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Doribax

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Doribax

Indications
Dosage
How Supplied

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

Recommended Dosage

The recommended dosage of DORIBAX® is 500 mg administered every 8 hours by intravenous infusion over one hour in patients ≥ 18 years of age. The recommended dosage and administration by infection is described in Table 1:

Table 1: Dosage of DORIBAX® by Infection

Infection Dosage Frequency Infusion Time (hours) Duration
Complicated intra-abdominal infection 500 mg every 8 hours 1 5-14 days*
Complicated UTI, including pyelonephritis 500 mg every 8 hours 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.

Patients With Renal Impairment

Table 2: Dosage of DORIBAX® in Patients with Renal Impairment

Estimated CrCl (mL/min) Recommended Dosage Regimen of DORIBAX®
> 50 No dosage adjustment necessary
≥ 30 to ≤ 50 250 mg* administered intravenously (over 1 hour) every 8 hours
> 10 to < 30 250 mg* administered intravenously (over 1 hour) every 12 hours
* [see Preparation of 250 mg DORIBAX® dose using the 250 mg vial and Preparation of 250 mg DORIBAX® dose using the 500 mg vial]

The following formula may be used to estimate CrCl. The serum creatinine used in the formula should represent a steady state of renal function.

Males: (weight in kg) x (140 – age)
(72) x serum creatinine (mg/100 mL)
Females: (0.85) x (above value)

DORIBAX® is hemodialyzable; however, there is insufficient information to make dose adjustment recommendations in patients on hemodialysis.

Preparation Of Solutions

DORIBAX® does not contain a bacteriostatic preservative. Aseptic technique must be followed in preparation of the infusion solution.

To prepare DORIBAX® infusions in Baxter Minibag Plus™ infusion bags consult the infusion bag manufacturer's instructions.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit. DORIBAX® infusions range from clear, colorless solutions to solutions that are clear and slightly yellow. Variations in color within this range do not affect the potency of the product.

Preparation of 500 mg DORIBAX® dose using the 500 mg vial
  • Constitute the 500 mg 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 approximately 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 approximately 4.5 mg/mL.
Preparation of 250 mg DORIBAX® dose using the 250 mg vial
  • Constitute the 250 mg 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 approximately 25 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 either 50 or 100 mL of normal saline or 5% dextrose; gently shake until clear. The final infusion solution concentration is approximately 4.2 mg/mL (50 mL infusion bag) or approximately 2.3 mg/mL (100 mL infusion bag).
Preparation of 250 mg DORIBAX® dose using the 500 mg vial
  • Constitute the 500 mg 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 approximately 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 (approximately 4.5 mg/mL).

Compatibility

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.

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 room temperature or under refrigeration should be completed according to the times in Table 3.

Table 3: Storage and Stability Times of Infusion Solutions Prepared in Normal Saline or 5% Dextrose

Infusion prepared in Stability Time at Room Temp. (includes room temperature storage and infusion time) Stability time at 2–8°C (Refrigeration) (includes refrigerator storage and infusion time)
Normal saline 12 hours 72 hours
5% Dextrose 4 hours 24 hours

Constituted DORIBAX® suspension or DORIBAX® infusion should not be frozen. This storage information applies also to DORIBAX® diluted in Baxter Minibag Plus™.

HOW SUPPLIED

Dosage Forms And Strengths

Single use clear glass vials containing 250 mg or 500 mg (on an anhydrous basis) of sterile doripenem powder.

Storage And Handling

DORIBAX® is supplied as single use type 1 clear glass vials containing 250 mg or 500 mg (on an anhydrous basis) of sterile doripenem powder. Vials are packaged individually and in cartons containing 10 vials.

NDC: 59630-320-01 – 500 mg/vial, single vial
NDC
: 59630-320-10 – 500 mg/vial, 10 vials/carton
NDC
: 59630-309-01 – 250 mg/vial, single vial
NDC: 59630-309-10 – 250 mg/vial, 10 vials/carton

Storage of DORIBAX® vials

DORIBAX® should be stored at 25°C (77°F); excursions permitted to 15°–30°C (59° to 86°F) [refer to USP controlled room temperature].

Manufactured by: Shionogi & Co. Ltd. Osaka 541-0045, Japan. Manufactured for: Shionogi Inc. Florham Park, NJ 07932. Revised: Jan 2014

Last reviewed on RxList: 1/30/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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