Product Information
Registration Status: ActiveADRIM – DOXORUBICIN HYDROCHLORIDE INJECTION USP 2MG/ML is approved to be sold in Singapore with effective from 2021-01-15. It is marketed by FRESENIUS KABI (SINGAPORE) PTE LTD, with the registration number of SIN16081P.
This product contains Doxorubicin 2 mg/ml in the form of INJECTION, SOLUTION. It is approved for INTRAVENOUS use.
This product is manufactured by Fresenius Kabi Oncology Ltd. in INDIA.
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.
Description
Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var. caesius. Doxorubicin binds to nucleic acids, presumably by specific intercalation of the planar anthracycline nucleus with the DNA double helix.
Indication
Doxorubicin is used to produce regression in disseminated neoplastic conditions like acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types. Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer.
Mechanism of Action
Doxorubicin has antimitotic and cytotoxic activity through a number of proposed mechanisms of action: Doxorubicin forms complexes with DNA by intercalation between base pairs, and it inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, preventing the religation portion of the ligation-religation reaction that topoisomerase II catalyzes.
Clearance
* 324-809 mL/min/m2 [by metabolism and biliary excretion] * 1088 mL/min/m2 [Men] * 433 mL/min/m2 [Women] * 1540 mL/min/m2 [children greater than 2 years of age receiving administration of 10 to 75 mg/m2 doses] * 813 mL/min/m2 [infants younger than 2 years of age receiving administration of 10 to 75 mg/m2 doses]
Toxicity
LD50=21800 ug/kg (rat, subcutaneous)
Active Ingredient/Synonyms
(1S,3S)-3-Glycoloyl-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-1-yl 3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranoside | (8S-cis)-10-((3-amino-2,3,6-Trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-5,12-naphthacenedione | 14-hydroxydaunomycin | 14-hydroxydaunorubicine | Doxorubicin | Doxorubicine | Doxorubicinum | Hydroxydaunorubicin | Doxorubicin |
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.