Product Information
Registration Status: ActiveSIN05419P
CARBOPLATIN INJECTION 10mg/ML is approved to be sold in Singapore with effective from 1991-02-18. It is marketed by PFIZER PTE LTD, with the registration number of SIN05419P.
This product contains Carboplatin 10mg/ml in the form of INJECTION. It is approved for INTRAVENOUS use.
This product is manufactured by PFIZER (PERTH) PTY LTD in AUSTRALIA.
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
An organoplatinum compound that possesses antineoplastic activity. [PubChem]
Indication
For the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of PARAPLATIN and cyclophosphamide. It is also indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin.
Mechanism of Action
Alkylating agents work by three different mechanisms: 1) attachment of alkyl groups to DNA bases, resulting in the DNA being fragmented by repair enzymes in their attempts to replace the alkylated bases, preventing DNA synthesis and RNA transcription from the affected DNA, 2) DNA damage via the formation of cross-links (bonds between atoms in the DNA) which prevents DNA from being separated for synthesis or transcription, and 3) the induction of mispairing of the nucleotides leading to mutations.
Pharmacokinetics
- Absorption
- The Cmax values and areas under the plasma concentration versus time curves from 0 to infinity (AUC inf) increase linearly with dose, although the increase was slightly more than dose proportional. Carboplatin exhibits linear pharmacokinetics.
- Distribution
- * 16 L [apparent volume of distribution, 30 minute IV infusion of 300 mg/m^2 to 500 mg/m^2]
- Metabolism
- Elimination
Clearance
* 4.4 L/hour [total body clearance, 30 minute IV infusion of 300 mg/m^2 to 500 mg/m^2]
Toxicity
Toxic by ingestion. May be create toxic effect through inhalation or skin contact. May cause reproductive defects. May act as a sensitizer. ORL-RAT LD50 343 mg kg-1; SCN-RAT LD50 72 mg kg-1; IPN-MUS LD50 118 mg kg-1
Active Ingredient/Synonyms
Carboplatin | CBDCA | cis-(1,1-Cyclobutanedicarboxylato)diammineplatinum(ii) | cis-Diammine(1,1-cyclobutanedicarboxylato)platinum | cis-Diammine(1,1-cyclobutanedicarboxylato)platinum(II) | Carboplatin |
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.