Product Information
Registration Status: ActiveSIN11083P
HYDRINE CAPSULE 500mg is approved to be sold in Singapore with effective from 1999-08-25. It is marketed by SHOEI UNIVERSAL CORPORATION PTE LTD, with the registration number of SIN11083P.
This product contains Hydroxyurea 500mg in the form of CAPSULE. It is approved for ORAL use.
This product is manufactured by KOREA UNITED PHARM. INC. in KOREA, and in REPUBLIC OF.
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 antineoplastic agent that inhibits DNA synthesis through the inhibition of ribonucleoside diphosphate reductase. [PubChem]
Indication
For management of melanoma, resistant chronic myelocytic leukemia, and recurrent, metastatic, or inoperable carcinoma of the ovary and Sickle-cell anemia.
Mechanism of Action
Hydroxyurea is converted to a free radical nitroxide (NO) in vivo, and transported by diffusion into cells where it quenches the tyrosyl free radical at the active site of the M2 protein subunit of ribonucleotide reductase, inactivating the enzyme. The entire replicase complex, including ribonucleotide reductase, is inactivated and DNA synthesis is selectively inhibited, producing cell death in S phase and synchronization of the fraction of cells that survive. Repair of DNA damaged by chemicals or irradiation is also inhibited by hydroxyurea, offering potential synergy between hydroxyurea and radiation or alkylating agents. Hydroxyurea also increases the level of fetal hemoglobin, leading to a reduction in the incidence of vasoocclusive crises in sickle cell anemia. Levels of fetal hemoglobin increase in response to activation of soluble guanylyl cyclase (sGC) by hydroxyurea-derived NO.
Pharmacokinetics
- Absorption
- Well absorbed from the gastrointestinal tract.
- Distribution
- Metabolism
- Hepatic.
- Elimination
Toxicity
Oral, mouse: LD50 = 7330 mg/kg; Oral, rat: LD50 = 5760 mg/kg Teratogenicity: Teratogenic effects have occurred in experimental animals.Hydroxyurea use during a small number of human pregnancies has been reported. Adverse effects have not been observed in any of the exposed newborns. Reproductive Effects: Adverse reproductive effects have occurred in experimental animals. Mutagenicity: Mutagenic effects have occurred in experimental animals.Mutagenic effects have occurred in humans.
Active Ingredient/Synonyms
Carbamohydroxamic Acid | Carbamohydroximic Acid | Carbamoyl Oxime | Carbamyl Hydroxamate | Hidroxicarbamida | Hydroxycarbamid | Hydroxycarbamide | Hydroxycarbamidum | Hydroxyharnstoff | Hydroxyurea | N-Carbamoylhydroxylamine | N-Hydroxyurea | Oxyurea | Hydroxyurea |
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.