These highlights do not include all the information needed to use CUBICIN safely and effectively. Renal Impairment No patients 1 to <2 years of age were enrolled. Clinical success rates in the CE population were 76.0% (158/208) in patients treated with daptomycin for injection and 76.7% (158/206) in patients treated with comparator drugs. The different age groups and doses evaluated were as follows: Adolescents (12 to 17 years, n=14 patients) treated with daptomycin for injection dosed at 7 mg/kg once daily, Children (7 to 11 years, n=19 patients) treated with daptomycin for injection dosed at 9 mg/kg once daily and Children (2 to 6 years, n=22 patients) treated with daptomycin for injection dosed at 12 mg/kg once daily. Daptomycin is a cyclic lipopeptide antibiotic that has a unique mechanism of action. The mean Cmax ranged from 60 to 70 mcg/mL in patients with CLCR ≥30 mL/min, while the mean Cmax for patients with CLCR <30 mL/min ranged from 41 to 58 mcg/mL. It is a naturally occurring compound found in the soil saprotroph Streptomyces roseosporus. Source: Lexi-Comp, Inc. (Lexi-Drugs). Tobramycin Distributed by: Because renal excretion is the primary route of elimination, adjustment of daptomycin for injection dosage interval is necessary in adult patients with severe renal impairment (CLCR <30 mL/min) [see Dosage and Administration (2.4)]. Concomitant administration of probenecid (500 mg 4 times daily) and a single dose of daptomycin for injection 4 mg/kg by IV infusion over a 30-minute period in adults did not significantly alter the Cmax or AUC0-∞ of daptomycin. The two core catalytic domains are an acyltransferase (AT) and a ketosynthase (KS). If this occurs, patients should contact their physician as soon as possible. The pharmacokinetics of daptomycin in patients with severe hepatic impairment (Child-Pugh Class C) have not been evaluated. Of the 54 patients with an entry diagnosis of Not Endocarditis, 1 (2%) had a final diagnosis of infective endocarditis as assessed by the Adjudication Committee. *When possible, administer daptomycin for injection following the completion of hemodialysis on hemodialysis days. Nervous System: vertigo, mental status change, paresthesia These whole-subunit exchanges have been coupled with the deletion of the Glu12-methyltransferase gene, with module exchanges at intradomain linker sites at Ala8 and Ser11, and with variations of natural fatty-acid side chains to generate over 70 novel lipopeptides in significant quantities; most of these resultant lipopeptides have potent antibacterial activities. It … Patients were given age-dependent doses once daily for a treatment period of up to 42 days (mean duration of IV treatment was 12 days). In pregnant rats, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 18. • Tubulointerstitial nephritis [see Warnings and Precautions (5.5)] In a combined fertility and pre/postnatal development study, daptomycin was administered intravenously to female rats at doses of 2, 25, 75 mg/kg/day from 14-days pre-mating through lactation/postpartum day 20). The AUC0-∞ of daptomycin was approximately 30% higher in moderately obese subjects and 31% higher in extremely obese subjects than in nonobese controls. Of the patients in the comparator group, 93% received initial gentamicin for a median of 4 days, compared with 1 patient (<1%) in the daptomycin for injection group. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile. pregnancy, upcoming surgery, etc. In a mass balance study of 5 healthy adult subjects using radiolabeled daptomycin, approximately 78% of the administered dose was recovered from urine based on total radioactivity (approximately 52% of the dose based on microbiologically active concentrations), and 5.7% of the administered dose was recovered from feces (collected for up to 9 days) based on total radioactivity. 1. Following administration of daptomycin for injection 4 mg/kg q24h by IV infusion over a 30-minute period, the mean CLT was 9%, 22%, and 46% lower among subjects and patients with mild (CLCR 50 to 80 mL/min), moderate (CLCR 30 to <50 mL/min), and severe (CLCR <30 mL/min) renal impairment, respectively, than in those with normal renal function (CLCR >80 mL/min). Slowly remove reconstituted liquid (50 mg daptomycin/mL) from the vial using a beveled sterile needle that is 21 gauge or smaller in diameter. Among patients with persisting or relapsing S. aureus infections, 8/19 daptomycin for injection-treated patients and 7/11 comparator treated patients died. Camber Pharmaceuticals, Inc. Wrap container with opaque material. Patients known to have bacteremia, osteomyelitis, endocarditis, and pneumonia at baseline were excluded. Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. No clinically significant gender-related differences in daptomycin pharmacokinetics have been observed. A study was conducted to assess safety, efficacy, and pharmacokinetics of daptomycin in pediatric patients (1 to 17 years old, inclusive) with cSSSI caused by Grampositive pathogens. In the bacteremia study, daptomycin for injection was discontinued in 3/55 (5.5%) patients due to an adverse reaction, while comparator was discontinued in 2/26 (7.7%) patients. Gram-Positive Bacteria Patients with persisting or relapsing S. aureus bacteremia/endocarditis or poor clinical response should have repeat blood cultures. Do not store it or any other medicine in the bathroom or near a sink. 31 In vitro and in vivo analysis established that daptomycin is effective in a concentration-dependent manner, has a long half-life (8 h), and demonstrates a prolonged post-antibiotic effect up to 6.8 h . The two trials were similar in design but differed in patient characteristics, including history of diabetes and peripheral vascular disease. Complicated Skin and Skin Structure Infection (cSSSI) Trials in Adults It binds to the bacterial cell membranes, causing rapid depolarization of the membrane due to potassium efflux and associated disruption of DNA, RNA, and protein synthesis; the result is rapid concentration-dependent bacterial death (see Effectiveness). • Myopathy and rhabdomyolysis [see Warnings and Precautions (5.2)] [See Warnings and Precautions (5.2, 5.6).] The efficacy endpoints in both trials were the clinical success rates in the intent-to-treat (ITT) population and in the clinically evaluable (CE) population. Psychiatric Disorders: hallucination NOS equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).Pediatric … Corynebacterium jeikeium 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; Recommended dosage regimen for adult patients: World Health Organization's List of Essential Medicines, "Cubicin 350 mg powder for solution for injection or infusion - Summary of Product Characteristics (SmPC)", "Cubicin- daptomycin injection, powder, lyophilized, for solution", "Cubicin RF- daptomycin injection, powder, lyophilized, for solution", "Single-dose pharmacokinetics and antibacterial activity of daptomycin, a new lipopeptide antibiotic, in healthy volunteers", "Efficacy profiles of daptomycin for treatment of invasive and noninvasive pulmonary infections with Streptococcus pneumoniae", "Highlights of Prescribing Information: CUBICIN (daptomycin for injection) for Intravenous Use", "Rhabdomyolysis and acute renal failure in a patient treated with daptomycin", "Rhabdomyolysis and acute renal failure associated with the co-administration of daptomycin and an HMG-CoA reductase inhibitor", "Daptomycin-mediated reorganization of membrane architecture causes mislocalization of essential cell division proteins", "Self-Assembly of the Cyclic Lipopeptide Daptomycin: Spherical Micelle Formation Does Not Depend on the Presence of Calcium Chloride", "A review of daptomycin for injection (Cubicin) in the treatment of complicated skin and skin structure infections", "A diverse intrinsic antibiotic resistome from a cave bacterium", "Daptomycin: a lipopeptide antibiotic for the treatment of serious Gram-positive infections", "Molecular cloning and physical mapping of the daptomycin gene cluster from Streptomyces roseosporus", "Combinatorial biosynthesis of novel antibiotics related to daptomycin", "Genetic engineering in Streptomyces roseosporus to produce hybrid lipopeptide antibiotics", "Development of daptomycin for gram-positive infections", "Antimicrobial peptides: an overview of a promising class of therapeutics", "Lipopeptides as anti-infectives: a practical perspective", "The safety and efficacy of daptomycin for the treatment of complicated skin and skin-structure infections", "FDA Rationale for Recognition Decision: Daptomycin", Benzathine benzylpenicillin/procaine benzylpenicillin, https://en.wikipedia.org/w/index.php?title=Daptomycin&oldid=996483638, Short description is different from Wikidata, Drugboxes which contain changes to verified fields, Drugboxes which contain changes to watched fields, Articles to be expanded from January 2015, Articles with unsourced statements from September 2019, All articles with vague or ambiguous time, Articles with unsourced statements from September 2012, Creative Commons Attribution-ShareAlike License, 7–11 hours (up to 28 hours in renal impairment), Gastrointestinal: diarrhea, abdominal pain, This page was last edited on 26 December 2020, at 21:46. In-Use Storage Conditions for Daptomycin for Injection Once Reconstituted in Acceptable Intravenous Diluents The exposure of daptomycin was higher in healthy elderly subjects than in healthy young adult subjects. Staphylococcus aureus (including methicillin-resistant isolates) The chemical structure is: The empirical formula is C72H101N17O26 ; the molecular weight is 1620.67g/mol. The diluted solution is stable in the infusion bag for 12 hours at room temperature and 48 hours if stored under refrigeration. Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to daptomycin. Micelles [ 18 ] by daptomycin may affect the mode of action, disrupting multiple aspects of cell! Ongoing antibacterial use thiol of the 2-minute period could not be used in granulation, compression and areas! Conducted to evaluate the safety of daptomycin than once a day gain was at! 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