Daptomycin In Sodium Chloride
Generic Name: daptomycin in sodium chloride
Brand Names:
Daptomycin In Sodium Chloride
11 DESCRIPTION Daptomycin in Sodium Chloride Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus . The chemical name is N -decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl- threo -3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ℇ1 -lactone. The chemical structure is: The empirical formula is C 72 H 101 N 17 O 26 ; the molecular weight is 1620.67.
Overview
11 DESCRIPTION Daptomycin in Sodium Chloride Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus . The chemical name is N -decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl- threo -3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ℇ1 -lactone. The chemical structure is: The empirical formula is C 72 H 101 N 17 O 26 ; the molecular weight is 1620.67.
Uses
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.
Dosage
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.
Side Effects
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 rec...
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) ].
Warnings
5 WARNINGS AND PRECAUTIONS • Anaphylaxis/hypersensitivity reactions (including life-threatening): Discontinue Daptomycin in Sodium Chloride Injection and treat signs/symptoms. (5.1) • Myopathy and rhabdomyolysis: Monitor CPK levels and follow muscle pain or weakness; if elevated CPK or myopathy occurs, consider discontinuation of Daptomycin in Sodium Chloride Injection. (5.2) • Eosinophilic pneumonia: Discontinue Daptomycin in Sodium Chloride Injection and consider treatment with systemic steroids. (5.3) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue Daptomycin in Sodium Chloride Injection and institute appropriate treatment. (5.4) • Tubulointerstitial Nephritis (TIN): Discontinue Daptomycin in Sodium Chloride Injection and institute appropriate treatment. 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)
Pregnancy
8.1 Pregnancy Risk Summary Limited published data on use of daptomycin for injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies performed in rats and rabbits daptomycin was administered intravenously during organogenesis at doses 2 and 4–times, respectively, the recommended 6 mg/kg human dose (on a body surface area basis). No evidence of adverse developmental outcomes was observed. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Daptomycin in Sodium Chloride Injection is supplied as a single-dose premixed frozen isosmotic sterile, nonpyrogenic solution in 50 mL or 100 mL GALAXY plastic containers as follows: Code Product Description NDC Number 2G3593 350 milligrams daptomycin in 50 mL (7 mg/mL) Supplied as 24 bags per carton 0338-0712-24 2G3594 500 milligrams daptomycin in 50 mL (10 mg...
Frequently Asked Questions
What is Daptomycin In Sodium Chloride used for?▼
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.
What are the side effects of Daptomycin In Sodium Chloride?▼
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 rec...
Can I take Daptomycin In Sodium Chloride during pregnancy?▼
8.1 Pregnancy Risk Summary Limited published data on use of daptomycin for injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies performed in rats and rabbits daptomycin was administered intravenously during organogenesis at doses 2 and 4–times, respectively, the recommended 6 mg/kg human dose (on a body surface area basis). No evidence of adverse developmental outcomes was observed. The background risk of major birth defects and miscarriage for the indicated population is unknown.
What are the important warnings for Daptomycin In Sodium Chloride?▼
5 WARNINGS AND PRECAUTIONS • Anaphylaxis/hypersensitivity reactions (including life-threatening): Discontinue Daptomycin in Sodium Chloride Injection and treat signs/symptoms. (5.1) • Myopathy and rhabdomyolysis: Monitor CPK levels and follow muscle pain or weakness; if elevated CPK or myopathy occurs, consider discontinuation of Daptomycin in Sodium Chloride Injection. (5.2) • Eosinophilic pneumonia: Discontinue Daptomycin in Sodium Chloride Injection and consider treatment with systemic steroids. (5.3) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue Daptomycin in Sodium Chloride Injection and institute appropriate treatment. (5.4) • Tubulointerstitial Nephritis (TIN): Discontinue Daptomycin in Sodium Chloride Injection and institute appropriate treatment. 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)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.