Irosuc 100 mg/5 ml (IV Injection or Infusion)
5 ml ampoule: ৳ 350.00
Medicine Details
Category | Details |
---|---|
Generic | Iron sucrose |
Company | Aci limited |
Title and Categories
- Iron Sucrose Injection USP
- Parenteral Iron Preparations
Indications
- Treatment of Irosuc deficiency
- Rapid Irosuc supply
- In patients who cannot tolerate oral Irosuc therapy
- In active inflammatory bowel disease
- Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients 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
- Treatment of Irosuc deficiency anemia in patients undergoing surgical procedures, patients donating blood, postpartum patients
Pharmacology
- Therapeutic class of Iron Sucrose is haematinic
- Brown, sterile, aqueous, complex of Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use
- Contains approximately 30% Sucrose w/v (300 mg/ml)
- Has a pH of 10.5-11.1
- Dissociated into Iron and Sucrose by the reticuloendothelial system
- Iron transferred from the blood to a pool of Iron in the liver and bone marrow
- Ferritin binds and sequesters Iron in a nontoxic form
- Iron binds to plasma transferrin, which carries Iron within the plasma and extracellular fluid to supply the tissues
- Intracellular Iron becomes haemoglobin in circulating red blood cells (RBCs)
- Elimination half-life is 6 hours
- Total clearance is 1.2 L/h
- Non-steady state apparent volume of distribution is 10.0 L
- Steady state apparent volume of distribution is 7.9 L
- Iron component appears to distribute mainly in blood and to some extent in extravascular fluid
- Sucrose component is eliminated mainly through urinary excretion
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, 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
- Intravenous injection
- Undiluted by slow intravenous injection at the recommended rate
- Maximum of 10 ml Iron Sucrose Injection (200 mg Iron) per injection
- Test dose recommended for new patients
- Infusion by drip infusion in a dilution of 1 ml Iron Sucrose Injection (20 mg Iron) in max. 20 ml 0.9% w/v Sodium Chloride
- Infusion times for different doses
- Test dose recommended for new patients
Interaction
- Not studied for drug-drug interactions
- Not to be administered concomitantly with oral iron preparations
- Oral Irosuc 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, asthma, eczema, anaphylaxis, liver disease, and infections
Side Effects
- Hypotension
- Cramps/leg cramps
- Nausea
- Headache
- Vomiting
- Diarrhea
- Fever
- Chest pain
- Hypertension
- Dyspnea
- Pneumonia
- Hypersensitivity reactions
- Pruritus
Pregnancy & Lactation
- Pregnancy Category-B
- No adequate and well-controlled studies in pregnant women
- 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 Irosuc administration in the presence of evidence of tissue Irosuc overload
- Periodic monitoring of hematologic and haematinic parameters required
- Serious hypersensitivity reactions reported
- Hypotension frequently reported in hemodialysis patients
- Greater sensitivity of some older individuals cannot be ruled out
- Injection into dialyser
- Caution to avoid Irosuc overload where anaemia unresponsive to treatment has been incorrectly diagnosed as Irosuc deficiency anaemia
Use in Special Populations
- Safety and effectiveness not established in pediatric patients
- No overall differences in safety observed between elder subjects and younger subjects
- Greater sensitivity of some older individuals cannot be ruled out
- Injection into dialyser for hemodialysis dependent-chronic kidney disease patients
- Administration guidelines for Non-dialysis dependent-chronic kidney disease Patient
Overdose Effects
- Excess dosages may lead to accumulation of Irosuc in storage sites leading to hemosiderosis
- Periodic monitoring of Irosuc parameters required
- Symptoms associated with overdosage or infusing Irosuc too rapidly
- Most symptoms have been successfully treated with IV fluids, hydrocortisone, and/or antihistamines
Storage Conditions
- Store in a cool (15°C- 30°C) & dry place
- Protected from light
- Keep out of the reach of children
- Do not freeze
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