Doribax

Generic Name: Doripenem
Class: Carbapenems
Chemical Name: (4R,5S,6S)-3-[((3S,5S)-5-[[(aminosulfonyl)amino] methyl]-3-pyrrolidinyl)thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo [3.2.0]hept-2-ene-2-carboxylic acid monohydrate.
Molecular Formula: C15H24N4O6S2
CAS Number: 148016-81-3

Introduction

Antibacterial; carbapenem β-lactam antibiotic.1 3

Uses for Doribax

Intra-abdominal Infections

Treatment of complicated intra-abdominal infections caused by susceptible Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. caccae, B. thetaiotaomicron, B. uniformis, B. vulgatus, Streptococcus intermedius, S. constellatus, or Peptostreptococcus micros.1 2 10

For initial empiric treatment of high-risk or severe community-acquired, extrabiliary, complicated intra-abdominal infections in adults, IDSA recommends either monotherapy with a carbapenem (doripenem, imipenem, meropenem) or the fixed combination of piperacillin and tazobactam, or a combination regimen that includes either a cephalosporin (cefepime, ceftazidime) or fluoroquinolone (ciprofloxacin, levofloxacin) in conjunction with metronidazole.39

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For empiric treatment of healthcare-associated complicated intra-abdominal infections in adults, IDSA recommends monotherapy with a carbapenem (doripenem, imipenem, meropenem) or the fixed combination of piperacillin and tazobactam, or a combination regimen that includes a cephalosporin (cefepime, ceftazidime) in conjunction with metronidazole.39

Consult current IDSA clinical practice guidelines at for additional information regarding management of intra-abdominal infections.39

Urinary Tract Infections

Treatment of complicated urinary tract infections (including pyelonephritis) caused by susceptible E. coli (including cases with concurrent bacteremia) or susceptible K. pneumoniae, Proteus mirabilis, Ps. aeruginosa, or Acinetobacter baumannii.1 10 27

Respiratory Tract Infections

Has been used for treatment of nosocomial pneumonia, including ventilator-associated pneumonia (VAP).13 14 28 29 However, not labeled by FDA for treatment of any type of pneumonia, including VAP.1 In addition, when used for treatment of VAP in clinical trial, lower cure rates and higher 28-day all-cause mortality reported with doripenem than with comparator drug (imipenem).1 28 29 (See Increased Mortality in Patients with Ventilator-associated Pneumonia under Cautions.)

Has been used for treatment of bronchopulmonary infections in patients with cystic fibrosis who are colonized with Ps. aeruginosa or Burkholderia cepacia (designated an orphan drug by FDA for this use).16

Doribax Dosage and Administration

Administration

Administer by IV infusion.1

Do not administer via inhalation.1 (See Pneumonitis under Cautions.)

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

IV Administration

Reconstitution

Use strict aseptic technique since drug product contains no preservative.1

Reconstitute vial containing 250 or 500 mg of doripenem with 10 mL of sterile water for injection or 0.9% sodium chloride injection; shake gently to provide a suspension containing 25 or 50 mg/mL, respectively.1

Reconstituted suspension is not for direct injection; must be further diluted in ≤1 hour following reconstitution.1 (See Storage under Stability.)

Dilution

For a 500-mg dose, withdraw contents of a reconstituted 500-mg vial with a 21-gauge needle and add it to an infusion bag containing 100 mL of 0.9% sodium chloride injection or 5% dextrose for injection; gently shake until clear.1 Final solution contains 500 mg (approximately 4.5 mg/mL).1

For a 250-mg dose, withdraw contents of a reconstituted 250-mg vial with a 21-gauge needle and add it to an infusion bag containing either 50 or 100 mL of 0.9% sodium chloride injection or 5% dextrose injection; gently shake until clear.1 Final solution contains 250 mg (approximately 4.2 or 2.3 mg/mL in 50- or 100-mL infusion bag, respectively).1

Alternatively, for a 250-mg dose, withdraw contents of a reconstituted 500-mg vial with a 21-gauge needle and add it to an infusion bag containing 100 mL of 0.9% sodium chloride injection or 5% dextrose for injection; gently shake until clear.1 Remove and discard 55 mL of the solution from the bag; remaining solution contains 250 mg (approximately 4.5 mg/mL).1

Alternatively, to prepare doripenem solutions for IV infusion in Baxter Minibag Plus infusion bags, consult instructions provided by infusion bag manufacturer.1

Rate of Administration

Administer by IV infusion over 1 hour.1

Dosage

Available as doripenem monohydrate; dosage expressed in terms of doripenem.1

Adults

Intra-abdominal Infections
IV

500 mg every 8 hours.1

Manufacturer states usual duration is 5–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days if clinical improvement demonstrated.1

IDSA recommends treatment duration of 4–7 days;39 longer treatment duration not associated with improved outcome and not recommended unless adequate source control difficult to achieve.39

Urinary Tract Infections
IV

500 mg every 8 hours.1

Manufacturer states usual duration is 10 days but may be extended up to 14 days for patients with concurrent bacteremia; treatment may be switched to an appropriate oral anti-infective after ≥3 days if clinical improvement demonstrated.1

Special Populations

Hepatic Impairment

No specific dosage recommendations.1

Renal Impairment

Dosage adjustments recommended in patients with Clcr ≤50 mL/minute.1

Dosage for Adults with Renal Impairment1

Clcr (mL/minute)

Daily Dosage

30–50

250 mg every 8 hours

11–29

250 mg every 12 hours

Insufficient data to recommend dosage adjustments in patients undergoing hemodialysis.1

Geriatric Patients

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

Cautions for Doribax

Contraindications

  • Known hypersensitivity to doripenem or other carbapenems.1

  • History of anaphylactic reaction to β-lactams.1

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity reactions (e.g., anaphylaxis) and serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) reported.1

If hypersensitivity occurs, discontinue and initiate appropriate emergency treatment as clinically indicated.1

Cross-hypersensitivity

Cross-allergenicity occurs among β-lactam antibiotics, including penicillins, cephalosporins, and other β-lactams.1

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to doripenem, cephalosporins, penicillins, or other drugs.1 Use with caution in patients allergic to penicillin or other β-lactams; contraindicated in those with history of anaphylactic reaction to β-lactams.1 (See Contraindications under Cautions.)

Increased Mortality in Patients with Ventilator-associated Pneumonia

In a clinical trial in patients with VAP, 28-day all-cause mortality in intent-to-treat population was higher in patients receiving doripenem (23%) than in those receiving imipenem (16.7%).1 28 29 In addition, clinical cure rate was lower in patients receiving doripenem (46%) than in those receiving imipenem (57%).1 28 29

Not labeled by FDA for treatment of any type of pneumonia, including VAP.1 29 Consider whether benefits of doripenem are likely to exceed potential risks in patients who develop pneumonia while on ventilators.29

CNS Effects

Seizures reported.1 In clinical trials, certain patients appeared to be at greater risk for seizures, including those with preexisting CNS disorders (e.g., stroke, history of seizures), patients with compromised renal function, and patients receiving doripenem dosages >500 mg every 8 hours.1

Seizures and other CNS effects (e.g., confusional states, myoclonic activity) also reported with other carbapenems (e.g., ertapenem, imipenem, meropenem), especially in those with underlying CNS disorders (e.g., brain lesions, history of seizures) and/or compromised renal function.8 10 24 25 26 Data from rodent studies suggest doripenem has less potential for convulsant activity than some other carbapenems (e.g., imipenem).8

Interactions

Patients with seizure disorders being controlled with valproic acid or valproate sodium are at increased risk of breakthrough seizures if doripenem used concomitantly.1 Serum valproic acid concentrations may decrease below therapeutic range (50–100 mcg/mL) by 12 hours after initiation of doripenem.1 Similar interactions reported when valproic acid used concomitantly with other carbapenems;1 some reports indicate that increasing dosage of valproic acid or valproate sodium does not result in higher serum valproic acid concentrations.1

Consider alternative antibacterial therapy in patients receiving valproic acid or valproate sodium.1 If use of doripenem is necessary, consider alternative or supplemental anticonvulsant therapy.1 (See Specific Drugs under Interactions.)

Pneumonitis

Pneumonitis reported following administration by inhalation;1 do not administer by inhalation.1

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.1 Monitor carefully, institute appropriate therapy if superinfection occurs.1

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 20 21 22 C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including doripenem, and may range in severity from mild diarrhea to fatal colitis.1 20 21 22 C. difficile produces toxins A and B which contribute to development of CDAD;1 20 hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.1

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 20 21 22 Obtain careful medical history since CDAD may occur as late as ≥2 months after anti-infective therapy is discontinued.1

If CDAD suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.1 20 Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.1 20 21 22

Selection and Use of Anti-infectives

Use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1

Use results of culture and in vitro susceptibility testing.1 If such data are unavailable, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1

Specific Populations

Pregnancy

Category B.1

Lactation

Not known if doripenem is distributed into milk.1 Use with caution.1

Pediatric Use

Safety and efficacy not established in patients <18 years of age.1

Geriatric Use

No substantial differences in safety relative to younger adults, but increased sensitivity cannot be ruled out.1

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

Hepatic Impairment

Pharmacokinetics not established; hepatic impairment not expected to affect pharmacokinetics.1

Renal Impairment

Increased AUC.1 Dosage adjustments and renal function monitoring recommended in patients with moderate or severe renal impairment (Clcr ≤50 mL/minute).1 (See Special Populations under Dosage and Administration.)

Risk of adverse reactions may be greater in patients with impaired renal function.1

Common Adverse Effects

Anemia, diarrhea, headache, nausea, phlebitis, rash, elevated hepatic enzymes.1

Interactions for Doribax

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Does not inhibit CYP isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, or 4A11.1 Not expected to induce CYP1A2, 2B6, 2C9, 2C19, or 3A4/5.1 Pharmacokinetic interactions unlikely with drugs metabolized by these isoenzymes.1

Drugs Metabolized by Uridine Diphosphate-glucuronosyltransferase (UGT) 1A1

Not expected to induce UGT 1A1;1 pharmacokinetic interactions unlikely with drugs metabolized by this enzyme.1

Specific Drugs

Drug

Interaction

Comments

Anti-infective agents (e.g., amikacin, co-trimoxazole, daptomycin, levofloxacin, linezolid, vancomycin)

Minimal potential to antagonize or be antagonized by other anti-infectives1 10

Probenecid

Decreased renal tubular secretion of doripenem; increased doripenem concentrations, AUC, and prolonged half-life1

Concomitant use not recommended1

Valproic acid or valproate sodium

Valproic acid concentrations may decrease to subtherapeutic levels by 12 hours after initiation of doripenem; increased risk of breakthrough seizures1

No effect on doripenem pharmacokinetics1

Consider alternative anti-infective; if use of doripenem necessary, consider alternative or supplemental anticonvulsant therapy1

Doribax Pharmacokinetics

Distribution

Extent

Distributed into intra-abdominal tissues and fluids (e.g., retroperitoneal fluid,1 peritoneal exudate,1 11 bile,1 gallbladder tissue,1 urine).1

Not known if distributed into milk.1

Plasma Protein Binding

Approximately 8.1%.1

Elimination

Metabolism

Partially metabolized to an inactive ring-opened metabolite (doripenem M1) principally via dehydropeptidase-I.1

Not metabolized by CYP isoenzymes.1

Elimination Route

Excreted principally in urine as unchanged drug (70%).1

Half-life

Approximately 1 hour.1

Special Populations

Pharmacokinetics in patients with hepatic impairment not established.1

Removed by hemodialysis.1

AUC increased in patients with renal impairment.1

Stability

Storage

Parenteral

Powder for Injection, for IV Infusion

25°C (may be exposed to 15–30°C).1

Reconstituted suspension containing 25 or 50 mg/mL in sterile water for injection or 0.9% sodium chloride injection: Stable in original vial for ≤1 hour; do not freeze.1

Diluted IV solutions prepared using reconstituted suspension and 0.9% sodium chloride injection: Stable for 12 hours at room temperature or 72 hours at 2–8°C (including infusion time); do not freeze.1

Diluted IV solutions prepared using reconstituted suspension and 5% dextrose for injection: Stable for 4 hours at room temperature or 24 hours at 2–8°C (including infusion time); do not freeze.1

Compatibility

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

Parenteral

Solution CompatibilityHID

Compatible

Dextrose 5% in water

Sodium chloride 0.9%

Drug CompatibilityHID
Y-site Compatibility

Compatible

Acyclovir sodium

Amikacin sulfate

Aminophylline

Amiodarone HCl

Anidulafungin

Atropine sulfate

Azithromycin

Bumetanide

Calcium gluconate

Carboplatin

Caspofungin acetate

Ceftaroline fosamil

Ciprofloxacin

Cisplatin

Cyclophosphamide

Cyclosporine

Daptomycin

Dexamethasone sodium phosphate

Digoxin

Diltiazem HCl

Diphenhydramine HCl

Dobutamine HCl

Docetaxel

Dopamine HCl

Doxorubicin HCl

Enalaprilat

Esmolol HCl

Esomeprazole sodium

Etoposide phosphate

Famotidine

Fentanyl citrate

Fluconazole

Fluorouracil

Foscarnet sodium

Furosemide

Gemcitabine HCl

Granisetron HCl

Heparin sodium

Hydrocortisone sodium succinate

Hydromorphone HCl

Ifosfamide

Insulin, regular

Labetalol HCl

Levofloxacin

Linezolid

Lorazepam

Magnesium sulfate

Mannitol

Meperidine HCl

Methotrexate sodium

Methylprednisolone sodium succinate

Metoclopramide HCl

Metronidazole

Micafungin sodium

Midazolam HCl

Milrinone lactate

Morphine sulfate

Moxifloxacin HCl

Norepinephrine bitartrate

Ondansetron HCl

Paclitaxel

Pantoprazole sodium

Phenobarbital sodium

Phenylephrine HCl

Potassium chloride

Ranitidine HCl

Sodium bicarbonate

Sodium phosphates

Tacrolimus

Telavancin HCl

Tigecycline

Tobramycin sulfate

Vancomycin HCl

Voriconazole

Zidovudine

Incompatible

Diazepam

Potassium phosphates

Propofol

Variable

Amphotericin B

Amphotericin B cholesteryl sulfate complex

Amphotericin B lipid complex

Amphotericin B liposomal

Actions and Spectrum

  • Synthetic carbapenem β-lactam antibiotic; structurally and pharmacologically related to other carbapenems (ertapenem, imipenem, meropenem).1 3

  • Bactericidal in action.1

  • Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.1 3 10

  • Spectrum of activity includes many aerobic and anaerobic gram-positive and gram-negative bacteria.1 3 4 5 10

  • Reported as more active than some other carbapenems against Enterobacteriaceae and Ps. aeruginosa.2 3 4 9 10 12 18

  • Gram-positive aerobes: Active in vitro and in clinical infections against Streptococcus intermedius1 and S. constellatus.1 Also active in vitro against Staphylococcus aureus (including oxacillin-susceptible [methicillin-susceptible] strains),1 4 S. epidermidis,4 S. agalactiae (group B streptococci),1 4 and S. pyogenes (group A β-hemolytic streptococci).1 Oxacillin-resistant (methicillin-resistant) staphylococci are resistant.1

  • Gram-negative aerobes: Active in vitro and in clinical infections against E. coli,1 4 Klebsiella pneumoniae,1 4 Proteus mirabilis,1 4 Ps. aeruginosa,1 4 and Acinetobacter baumannii.1 Also active in vitro against Citrobacter freundii,1 Enterobacter cloacae,1 4 E. aerogenes,1 4 K. oxytoca,1 4 Morganella morganii,1 and Serratia marcescens1 and some strains of Burkholderia cepacia.17 18

  • Anaerobes: Active in vitro and in clinical infections against Bacteroides fragilis,1 4 5 B. caccae,1 4 B. thetaiotaomicron,1 4 5 B. uniformis,1 4 B. vulgatus,1 4 and Peptostreptococcus micros.1 4 5

  • Cross-resistance may occur with other carbapenems; however, some isolates (e.g., some strains of Ps. aeruginosa) resistant to other carbapenems may be susceptible to doripenem.1 4

Advice to Patients

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

  • Importance of completing full course of therapy, 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 doripenem or other antibacterials in the future.1

  • Importance of informing clinicians of any previous hypersensitivity reactions to doripenem, other carbapenems, β-lactams, or other allergens.1

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

  • Importance of informing clinicians of existing CNS disorders (e.g., stroke, history of seizures) or treatment with valproic acid or valproate sodium.1

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

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

  • Importance of informing 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.

Doripenem (Monohydrate)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for IV infusion

250 mg (of doripenem)

Doribax

Shionogi

500 mg (of doripenem)

Doribax

Shionogi

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 3, 2014. 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. Shionogi, Inc. Doribax (doripenem for injection) prescribing information. Florham Park, NJ; 2014 Jan.

2. Lucasti C, Jasovich A, Umeh O et al. Efficacy and tolerability of IV doripenem versus meropenem in adults with complicated intra-abdominal infection: a phase III, prospective, multicenter, randomized, double-blind, noninferiority study. Clin Ther. 2008; 30:868-83. [PubMed 18555934]

3. Zhanel GG, Wiebe R, Dilay L et al. Comparative review of the carbapenems. Drugs. 2007; 67:1027-52. [PubMed 17488146]

4. Goldstein EJ, Citron DM, Merriam CV et al. In vitro activities of doripenem and six comparator drugs against 423 aerobic and anaerobic bacterial isolates from infected diabetic foot wounds. Antimicrob Agents Chemother. 2008; 52:761-6. [PubMed 18070958]

5. Wexler HM, Engel AE, Glass D et al. In vitro activities of doripenem and comparator agents against 364 anaerobic clinical isolates. Antimicrob Agents Chemother. 2005; 49:4413-7. [PubMed 16189137]

8. Horiuchi M, Kimura M, Tokumura M et al. Absence of convulsive liability of doripenem, a new carbapenem antibiotic, in comparison with beta-lactam antibiotics. Toxicology. 2006; 222:114-24. [PubMed 16549226]

9. Hagerman JK, Knechtel SA, Klepser ME. Doripenem: a new extended-spectrum carbapenem antibiotic. Formulary. 2007; 42:676-88.

10. Nicolau DP. Carbapenems: a potent class of antibiotics. Expert Opin Pharmacother. 2008; 9:23-37. [PubMed 18076336]

11. Ikawa K, Morikawa N, Urakawa N et al. Peritoneal penetration of doripenem after intravenous administration in abdominal-surgery patients. J Antimicrob Chemother. 2007; 60:1395-7. [PubMed 17884833]

12. Mesaros N, Nordmann P, Plésiat P et al. Pseudomonas aeruginosa: resistance and therapeutic options at the turn of the new millennium. Clin Microbiol Infect. 2007; 13:560-78. [PubMed 17266725]

13. Réa-Neto A, Niederman M, Lobo SM et al. Efficacy and safety of doripenem versus piperacillin/tazobactam in nosocomial pneumonia: a randomized, open-label, multicenter study. Curr Med Res Opin. 2008; 24:2113-26. [PubMed 18549664]

14. Chastre J, Wunderink R, Prokocimer P et al. Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilator-associated pneumonia: a multicenter, randomized study. Crit Care Med. 2008; 36:1089-96. [PubMed 18379232]

15. Davies TA, Shang W, Bush K et al. Affinity of doripenem and comparators to penicillin-binding proteins in Escherichia coli and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2008; 52:1510-2. [PubMed 18250190]

16. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; 2004 July. From FDA web site. Accessed August 2008.

17. Chen Y, Garber E, Zhao Q et al. In vitro activity of doripenem (S-4661) against multidrug-resistant gram-negative bacilli isolated from patients with cystic fibrosis. Antimicrob Agents Chemother. 2005; 49:2510-1. [PubMed 15917558]

18. Traczewski MM, Brown SD. In vitro activity of doripenem against Pseudomonas aeruginosa and Burkholderia cepacia isolates from both cystic fibrosis and non-cystic fibrosis patients. Antimicrob Agents Chemother. 2006; 50:819-21. [PubMed 16436756]

20. Cohen SH, Gerding DN, Johnson S et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010; 31:431-55. [PubMed 20307191]

21. 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] [PubMed 9149180]

22. 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]

24. Merck & Co., Inc. Invanz (ertapenem) for injection prescribing information. Whitehouse Station, NJ; 2008 Feb.

25. Merck & Co., Inc. Primaxin I.V. (imipenem and cilastatin) for injection prescribing information. Whitehouse Station, NJ; 2007 Dec.

26. AstraZeneca. Merrem I.V. (meropenem) for injection for intravenous use only prescribing information. Wilmington, DE; 2008 Mar.

27. Naber KG, Llorens L, Kaniga K et al. Intravenous doripenem at 500 milligrams versus levofloxacin at 250 milligrams, with an option to switch to oral therapy, for treatment of complicated lower urinary tract infection and pyelonephritis. Antimicrob Agents Chemother. 2009; 53:3782-92. [PubMed 19581455]

28. Kollef MH, Chastre J, Clavel M et al. A randomized trial of 7-day doripenem versus 10-day imipenem-cilastatin for ventilator-associated pneumonia. Crit Care. 2012; 16:R218. [PubMed 23148736]

29. US Food and Drug Administration. FDA drug safety communication: FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pnumonia. 2014 Mar 6. From FDA website.

39. Solomkin JS, Mazuski JE, Bradley JS et al. Diagnosis and management of complicated intra-abdominal infection in adults and children: guidelines by the Surgical Infection Society and the Infectious Diseases Society of America. Clin Infect Dis. 2010; 50:133-64. [PubMed 20034345]

HID. Trissel LA. Handbook on injectable drugs. 17th ed. Bethesda, MD: American Society of Health-Systems Pharmacists; 2013:407-11.

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