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

5 ml ampoule: ৳ 326.00

Medicine Details

Category Details
Generic Iron sucrose
Company Novatek pharmaceuticals ltd

Indications

  • Rapid Iromate supply
  • Inability to tolerate oral Iromate therapy
  • Non-compliance with oral Iromate 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)
  • Iromate deficiency anemia in surgical patients
  • Iromate deficiency anemia in blood donors
  • Iromate deficiency anemia in postpartum patients

Pharmacology

  • Therapeutic class: haematinic
  • Contains approximately 30% Sucrose w/v
  • pH range of 10.5-11.1
  • Dissociates into Iron and Sucrose
  • Iron transfer from blood to liver and bone marrow
  • Ferritin binds and sequesters Iron
  • Iron binds to plasma transferrin for tissue supply

Dosage

  • Adult dosage: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week
  • Children dosage: Not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight

Administration

  • Intravenous injection at recommended rate
  • Maximum 10 ml Iron Sucrose Injection (200 mg Iron) per injection
  • Test dose before therapeutic dose in new patients
  • Preferably administered by drip infusion

Interaction

  • Should not be administered concomitantly with oral iron preparations
  • Oral Iromate therapy should not be given until 5 days after last injection

Contraindications

  • Evidence of Iron overload
  • Known hypersensitivity to Iron Sucrose or its inactive components
  • Anaemia not caused by Iron deficiency
  • History of allergic disorders, liver disease, or infections

Side Effects

  • Hypotension
  • Leg cramps
  • Nausea
  • Headache
  • Vomiting
  • Diarrhea
  • Fever
  • Pain
  • Asthenia
  • Malaise
  • Accidental injury
  • Hypertension
  • Hypervolemia
  • Abdominal pain
  • Elevated liver enzymes
  • Dizziness
  • Musculoskeletal pain
  • Dyspnea
  • Pneumonia
  • Cough
  • Pruritus
  • Application site reaction
  • Hypersensitivity reactions
  • Anaphylactoid reactions

Pregnancy & Lactation

  • Pregnancy Category-B
  • Use during pregnancy only if clearly needed
  • Caution advised when administered to nursing women

Precautions & Warnings

  • Periodic monitoring of hematologic and haematinic parameters required
  • Caution regarding tissue Iron overload
  • Monitoring of serum Iromate values 48 hours after IV dosing
  • Caution in patients with hypersensitivity reactions
  • Monitoring for hypotension
  • Pediatric use not established
  • No significant safety differences observed in geriatric use
  • Caution in administration to dialyser, HDD-CKD, and NDD-CKD patients

Use in Special Populations

  • Safety and effectiveness in pediatric patients not established
  • No significant safety differences observed in geriatric use

Overdose Effects

  • Accumulation of Iron leading to hemosiderosis
  • Monitoring of serum ferritin and transferrin saturation advisable
  • Symptoms include hypotension, headache, vomiting, nausea, dizziness, joint aches, and more
  • Management with IV fluids, hydrocortisone, and antihistamines
  • Caution in infusing Iromate at a slower rate

Therapeutic Class

  • Parenteral Iron Preparations

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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