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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