Bedapt Daptomycin

Adult ≥18 yr & ped 1-17 yr w/ complicated skin & skin structure infections (cSSSI) caused by gram +ve bacteria susceptible isolates: Staph aureus (including methicillin-resistant isolates), Strep pyogenes, Strep agalactiae, Strep dysgalactiae subsp equisimilis & Enterococcus faecalis (vancomycin-susceptible isolates only). Adult ≥18 yr w/ Staph aureus bloodstream infections including those w/ right-sided infective endocarditis caused by methicillin-susceptible & -resistant isolates. Ped 1-17 yr w/ Staph aureus bloodstream infections caused by methicillin-susceptible & -resistant isolates.

IV cSSSI Adult 4 mg/kg every 24 hr for 7-14 days, administer by inj over 2-min or infusion over 30-min. Adult w/ renal impairment CrCl ≥30 mL/min 4 mg/kg every 24 hr, <30 mL/min 4 mg/kg every 48 hr. Duration of therapy: 7-14 days. Ped 12-17 yr 5 mg/kg every 24 hr infuse over 30 min, 7-11 yr 7 mg/kg every 24 hr infuse over 30 min, 2-6 yr 9 mg/kg every 24 hr infuse over 60 min, 1 to <2 yr 10 mg/kg every 24 hr infuse over 60 min. Duration of therapy: Up to 14 days. Staph aureus bloodstream infection (bacteremia) Adult 6 mg/kg every 24 hr for 2-6 wk, administer by inj over 2-min or infusion over 30-min. Ped 12-17 yr 7 mg/kg every 24 hr infuse over 30 min, 7-11 yr 9 mg/kg every 24 hr infuse over 30 min, 1-6 yr 12 mg/kg every 24 hr infuse over 60 min. Duration: Up to 42 days. Staph aureus bacteremia including right-sided endocarditis Adult w/ renal impairment CrCl ≥30 mL/min 6 mg/kg every 24 hr, <30 mL/min 6 mg/kg every 48 hr. Duration of therapy: 2-6 wk.

Hypersensitivity.

Anaphylaxis/hypersensitivity reactions w/ daptomycin or antibacterial agents. Discontinue use & institute appropriate therapy if allergic reaction occurs. Not indicated for left-sided infective endocarditis due to Staph aureus. Patients w/ prosthetic valve endocarditis. Not to be used for pneumonia. May increase plasma creatine phosphokinase (CPK) levels, muscular pain, weakness &/or rhabdomyolysis. Monitor for muscle pain or weakness development particularly in distal extremities. Measure CPK levels at baseline & regular intervals (at least wkly) & more frequently in patients who received recent prior or concomitant therapy w/ HMG-CoA reductase inhibitor or in whom CPK elevations occur during treatment w/ daptomycin. Discontinue use in patients w/ unexplained signs & symptoms of myopathy in conjunction w/ CPK elevations to levels >1,000 u/L (approx 5x ULN) & in patients w/o reported symptoms who have marked CPK elevations w/ levels >2,000 u/L (≥10x ULN). Physicians should be alert to signs & symptoms of peripheral neuropathy. Prompt medical evaluation & immediately discontinue use in patients who develop signs & symptoms of eosinophilic pneumonia while receiving daptomycin; treatment w/ systemic steroids is recommended. Promptly discontinue use & institute appropriate treatment if DRESS or tubulointerstitial nephritis is suspected. If Clostridioides difficile-associated diarrhea (CDAD) is suspected or confirmed, may need to discontinue ongoing antibiotic use not directed against Clostridioides difficile; institute appropriate fluid & electrolyte management, protein supplementation, antibiotic treatment of Clostridioides difficile & surgical evaluation. Repeat blood cultures in patients w/ persisting or relapsing Staph aureus bacteremia/endocarditis or poor clinical response. Perform min inhibitory conc susceptibility testing of isolate using standardized procedure if +ve blood culture for Staph aureus; initiate appropriate surgical intervention (eg, debridement, prosthetic devices removal, valve replacement surgery) &/or consider change in antibacterial regimen. Possible false prothrombin time prolongation & INR elevation when certain recombinant thromboplastin reagents are utilized for the assay. May promote overgrowth of non-susceptible microorganisms w/ antibacterials. Monitor renal function & CPK more frequently than once wkly in patients w/ renal impairment. Severe hepatic impairment (Child-Pugh class C). Pregnancy. Avoid breast-feeding during treatment. Not to be given in ped <1 yr due to risk of potential effects on muscular, neuromuscular &/or nervous systems.

Anemia; GI & abdominal pain, diarrhea, vomiting, flatulence, bloating, distension, constipation, nausea; asthenia, pyrexia, infusion site reaction; UTI, fungal & candida infections; increased blood CPK, abnormal LFTs (increased ALT, AST or ALP); limb pain; dizziness, headache; anxiety, insomnia; pruritus, rash; HTN, hypotension.

Concomitant use w/ warfarin; monitor anticoagulant activity for the 1st several days after therapy initiation. Consider temporarily suspending HMG-CoA reductase inhibitors. Co-administration w/ tobramycin.

Other Antibiotics

J01XX09 - daptomycin ; Belongs to the class of other antibacterials. Used in the systemic treatment of infections.

POM