Xenofer 100 mg/5 ml (IV Injection or Infusion)
5 ml ampoule: ৳ 350.00
Medicine Details
Category | Details |
---|---|
Generic | Iron sucrose |
Company | Beacon pharmaceuticals plc |
Also available as |
Product Title
- Iron Sucrose Injection USP
Categories
- Medicine
- Parenteral Iron Preparations
Description
- Indicated for the treatment of Xenofer deficiency in various conditions including chronic kidney disease, surgical procedures, blood donation, and postpartum patients
- Therapeutic class is haematinic
- Aqueous complex of Polynuclear Iron (III) Hydroxide in Sucrose for intravenous use
- Contains approximately 30% Sucrose w/v (300 mg/ml) and has a pH of 10.5-11.1
Indications
- Rapid supply of Xenofer when clinically needed
- Treatment in patients unable to tolerate oral Xenofer therapy or who are non-compliant
- Treatment in active inflammatory bowel disease where oral Xenofer preparations are ineffective
- Treatment in non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving or not receiving an erythropoietin
- Treatment in hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin
- Treatment in peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin
- Treatment of Xenofer deficiency anaemia in patients undergoing surgical procedures, blood donation, postpartum patients
Pharmacology
- Dissociated into Iron and Sucrose by the reticuloendothelial system after intravenous administration
Dosage
- Adults and Elderly: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week depending on the hemoglobin level
- Children: Limited data available, not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level
Administration
- Can be administered undiluted by slow intravenous injection at recommended rate
- Preferably administered by drip infusion to reduce the risk of hypotensive episodes and paravenous injection
- Test dose recommended before therapeutic dose for new patients
Interaction
- Not studied for drug-drug interactions
- Should not be administered concomitantly with oral iron preparations
- Oral Xenofer therapy should not be given until 5 days after last injection
Contraindications
- Patients with evidence of Iron overload
- Patients with known hypersensitivity to Iron Sucrose or any of its inactive components
- Patients with anaemia not caused by Iron deficiency
- Patients with history of allergic disorders, liver disease, or infections
Side Effects
- Adverse reactions such as hypotension, nausea, headache, vomiting, diarrhea
- Body as a Whole: headache, fever, pain, asthenia, malaise
- Cardiovascular Disorders: hypotension, chest pain, hypertension, hypervolemia
- Gastrointestinal Disorders: nausea, vomiting, abdominal pain, elevated liver enzymes
- Central and Peripheral Nervous System: dizziness
- Respiratory System: dyspnea, pneumonia, cough
- Skin and appendages: pruritus, application site reaction
- Hypersensitivity reactions: wheezing, dyspnea, hypotension, rashes, anaphylactoid reactions including serious or life-threatening reactions
Pregnancy & Lactation
- Pregnancy Category-B
- Should be used during pregnancy only if clearly needed
- Caution should be exercised when administered to a nursing woman
Precautions & Warnings
- Caution should be exercised to withhold Xenofer administration in the presence of evidence of tissue Xenofer overload
- Periodic monitoring of hematologic and haematinic parameters required for patients receiving Xenofer
- Patients may experience serious hypersensitivity reactions and hypotension
Use in Special Populations
- Safety and effectiveness in pediatric patients not established
- No overall differences in safety observed between elder and younger subjects
- Injection directly into dialyser possible
- Specific dosage recommendations for chronic kidney disease patients
Overdose Effects
- Excess dosage may lead to accumulation of Iron in storage sites leading to hemosiderosis
- Symptoms associated with overdosage include hypotension, headache, vomiting, nausea, dizziness, joint aches, and cardiovascular collapse
Therapeutic Class
- Parenteral Iron Preparations
Storage Conditions
- Store in a cool (15°C-30°C) & dry place, protected from light
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