Safety and Dosing

Rates of adverse effects similar to comparators in pivotal clinical trials

  • The most common adverse reactions reported in clinical trials ( >5%) were headache, nausea, diarrhea, rash, and phlebitis
    • During clinical trials, adverse reactions that led to discontinuation of DORIBAX® were
      nausea (0.2%), vulvomycotic infection (0.1%), and rash (0.1%)

Please click here for additional Important Safety Information.


Dosing and administration

  • Recommended dosing in patients >18 years of age: 500 mg administered every 8 h by IV infusion over 1 h

Dosing by infection in patients with normal renal function

 
Infection Dosage Frequency Infusion
time (hr)		 Duration
Complicated IAI 500 mg q8h 1 5-14 days*
Complicated UTI,
including
pyelonephritis		 500 mg q8h 1 10 days*†
 

  • * Duration includes a possible switch to an appropriate oral therapy, after at least 3 days of parenteral therapy,
    once clinical improvement has been demonstrated.
  • † Duration can be extended up to 14 days for patients with concurrent bacteremia.

Dosing in patients with impaired renal function (all indications)

 
Creatinine Clearance Dosage Frequency Infusion time (h)
>50 mL/min No dosage adjustment necessary
>30 to <50 mL/min 250 mg q8h 1
>10 to <30 mL/min 250 mg q12h 1
 

Dosing in patients with impaired renal function

  • Unlike Primaxin®‡ (imipenem/cilastatin sodium), body weight does not influence the dosing of DORIBAX®1

 
Required dosing considerations DORIBAX® Primaxin®
Creatinine clearance
Body weight  
 

‡ Primaxin is a registered trademark of Merck & Co., Inc.


DORIBAX® provides a favorable stability profile following reconstitution1,2


Storage of infusion solutions prepared in normal saline or 5% dextrose

 
  Diluent Stability time (h)
Room temperature 2°-8°C (refrigeration)
DORIBAX®§ Normal saline 8 24
Imipenem2 Normal saline 4 24
Meropenemll3 Normal saline 4 24
DORIBAX®§ 5% dextrose 4 24
Imipenem2 5% dextrose 4 24
Meropenemll3 5% dextrose 1 4
 
  • § Following dilution of the suspension with normal saline or 5% dextrose, DORIBAX® infusions stored at controlled room
    temperature or under refrigeration should be completed according to the times in the above table.
  • ll In plastic IV bags.
  • In normal saline, DORIBAX® has longer stability vs imipenem and meropenem at room temperature
  • In 5% dextrose, DORIBAX® has longer stability vs meropenem at room temperature and refrigeration
  • Longer stability can result in less product waste, which may reduce institutional costs


DORIBAX®
DOSING CARD
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