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doripenem (Rx)Brand and Other Names:Doribax

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 500mg/vial
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Complicated Intra-abdominal Infection

500 mg IV infusion over 1 hour q8hr x 5-14 days

At least 3 days IV, may switch to an appropriate PO treatment if clinical improvement noted

Complicated UTI

500 mg IV infusion over 1 hour q8hr x 10 days

Can be extended up to 14 days if concurrent bacteremia

Bronchopulmonary Infection (Orphan)

Treatment of bronchopulmonary infection in patients with cystic fibrosis who are colonized with Pseudomonas aeruginosa or Burkholderia cepacia

Orphan indication sponsor

  • Johnson & Johnson Pharmaceutical, Research & Dev; 920 US Highway 202, P. O. Box 300; Raritan, NJ 08869

Renal Impairment

CrCl >50 mL/min: No adjustment

CrCl 30-50 mL/min: 250 mg IV q8hr

CrCl 10-30 mL/min: 250 mg IV q12hr

Other Indications & Uses

P. aeruginosa, K. pneumoniae, E. coli, Bacteroides caccae, B. fragilis, B. thetaiotaomicron, B. uniformis, B. vulgatus, Streptococcus intermedius, S. constellatus, Peptostreptococcus micros, Acinetobacter baumannii, Proteus mirabilis

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

doripenem and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (4-16%)

            Nausea (4-12%)

            Diarrhea (6-11%)

            1-10%

            Anemia (2-10%)

            Phlebitis (4-8%)

            Rash (1-5%)

            Pruritus (3%)

            Transaminases elevated (1-2%)

            Oral candidiasis (1%)

            Renal impairment/failure (1%)

            Postmarketing Reports

            Anaphylaxis

            Leukopenia

            Neutropenia

            Seizure

            Thrombocytopenia

            Toxic epidermal necrolysis, Stevens-Johnson Syndrome

            Interstitial pneumonia

            Renal impairment/failure

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            Warnings

            Contraindications

            Hypersensitivity to doripenem, beta-lactams or similar drugs

            Cautions

            History of sensitivity to multiple allergens

            May reduce serum valproic acid conc to subtherapeutic level: monitor levels frequently

            Risk of Clostridium difficile-associated diarrhea on long-term use

            Seizures reported with use

            Not approved for ventilator-associated bacterial pneumonia (or any type of pneumonia); increased mortality when compared with imipenem/cilastatin (23% vs 16.7%); additionally, clinical response rates were lower with doripenem

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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: unknown if excreted in breast milk; use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits cell-wall biosynthesis by inactivating multiple penicillin-binding proteins (PBPs), resulting in cell death

            Stable to hydrolysis by most beta-lactamases

            Distribution

            Penetrates into several body fluids and tissues, especially peritoneal and retroperitoneal

            Protein Bound: 8.1%

            Vd: 16.8 L

            Metabolism

            Dehydropeptidase-I

            Elimination

            Half-life: 1 hr (normal renal function)

            Plasma Clearance: 15.9 L/hr

            Excretion: urine

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            Administration

            IV Preparation

            Reconstitute vial with 10 mL SWI or NS; shake gently to form suspension

            • Add to infusion bag containing 100 mL NS or D5W
            • Shake gently until clear

            To prepare 250 mg infusion soln for pts w/ renal impairment

            • Remove 55 mL of soln from bag & discard
            • Infuse remaining soln

            IV Administration

            Infuse over 1 hr

            Storage

            Store vials at 25°C (77°F)

            Constituted Doribax suspension in vial may be held for 1 hr prior to transfer & dilution in infusion bag

            Diluted suspension (already in infusion bag) in NS may be stored for 8 hr and in D5W for 4 hr at room temp (includes storage & infusion time) OR in either diluent for 24 hr at 2-8°C (includes storage & infusion time)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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