Cubicin

Cubicin

daptomycin

Manufacturer:

MSD

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Daptomycin
Indications/Uses
Complicated skin & skin structure infections (cSSSI) in adult & ped patients 1-17 yr caused by susceptible isolates of the following Gm +ve bacteria: Staph aureus (including methicillin-resistant isolates), Strep pyogenes, Strep agalactiae, & Strep dysgalactiae subsp. equisimilis. Staph aureus bloodstream infections (bacteremia) in adult patients, including adults w/ right-sided infective endocarditis caused by methicillin-susceptible & -resistant isolates. Staph aureus bloodstream infections (bacteremia) in ped patients (1-17 yr).
Dosage/Direction for Use
cSSSI Adult 4 mg/kg IV in 0.9% NaCl inj once every 24 hr for 7-14 days. Administer by IV inj over a 2-min period or by IV infusion over a 30-min period. Childn 12-17 yr 5 mg/kg once every 24 hr infused over 30 min for up to 14 days, 7-11 yr 7 mg/kg once every 24 hr infused over 30 min for up to 14 days, 2-6 yr 9 mg/kg once every 24 hr infused over 60 min for up to 14 days, 1 to <2 yr 10 mg/kg once every 24 hr infused over 60 min for up to 14 days. Adult patient w/ renal impairment CrCl ≥30 mL/min 4 mg/kg once every 24 hr, CrCl <30 mL/min, including patient on hemodialysis & CAPD 4 mg/kg once every 48 hr. Staph aureus bloodstream infections Adult 6 mg/kg IV in 0.9% NaCl inj once every 24 hr for 2-6 wk. Administer by IV inj over a 2-min period or by IV infusion over a 30-min period. Childn 12-17 yr 7 mg/kg once every 24 hr infused over 30 min for up to 42 days, 7-11 yr 9 mg/kg once every 24 hr infused over 30 min for up to 42 days, 1-6 yr 12 mg/kg once every 24 hr infused over 60 min for up to 42 days. Adult patient w/ renal impairment CrCl ≥30 mL/min 6 mg/kg once every 24 hr, CrCl <30 mL/min, including patient on hemodialysis or CAPD 6 mg/kg once every 48 hr.
Contraindications
Special Precautions
Reports of anaphylaxis/hypersensitivity reactions; myopathy & rhabdomyolysis; eosinophilic pneumonia; peripheral neuropathy; C. difficile-associated diarrhea (CDAD). Promptly discontinue & institute appropriate treatment if drug reaction w/ eosinophilia & systemic symptoms (DRESS) or tubulointerstitial nephritis is suspected. Patients w/ persisting or relapsing Staph aureus bacteremia/endocarditis or poor clinical response. May promote overgrowth of non-susceptible microorganisms. Clinically relevant plasma conc of daptomycin have been observed to cause a significant conc-dependent false prothrombin time prolongation & INR elevation when certain recombinant thromboplastin reagents are used for the assay. Patients w/ moderate to severe renal impairment. Pregnancy & lactation. Avoid use in ped patients <1 yr. Not indicated in ped patients w/ renal impairment. Elderly.
Adverse Reactions
Adult cSSSI trial: Diarrhea; headache, dizziness; rash; abnormal LFTs, elevated blood creatine phosphokinase (CPK); UTI; hypotension; dyspnea. Ped cSSSI trial: Diarrhea, vomiting, abdominal pain; pruritus; pyrexia; increased CPK; headache. Adult S. aureus bacteremia/endocarditis trial: Sepsis, bacteremia; abdominal pain; chest pain, edema; pharyngolaryngeal pain; pruritus, increased sweating; insomnia; increased blood CPK; HTN. Ped S. aureus bacteremia trial: Vomiting; increased blood CPK.
Drug Interactions
Elevated CPK w/ HMG-CoA reductase inhibitors.
MIMS Class
Other Antibiotics
ATC Classification
J01XX09 - daptomycin ; Belongs to the class of other antibacterials. Used in the systemic treatment of infections.
Presentation/Packing
Form
Cubicin powd for inj 500 mg/10 mL
Packing/Price
1's
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