Product Information
Registration Status: ActiveSIN13501P
CUBICIN (DAPTOMYCIN FOR INJECTION) 500MG is approved to be sold in Singapore with effective from 2008-07-28. It is marketed by MSD PHARMA (SINGAPORE) PTE LTD, with the registration number of SIN13501P.
This product contains Daptomycin 500mg/vial in the form of INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION. It is approved for INTRAVENOUS use.
This product is manufactured by OSO BIOPHARMACEUTICALS MANUFACTURING LLC (manufacture in UNITED STATES, and primary packaging) in ITALY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Daptomycin is a lipopeptide antibiotic that kills susceptible gram positive bacteria by disrupting their membrane potential. It is a naturally-occurring compound found in the soil bacterium Streptomyces roseosporus. Antibiotics are used in the treatment of infections caused by bacteria. They work by killing bacteria or preventing their growth. Daptomycin will not work for colds, flu, or other virus infections. It was approved in September 2003 for the treatment of complicated skin and soft tissue infections. It has a safety profile similar to other agents commonly administered to treat gram-positive infections.
Indication
For the treatment of complicated skin and skin structure infections caused by susceptible strains of Gram-positive microorganisms.
Mechanism of Action
Daptomycin appears to bind or insert into the outer membrane of gram positive bacteria. The binding and integration of daptomycin into the cell membrane is calcium dependent. Calcium ions cause a conformational change in daptomycin, augmenting its amphipathicity (hydrophilic head group and hydrophobic tail group), leading to incorporation into the cell membrane. This binding causes rapid depolarisation, resulting in a loss of membrane potential leading to inhibition of protein, DNA and RNA synthesis, which results in bacterial cell death. The bactericidal activity of daptomycin is concentration-dependent. There is in vitro evidence of synergy with β-lactam antibiotics.
Pharmacokinetics
- Absorption
- Generally exhibits linear and time-independent pharmacokinetics at a dosage of 4–12 mg/kg IV once every 24 hours. Steady-state trough serum concentrations are achieved by the third daily dose.
- Distribution
- * 0.1 L/Kg [healthy adult subjects]
- Metabolism
- Minor amounts of three oxidative metabolites and one unidentified compound have been detected in urine. The site of metabolism has not been identified.
- Elimination
Clearance
Excreted primarily in the urine as unchanged drug (78%) and in the feces (6%)
Active Ingredient/Synonyms
Daptomycin | Daptomycin |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.