Classes
DEA Class; Rx
Common Brand Names; Cubicin, Dapzura RT
- Lipopeptides
Description
Intravenous, cyclic lipopeptide antibiotic
Used for susceptible gram-positive infections, including MRSA, complicated skin and skin structure infections, and bacteremia, including patients with right-sided infective endocarditis
Inactivated by pulmonary surfactant, therefore ineffective for pneumonia
Indications
Indication includes those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates
Indicated for treatment of complicated skin and skin structure infections (cSSSI)
Susceptible isolates
- Staphylococcus aureus (including methicillin-resistant isolates [MRSA])
- Streptococcus pyogenes
- Streptococcus agalactiae
- Streptococcus dysgalactiae ssp equisimilis
- Enterococcus faecalis (vancomycin-susceptible only)
Contraindications
Hypersensitivity
Adverse Effects
- Insomnia (9.0%)
- Pharyngolaryngeal pain (8.0%)
- Chest pain (7.0%)
- Elevated blood creatine phosphokinase (7.0%)
- Edema (7.0%)
- Abdominal pain (6.0%)
- Hypertension (6.0%)
- Pruritus (6.0%)
- Headache (5.4%)
- Diarrhea (5.2%)
- Sweating (5.0%)
- Bacteremia (5.0%)
- Sepsis (5.0%)
- Rash (4.3%)
- Abnormal LFTs (3.0%)
- UTI (2.4%)
- Hypotension (2.4%)
- Dizziness (2.2%)
- Dyspnea (2.1%)
Warnings
Anaphylaxis/hypersensitivity reactions have been reported and may be life-threatening; discontinue the drug and institute appropriate therapy if allergic reaction occurs
May cause eosinophilic pneumonia characterized by fever, cough, shortness of breath, and difficulty breathing; may result in progressive respiratory failure and is potentially fatal; prompt medical evaluation, and treatment should be discontinued immediately if signs/symptoms develop; treatment with systemic steroids is recommended
Prolonged use may result in fungal or bacterial superinfection Perform susceptibility testing and rule out sequestered foci of infection if persisting or relapsing S. aureus bacteremia/endocarditis occurs
Avoid use in pediatric patients <12 months; potential nervous system or muscular system effects
Decreased efficacy reported in patients with moderate baseline renal impairment
Fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organizing pneumonia
Drug reaction with eosinophilia and systemic symptoms (DRESS) reported postmarketing; patients who develop skin rash, fever, peripheral eosinophilia, and systemic organ (for example, hepatic, renal, pulmonary) impairment while receiving therapy should undergo medical evaluation; if DRESS suspected, discontinue therapy promptly and institute appropriate treatment
Tubulointerstitial nephritis (TIN) reported post-marketing experience; patients who develop new or worsening renal impairment while receiving therapy should undergo medical evaluation; if TIN suspected, discontinue therapy promptly and institute appropriate treatment
Cases of peripheral neuropathy have been reported during the daptomycin postmarketing experience; monitor and consider discontinuation
Clinically relevant plasma concentrations of daptomycin reported to cause a significant concentration-dependent false prolongation of prothrombin time (PT) and elevation of International Normalized Ratio (INR) when certain recombinant thromboplastin reagents are utilized for the assay
Prescribing in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit and increases risk of development of drug-resistant bacteria
Pregnancy and Lactation
Limited published data on use in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage; no evidence of adverse developmental outcomes observed in animal reproduction studies
Limited published data report that daptomycin is present in human milk at infant doses of 0.1% of maternal dose
Maximum Dosage
6 mg/kg/dose IV every 24 hours is FDA-approved maximum dosage; however, doses up to 12 mg/kg/dose IV every 24 hours have been used off-label.
6 mg/kg/dose IV every 24 hours is FDA-approved maximum dosage; however, doses up to 12 mg/kg/dose IV every 24 hours have been used off-label.
7 mg/kg/dose IV every 24 hours is FDA-approved maximum dosage; however, doses up to 10 mg/kg/dose IV every 24 hours have been used off-label.
12 years: 7 mg/kg/dose IV every 24 hours is FDA-approved maximum dosage; however, doses up to 10 mg/kg/dose IV every 24 hours have been used off-label.
7 to 11 years: 9 mg/kg/dose IV every 24 hours is FDA-approved maximum dosage; however, doses up to 10 mg/kg/dose IV every 24 hours have been used off-label.
1 to 6 years: 12 mg/kg/dose IV every 24 hours.
Safety and efficacy have not been established; doses up to 10 mg/kg/dose IV every 24 hours have been used off-label.
Safety and efficacy have not been established; doses up to 15 mg/kg/dose IV every 12 hours have been used off-label.
How supplied
Daptomycin
injection, lyophilized powder for reconstitution
- 500mg/vial (Cubicin, Cubicin RF, Dapzura RT)