DORIBAX SUMMARY
DORIBAX®, doripenem monohydrate for injection vials contain 500 mg of doripenem on an anhydrous basis, a white to slightly-yellowish off-white sterile crystalline powder. All references to doripenem activity are expressed in terms of the active doripenem moiety. The powder is constituted for intravenous infusion. The pH of the infusion solution is between 4.5 and 5.5.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORIBAX® and other antibacterial drugs, DORIBAX® should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Complicated Intra-Abdominal Infections
DORIBAX® (doripenem for injection) is indicated as a single agent for the treatment of complicated intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides caccae, Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Streptococcus intermedius, Streptococcus constellatus and Peptostreptococcus micros.
Complicated Urinary Tract Infections, Including Pyelonephritis
DORIBAX® (doripenem for injection) is indicated as a single agent for the treatment of complicated urinary tract infections, including pyelonephritis caused by Escherichia coli including cases with concurrent bacteremia, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Acinetobacter baumannii.
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NEWS HIGHLIGHTS
Published Studies Related to Doribax (Doripenem)
Influence of continuous venovenous hemofiltration and continuous venovenous hemodiafiltration on the disposition of doripenem. [2011.03]
The pharmacokinetics, safety, and tolerability of a single 1-hour, 500-mg intravenous infusion of doripenem were assessed in dialysis-dependent subjects with stage 5 chronic kidney disease undergoing continuous renal replacement therapy (CRRT) via 12-hour continuous venovenous hemofiltration (CVVH) (n = 6) or continuous venovenous hemodiafiltration (CVVHDF) (n = 5)...
Safety and efficacy of intravenous doripenem for the treatment of complicated urinary tract infections and pyelonephritis. [2010.12]
Doripenem was evaluated in adults with complicated urinary tract infections and pyelonephritis in two phase 3 studies. DORI-05, a randomized, double-blind study compared doripenem 500 mg every 8 hours with levofloxacin 250 mg every 24 hours.coli infections were often due to infection with new strains.
Pharmacokinetics, safety, and tolerability of doripenem after 0.5-, 1-, and 4-hour infusions in healthy volunteers. [2009.07]
The pharmacokinetics, safety, and tolerability of doripenem in healthy subjects were evaluated in 2 studies. Study 1 was a double-blind, randomized, placebo-controlled dose-escalation study in which doripenem was administered for 7 days by infusion over 30 minutes (500 mg) or 1 hour (1000 mg)... All regimens of doripenem were safe and well tolerated.
Urinary bactericidal activity of Doripenem versus that of levofloxacin in patients with complicated urinary tract infections or pyelonephritis. [2009.04]
The aim of this study was to investigate the urinary bactericidal titers (UBTs) and 24-h area under the UBT-versus-time curve (AUBT) of intravenous doripenem (500 mg every 8 h [q8h]), a new carbapenem, versus those of intravenous levofloxacin (250 mg q24h) in patients with complicated urinary tract infections (cUTIs) or pyelonephritis...
Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilator-associated pneumonia: a multicenter, randomized study. [2008.04]
OBJECTIVE: Doripenem is an investigational carbapenem with broad-spectrum activity against gram-negative and gram-positive pathogens, including multidrug-resistant strains, commonly responsible for ventilator-associated pneumonia (VAP). This large, phase III study compared doripenem with imipenem for the treatment of ventilator-associated pneumonia... CONCLUSIONS: In this large, phase III study of patients with ventilator-associated pneumonia, a 4-hr intravenous infusion of doripenem was clinically efficacious and therapeutically noninferior to imipenem.
Clinical Trials Related to Doribax (Doripenem)
Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects [Completed]
This study is being performed to measure the amount of the antibiotic doripenem (study drug)
found in the fluid and cells of the lung and blood after receiving three doses of doripenem.
The major objectives of this research are to see how much and for how long doripenem gets
into the fluids and cells of the lungs of healthy adult subjects.
The Pharmacodynamics of Doripenem Between 4-hour and 1-hour Infusion in Patients With Ventilator-associated Pneumonia [Completed]
This is prospective and randomized study to assess the pharmacodynamics (t>MIC) of 0. 5 g
every 8 h of doripenem in patients with VAP following administration by a 4 h infusion or 1
h infusion.
Clinical and laboratory data such as Age,Sex, Body weight, Electrolyte, Vital signs, APACHE
II score, BUN, Cr, Blood culture will be collected.
Twelve patients will be enrolled in this study. After completion of the doripenem therapy
for 3 days in this study, all patients will receive other sensitive antibiotics to eradicate
their bacterial infections.
Doripenem pharmacokinetic study will be carried out during the doripenem therapy. Blood
samples (approximately 2 ml) in group " 0. 5 g of doripenem with 4 h infusion every 8 h
regimen" will be obtained by direct venepuncture at the following time: 0, 0. 5, 1, 2, 3, 4,
4. 5, 5, 6, 7 and 8 h after 7th dose of doripenem.
Blood samples (approximately 2 ml) in group " 0. 5 g of doripenem with 1 h infusion every 8 h
regimen" will be obtained by direct venepuncture at the following time: 1, 1. 5, 2, 4, 5, 6,
7 and 8 h after 7th dose of doripenem.
The doripenem assays by method of Ikeda K et al. (J Chromatogr B, 2008) will be performed.
Concentration of doripenem in plasma will be simulated in Monte Carlo technique (Computer
model) to get PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment)
and %CFR (Cumulative Faction Response)
A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections [Completed]
The purpose of this study is to assess the safety and efficacy of doripenem in participants
with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy;
pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal
(in belly) infections and complicated urinary tract infections (bladder infections).
A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections [Completed]
The purpose of this study is to assess the safety and effectiveness of doripenem treatment
among Filipino patients with nosocomial pneumonia, complicated intra-abdominal infections,
and complicated urinary tract infection.
To Compare Safety and Efficacy of Doripenem Versus Imipenem-Cilastatin in Patients With Ventilator-Associated Pneumonia [Terminated]
The purpose of this study is to show that doripenem is as effective as imipenem-cilastatin
in the treatment of patients with ventilator-associated pneumonia.
Reports of Suspected Doribax (Doripenem) Side Effects
Epilepsy (3),
Shock (3),
Death (2),
Cholecystitis (2),
Leukoencephalopathy (2),
Oxygen Saturation Decreased (2),
Chills (1),
OFF Label USE (1),
Glomerulonephritis (1),
Bronchospasm (1), more >>
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Page last updated: 2011-12-09
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