Daptomycin in Sodium Chloride 1000 mg/100mL
Daptomycin in Sodium Chloride · INJECTION, SOLUTION · Baxter Healthcare Corporation
Daptomycin in Sodium Chloride is a injection, solution containing daptomycin in sodium chloride at 1000 mg/100mL, taken intravenous. Manufactured by Baxter Healthcare Corporation.
Key Facts
- Brand Name
- Daptomycin in Sodium Chloride
- Generic Name
- Daptomycin in Sodium Chloride
- NDC Code (Product)
0338-0718- Manufacturer
- Baxter Healthcare Corporation
- Strength
- 1000 mg/100mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA213645
- Drug Class
- Lipopeptide Antibacterial [EPC]
- Marketing Start
- 01/25/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Daptomycin in Sodium Chloride Injection 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) for whom appropriate dosing can be achieved ( 1.1 ) and, • Staphylococcus aureus bloodstream infections (bacteremia), in adult patients for whom appropriate dosing can be achieved, including those with right-sided infective endocarditis, ( 1.2 ) • Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved. ( 1.3 ) Limitations of Use • Daptomycin in Sodium Chloride Injection is not indicated for the treatment of pneumonia. ( 1.4 ) • Daptomycin in Sodium Chloride Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. ( 1.4 ) • Daptomycin in Sodium Chloride Injection 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 …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION If a dose of Daptomycin in Sodium Chloride Injection is required that does not equal 350 mg, 500 mg, 700 mg or 1,000 mg, this product is not recommended for use and an alternative formulation of daptomycin should be considered. ( 2.1 ) Adult Patients • Administer to adult patients intravenously 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* 6 mg/kg once every 48 hours* *Administered following hemodialysis on hemodialysis days. Pediatric Patients • Administer to pediatric patients intravenously 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* Duration of therapy 12 to 17 years 5 mg/kg once every 24 hours infused over 30 minutes Up to 14 days 7 to 11 years 7 mg/kg once every 24 hours infused over…
Contraindications
4 CONTRAINDICATIONS Daptomycin in Sodium Chloride Injection is contraindicated in patients with known hypersensitivity to daptomycin [see Warnings and Precautions (5.1) ]. • Known hypersensitivity to daptomycin (4)
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 Daptomycin in Sodium Chloride Injection. 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 Internatio…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • 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 (5.11) 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, pruritus,…
Frequently Asked Questions
What is Daptomycin in Sodium Chloride used for?
Daptomycin in Sodium Chloride contains Daptomycin in Sodium Chloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Daptomycin in Sodium Chloride a controlled substance?
Daptomycin in Sodium Chloride is not classified as a controlled substance by the DEA.
What is the generic name for Daptomycin in Sodium Chloride?
The generic name for Daptomycin in Sodium Chloride is Daptomycin in Sodium Chloride. There are no other listed brand versions of Daptomycin in Sodium Chloride.
What is the NDC code for Daptomycin in Sodium Chloride 1000 mg/100mL?
The NDC (National Drug Code) for Daptomycin in Sodium Chloride 1000 mg/100mL is 0338-0718, listed by Baxter Healthcare Corporation.
Other Daptomycin in Sodium Chloride Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)