Cautions
Contraindications
Warnings/Precautions
Warnings
Superinfection/Clostridium difficile-associated Colitis
Possible emergence and overgrowth of nonsusceptible bacteria or fungi. Discontinue and institute appropriate therapy if superinfection occurs.
Treatment with anti-infectives may permit overgrowth of clostridia. Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.
Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone. 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.
Sensitivity Reactions
Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, reported with penicillins.
Prior to initiation of therapy, make careful inquiry regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other drugs. Partial cross-allergenicity occurs among penicillins and other β-lactam antibiotics including cephalosporins and cephamycins.
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).
General Precautions
Selection and Use of Anti-infectives
To reduce development of drug-resistant bacteria and maintain effectiveness of ampicillin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.
When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.
Mononucleosis
Possible increased risk of rash in patients with mononucleosis; use in these patients not recommended.
Ampicillin-resistant Haemophilus influenzae
Because of increasing prevalence of ampicillin-resistant H. influenzae, the drug should not be used alone for empiric treatment of serious infections (e.g., meningitis, pneumonia) when H. influenzae may be involved.
Laboratory Monitoring
Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during prolonged therapy.
Sodium Content
Powder for injection contains 2.9 mEq of sodium per g of ampicillin.
Specific Populations
Pregnancy
Category B.
Lactation
Distributed into milk. Use with caution.
Pediatric Use
Renal clearance of ampicillin may be delayed in neonates and young infants because of incompletely developed renal function. Use lowest effective dosage.
Renal Impairment
Dosage adjustments necessary in renal impairment. (See Renal Impairment under Dosage and Administration.)
Common Adverse Effects
GI effects (diarrhea, nausea), rash.
Drug Interactions
Specific Drugs and Laboratory Tests
| Drug or Test |
Interaction |
Comments |
| Allopurinol |
Possible increased incidence of rash |
Unclear whether potentiation of rash is caused by allopurinol or hyperuricemia present in these patients
Clinical importance has not been determined; some clinicians suggest that concomitant use of the drugs should be avoided if possible |
| Aminoglycosides |
In vitro evidence of synergistic antibacterial effects against enterococci; used to therapeutic advantage in treatment of endocarditis and other severe enterococcal infections
Potential in vitro and in vivo inactivation of aminoglycosides |
|
| Chloramphenicol |
In vitro evidence of antagonism |
Clinical importance unclear |
| Hormonal contraceptives |
Possible decreased efficacy of estrogen-containing oral contraceptives and increased incidence of breakthrough bleeding |
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 ampicillin |
| Methotrexate |
Possible decreased renal clearance of methotrexate with penicillins; possible increased methotrexate concentrations and hematologic and GI toxicity |
Monitor closely if used concomitantly |
| Probenecid |
Decreased renal tubular secretion of ampicillin; increased and prolonged ampicillin concentrations may occur |
|
| Sulbactam |
Synergistic bactericidal effect against many strains of β-lactamase-producing bacteria |
|
| Sulfonamides |
In vitro evidence of antagonism |
Clinical importance unclear |
| Tests for glucose |
Possible false-positive reactions in urine glucose tests using Clinitest®, Benedict’s solution, or Fehling’s solution |
Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix®, Tes-Tape®) |
| Tests for uric acid |
Possible falsely increased serum uric acid concentrations when copper-chelate method is used; phosphotungstate and uricase methods appear to be unaffected by the ampicillin |
|