- Approval Id
- 5bfbbcef5c92022c
- Drug Name
- DAPTOCCORD 500 POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MG/VIAL
- Product Name
- DAPTOCCORD 500 POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MG/VIAL
- Approval Number
- SIN16071P
- Approval Date
- 2020-12-29
- Registrant
- ACCORD HEALTHCARE PRIVATE LIMITED
- Licence Holder
- ACCORD HEALTHCARE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Dosage
- **4.2 Posology and method of administration**
Posology
_Adults_
Complicated Skin and Skin Structure Infections
Daptomycin 4mg/kg is administered intravenously in 0.9% sodium chloride once every 24 hours for 7 to 14 days, either by injection over a 2-minute period or by infusion over a 30-minute period. Do not dose Daptomycin more frequently than once a day, and measure creatine phosphokinase (CPK) levels at baseline and at regular intervals (at least weekly).
Staphylococcus aureus Bloodstream Infections (Bacteremia)
Daptomycin 6mg/kg is administered intravenously in 0.9% sodium chloride once every 24 hours for 2 to 6 weeks, either by injection over a 2-minute period or by infusion over a 30-minute period.
Duration of treatment is based on the treating physician’s working diagnosis. Do not dose Daptomycin more frequently than once a day, and measure CPK levels at baseline and at regular intervals (at least weekly).
_Renal impairment_
Daptomycin is eliminated primarily by the kidney.
Due to limited clinical experience (see table and footnotes below) daptomycin should only be used in adult patients with any degree of renal impairment (CrCl< 80 ml/min) when it is considered that the expected clinical benefit outweighs the potential risk. The response to treatment, renal function and creatine phosphokinase (CPK) levels should be closely monitored in all patients with any degree of renal impairment (see also sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The dosage regimen for Daptomycin in paediatric patients with renal impairment has not been established.
Dose adjustments in adult patients with renal impairment by indication and creatinine clearance.
_Hepatic impairment_
No dose adjustment is necessary when administering Daptomycin to patients with mild or moderate hepatic impairment (Child-Pugh Class B) (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No data are available in patients with severe hepatic impairment (Child-Pugh Class C). Therefore, caution should be exercised if Daptomycin is given to such patients.
_Elderly patients_
The recommended doses should be used in elderly patients except those with severe renal impairment (see above and section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
_Paediatric patients_
Safety and effectiveness of daptomycin in patients under the age of 18 have not been established.
Paediatric patients below the age of one year should not be given daptomycin due to the risk of potential effects on muscular, neuromuscular and/or nervous systems (either peripheral and/or central) that were observed in neonatal dogs (see section 5.3 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Route Of Administration
- INTRAVENOUS
- Indication Info
- **4.1 Therapeutic indications**
Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- 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 subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).
- Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis (SAB/RIE), caused by methicillin-susceptible and methicillin resistant isolates.
Daptomycin is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. The efficacy of Daptomycin in patients with left-sided infective endocarditis due to S.aureus has not been demonstrated. The clinical trial of Daptomycin in patients with S. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor. Daptomycin has not been studied in patients with prosthetic valve endocarditis.
Daptomycin is not indicated for the treatment of pneumonia.
Daptomycin is active against Gram-positive bacteria only (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In mixed infections where Gram-negative and/or certain types of anaerobic bacteria are suspected, Daptomycin should be co-administered with appropriate antibacterial agent(s).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
- Contraindications
- **4.3 Contraindications**
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
- Atc Code
- J01XX09
- Atc Item Name
- daptomycin
- Pharma Manufacturer Name
- ACCORD HEALTHCARE PRIVATE LIMITED
- Company Detail Path
- /organization/7b2062edde9ff0f1/accord-healthcare-private-limited
