Doripenem - DORIBAX™
|
| The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. |
Usual Diluents
|
| NS, D5W |
Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
|
[ 500 mg ] [ 100 ml ] [ 1 hour ]
(Total volume: 110 ml)
[ 250 mg ] [ 50 ml ] [ 1 hour ]
(Total volume: 55 ml)
Reconstitute the 500 mg vial with 10 mL of sterile water or 0.9% NS. |
Stability / Miscellaneous
|
Stability data:
|
| Drug |
Stability
Refrigerated |
Stability
Room Temp. |
Reconstituted
Vial/Powder |
Notes |
| Doripenem |
Infusion prepared in || Stability time at 2–8°C (Refrigeration) (includes refrigerator storage and infusion time)
Normal saline - 72 hrs
5% Dextrose - 24 hours |
DORIBAX® should be stored at 25°C (77°F); excursions permitted to 15°–30°C (59° to 86°F)
Infusion prepared in | Stability Time at Room Temp. (includes room temperature storage and infusion time)
Normal saline - 12 hours
5% Dextrose - 4 hours |
Powder |
The compatibility of DORIBAX® with other drugs has not been established. DORIBAX® should not be mixed with or physically added to solutions containing other drugs.
Do not freeze. |
DOSAGE AND ADMINISTRATION:
500 mg every 8 hours by intravenous infusion administered over one hour for
patients ≥18 years of age.
Renal Dosing:
| CrCl (mL/min) |
Recommended Dose |
| >50 |
No dosage adjustment necessary |
| ≥ 30 to ≤ 50 |
250 mg IV (over 1 hour) every 8 hours |
| >10 to < 30 |
250 mg IV (over 1 hour) every 12 hours |
| Hemodialysis |
DORIBAX™ is hemodialyzable; however, there is insufficient information to make
dose adjustment recommendations in patients on hemodialysis |
PREPARATION:
DORIBAX does not contain a bacteriostatic preservative. Aseptic technique must be followed in preparation of the infusion solution.
Preparation of 500 mg dose: Constitute the vial with 10 mL of sterile water for injection or 0.9% sodium chloride injection (normal saline) and gently shake to form a suspension. The resultant concentration is 50 mg/mL. CAUTION: THE CONSTITUTED SUSPENSION IS NOT FOR DIRECT INJECTION. Withdraw the suspension using a syringe with a 21 gauge needle and add it to an infusion bag containing 100 mL of normal saline or 5% dextrose; gently shake until clear. The final infusion solution concentration is 4.5 mg/mL.
Preparation of 250 mg dose for patients with moderate or severe renal impairment: Constitute the vial with 10 mL of sterile water for injection or 0.9% sodium chloride injection (normal saline) and gently shake to form a suspension. The resultant concentration is 50 mg/mL. CAUTION: THE CONSTITUTED SUSPENSION IS NOT FOR DIRECT INJECTION. Withdraw the suspension using a syringe with a 21 gauge needle and add it to an infusion bag containing 100 mL of normal saline or 5% dextrose; gently shake until clear. Remove 55 mL of this solution from the bag and discard. Infuse the remaining solution, which contains 250 mg (4.5 mg/mL).
STABILITY:
Storage of Constituted Solutions
Upon constitution with sterile water for injection or 0.9% sodium chloride (normal
saline) injection, DORIBAX suspension in the vial may be held for 1-hour prior to
transfer and dilution in the infusion bag. 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 following table:
| Infusion prepared in: |
Stability at room temp |
Stability if refrigerated |
| Normal saline |
12 hours |
72 hours |
| D5W |
4 hours |
24 hours |
Source: Ortho-McNeil Pharmaceutical, Inc. (Manufactured by:Shionogi & Co. Ltd). Doripenem (DORIBAX™) [package insert]. Raritan, NJ 08869; 2007. |
