Unifer IV Injection or Infusion 100 mg/5 ml
Unifer IV Injection or Infusion 100 mg/5 ml Uses, Dosage, Side Effects, Food Interaction and all others data.
Following intravenous administration, this is dissociated into Iron and Sucrose by the reticuloendothelial system, and Iron is transferred from the blood to a pool of Iron in the liver and bone marrow. Ferritin, an Iron storage protein, binds and sequesters Iron in a nontoxic form, from which Iron is easily available. Iron binds to plasma transferrin, which carries Iron within the plasma and the extracellular fluid to supply the tissues. The transferrin receptor, located in the cell, and the transferrin-receptor complex is returned to the cell membrane. Transferrin without Iron (apotransferrin) is then released to the plasma. The intracellular Iron becomes (mostly) haemoglobin in circulating red blood cells (RBCs). Transferrin synthesis is increased and ferritin production reduced in Iron deficiency.The converse is true when Iron is plentiful.
Significant increases in serum iron and serum ferritin and significant decreases in total iron binding capacity occurred four weeks from the initiation of iron sucrose treatment.
| Trade Name | Unifer IV Injection or Infusion 100 mg/5 ml |
| Generic | Iron Sucrose |
| Iron Sucrose Other Names | Ferric hydroxide sucrose complex, Iron oxide saccharated, Iron saccharate, Iron sucrose, Iron sucrose complex, Iron sugar, Saccharated ferric oxide, Saccharated iron, Saccharated iron oxide, Sucroferric oxyhydroxide |
| Weight | 100 mg/5 ml |
| Type | IV Injection or Infusion |
| Formula | C12H29Fe5Na2O23 |
| Weight | Average: 866.546 Monoisotopic: 866.764181 |
| Protein binding | It binds with transferrin. |
| Groups | Approved |
| Therapeutic Class | Parenteral Iron Preparations |
| Manufacturer | Ziska Pharmaceuticals Ltd. |
| Available Country | Bangladesh |
| Last Updated: | October 19, 2023 at 6:27 am |
Uses
This is used for the treatment of Iron deficiency in the following indications:
- Where there is a clinical need for a rapid Iron supply
- In patients who can not tolerate oral Iron therapy or who are non-compliant
- In active inflammatory bowel disease where oral Iron preparations are ineffective
- Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin
- Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin
- Hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin
- Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin
It is also used for the treatment of Iron deficiency anaemia in patients undergoing surgical procedures, patients donating blood, postpartum patients.
Unifer IV Injection or Infusion 100 mg/5 ml is also used to associated treatment for these conditions: Hyperphosphataemia
How Unifer IV Injection or Infusion 100 mg/5 ml works
Following intravenous administration, iron sucrose 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.
Dosage
Unifer IV Injection or Infusion 100 mg/5 ml dosage
Adults and Elderly: 5-10 ml (100-200 mg Iron) once to three times a week depending on the hemoglobin level.
Unifer IV Injection or Infusion 100 mg/5 ml has exclusively to be administered intravenously by slow injection or by drip infusion or directly into the venous limb of the dialyzer. Unifer IV Injection or Infusion 100 mg/5 ml must not be used for intramuscular injection.
Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.
As injection: Unifer IV Injection or Infusion 100 mg/5 ml can also be administered undiluted by slow IV injection at a rate of 1 ml Unifer IV Injection or Infusion 100 mg/5 ml (20 mg Iron) in at least 1 minute a maximum of 10 ml Unifer IV Injection or Infusion 100 mg/5 ml (200 mg Iron) can be administered per injection in at least 10 minutes.
As infusion: Unifer IV Injection or Infusion 100 mg/5 ml should preferably be administered by drip infusion ( in order to reduce hypotensive episodes) in a dilution of 1 ml Unifer IV Injection or Infusion 100 mg/5 ml in maximum 20 ml 0.9% NaCl etc up to 25 ml Unifer IV Injection or Infusion 100 mg/5 ml in maximum 500 ml 0.9% NaCl. Dilution must take place immediately prior to infusion and solution must be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes ete. Normal posology is to use 5-10 ml Unifer IV Injection or Infusion 100 mg/5 ml 1-3 times a week depending on the Hemoglobin level. For the administration of the maximum tolerable dose of 7 mg Iron/kg body weight an infusion time of at least 3.5 hours has to be respected, independently of the total dose.
Side Effects
Unifer IV Injection or Infusion 100 mg/5 ml is generally well tolerated. However, occasionally metallic taste, headache, nausea, vomiting and hypotension may occur. Less frequently side-effects are paresthesia, abdominal disorders, muscular pain, fever, urticaria, flushing, edema of the extremities, anaphylactic (pseudoallergic) reactions and in the region of the punctured vein, phlebitis and venous spasm have been observed.
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.
Precaution
Unifer IV Injection or Infusion 100 mg/5 ml should be administered with caution in patients with asthma, eczema, other atopic allergies or allergic reaction to other parenteral Iron preparations, low binding capacity and/or folic acid deficiency, liver dysfunction, acute or chronic infection.
Baseline tests: Ensure Hgb, Hct, serum ferritin and transferrin saturation is determined before starting therapy and periodically during treatment. Note that serum Iron levels may be reliably obtained 48 hours after IV dosing.
Blood Pressure: Monitor Blood Pressure during infusion. If hypotension occurs, slow the rate of infusion. If hypotension continues, discontinue infusion and be prepared to treat appropriately.
Discontinue oral Iron preparations before administering parenteral Iron products. Co administration of parenteral Iron preparations may reduce absorption of oral Iron.The dose will be in terms of elemental Iron. For IV administration only. Not for intradermal, subcutaneous, IM, or intra-arterial administration. Medication is administered 1 to 3 times/ week. Do not administer more than 3 times/week. Discard any unused diluted solution. Do not save unused solution for future use. Do not administer if particulate matter or discoloration noted.
Interaction
Drug-drug interactions involving Unifer IV Injection or Infusion 100 mg/5 ml have not been studied. Unifer IV Injection or Infusion 100 mg/5 ml Injection should not be administered concomitantly with oral iron preparations since the absorption of oral Iron is reduced. Even oral Iron therapy should not be given until 5 days after last injection.
Food Interaction
- Take with food. Take with meals to maximize phosphate binding capacity and reduce phosphate absorption.
Volume of Distribution
Vd is 7.3 L
Elimination Route
The intravensously administered iron sucrose 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.
Half Life
6 hours.
Clearance
Total body clearance is 20.5 ml/min.
Elimination Route
Renal elimination of iron contributed very little to the total elimination (in average less than 5%). While, renal elimination of sucrose accounts for 68-75% of the administered dose after 4 and 24 hours respectively.
Pregnancy & Breastfeeding use
Pregnant women: FDA pregnancy category B.
Lactating mothers: It is not known whether this drug is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Unifer IV Injection or Infusion 100 mg/5 ml is administered to a nursing woman.
Contraindication
The use of Unifer IV Injection or Infusion 100 mg/5 ml is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Unifer IV Injection or Infusion 100 mg/5 ml or any of its inactive components, and in patients with anaemia not caused by Iron deficiency. It is also contraindicated in patients with history of allergic disorders including asthma, eczema and anaphylaxis, liver disease and infections.
Acute Overdose
Overdosage can cause acute iron overloading wich may manifests itself as haemosiderosis. Symptoms associated with overdosage or infusing Unifer IV Injection or Infusion 100 mg/5 ml too rapidly included hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema, and cardiovascular collapse. Overdosage should be treated with supportive measures and, if required, an Iron chelating agent. Most symptoms have been successfully treated with IV fluids, hydrocortisone, and/or antihistamines. Infusing the solution as recommended or at a slower rate may also alleviate symptoms.
Storage Condition
Store below 25° C. Do not freeze. Use immediately after dilution in saline.
Innovators Monograph
You find simplified version here Unifer IV Injection or Infusion 100 mg/5 ml
Unifer IV Injection or Infusion 100 mg/5 ml contains Iron Sucrose see full prescribing information from innovator Unifer IV Injection or Infusion 100 mg/5 ml Monograph, Unifer IV Injection or Infusion 100 mg/5 ml MSDS, Unifer IV Injection or Infusion 100 mg/5 ml FDA label
FAQ
What is Unifer IV Injection or Infusion 100 mg/5 ml used for?
Unifer IV Injection or Infusion 100 mg/5 ml injection is an iron replacement product used to treat iron deficiency anemia in people with kidney disease. Unifer IV Injection or Infusion 100 mg/5 ml is usually given with another medication to promote the growth of red blood cells.
How safe is Unifer IV Injection or Infusion 100 mg/5 ml?
Unifer IV Injection or Infusion 100 mg/5 ml has been reported to be safe with an excellent profile in clinical use.
How does Unifer IV Injection or Infusion 100 mg/5 ml work?
Unifer IV Injection or Infusion 100 mg/5 ml works by replenishing iron stores so that the body can make more red blood cells.
What are the common side effects of Unifer IV Injection or Infusion 100 mg/5 ml?
Common side effects of Unifer IV Injection or Infusion 100 mg/5 ml are include:
- Bloating or swelling of the face, arms, hands, lower legs, or feet.
- chest pain or tightness in the chest.
- difficult or labored breathing.
- headache.
- slow or fast heartbeat.
- tingling of the hands or feet.
- unusual tiredness or weakness.
Is Unifer IV Injection or Infusion 100 mg/5 ml safe during pregnancy?
Unifer IV Injection or Infusion 100 mg/5 ml has been reported to be safe and effective during pregnancy.
Is Unifer IV Injection or Infusion 100 mg/5 ml safe during breastfeeding?
Unifer IV Injection or Infusion 100 mg/5 ml supplements are perfectly safe to take when you're breastfeeding. Your provider may give you a prescription, or recommend an over-the-counter supplement that's right for you
Can I drink alcohol with Unifer IV Injection or Infusion 100 mg/5 ml?
drinking alcohol increases the risk of cancer and is linked to other health concerns, you shouldn't start drinking alcohol to increase iron absorption.
When should I take Unifer IV Injection or Infusion 100 mg/5 ml ?
Administer Unifer IV Injection or Infusion 100 mg/5 ml early during the dialysis session. The usual total treatment course of Unifer IV Injection or Infusion 100 mg/5 ml is 1000 mg. Venofer treatment may be repeated if iron deficiency reoccurs.
How is Unifer IV Injection or Infusion 100 mg/5 ml given?
Unifer IV Injection or Infusion 100 mg/5 ml is given by injection into a vein as directed by your doctor. It is usually given slowly over 2 to 5 minutes or as directed by your doctor. Unifer IV Injection or Infusion 100 mg/5 ml can also be mixed in a saline solution and given through an IV over a longer time.
How long does Unifer IV Injection or Infusion 100 mg/5 ml take to work?
Unifer IV Injection or Infusion 100 mg/5 ml complex is effective because of the rapid removal from the plasma and the availability of iron for erythropoiesis. After a bolus dose of iron sucrose, the plasma peak occurs in 10 minutes.
How often can I give Unifer IV Injection or Infusion 100 mg/5 ml ?
Unifer IV Injection or Infusion 100 mg/5 ml can be given as a maximum of 200mg not more than 3 times per week; doses must be 24 hours apart.
Who should not take Unifer IV Injection or Infusion 100 mg/5 ml?
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your iron sucrose injection.
What happens if I overdose?
Seek emergency medical attention
Can too much Unifer IV Injection or Infusion 100 mg/5 ml cause infertility?
Haemochromatosis is well established as a cause of infertility in both men and women, usually because iron deposition in the pituitary or the gonads leads to hypogonadism.
Is iron hard on my heart?
Unifer IV Injection or Infusion 100 mg/5 ml has a big job in our bodies as a crucial part of the proteins that deliver oxygen to our tissues. With low iron, the heart must pump harder, which can lead to fatigue, shortness of breath, and a higher risk of heart attacks and strokes.
Can Unifer IV Injection or Infusion 100 mg/5 ml affects my kidney?
Unifer IV Injection or Infusion 100 mg/5 ml increased proteinuria, the long-term effects of repeated non-dextran iron on kidney function requires further study.
Does Unifer IV Injection or Infusion 100 mg/5 ml increase hemoglobin?
One way of treating anemia is with intravenous Unifer IV Injection or Infusion 100 mg/5 ml, which is delivered into the vein through a needle to increase the levels of iron and hemoglobin in the body.
