Overview
11 DESCRIPTION Daptomycin for 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 ε 1 -lactone.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Daptomycin is an antibacterial drug [see Clinical Pharmacology ( 12.4 )] . 12.2 Pharmacodynamics Based on animal models of infection, the antimicrobial activity of daptomycin appears to correlate with the AUC/MIC (area under the concentration-time curve/minimum inhibitory concentration) ratio for certain pathogens, including S. aureus. The principal pharmacokinetic/pharmacodynamic parameter best associated with clinical and microbiological cure has not been elucidated in clinical trials with daptomycin. 12.
Indications
- 1 INDICATIONS AND USAGE Daptomycin for 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) ( 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 : • Daptomycin for injection is not indicated for the treatment of pneumonia. ( 1.
Common Doses
- 30 mL
- 4 mg
- 6 mg
- 5 mg
Dosage
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
Contraindications
- 4 CONTRAINDICATIONS Daptomycin for injection is contraindicated in patients with known hypersensitivity to daptomycin. [see Warnings and Precautions ( 5.1 )]. • Known hypersensitivity to daptomycin ( 4 )
Side Effects
- 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.
Interactions
- 7 DRUG INTERACTIONS 7.1 HMG-CoA Reductase Inhibitors In healthy adult subjects, concomitant administration of daptomycin 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.