DAPTOMYCIN

Daptomycin Administered over a 30-Minute Period in Adults The mean and standard deviation (SD) pharmacokinetic parameters of daptomycin at steady-state following intravenous (IV) administration of daptomycin over a 30-minute period at 4 to 12 mg/kg every 24h to healthy young adults are summarized in Table 11.

Table 11Mean (SD) Daptomycin Pharmacokinetic Parameters in Healthy Adult Volunteers at Steady-State Dose *† (mg/kg) Pharmacokinetic Parameters ‡ AUC 0-24 (mcg

• h/mL) t 1/2 (h) V ss (L/kg) ...

14.1 Complicated Skin and Skin Structure Infections Adults with cSSSI Adult patients with clinically documented complicated skin and skin structure infections (cSSSI) (Table 15) were enrolled in two randomized, multinational, multicenter, investigator-blinded trials comparing daptomycin (4 mg/kg IV every 24h) with either vancomycin (1 g IV every 12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g IV per day). Patients could switch to oral therapy after a minimum of 4 days of IV treatment if clinical improvement was dem...

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 Warning...

Daptomycin for injection is contraindicated in patients with known hypersensitivity to daptomycin. [see Warnings and Precautions ( 5.1 )].

• Known hypersensitivity to daptomycin ( 4 )

• Anaphylaxis/hypersensitivity reactions (including life-threatening): Discontinue daptomycin 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. ( 5.2 )
• Eosinophilic pneumonia: Discontinue daptomycin and consider treatment with systemic steroids. ( 5.3 )
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue daptomycin and instit...

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 associa...