Product Information
Registration Status: ActiveSIN14727P
VELPHORO CHEWABLE TABLET 500MG is approved to be sold in Singapore with effective from 2015-01-29. It is marketed by FRESENIUS KABI (SINGAPORE) PTE LTD, with the registration number of SIN14727P.
This product contains Sucroferric Oxyhydroxide 500mg (iron) in the form of TABLET, CHEWABLE. It is approved for ORAL use.
This product is manufactured by Catalent Germany Schorndorf GmbH in SWITZERLAND, andVifor SA in GERMANY.
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
Iron saccharate (Sucroferric oxyhydroxide or Iron Sucrose) is used as a source of iron in patients with iron deficiency anemia with chronic kidney disease (CKD), including those who are undergoing dialysis (hemodialysis or peritoneal) and those who do not require dialysis. Due to less side effects than iron dextran, iron saccharate is more preferred in chronic kidney disease patients.
Indication
Iron sucrose is elemental iron as an injection. It replenishes body iron stores in patients with iron deficiency.
Mechanism of Action
Following intravenous administration, iron saccharate is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells. The iron is then incorporated into hemoglobin as the cells mature into red blood cells.
Pharmacokinetics
- Absorption
- The intravensously administered iron sacchrate injection would result rapidly in high serum iron levels. Maximum measured levels occured after 10 min of injection with an average of 30.00 mg/l.
- Distribution
- Vd is 7.3 L
- Metabolism
- Following IV administration, dissociated into iron and sucrose by the reticuloendothelial system.
- Elimination
Clearance
Total body clearance is 20.5 ml/min.
Toxicity
Hypersensitivity reactions, including anaphylactic shock, loss of consciousness, collapse, hypotension, dyspnea, and seizure. Monitor iron toxicity through the periodic evaluation of lab works which monitor the body concentration of iron. Lab monitoring of the following parameters: transferrin saturation, serum ferritin concentrations, hemoglobin, and hematocrit could be helpful to avoid iron overload. Severe allergic symptoms include: rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning or pain at the injection site; burning, numbness, or tingling; chest pain; fainting; loss of consciousness; severe or persistent dizziness, headache, or light-headedness; seizures; shortness of breath; swelling of the hands, ankles, or feet.
Active Ingredient/Synonyms
Ferric hydroxide sucrose complex | Iron oxide saccharated | Iron sucrose | Iron sucrose complex | Iron sugar | Iron(III) hydroxide sucrose complex | Saccharated ferric oxide | Saccharated iron | Saccharated iron oxide | Sucroferric oxyhydroxide | Iron saccharate |
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.