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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