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 |
8 hours |
24 hours |
| D5W |
4 hours |
24 hours |
Source: Ortho-McNeil Pharmaceutical,
Inc.
(Manufactured by:Shionogi & Co.
Ltd).
Doripenem (DORIBAX™)
[package insert].
Raritan, NJ 08869; 2007.
|
