- Approval Id
- fd4944880aeabcea
- Drug Name
- PENMIX DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL
- Product Name
- PENMIX DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL
- Approval Number
- SIN16813P
- Approval Date
- 2023-06-27
- Registrant
- SHOEI UNIVERSAL CORPORATION PTE LTD
- Licence Holder
- SHOEI UNIVERSAL CORPORATION PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<ol>
<li><p>Dosage in Adults for cSSSI:<br>
Administer Penmix Daptomycin Injection 500mg 4mg/kg to adult patients intravenously in 0.9% sodium chloride injection once every 24 hours for 7 to 14 days over a 30-minute period or as an injection over 2 minutes. Unlike in adults, Penmix Daptomycin Injection 500mg should not be administered by injection over a two minute period in pediatric patients.</p></li>
<li><p>Dosage in Pediatric Patients (1 to 17 Years of Age) with Complicated Skin and Skin Structure Infections, Based on Age<br>
Penmix Daptomycin Injection 500mg should be administered intravenously in 0.9% sodium chloride for injection once every 24 hours for up to 14 days.<br>
Unlike in adults, Penmix Daptomycin Injection 500mg should not be administered by injection over a two (2) minute period in pediatric patients.</p>
<img src="/TGIF/PenmixDaptomycin-Table1.png" alt="Penmix Daptomycin Dosage Table 1" /><br><br>
</li>
<li><p>Recommended Dosage of Penmix Daptomycin Injection 500mg in Pediatric Patients (1 to 17 Years of Age) with S. aureus Bloodstream Infections, Based on Age</p>
<img src="/TGIF/PenmixDaptomycin-Table2.png" alt="Penmix Daptomycin Dosage Table 2" /><br><br>
</li>
<li><p>Dosage in Adult Patients with Staphylococcus aureus Bloodstream Infections (Bacteremia), Including Those with Right-Sided Infective Endocarditis, Caused by Methicillin-Susceptible and Methicillin- Resistant Isolates:<br>
Administer Penmix Daptomycin Injection 500mg 6 mg/kg to adult patients intravenously in 0.9% sodium chloride for injection once every 24 hours for 2 to 6 weeks over a 30-minute period or as an injection over 2 minutes. Unlike in adults, Penmix Daptomycin Injection 500mg should not be administered by injection over a two minute period in pediatric patients. There are limited safety data for the use of Penmix Daptomycin Injection 500mg for more than 28 days of therapy. In the Phase 3 trial, there were a total of 14 adult patients who were treated with daptomycin for more than 28 days.</p></li>
<li><p>Dosage in Patients with Renal Impairment:<br>
The recommended dosage regimen in adult patients with impaired renal functions as follows; When possible, for adult patients on hemodialysis administer Penmix Daptomycin Injection 500mg following the completion of dialysis on dialysis days.</p>
<img src="/TGIF/PenmixDaptomycin-Table3.png" alt="Penmix Daptomycin Dosage Table 3" /><br><br>
<p>In adult patients with renal impairment, monitor both renal function and CPK more frequently than once weekly.<br>
Due to limited clinical experience, daptomycin 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.</p>
<p>The dosage regimen for Penmix Daptomycin Injection 500mg in pediatric patients with renal impairment has not been established.</p>
</li>
</ol>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>INDICATIONS</strong><br>
Penmix Daptomycin Injection 500mg is indicated for the treatment of the following infections:</p>
<ol>
<li><p>Adult 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 (vancomysin-susceptible isolates only).</p></li>
<li><p>Adult patient with Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis (SAB/RIE), caused by methicillin-susceptible and methicillin-resistant isolates.</p></li>
<li><p>Pediatric patients (1 to 17 years of age) with S. aureus bloodstream infections (bacteremia) caused by methicillin-susceptible and methicillin-resistant isolates.</p></li>
<li><p>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.</p></li>
</ol>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
Penmix Daptomycin Injection 500mg is contraindicated in patients with known hypersensitivity to daptomycin.</p>
- Atc Code
- J01XX09
- Atc Item Name
- daptomycin
- Pharma Manufacturer Name
- SHOEI UNIVERSAL CORPORATION PTE LTD
