Kidifer 100 mg/5 ml (IV Injection or Infusion)

5 ml ampoule: ৳ 350.00

Medicine Details

Category Details
Generic Iron sucrose
Company General pharmaceuticals ltd

Therapeutic Class

  • Parenteral Iron Preparations

Indications

  • Treatment of Kidifer deficiency
  • Rapid Kidifer supply
  • Patients intolerant to oral Kidifer therapy
  • Active inflammatory bowel disease
  • Non-dialysis dependent-chronic kidney disease (NDD-CKD)
  • Hemodialysis dependent-chronic kidney disease (HDD-CKD)
  • Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD)
  • Treatment of Kidifer deficiency anemia in surgical patients
  • Treatment of Kidifer deficiency anemia in blood donors
  • Treatment of Kidifer deficiency anemia in postpartum patients

Pharmacology

  • Therapeutic class: Haematinic
  • Iron Sucrose Injection USP is a brown, sterile, 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
  • Disassociates into Iron and Sucrose by the reticuloendothelial system after intravenous administration
  • Iron transfers from the blood to a pool 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
  • Transferrin receptor located in the cell, transferrin-receptor complex returned to the cell membrane
  • Intracellular Iron becomes haemoglobin in circulating red blood cells
  • Elimination half-life: 6 h, total clearance: 1.2 L/h, non-steady state apparent volume of distribution: 10.0 L, steady-state apparent volume of distribution: 7.9 L
  • Iron component distributes mainly in blood and to some extent in extravascular fluid, significant amount distributes in the liver, spleen, and bone marrow
  • 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 hemoglobin level
  • Children: Limited data, recommended not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week depending on haemoglobin level

Administration

  • Intravenous injection: Administer undiluted by slow intravenous injection at the recommended rate
  • Infusion: Preferably administered 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
  • Before administration of the therapeutic dose in a new patient, a test dose should be injected to monitor adverse reactions

Interaction

  • Kidifer Injection should not be administered concomitantly with oral iron preparations
  • Oral Kidifer therapy should not be given until 5 days after the 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 including asthma, eczema, anaphylaxis, liver disease, and infections

Side Effects

  • Hypotension
  • Cramps/leg cramps
  • Nausea
  • Headache
  • Vomiting
  • Diarrhea
  • Hypersensitivity reactions
  • Elevated liver enzymes
  • Dyspnea
  • Pneumonia
  • Cough
  • Pruritus
  • Application site reaction

Pregnancy & Lactation

  • Pregnancy Category-B
  • No adequate and well-controlled studies in pregnant women
  • Use during pregnancy only if clearly needed
  • Caution should be exercised when administered to a nursing woman

Precautions & Warnings

  • Caution should be exercised to withhold Kidifer administration in the presence of evidence of tissue Kidifer overload
  • Periodic monitoring of hematologic and haematinic parameters required for patients receiving Kidifer
  • Hypersensitivity reactions may occur in patients receiving Kidifer
  • Caution should be taken to administer Kidifer according to recommended guidelines to avoid hypotension
  • Safety and effectiveness in pediatric patients not established
  • Caution should be taken in geriatric patients

Use in Special Populations

  • Safety and effectiveness in pediatric patients not established
  • No overall differences in safety observed between the elderly and younger subjects
  • Greater sensitivity of some older individuals cannot be ruled out

Overdose Effects

  • Dosages in excess of Kidifer needs may lead to accumulation of Kidifer in storage sites leading to hemosiderosis
  • Periodic monitoring of Kidifer parameters may assist in recognizing Kidifer accumulation
  • Particular caution should be exercised to avoid Kidifer overload
  • Symptoms associated with overdosage or rapid infusion include hypotension, headache, vomiting, nausea, dizziness, joint aches, and cardiovascular collapse

Storage Conditions

  • Store in a cool and dry place (15°C - 30°C)
  • Protected from light
  • Keep out of the reach of children
  • Do not freeze

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