe infections.101 102

For solution and drug compatibility information, see Compatibility under Stability.

IV Administration

Reconstitution and Dilution

IV solutions are prepared by reconstituting vials containing 1.5 or 3 g of combined ampicillin and sulbactam with sterile water for injection to provide solutions containing 375 mg/mL (250 mg of ampicillin and 125 mg of sulbactam per mL).1 An appropriate volume of the reconstituted solution should then be immediately diluted with a compatible IV solution to yield solutions containing 3–45 mg/mL (2–30 mg of ampicillin and 1–15 mg of sulbactam per mL).1

ADD-Vantage vials containing 1.5 or 3 g of combined ampicillin and sulbactam should be reconstituted according to the manufacturer’s directions with the 0.9% sodium chloride injection diluent provided.1

Infusion bottles containing 1.5 or 3 g of combined ampicillin and sulbactam may be reconstituted to the desired concentration with a compatible IV solution (see Solution Compatibility under Stability.)1

IV solutions should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for complete solubilization.1

Rate of Administration

For IV injection, given slowly over a period of ≥10–15 minutes.1

IV infusions should be infused slowly over 15–30 minutes.1

IM Administration

IM injections should be made deeply into a large muscle mass.1

Reconstitution

IM solutions are prepared by reconstituting vials containing 1.5 or 3 g of combined ampicillin and sulbactam with 3.2 or 6.4 mL, respectively, of sterile water for injection or 0.5 or 2% lidocaine hydrochloride injection to provide a solution containing 375 mg of the drug per mL (250 mg of ampicillin and 125 mg of sulbactam per mL).1 Use of lidocaine hydrochloride can minimize local pain associated with IM injection of the drug.47 64 92

IM solutions should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for complete solubilization.1 IM solutions should be used within 1 hour after reconstitution.1

Dosage

Available as fixed combination containing ampicillin sodium and sulbactam sodium; dosage generally expressed in terms of the total of the ampicillin and sulbactam content of the fixed combination.1 Potency of both ampicillin sodium and sulbactam sodium are expressed in terms of the bases.1

Pediatric Patients

General Pediatric Dosage
IV

Children ≥1 month of age: AAP recommends 100–150 mg/kg of ampicillin daily in 4 divided doses for treatment of mild to moderate infections or 200–400 mg/kg of ampicillin daily in 4 divided doses for treatment of severe infections.5

Skin and Skin Structure Infections
IV

Children ≥1 year of age: 300 mg/kg daily (200 mg of ampicillin and 100 mg of sulbactam) in equally divided doses every 6 hours.1

Manufacturer recommends that IV treatment in pediatric patients not exceed 14 days; in clinical studies, most children received an appropriate oral anti-infective after an initial IV regimen of ampicillin and sulbactam.1

Acute Pelvic Inflammatory Disease
IV

Adolescents: 3 g (2 g of ampicillin and 1 g of sulbactam) every 6 hours in conjunction with doxycycline (100 mg orally or IV every 12 hours).6 Parenteral regimen may be discontinued 24 hours after clinical improvement; oral doxycycline (100 mg twice daily) should be continued to complete 14 days of therapy.6

Adults

General Adult Dosage
Intra-abdominal, Gynecologic, or Skin and Skin Structure Infections
IV or IM

1.5 g (1 g of ampicillin and 0.5 g of sulbactam) to 3 g (2 g of ampicillin and 1 g of sulbactam) every 6 hours.1

Acute Pelvic Inflammatory Disease
IV

3 g (2 g of ampicillin and 1 g of sulbactam) every 6 hours in conjunction with doxycycline (100 mg orally or IV every 12 hours).6 7 Parenteral regimen may be discontinued 24 hours after clinical improvement; oral doxycycline (100 mg twice daily) should be continued to complete 14 days of therapy.6 7

Prescribing Limits

Pediatric Patients

IV

Maximum sulbactam dosage is 4 g (i.e., 8 g of ampicillin and 4 g of sulbactam in fixed combination) daily.1

Duration of therapy should be ≤14 days.1

Adults

IV or IM

Maximum sulbactam dosage is 4 g (i.e., 8 g of ampicillin and 4 g of sulbactam in fixed combination) daily.1

Special Populations

Renal Impairment

Dosage adjustments necessary in patients with renal impairment.1 3

Patients with renal impairment should receive the usually recommended dose but these doses should be given less frequently than usual; dosing intervals are based on the patient’s Clcr.1 The manufacturer recommends that patients with Clcr ≥30 mL/minute per 1.73 m2 should receive 1.5 g (1 g of ampicillin and 0.5 g of sulbactam) to 3 g (2 g of ampicillin and 1 g of sulbactam) every 6–8 hours and patients with Clcr 15–29 or 5–14 mL/minute per 1.73 m2 receive these doses every 12 or 24 hours, respectively.1

Some clinicians suggest that patients undergoing hemodialysis receive 1.5 g (1 g of ampicillin and 0.5 g of sulbactam) to 3 g (2 g of ampicillin and 1 g of sulbactam) once every 24 hours and that the dose should preferably be given immediately after dialysis.34 72

Geriatric Patients

No dosage adjustments except those related to renal impairment. (See Renal Impairment under Dosage and Administration.)

Cautions for Ampicillin Sodium and Sulbactam Sodium

Contraindications

  • Known hypersensitivity to any penicillin.1

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi (e.g., Pseudomonas, Candida).1 Discontinue and institute appropriate therapy if superinfection occurs.1

Treatment with anti-infectives may permit overgrowth of clostridia.1 103 104 105 106 107 Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.1

Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone.1 103 104 105 106 107 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.1 HID 103 104 105 106 107

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, reported with penicillins.1 3 21 15

Prior to initiation of therapy, make careful inquiry regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other drugs.1 Partial cross-allergenicity occurs among penicillins and other β-lactam antibiotics including cephalosporins and cephamycins.1 3 13 16

If a severe hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).1

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1

Mononucleosis

Possible increased risk of rash in patients with mononucleosis; use in these patients not recommended.1

Sodium Content

Each 1.5 g (1 g of ampicillin and 0.5 g of sulbactam) contains approximately 5 mEq (115 mg) of sodium.1

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category B.1

Lactation

Both ampicillin and sulbactam distributed into milk in low concentrations.1 Use with caution.1

Pediatric Use

Safety and efficacy of IM ampicillin and sulbactam have not been established for any indication in pediatric patients.1

Safety and efficacy of IV ampicillin and sulbactam have not been established in children <1 year of age.1 Safety and efficacy of the IV route have been established for treatment of skin and skin structure infections in children ≥1 year of age, but have not been established for any other indication in this age group.1

Adverse effects reported in pediatric patients similar to those reported in adults.1

Geriatric Use

Serum half-lives of ampicillin and sulbactam slightly longer in geriatric adults than in younger adults;3 31 not considered clinically important in geriatric patients with renal function normal for their age.66

Substantially eliminated by kidneys; risk of toxicity may be greater in patients with impaired renal function.1 Select dosage with caution and assess renal function periodically since geriatric patients are more likely to have renal impairment.1

No dosage adjustments except those related to renal function.1 (See Renal Impairment under Dosage and Administration.)

Renal Impairment

Dosage adjustments necessary in renal impairment.1

Common Adverse Effects

Local reactions (pain at IM or IV injection sites, thrombophlebitis);1 29 30 57 77 79 80 87 92 GI effects (diarrhea, nausea, vomiting),1 29 30 92 rash.1 29

Interactions for Ampicillin Sodium and Sulbactam Sodium

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Allopurinol

Possible increased incidence of rash reported with ampicillin;1 14 19 22 data not available regarding ampicillin and sulbactam 1

Unclear whether potentiation of rash is caused by allopurinol or hyperuricemia present in these patients1

Clinical importance has not been determined;27 some clinicians suggest that concomitant use of ampicillin and allopurinol should be avoided if possible14

Aminoglycosides

In vitro evidence of synergistic antibacterial effects against enterococci;9 10 11 24 used to therapeutic advantage in treatment of endocarditis and other severe enterococcal infections8 10 24

Potential in vitro and in vivo inactivation of aminoglycosidesHID 3 70

Chloramphenicol

In vitro evidence of antagonism with ampicillin12 28

Clinical importance unclear12 27

Hormonal contraceptives

Possible decreased efficacy of estrogen-containing oral contraceptives and increased incidence of breakthrough bleeding reported with ampicillin3

Some clinicians suggest that a supplemental method of contraception be used in patients receiving oral contraceptives and ampicillin concomitantly; other clinicians state that most women taking oral contraceptives probably do not need to use alternative contraceptive precautions while receiving ampicillin17 18 25 26

Methotrexate

Possible decreased renal clearance of methotrexate with penicillins; possible increased methotrexate concentrations and hematologic and GI toxicity109

Monitor closely if used concomitantly109

Probenecid

Decreased renal tubular secretion of ampicillin and sulbactam; increased and prolonged ampicillin and sulbactam concentrations may occur1 3 29 30 33 65 92

Tests for glucose

Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution1

Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)1

Tests for uric acid

Possible falsely increased serum uric acid concentrations when copper-chelate method is used;20 phosphotungstate and uricase methods appear to be unaffected by ampicillin20

Ampicillin Sodium and Sulbactam Sodium Pharmacokinetics

Absorption

Bioavailability

Peak ampicillin serum concentrations attained with ampicillin and sulbactam are similar to those attained with ampicillin alone.1

Peak serum concentrations of ampicillin and sulbactam attained immediately following completion of a 15-minute IV infusion of ampicillin and sulbactam.1 63

Following IM injection, both drugs are rapidly and almost completely absorbed;30 33 46 67 peak serum concentrations of ampicillin and sulbactam generally attained within 30–40 and 30–52 minutes, respectively.30 67

Peak serum concentrations and AUCs of ampicillin and sulbactam are slightly higher in geriatric patients than in younger adults, presumably because of reduced renal clearance in the elderly.3 31

Distribution

Extent

Both ampicillin and sulbactam widely distributed into fluids and tissues,1 3 29 30 33 including peritoneal fluid,1 3 29 30 43 44 60 65 blister fluid,1 3 29 30 36 65 68 tissue fluid,1 sputum,3 30 middle ear effusion,3 65 intestinal mucosa,1 30 45 65 bronchial wall,42 alveolar lining fluid,42 sternum,41 pericardium,41 myocardium,41 endocardium,41 prostate,29 30 65 gallbladder,29 30 39 65 bile,30 39 65 myometrium,30 65 73 salpinges,30 65 73 ovaries,30 65 73 and appendix.1 60 65 Concentrations of the drugs in most of these tissues and fluids are 53–100% of concurrent serum concentrations.33 42 43 65

Both ampicillin and sulbactam distributed into CSF in low concentrations following IV or IM administration.1 3 29 30 35 37 38 59 65 CSF concentrations generally higher in patients with inflamed meninges than in those with uninflamed meninges.35 37 38 59 65

Ampicillin and sulbactam both readily cross the placenta3 30 65 and concentrations in umbilical cord blood may be similar to serum concentrations.65 Ampicillin and sulbactam both distributed into milk in low concentrations.1 30 65 108

Plasma Protein Binding

Ampicillin approximately 15–28% and sulbactam approximately 38% bound to serum proteins.1 3 29 33 65

Elimination

Metabolism

Both ampicillin and sulbactam partially metabolized in the liver.3 Ampicillin partially metabolized by hydrolysis of the β-lactam ring to penicilloic acid which is microbiologically inactive.3

Elimination Route

Both ampicillin and sulbactam eliminated in urine principally by glomerular filtration and tubular secretion.3 29 30 33 34 46 65 Only small amounts of the drugs eliminated in feces and bile.3 33 45

Following IM or IV administration in adults with normal renal function, approximately 75–92% of the dose of both ampicillin and sulbactam excreted unchanged in urine within 8 hours.1 65 67

Ampicillin and sulbactam both removed by hemodialysis.1 34

Half-life

In healthy adults with normal renal function, both ampicillin and sulbactam have a distribution half-life of about 15 minutes and an elimination half-life of about 1 hour.1 33 65 67

In infants and children <12 years of age, sulbactam has an elimination half-life of 0.92–1.9 hours.29 32 33 In neonates, half-lives of ampicillin and sulbactam vary inversely with age; as renal tubular function matures, the drugs are cleared more rapidly.33 40 65 66 In premature neonates ≤6 days of age, half-life of ampicillin averages 9.4 hours and half-life of sulbactam averages 7.9 hours.29

Special Populations

Half-lives are slightly longer in geriatric adults than in younger adults3 29 31 (2.2 hours compared with 0.8–1.2 hours in younger adults).29

Serum concentrations of both ampicillin and sulbactam are higher and half-lives prolonged in patients with renal impairment.1 3 29 30 33 34 65 Half-lives of ampicillin and sulbactam average 1.6 and 1.6 hours, respectively, in adults with Clcr 30–60 mL/minute and average 3.4 and 3.7 hours, respectively, in those with Clcr 7–30 mL/minute.34 In adults with Clcr <7 mL/minute, elimination half-life of ampicillin and sulbactam average 17.4 and 13.4 hours, respectively.34

Cystic fibrosis patients may eliminate sulbactam at faster rates than healthy individuals.29 32 65

Stability

Storage

Parenteral

Powder for Injection or Infusion

≤30°C.1 HID

IV solutions containing 45 mg/mL (30 mg of ampicillin and 15 mg of sulbactam per mL) prepared using sterile water for injection or 0.9% sodium chloride injection are stable for 8 hours at 25°C or 48 hours at 4°C;1 solutions containing 30 mg/mL (20 mg of ampicillin and 10 mg of sulbactam per mL) are stable for 72 hours at 4°C.1 IV solutions containing 45 mg/mL (30 mg of ampicillin and 15 mg of sulbactam per mL) in lactated Ringer’s injection or (1/6) M sodium lactate injection are stable for 8 hours at 25°C or for 24 or 8 hours, respectively, when refrigerated at 4°C.1

IV solutions containing 30 mg/mL (20 mg of ampicillin and 10 mg of sulbactam per mL) in 5% dextrose injection are stable for 2 hours at 25°C or 4 hours when refrigerated at 4°C; those containing 3 mg/mL (2 mg of ampicillin and 1 mg of sulbactam per mL) are stable for 4 hours at 25°C.1

IV solutions in ADD-Vantage containers reconstituted with 0.9% sodium chloride injection to concentrations ≤30 mg/mL (20 mg of ampicillin and 10 mg of sulbactam per mL) are stable for 8 hours at 25°C.1 Final solutions should be completely administered within 8 hours to ensure proper potency.1

IM solutions containing 375 mg/mL (250 mg of ampicillin and 125 mg of sulbactam per mL) prepared using sterile water for injection or 0.5 or 2% lidocaine hydrochloride injection should be used within 1 hour after reconstitution.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible

Sodium chloride 0.9%

Drug Compatibility
Admixture CompatibilityHID

Compatible

Aztreonam

Incompatible

Ciprofloxacin

Y-site CompatibilityHID

Compatible

Amifostine

Anidulafungin

Aztreonam

Bivalirudin

Dexmedetomidine HCl

Docetaxel

Enalaprilat

Etoposide phosphate

Famotidine

Fenoldopam mesylate

Filgrastim

Fluconazole

Fludarabine phosphate

Gallium nitrate

Gemcitabine HCl

Granisetron HCl

Heparin sodium

Hetastarch in lactated electrolyte injection (Hextend)

Insulin, regular

Linezolid

Meperidine HCl

Morphine sulfate

Paclitaxel

Palonosetron HCl

Pemetrexed sodium

Remifentanil HCl

Tacrolimus

Telavancin HCl

Teniposide

Theophylline

Thiotepa

Incompatible

Amiodarone HCl

Amphotericin B cholesteryl sulfate complex

Ciprofloxacin

Idarubicin HCl

Nicardipine HCl

Ondansetron HCl

Sargramostim

Variable

Cisatracurium besylate

Diltiazem HCl

Vancomycin HCl

Actions and Spectrum

  • Fixed combination of ampicillin sodium (an aminopenicillin) and sulbactam sodium (a β-lactamase inhibitor).1 3

  • Sulbactam synergistically expands activity of ampicillin against β-lactamase-producing bacteria by irreversibly and competitively inhibiting β-lactamases.1 3 Active against bacteria susceptible to ampicillin alone and also active against many β-lactamase-producing bacteria resistant to ampicillin alone.1 3

  • Usually bactericidal.1

  • Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.1 3

  • Spectrum of activity includes many gram-positive and -negative aerobes and some anaerobes.1 3

  • Gram-positive aerobes: active in vitro against β-lactamase-producing and non-β-lactamase-producing strains of Staphylococcus, S. epidermidis, and S. saprophyticus.1 Also active in vitro against Streptococcus pneumoniae, S. pyogenes (group A β-hemolytic streptococci), and Enterococcus faecalis.1 Oxacillin-resistant (methicillin-resistant) staphylococci are resistant.3

  • Gram-negative aerobes: active in vitro against β-lactamase-producing and non-β-lactamase-producing strains of Haemophilus influenzae, Moraxella catarrhalis, Escherichia coli, Klebsiella, Proteus mirabilis, and Neisseria gonorrhoeae.1 Also active in vitro against P. vulgaris, Providencia rettgeri, P. stuartii, and Morganella morganii.1 Inactive against Pseudomonas aeruginosa.1

  • Anaerobes: active in vitro against Bacteroides (including B. fragilis),1 3 Clostridium, Peptococcus, and Peptostreptococcus.1

Advice to Patients

  • Advise patients that antibacterials (including ampicillin and sulbactam) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).1

  • Importance of completing the entire prescribed course of treatment, even if feeling better after a few days.1

  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with ampicillin and sulbactam or other antibacterials in the future.1

  • Importance of discontinuing therapy and informing clinician if an allergic reaction occurs.1

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ampicillin Sodium and Sulbactam Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection

1 g (of ampicillin) and 0.5 g (of sulbactam) (labeled as a combined total potency of 1.5 g)*

Ampicillin and Sulbactam for Injection

Baxter

Unasyn

Pfizer

2 g (of ampicillin) and 1 g (of sulbactam) (labeled as a combined total potency of 3 g)*

Ampicillin and Sulbactam for Injection

Baxter

Unasyn

Pfizer

10 g (of ampicillin) and 5 g (of sulbactam) (labeled as a combined total potency of 15 g) pharmacy bulk package*

Ampicillin and Sulbactam for Injection

Baxter

Unasyn

Pfizer

For injection, for IV infusion

1 g (of ampicillin) and 0.5 g (of sulbactam) (labeled as a combined total potency of 1.5 g)

Unasyn

Pfizer

Unasyn ADD-Vantage

Pfizer

Unasyn Piggyback

Pfizer

2 g (of ampicillin) and 1 g (of sulbactam) (labeled as a combined total potency of 3 g)

Unasyn

Pfizer

Unasyn ADD-Vantage

Pfizer

Unasyn Piggyback

Pfizer

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions June 18, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Pfizer. Unasyn (ampicillin sodium/sulbactam sodium) prescribing information. New York, NY; 2003 Sep.

HID. Trissel LA. Handbook on injectable drugs. 17th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2013:113-7.

3. Kucers A, Crowe S, Grayson ML et al, eds. The use of antibiotics. A clinical review of antibacterial, antifungal, and antiviral drugs. 5th ed. Jordan Hill, Oxford: Butterworth-Heinemann; 1997: 108-33,209-19.

4. Anon. The choice of antibacterial drugs. Med Lett Drugs Ther. 2001; 43:69-78. [PubMed 11518876]

5. Committee on Infectious Diseases, American Academy of Pediatrics. Red book: 2000 report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000.

6. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR Morb Mortal Wkly Rep. 2002; 51(No. RR-6):1-78.

7. Anon. Treatment of sexually transmitted diseases. Med Lett Drugs Ther. 1999; 41:85-90. [PubMed 10906932]

8. Chambers HF. Penicillins. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett’s principles and practice of infectious diseases. 5th ed. New York: Churchill Livingstone; 2000: 261-74.

9. Lorian V, ed. Antibiotics in laboratory medicine. Baltimore: Williams & Wilkins; 1980:298-341, 418-73, 607-722.

10. Serra P, Brandimarte C, Martino P et al. Synergistic treatment of enterococcal endocarditis: in vitro and in vivo studies. Arch Intern Med. 1977; 137:1562-7. [PubMed 921443]

11. Iannini PB, Ehret J, Eickhoff TC. Effects of ampicillin-amikacin and ampicillin-rifampin on enterococci. Antimicrob Agents Chemother. 1976; 9:448-51. [PubMed 1045914]

12. Rocco V, Overturf G. Chloramphenicol inhibition of the bactericidal effect of ampicillin against Haemophilus influenzae. Antimicrob Agents Chemother. 1982; 21:349-51. [IDIS 146670] [PubMed 6978674]

13. Erffmeyer JE. Adverse reactions to penicillin. Ann Allergy. 1981; 47:288-300. [PubMed 6171185]

14. Murphy TF. Ampicillin rash and hyperuricemia. Ann Intern Med. 1979; 91:324. [PubMed 157097]

15. MacFarlane MD, McCarron MM. Anaphylactic shock and anaphylactoid reaction: analysis of 62 cases. Drug Intell Clin Pharm. 1973; 7:394-405.

16. Isbister JP. Penicillin allergy: a review of the immunological and clinical aspects. Med J Aust. 1971; 1:1067-74. [PubMed 4398272]

17. Friedman DI, Huneke AL, Kim MH et al. The effect of ampicillin on oral contraceptive effectiveness. Obstet Gynecol. 1980; 55:33-6. [IDIS 111248] [PubMed 7188714]

18. Back DJ, Breckenridge AM, MacIver M et al. The interaction between ampicillin and oral contraceptive steroids in women. Proc Br Pharmacol Soc. 1981; 280-1.

19. Jick H, Porter JB. Potentiation of ampicillin skin reactions by allopurinol or hyperuricemia. J Clin Pharmacol. 1981; 21:456-8. [IDIS 141506] [PubMed 6458626]

20. Lum G, Gambino SR. Comparison of four methods for measuring uric acid: copper-chelate, phosphotungstate, manual uricase, and automated kinetic uricase. Clin Chem. 1973; 19:1184-6. [PubMed 4741958]

21. Willis RR, Phair JP. Anaphylactoid reactions with oral use of ampicillin. Arch Intern Med. 1970; 125:312-3. [PubMed 5412022]

22. Almeyda J, Levantine A. Drug reactions XIX: adverse cutaneous reactions to the penicillins—ampicillin rashes. Br J Dermatol. 1972; 87:293-6. [PubMed 4342950]

23. Murillo J, Standiford HC, Tatem BA et al. Parenteral prophylaxis against enterococcal endocarditis. Am J Med Sci. 1979; 277:195-200. [IDIS 122705] [PubMed 463947]

24. Sande MA, Scheld WM. Combination antibiotic therapy of bacterial endocarditis. Ann Intern Med. 1980; 92:390-5. [IDIS 110085] [PubMed 6986829]

25. Back DJ, Breckenridge AM, Crawford FE et al. Interindividual variation and drug interactions with hormonal steroid contraceptives. Drugs. 1981; 21:46-61. [IDIS 164891] [PubMed 7009137]

26. Back DJ, Breckenridge AM, MacIver M et al. The effects of ampicillin on oral contraceptive steroids in women. Br J Clin Pharmacol. 1982; 14:43-8. [IDIS 153770] [PubMed 6809025]

27. Hansten PD. Drug interactions. 4th ed. Philadelphia: Lea & Febiger; 1979:130, 133, 141, 143, 155, 156.

28. Schauf V, Green DC, Van Der Stuyf L et al. Chloramphenicol kills Haemophilus influenzae more rapidly than does ampicillin or cefamandole. Antimicrob Agents Chemother. 1981; 23:364-8.

29. Benson JM, Nahata MC. Sulbactam/ampicillin, a new beta-lactamase inhibitor/beta-lactam antibiotic combination. DICP. 1988; 22:534-41.

30. Campoli-Richards DM, Brogden RN. Sulbactam/ampicillin: a review of its antibacterial activity, pharmacokinetic properties, and therapeutic use. Drugs. 1987; 33:577-609. [IDIS 232439] [PubMed 3038500]

31. Meyers BR, Wilkinson P, Mendelson MH et al. Pharmacokinetics of ampicillin-sulbactam in healthy elderly and young volunteers. Antimicrob Agents Chemother. 1991; 35:2098-101. [IDIS 288659] [PubMed 1759832]

32. Schaad UB, Guenin K, Straehl P. Single-dose pharmacokinetics of intravenous sulbactam in pediatric patients. Rev Infect Dis. 1986; 8(Suppl 5):S512-6. [PubMed 3025998]

33. Foulds G. Pharmacokinetics of sulbactam/ampicillin in humans: a review. Rev Infect Dis. 1986; 8(Suppl 5):S503-10. [IDIS 230969] [PubMed 3025997]

34. Blum RA, Kohli RK, Harrison NJ et al. Pharmacokinetics of ampicillin (2.0 grams) and sulbactam (1.0 gram) coadministered to subjects with normal and abnormal renal function and with end-stage renal disease on hemodialysis. Antimicrob Agents Chemother. 1989; 33:1470-6. [IDIS 260451] [PubMed 2817847]

35. Foulds G, McBride TJ, Knirsch AK et al. Penetration of sulbactam and ampicillin into cerebrospinal fluid of infants and young children with meningitis. Antimicrob Agents Chemother. 1987; 31:1703-5. [IDIS 236780] [PubMed 3435118]

36. Brown RM, Wise R, Andrews JM et al. Comparative pharmacokinetics and tissue penetration of sulbactam and ampicillin after concurrent intravenous administration. Antimicrob Agents Chemother. 1982; 21:565-7. [IDIS 157791] [PubMed 6282211]

37. Stahl JP, Bru JP, Fredj G et al. Penetration of sulbactam into the cerebrospinal fluid of patients with bacterial meningitis receiving ampicillin therapy. Rev Infect Dis. 1986; 8(Suppl 5):S612-6. [IDIS 230985] [PubMed 3026013]

38. Hänninen P, Rossi T. Penetration of sulbactam into cerebrospinal fluid of patients with viral meningitis or without meningitis. Rev Infect Dis. 1986; 8(Suppl 5):S609-11. [IDIS 230984] [PubMed 3026012]

39. Morris DL, Ubhi CS, Roberson CS et al. Biliary pharmacokinetics of sulbactam plus ampicillin in humans. Rev Infect Dis. 1986; 8(Suppl 5):S589-92.

40. 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):S518-22. [IDIS 230970] [PubMed 3025999]

41. Wildfeuer A, Müller V, Springsklee M et al. Pharmacokinetics of ampicillin and sulbactam in patients undergoing heart surgery. Antimicrob Agents Chemother. 1991; 35:1772-6. [IDIS 287976] [PubMed 1952846]

42. Valcke YJ, Rosseel MT, Pauwels RA et al. Penetration of ampicillin and sulbactam in the lower airways during respiratory infections. Antimicrob Agents Chemother. 1990; 34:958-62. [IDIS 267801] [PubMed 2393293]

43. Wise R, Donovan IA, Andrews JM et al. Penetration of sulbactam and ampicillin into peritoneal fluid. Antimicrob Agents Chemother. 1983; 24:290-2. [IDIS 174918] [PubMed 6314889]

44. Houang ET, Colley N, Chapman M. Penetration of sulbactam-ampicillin and clavulanic acid-amoxicillin into the pelvic peritoneum. Antimicrob Agents Chemother. 1985; 28:165-6. [IDIS 203418] [PubMed 2994556]

45. Kager L, Liljeqvist L, Malmborg AS et al. Effects of ampicillin plus sulbactam on bowel flora in patients undergoing colorectal surgery. Antimicrob Agents Chemother. 1982; 22:208-12. [IDIS 154960] [PubMed 6100422]

46. Foulds G, Stankewich JP, Marshall DC et al. Pharmacokinetics of sulbactam in humans. Antimicrob Agents Chemother. 1983; 23:692-9. [IDIS 170758] [PubMed 6307133]

47. Lees L, Milson JA, Knirsch AK et al. Sulbactam plus ampicillin: interim review of efficacy and safety for therapeutic and prophylactic use. Rev Infect Dis. 1986; 8(Suppl 5):S644-50. [IDIS 230991] [PubMed 3026019]

48. Stromberg BV, Reines HD, Hunt P. Comparative clinical study of sulbactam and ampicillin and clindamycin and tobramycin in infections of soft tissues. Surg Gynecol Obstet. 1986; 162:575-8. [IDIS 216284] [PubMed 3012808]

49. Senft HH, Stiglmayer R, Eibach HW et al. Sulbactam/ampicillin versus cefoxitin in the treatment of obstetric and gynaecological infections. Drugs. 1986; 31(Suppl 2):18-21. [IDIS 216883] [PubMed 3013568]

50. Hemsell DL. Sulbactam/ampicillin for treatment of polymicrobial pelvic infections. Drugs. 1986; 31(Suppl 2):22-5. [IDIS 216884] [PubMed 3013569]

51. Krohn KT. Effect of prophylactic administration of sulbactam/ampicillin on the rate of postoperative endometritis after first-trimester abortion. Rev Infect Dis. 1986; 8(Suppl 5):S576-8. [IDIS 230977] [PubMed 3026006]

52. Giamarellou H, Trouvas G, Avlami A et al. Efficacy of sulbactam plus ampicillin in gynecologic infections. Rev Infect Dis. 1986; 8(Suppl 5):S579-82. [IDIS 230978] [PubMed 3026007]

53. Study Group of Intraabdominal Infections. A randomized controlled trial of ampicillin plus sulbactam vs. gentamicin plus clindamycin in the treatment of intraabdominal infections: a preliminary report. Rev Infect Dis. 1986; 8(Suppl 5):S583-8.

54. Martens MG, Faro S, Hammill HA et al. Ampicillin/sulbactam versus clindamycin in the treatment of postpartum endomyometritis. South Med J. 1990; 83:408-13. [IDIS 266041] [PubMed 2181689]

55. Crombleholme WR, Ohm-Smith M, Robbie MO et al. Ampicillin/sulbactam versus metronidazole-gentamicin in the treatment of soft tissue pelvic infections. Am J Obstet Gynecol. 1987; 156:507-12. [IDIS 227309] [PubMed 3030109]

56. Reed SD, Landers DV, Sweet RL. Antibiotic treatment of tuboovarian abscess: comparison of broad-spectrum β-lactam agents versus clindamycin-containing regimens. Am J Obstet Gynecol. 1991; 164:1556-62. [IDIS 284591] [PubMed 2048603]

57. Mehtar S, Croft RJ, Hilas A. A non-comparative study of parenteral ampicillin and sulbactam in intra-thoracic and intra-abdominal infections. J Antimicrob Chemother. 1986; 17:389-96. [PubMed 3009384]

58. Löffler L, Bauernfeind A, Keyl W et al. An open, comparative study of sulbactam plus ampicillin vs. cefotaxime as initial therapy for serious soft tissue and bone and joint infections. Rev Infect Dis. 1986; 8(Suppl 5):S593-8. [IDIS 230981] [PubMed 3026009]

59. Rodrgúez WJ, Khan WN, Puig J et al. Sulbactam/ampicillin vs. chloramphenicol/ampicillin for the treatment of meningitis in infants and children. Rev Infect Dis. 1986; 8(Suppl 5):S620-9. [IDIS 230987] [PubMed 3026015]

60. Foster MC, Kapila L, Morris DL et al. A randomized comparative study of sulbactam plus ampicillin vs. metronidazole plus cefotaxime in the management of acute appendicitis in children. Rev Infect Dis. 1986; 8(Suppl 5):S634-8.

61. Galante D, Esposito S, Barba D et al. Clinical efficacy and safety of sulbactam/ampicillin in patients suffering from chronic liver disease. J Antimicrob Chemother. 1987; 19:527-32. [PubMed 3034850]

62. Aronoff SC, Scoles PV, Makley JT et al. Efficacy and safety of sequential treatment of parenteral sulbactam/ampicillin and oral sultamicillin for skeletal infections in children. Rev Infect Dis. 1986; 8(Suppl 5):S639-42. [IDIS 230990] [PubMed 3026018]

63. Hampel B, Lode H, Bruckner G et al. Comparative pharmacokinetics of sulbactam/ampicillin and clavulanic acid/amoxycillin in human volunteers. Drugs. 1988; 35(Suppl 7):29-33. [IDIS 246204] [PubMed 3220007]

64. Itokazu GS, Danziger LH. Ampicillin-sulbactam and ticarcillin-clavulanic acid: a comparison of their in vitro activity and review of their clinical efficacy. Pharmacotherapy. 1991; 11:382-414. [IDIS 387558] [PubMed 1745624]

65. Noguchi JK, Gill MA. Sulbactam: a β-lactamase inhibitor. Clin Pharm. 1988; 7:37-51. [IDIS 237930] [PubMed 3278833]

66. Watson ID, Stewart MJ, Platt DJ. Clinical pharmacokinetics of enzyme inhibitors in antimicrobial chemotherapy. Clin Pharmacokinet. 1988; 15:133-64. [IDIS 246142] [PubMed 3052984]

67. Ripa S, Ferrante L, Prenna M. Pharmacokinetics of sulbactam/ampicillin in humans after intravenous and intramuscular injection. Chemotherapy. 1990; 36:185-92. [IDIS 266393] [PubMed 2338029]

68. Jaresko GS, Barriere SL, Johnson BL Jr. Serum and blister fluid pharmacokinetics and bactericidal activities of ampicillin-sulbactam, cefotetan, cefoxitin, ceftizoxime, and ticarcillin-clavulanate. Antimicrob Agents Chemother. 1992; 36:2233-8. [IDIS 303569] [PubMed 1444304]

69. Aswapokee N, Neu HC. A sulfone β-lactam compound which acts as a β-lactamase inhibitor. J Antibiot. 1978; 31:1238-44. [PubMed 310815]

70. Fuchs PC, Stickel S, Anderson PH et al. In vitro inactivation of aminoglycosides by sulbactam, other β-lactams, and sulbactam-β-lactam combinations. Antimicrob Agents Chemother. 1991; 35:182-4. [IDIS 278388] [PubMed 2014975]

71. Nichols RL, Smith JW, Adinolfi MF et al. Inhibition of β-lactamase-induced resistance in soft-tissue infections. Arch Surg. 1985; 120:36-42. [IDIS 194169] [PubMed 2981523]

72. Kerins DM. Ampicillin/sulbactam—a combination of an old and a new agent in the treatment of infection. Am J Med Sci. 1991; 301:406-11. [IDIS 283765] [PubMed 2039029]

73. Schwiersch U, Lang N, Wildfeuer DA. Concentration of sulbactam and ampicillin in serum and the myometrium. Drugs. 1986; 31(Suppl 2):26-8. [IDIS 216885] [PubMed 3013570]

74. Gunning J. A comparison of parenteral sulbactam/ampicillin versus clindamycin/gentamicin in the treatment of pelvic inflammatory disease. Drugs. 1986; 31(Suppl 2):14-7. [IDIS 216882] [PubMed 3013567]

75. Crombleholme W, Landers D, Ohm-Smith M et al. Sulbactam/ampicillin versus metronidazole/gentamicin in the treatment of severe pelvic infections. Drugs. 1986; 31(Suppl 2):11-3. [IDIS 216881] [PubMed 3013566]

76. Bruhat MA, Pouly JL, Le Boedec G et al. Treatment of acute salpingitis with sulbactam/ampicillin: comparison with cefoxitin. Drugs. 1986; 31(Suppl 2):7-10. [IDIS 216880] [PubMed 3013571]

77. Oviasu VO, Obasohan AO. Effectiveness of sulbactam/ampicillin in the treatment of lobar pneumonia. Curr Ther Res. 1987; 41:99-104.

78. Dutse AI, Fakunle YM, Oyeyinka GO et al. Sulbactam/ampicillin in epidemic meningococcal meningitis in northern Nigeria. Curr Ther Res. 1987; 41:128-34.

79. Odugbemi T. An open evaluative study of sulbactam/ampicillin with or without probenecid in gonococcal infections in Lagos. Curr Ther Res. 1987; 41:542-51.

80. Rotowa NA, Asuzu MC, Adelushi B et al. The efficacy of sulbactam/ampicillin in the treatment of uncomplicated penicillin-resistant gonococcal infection. Curr Ther Res. 1987; 42:351-6.

81. Valcke Y, Van der Straeten M. A noncomparative study of the safety and efficacy of parenteral sulbactam/ampicillin followed by oral sultamicillin for the treatment of lower respiratory tract infections. Curr Ther Res. 1989; 45:43-7.

82. Ito MK, Gill MA, Yellin AE et al. The cost effectiveness of sulbactam-ampicillin versus moxalactam in the management of acute cholecystitis. Curr Ther Res. 1989; 46:747-54.

83. Cunha BA. Treatment of pelvic inflammatory disease. Clin Pharm. 1990; 9:275-85. [IDIS 265474] [PubMed 2184973]

84. Morales JJ, de la Cabada Cortesé FJ, Villanueva JA et al. Sulbactam plus ampicillin in the treatment of lower respiratory tract infections. Curr Ther Res. 1990; 48:548-54.

85. Zenon GJ, Cadle RM, Hamill RJ. Ampicillin-sulbactam therapy for multiple pyogenic hepatic abscesses. Clin Pharm. 1990; 9:939-47. [IDIS 275455] [PubMed 2292177]

86. Andreoni M, Raillard P, Concia E et al. Sulbactam/ampicillin in the treatment of skin and soft-tissue infections due to methicillin-resistant staphylococci. Curr Ther Res. 1991; 50:386-95.

87. Dajani AS. Sulbactam/ampicillin in paediatric infections. Drugs. 1988; 35(Suppl 7):35-8. [IDIS 246205] [PubMed 3065053]

88. Gunëren MF. Clinical experience with intramuscular sulbactam/ampicillin in the outpatient treatment of various infections: a multicentre trial. Drugs. 1988; 35(Suppl 7):57-68.

89. Castellano MA. Sulbactam/ampicillin in the treatment of lower respiratory infections. Drugs. 1988; 35(Suppl 7):53-6. [IDIS 246208] [PubMed 3065054]

90. Löffler L, Bauernfeind A, Keyl W. Sulbactam/ampicillin versus cefotaxime as initial therapy in serious soft tissue, joint and bone infections. Drugs. 1988; 35(Suppl 7):46-52. [IDIS 246207] [PubMed 3265378]

91. Hemsell DL, Heard MC, Hemsell PG et al. Sulbactam/ampicillin versus cefoxitin for uncomplicated and complicated acute pelvic inflammatory disease. Drugs. 1988; 35(Suppl 7):39-42. [IDIS 246206] [PubMed 3220008]

92. Roerig. Unasyn IM/IV (ampicillin sodium/sulbactam sodium) formulary review. New York, NY; 1987 Sep.

93. Urban C, Go E, Mariano N et al. Effect of sulbactam on infections caused by imipenem-resistant Acinetobacter calcoaceticus biotype anitratus. J Infect Dis. 1993; 167:448-51. [IDIS 308743] [PubMed 8421178]

94. Kim JH, Choi KH, Kim YT et al. Treatment of infections due to multiresistant Neisseria gonorrhoeae with sulbactam/ampicillin. Rev Infect Dis. 1986; 8(Suppl 5):S599-602. [IDIS 230982] [PubMed 3026010]

95. Houang ET, Reardon P. Single-dose intramuscular sulbactam and ampicillin in treating acute uncomplicated gonorrhoea. Genitourin Med. 1985; 61:209-13. [PubMed 2989156]

96. ASHP Commission on Therapeutics. ASHP therapeutic guidelines on antimicrobial prophylaxis in surgery. Clin Pharm. 1992; 11:483-513. [IDIS 296734] [PubMed 1600684]

97. Anon. Antimicrobial prophylaxis in surgery. Med Lett Drugs Ther. 1997; 41:75-9.

98. Edwards GF, Lindsay G, Taylor EW. A bacteriologic assessment of ampicillin with sulbactam as antibiotic prophylaxis in patients undergoing biliary tract operations. The West of Scotland Surgical Infection Study Group. J Hosp Infect. 1990; 16:249-55. [PubMed 1979575]

99. Wittmann DH, Koltowski O, Oleszkiewicz J et al. Infectious complications after 809 biliary tract operations and results of a prospective randomized single-blind study comparing cefoxitin versus ampicillin plus an inhibitor of β-lactamases. Infection. 1990; 18:41-7. [PubMed 2179137]

100. Wells GR, Taylor EW, Lindsay G et al. Relationship between bile colonization, high-risk factors and postoperative sepsis in patients undergoing biliary tract operations while receiving a prophylactic antibiotic. The West of Scotland Surgical Infection Study Group. Br J Surg. 1989; 76:374-7. [PubMed 2497926]

101. Reviewers’ comments (personal observations).

102. Pfizer Inc, New York, NY: Personal communication.

103. Johnson S, Gerding DN. Clostridium difficile-associated diarrhea. Clin Infect Dis. 1998; 26:1027-36. [IDIS 407733] [PubMed 9597221]

104. Gerding DN, Johnson S, Peterson LR et al for the Society for Healthcare Epidemiology of American. Position paper on Clostridium difficile-associated diarrhea and colitis. Infect Control Hosp Epidemiol. 1995; 16:459-77. [PubMed 7594392]

105. Fekety R for the American College of Gastroenterology Practice Parameters Committee. Guidelines for the diagnosis and management of Clostridium difficile-associated diarrhea and colitis. Am J Gastroenterol. 1997; 92:739-50 (IDIS 386628) [IDIS 386628] [PubMed 9149180]

106. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile-associated disease. Am J Health-Syst Pharm. 1998; 55:1407-11. [IDIS 407213] [PubMed 9659970]

107. Wilcox MH. Treatment of Clostridium difficile infection. J Antimicrob Chemother. 1998; 41(Suppl C):41-6. [IDIS 407246] [PubMed 9630373]

108. Foulds G, Miller RD, Knirsch AK et al. Sulbactam kinetics and excretion into breast milk in postpartum women. Clin Pharmacol Ther. 1985; 38:692-6. [IDIS 208991] [PubMed 2998677]

109. Lederle. Methotrexate sodium tablets, methotrexate sodium for injection, methotrexate LPF sodium injection, and methotrexate sodium injection prescribing information. Pearl River, NY; 2001 Aug 28.

Hide
(web3)