Dilution Doripenem - DORIBAX™

Doripenem - DORIBAX™

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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.