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Uses

Urinary Tract Infections (UTIs)

Treatment of acute or chronic infections of the upper and lower urinary tract or for asymptomatic bacteriuria caused by susceptible enterococci, Enterobacter, Escherichia coli, Morganella morganii, Proteus mirabilis, P. vulgaris, Providencia rettgeri, Pseudomonas, or enterococci.

Not a drug of choice for these UTIs. Because only low carbenicillin concentrations are attained in urine and renal parenchyma in patients with severe renal impairment, the drug may be ineffective for treatment of UTIs in patients with Cl_cr <10 mL/minute.

Prostatitis

Treatment of acute or chronic prostatitis caused by susceptible Enterobacter, E. coli, P. mirabilis, or enterococci.

Perioperative Prophylaxis

Has been used for perioperative prophylaxis in patients undergoing transrectal biopsy of the prostate†; not a drug of choice for such prophylaxis.

Dosage and Administration

Administration

Oral Administration

Administer orally.

Dosage

Available as carbenicillin indanyl sodium; dosage expressed in terms of carbenicillin.

Adults

Urinary Tract Infections (UTIs)

UTIs Caused by Enterobacter, E. coli, or Proteus

Oral

382–764 mg 4 times daily. Usual duration is ≥10 days; prolonged therapy may be required for chronic UTIs.

UTIs Caused by Pseudomonas or Enterococcus

Oral

764 mg 4 times daily. Usual duration is ≥10 days; prolonged therapy may be required for chronic UTIs.

Prostatitis

Oral

764 mg 4 times daily. Usual duration is ≥2–4 weeks.

Special Populations

Dosage in Renal Impairment

Dosage may need to be decreased in patients with Cl_cr 10–20 mL/minute. Should not be used in those with Cl_cr <10 mL/minute.

Geriatric Patients

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

Cautions

Contraindications

• Known hypersensitivity to any penicillin.

Warnings/Precautions

Warnings

Superinfection

Possible emergence and overgrowth of nonsusceptible bacteria or fungi. Discontinue and institute appropriate therapy if superinfection occurs.

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity reactions (including anaphylaxis) reported with penicillins. Anaphylaxis occurs most frequently with parenteral penicillins but has occurred with oral 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 hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).

General Precautions

Laboratory Monitoring

Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during prolonged therapy.

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of carbenicillin 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.

Coombs' Test Results

Positive direct Coombs’ test results reported with carbenicillin. This may interfere with certain hematologic studies or transfusion cross-matching procedures.

Sodium Content

Each tablet of carbenicillin indanyl sodium containing 382 mg of carbenicillin contains 23 mg of sodium.

Specific Populations

Pregnancy

Category B.

Lactation

Distributed into milk. Use with caution.

Pediatric Use

Safety and efficacy not established in pediatric patients.

A high incidence of nausea, vomiting, and diarrhea reported when the drug was used in children†.

Hepatic Impairment

Serum concentrations of extended-spectrum penicillins may be increased and half-life prolonged in patients with hepatic impairment.

Renal Impairment

Dosage adjustment may be necessary in patients with Cl_cr 10–20 mL/minute to prevent accumulation of the drug.

Should not be used in patients with severe renal impairment (i.e., Cl_cr <10 mL/minute) since these patients will not achieve therapeutic concentrations in urine.

Common Adverse Effects

GI effects, including dose-related nausea, vomiting, diarrhea, abdominal cramps, and flatulence. Unpleasant aftertaste and smell.