Doribax, (doripenem) dosing, indications, interactions, adverse effects, and more

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Sections doripenem
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
Administration
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Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

500mg/vial

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

Interaction Checker

Enter a drug name and doripenem

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Interactions Found

Contraindicated

Serious - Use Alternative

Significant - Monitor Closely

Minor

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Contraindicated (0)

Serious - Use Alternative (1)

microbiota oral
doripenem decreases effects of microbiota oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Microbiota oral contains bacterial spores. Antibacterial agents may decrease efficacy if coadministered. Complete antibiotic regimens 2-4 days before initiating microbiota oral. .

Monitor Closely (0)

Minor (0)

>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

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

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.

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

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)

Images

No images available for this drug.

Patient Handout

A Patient Handout is not currently available for this monograph.

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.

View explanations for tiers and restrictions

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.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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Sections doripenem
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
Administration
Images
Patient Handout
Formulary

doripenem (Rx)