DAPZURA RT 500 mg/10mL

daptomycin · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Baxter Healthcare Corporation

No Recall History

Plain English

DAPZURA RT is a injection, powder, lyophilized, for solution containing daptomycin at 500 mg/10mL, taken intravenous. Manufactured by Baxter Healthcare Corporation.

Key Facts

Brand Name: DAPZURA RT
Generic Name: daptomycin
NDC Code (Product): 60977-145
Manufacturer: Baxter Healthcare Corporation
Strength: 500 mg/10mL
Dosage Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA213645
Drug Class: Lipopeptide Antibacterial [EPC]
Marketing Start: 01/25/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective726 reports

off label use673 reports

acute kidney injury558 reports

pyrexia467 reports

eosinophilic pneumonia447 reports

eosinophilia353 reports

rhabdomyolysis347 reports

blood creatine phosphokinase increased331 reports

drug reaction with eosinophilia and systemic symptoms329 reports

neutropenia283 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE DAPZURA RT is a lipopeptide antibacterial indicated for the treatment of: • Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) ( 1.1 ) and, • Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, ( 1.2 ) • Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). ( 1.3 ) Limitations of Use: • DAPZURA RT is not indicated for the treatment of pneumonia. ( 1.4 ) • DAPZURA RT is not indicated for the treatment of left-sided infective endocarditis due to S. aureus . ( 1.4 ) • DAPZURA RT is not recommended in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs. ( 1.4 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of DAPZURA RT and other antibacterial drugs, DAPZURA RT should be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.5 ) 1.1 Complicated Sk…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Adult Patients • Administer to adult patients intravenously in 0.9% sodium chloride, either by injection over a 2-minute period or by infusion over a 30-minute period. ( 2.1 , 2.7 ) • Recommended dosage regimen for adult patients ( 2.2 , 2.4 , 2.6 ): Creatinine Clearance (CL CR ) Dosage Regimen cSSSI For 7 to 14 days S. aureus Bacteremia For 2 to 6 weeks ≥30 mL/min 4 mg/kg once every 24 hours 6 mg/kg once every 24 hours <30 mL/min, including hemodialysis and CAPD 4 mg/kg once every 48 hours Administered following hemodialysis on hemodialysis days. 6 mg/kg once every 48 hours Pediatric Patients • Unlike in adults, do NOT administer by injection over a two (2) minute period to pediatric patients. ( 2.1 , 2.7 ) • Administer to pediatric patients intravenously in 0.9% sodium chloride, by infusion over a 30- or 60-minute period, based on age. ( 2.1 , 2.7 ) • Recommended dosage regimen for pediatric patients (1 to 17 years of age) with cSSSI, based on age ( 2.3 ): Age group Dosage Recommended dosage is for pediatric patients (1 to 17 years of age) with normal renal function. Dosage adjustment for pediatric patients with renal impairment has not been establishe…

Contraindications

4 CONTRAINDICATIONS DAPZURA RT is contraindicated in: • Patients with known hypersensitivity to daptomycin [see Warnings and Precautions (5.1) ]. • Patients with known or suspected Hereditary Fructose Intolerance (HFI) [see Warnings and Precautions (5.11) ]. • Known hypersensitivity to daptomycin ( 4 ) • Known or suspected Hereditary Fructose Intolerance (HFI) ( 4, 5.11 )

Drug Interactions

7 DRUG INTERACTIONS 7.1 HMG-CoA Reductase Inhibitors In healthy adult subjects, concomitant administration of daptomycin for injection and simvastatin had no effect on plasma trough concentrations of simvastatin, and there were no reports of skeletal myopathy [see Clinical Pharmacology (12.3) ]. However, inhibitors of HMG-CoA reductase may cause myopathy, which is manifested as muscle pain or weakness associated with elevated levels of creatine phosphokinase (CPK). In the adult Phase 3 S. aureus bacteremia/endocarditis trial, some patients who received prior or concomitant treatment with an HMG-CoA reductase inhibitor developed elevated CPK [see Adverse Reactions (6.1) ]. Experience with the coadministration of HMG-CoA reductase inhibitors and daptomycin for injection in patients is limited; therefore, consideration should be given to suspending use of HMG-CoA reductase inhibitors temporarily in patients receiving DAPZURA RT. 7.2 Drug-Laboratory Test Interactions Clinically relevant plasma concentrations of daptomycin have been observed to cause a significant concentration-dependent false prolongation of prothrombin time (PT) and elevation of International Normalized Ratio (INR) wh…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: • Anaphylaxis/Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.2) ] • Eosinophilic Pneumonia [see Warnings and Precautions (5.3) ] • Drug Reaction with Eosinophilia and Systemic Symptoms [see Warnings and Precautions (5.4) ] • Tubulointerstitial Nephritis [see Warnings and Precautions (5.5) ] • Peripheral Neuropathy [see Warnings and Precautions (5.6) ] • Increased International Normalized Ratio (INR)/Prolonged Prothrombin Time [see Warnings and Precautions (5.12) and Drug Interactions (7.2) ] • Adult cSSSI Patients: The most common adverse reactions that occurred in ≥2% of adult cSSSI patients receiving daptomycin for injection 4 mg/kg were diarrhea, headache, dizziness, rash, abnormal liver function tests, elevated creatine phosphokinase (CPK), urinary tract infections, hypotension, and dyspnea. ( 6.1 ) • Pediatric cSSSI Patients: The most common adverse reactions that occurred in ≥2% of pediatric patients receiving daptomycin for injection were diarrhea, vomiting, abdominal pain, pruri…

Frequently Asked Questions

What is DAPZURA RT used for?

DAPZURA RT contains daptomycin. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.

Is DAPZURA RT a controlled substance?

DAPZURA RT is not classified as a controlled substance by the DEA.

What is the generic name for DAPZURA RT?

The generic name for DAPZURA RT is daptomycin. There are 12 other brand versions of daptomycin.

What is the NDC code for DAPZURA RT 500 mg/10mL?

The NDC (National Drug Code) for DAPZURA RT 500 mg/10mL is 60977-145, listed by Baxter Healthcare Corporation.

Product NDC

60977-145

Other Daptomycin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)