Patients known to have bacteremia, osteomyelitis, endocarditis, and pneumonia at baseline were excluded. Do not exceed the listed shelf-life of reconstituted and diluted solutions of Cubicin RF. Of the 120 adult patients treated with CUBICIN in the Phase 3 controlled clinical trial of The exposure of daptomycin was higher in healthy elderly subjects than in healthy young adult subjects. Patients were given age-dependent doses once daily for a treatment period of up to 14 days (median treatment period was 3 days). Copy the URL below and paste it into your RSS Reader application. In neonatal dogs, adverse nervous system and/or muscular system effects were associated with a CAt higher dose levels of 50 and 75 mg/kg/day with associated CHistopathological assessment did not reveal any daptomycin-related changes in the peripheral and central nervous system tissue, as well as in the skeletal muscle or other tissues assessed, at any dose level.No adverse effects were observed in the dogs that received daptomycin at 10 mg/kg/day, the NOAEL, with associated CAdult patients with clinically documented complicated skin and skin structure infections (cSSSI) (Table 16) were enrolled in two randomized, multinational, multicenter, investigator-blinded trials comparing CUBICIN (4 mg/kg IV q24h) with either vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g IV per day). Maternal body weight gain and food consumption were decreased at 75 mg/kg/day. Store original packages at refrigerated temperatures, 2° to 8°C (36° to 46°F); avoid excessive heat [see Dosage and Administration (2.7)]. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever), even as late as 2 or more months after having received the last dose of the antibacterial.
Of the 534 patients treated with CUBICIN, 1 (0.2%) had symptoms of muscle pain or weakness associated with CPK elevations to greater than 4 times the upper limit of normal (ULN). Due to inconsistencies between the drug labels on DailyMed and the pill images provided by See full prescribing information for CUBICIN. The symptoms resolved within 3 days and CPK returned to normal within 7 to 10 days after treatment was discontinued The safety of CUBICIN was evaluated in one clinical trial (in cSSSI), which included 256 pediatric patients (1 to 17 years of age) treated with intravenous CUBICIN and 133 patients treated with comparator agents. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by CUBICIN RF or other antibacterial drugs in the future.Distributed by: Merck Sharp & Dohme Corp., a subsidiary ofFor patent information: www.merck.com/product/patent/home.htmlThe trademarks depicted herein are owned by their respective companies. The contents of a Cubicin RF vial should be reconstituted, using aseptic technique, to 50 mg/mL as follows:Parenteral drug products should be inspected visually for particulate matter prior to administration.Slowly remove reconstituted liquid (50 mg daptomycin/mL) from the vial using a beveled sterile needle that is 21 gauge or smaller in diameter. CUBICIN is a lipopeptide antibacterial indicated for the treatment of: To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN and other antibacterial drugs, CUBICIN should be used to treat infections that are proven or strongly suspected to be caused by bacteria. The clinical success rates determined at 7–14 days after last dose of therapy (IV and oral) (TOC visit) were 88% (227/257) for CUBICIN and 86% (114/132) for comparator.The efficacy of CUBICIN in the treatment of adult patients with Upon entry, patients were classified for likelihood of endocarditis using the modified Duke criteria (Possible, Definite, or Not Endocarditis). In juvenile dogs, nerve effects were noted at lower daptomycin blood concentrations than in adult dogs following 28 days of dosing. Of the 396 subjects randomized in the study, 389 subjects were treated with CUBICIN or comparator and included in the ITT population. In the adult Phase 3 Clinically relevant plasma concentrations of daptomycin have been observed 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. Easy to read FDA package insert, drug facts, dosage and administration, and adverse effects for Cubicin (daptomycin) Skip to: full site navigation. In one case, a non-susceptible In subsequent clinical trials in adult patients, non-susceptible isolates were recovered. If the same IV line is used for sequential infusion of different drugs, the line should be flushed with a compatible intravenous solution before and after infusion with CUBICIN RF.For Injection: 500 mg daptomycin as a sterile, pale yellow to light brown lyophilized powder for reconstitution in a single-dose vial.CUBICIN RF is contraindicated in patients with known hypersensitivity to daptomycin.Anaphylaxis/hypersensitivity reactions have been reported with the use of antibacterial agents, including CUBICIN, and may be life-threatening. The pharmacokinetics of daptomycin were not altered in subjects with moderate hepatic impairment.
Of the 534 patients treated with CUBICIN, 1 (0.2%) had symptoms of muscle pain or weakness associated with CPK elevations to greater than 4 times the upper limit of normal (ULN). Due to inconsistencies between the drug labels on DailyMed and the pill images provided by See full prescribing information for CUBICIN. The symptoms resolved within 3 days and CPK returned to normal within 7 to 10 days after treatment was discontinued The safety of CUBICIN was evaluated in one clinical trial (in cSSSI), which included 256 pediatric patients (1 to 17 years of age) treated with intravenous CUBICIN and 133 patients treated with comparator agents. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by CUBICIN RF or other antibacterial drugs in the future.Distributed by: Merck Sharp & Dohme Corp., a subsidiary ofFor patent information: www.merck.com/product/patent/home.htmlThe trademarks depicted herein are owned by their respective companies. The contents of a Cubicin RF vial should be reconstituted, using aseptic technique, to 50 mg/mL as follows:Parenteral drug products should be inspected visually for particulate matter prior to administration.Slowly remove reconstituted liquid (50 mg daptomycin/mL) from the vial using a beveled sterile needle that is 21 gauge or smaller in diameter. CUBICIN is a lipopeptide antibacterial indicated for the treatment of: To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN and other antibacterial drugs, CUBICIN should be used to treat infections that are proven or strongly suspected to be caused by bacteria. The clinical success rates determined at 7–14 days after last dose of therapy (IV and oral) (TOC visit) were 88% (227/257) for CUBICIN and 86% (114/132) for comparator.The efficacy of CUBICIN in the treatment of adult patients with Upon entry, patients were classified for likelihood of endocarditis using the modified Duke criteria (Possible, Definite, or Not Endocarditis). In juvenile dogs, nerve effects were noted at lower daptomycin blood concentrations than in adult dogs following 28 days of dosing. Of the 396 subjects randomized in the study, 389 subjects were treated with CUBICIN or comparator and included in the ITT population. In the adult Phase 3 Clinically relevant plasma concentrations of daptomycin have been observed 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. Easy to read FDA package insert, drug facts, dosage and administration, and adverse effects for Cubicin (daptomycin) Skip to: full site navigation. In one case, a non-susceptible In subsequent clinical trials in adult patients, non-susceptible isolates were recovered. If the same IV line is used for sequential infusion of different drugs, the line should be flushed with a compatible intravenous solution before and after infusion with CUBICIN RF.For Injection: 500 mg daptomycin as a sterile, pale yellow to light brown lyophilized powder for reconstitution in a single-dose vial.CUBICIN RF is contraindicated in patients with known hypersensitivity to daptomycin.Anaphylaxis/hypersensitivity reactions have been reported with the use of antibacterial agents, including CUBICIN, and may be life-threatening. The pharmacokinetics of daptomycin were not altered in subjects with moderate hepatic impairment.