DAPTOMYCIN BIOCON POWDER FOR SOLUTION FOR INJECTION/INFUSION 500MG/VIAL [SIN17408P]

Product Info

DAPTOMYCIN BIOCON POWDER FOR SOLUTION FOR INJECTION/INFUSION 500MG/VIAL

[SIN17408P]

Indication

4.1 Therapeutic indications

Daptomycin Biocon is indicated for the treatment of the infections listed below.

Complicated Skin and Skin Structure Infections
Adult (≥18 years of age) and pediatric (1 to 17 years of age) patients 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 subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

Staphylococcus aureus Bloodstream Infections (Bacteremia)
Adult patients (≥18 years of age) with Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis (SAB/RIE), caused by methicillin-susceptible and methicillin-resistant isolates.

Pediatric patients (1 to 17 years of age) with S. aureus bloodstream infections (bacteremia) caused by methicillin-susceptible and methicillin-resistant isolates.

Daptomycin Biocon is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. The efficacy of Daptomycin Biocon 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 Biocon has not been studied in patients with prosthetic valve endocarditis.

Daptomycin Biocon is not indicated for the treatment of pneumonia [See 4.4 Special Warnings and Precautions, Pneumonia – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Dosing

4.2 Posology and method of administration

Adults

Complicated Skin and Skin Structure Infections

Daptomycin Biocon 4 mg/kg is administered to adult patients intravenously in 0.9% sodium chloride for injection 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 Biocon more frequently than once a day, and measure creatine phosphokinase (CPK) levels at baseline and at regular intervals (at least weekly). [See 6.6 Special precautions for disposal and other handling, Preparation of Daptomycin Biocon for Administration – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.]

Staphylococcus aureus Bloodstream Infections (Bacteremia)

Daptomycin Biocon 6 mg/kg is administered to adult patients intravenously in 0.9% sodium chloride for injection 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 Biocon more frequently than once a day, and measure CPK levels at baseline and at regular intervals (at least weekly). [See 6.6 Preparation of Daptomycin Biocon for Administration – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.]

Pediatric Patients (1 to 17 Years of Age)

Complicated Skin and Skin Structure Infections

The recommended dosage regimens based on age for pediatric patients with cSSSI are shown in Table 1. Daptomycin Biocon should be administered intravenously in 0.9% sodium chloride for injection once every 24 hours for up to 14 days.

Unlike in adults, Daptomycin Biocon should not be administered by injection over a two (2) minute period in pediatric patients.

Staphylococcus aureus Bloodstream Infections (Bacteremia)

The recommended dosage regimens based on age for pediatric patients with S. aureus bloodstream infections (bacteremia) are shown in Table 2. Daptomycin Biocon should be administered intravenously in 0.9% sodium chloride for injection once every 24 hours for up to 42 days.

Renal Impairment
Daptomycin is eliminated primarily by the kidneys; therefore, an adjustment of Daptomycin Biocon dosage interval is recommended for adult patients with creatinine clearance (CL_CR) <30 mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). The recommended dosing regimen for these adult patients is 4 mg/kg (cSSSI) or 6 mg/kg (S. aureus bloodstream infections) once every 48 hours. When possible, administer Daptomycin Biocon following the completion of hemodialysis on hemodialysis days. In adult patients with renal impairment, monitor both renal function and CPK more frequently than once weekly.

No dosage interval adjustment is required for adult patients with CL_CR ≥30 mL/min.

Due to limited clinical experience, Daptomycin Biocon should only be used in adult patients with any degree of renal impairment (creatinine clearance <80 mL/min) when it is considered that the expected clinical benefit outweighs the potential risk. The response to treatment and renal function should be closely monitored in all adult patients with some degree of renal impairment.

Dose adjustments in adult patients with renal impairment by indication and creatinine clearance:

The dosage regimen for Daptomycin Biocon in pediatric patients with renal impairment has not been established.

Contraindications

4.3 Contraindications

Daptomycin Biocon is contraindicated in patients with known hypersensitivity to daptomycin.