DAPTOMYCIN PACKAGE INSERT PDF

Indications: CUBICIN and CUBICIN RF are indicated for the treatment of adult and pediatric patients 1 to 17 years of age with complicated skin and skin structure infections cSSSI caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus including methicillin-resistant isolates , Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subspecies equisimilis, and Enterococcus faecalis vancomycin-susceptible isolates only. When culture and susceptibility information is available, it should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Empiric therapy may be initiated while awaiting test results.

Author:Vudolkis Akinorr
Country:Nigeria
Language:English (Spanish)
Genre:Love
Published (Last):7 August 2018
Pages:234
PDF File Size:7.32 Mb
ePub File Size:16.67 Mb
ISBN:530-5-41340-313-9
Downloads:25169
Price:Free* [*Free Regsitration Required]
Uploader:Kakora



Of the 11 daptomycin-treated patients, 4 had prior or concomitant treatment with an HMG-CoA reductase inhibitor. Three of these 11 daptomycin-treated patients discontinued therapy due to CPK elevation, while the one comparator-treated patient did not discontinue therapy [see Warnings and Precautions 5.

Post-Marketing Experience The following adverse reactions have been identified during post-approval use of daptomycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: anemia, thrombocytopenia General and administration site conditions: pyrexia Immune System Disorders: anaphylaxis; hypersensitivity reactions, including angioedema, drug rash with eosinophilia and systemic symptoms DRESS , pruritus, hives, shortness of breath, difficulty swallowing, truncal erythema, and pulmonary eosinophilia [see Contraindications 4 , Warnings and Precautions 5.

However, inhibitors of HMG-CoA reductase may cause myopathy, which is manifested as muscle pain or weakness associated with elevated levels of creatine phosphokinase CPK. In the adult Phase 3 S. Drug-Laboratory Test Interactions 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.

However, sufficient daptomycin concentrations may be present at trough to cause interaction. No evidence of adverse developmental outcomes was observed.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. Lactation Risk Summary Limited published data report that daptomycin is present in human milk at infant doses of 0. There is no information on the effects of daptomycin on the breastfed infant or the effects of daptomycin on milk production.

Pediatric Use Safety and effectiveness in pediatric patients below the age of one year have not been established. The exposure of daptomycin was higher in healthy elderly subjects than in healthy young adult subjects.

In adult patients with renal impairment, both renal function and creatine phosphokinase CPK should be monitored more frequently than once weekly [see Dosage and Administration 2.

Overdosage In the event of overdosage, supportive care is advised with maintenance of glomerular filtration. The use of high-flux dialysis membranes during 4 hours of hemodialysis may increase the percentage of dose removed compared with that removed by low-flux membranes.

The only inactive ingredient is sodium hydroxide, which is used for pH adjustment.

BHARATBENZ 2523 PDF

Daptomycin for Injection

Of the 11 daptomycin-treated patients, 4 had prior or concomitant treatment with an HMG-CoA reductase inhibitor. Three of these 11 daptomycin-treated patients discontinued therapy due to CPK elevation, while the one comparator-treated patient did not discontinue therapy [see Warnings and Precautions 5. Post-Marketing Experience The following adverse reactions have been identified during post-approval use of daptomycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: anemia, thrombocytopenia General and administration site conditions: pyrexia Immune System Disorders: anaphylaxis; hypersensitivity reactions, including angioedema, drug rash with eosinophilia and systemic symptoms DRESS , pruritus, hives, shortness of breath, difficulty swallowing, truncal erythema, and pulmonary eosinophilia [see Contraindications 4 , Warnings and Precautions 5. However, inhibitors of HMG-CoA reductase may cause myopathy, which is manifested as muscle pain or weakness associated with elevated levels of creatine phosphokinase CPK. In the adult Phase 3 S.

GARDEN OF EMUNAH PDF

Daptomycin Injection

.

Related Articles