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

Title

• Iron Sucrose Injection USP

Categories

• Medicine
• Pharmaceutical
• Healthcare

Description

• Iron Sucrose Injection USP is indicated for the treatment of Ferimax deficiency in various patient populations, including those with chronic kidney disease, inflammatory bowel disease, and those with a clinical need for rapid Ferimax supply. It is administered via intravenous injection or infusion and is contraindicated in patients with evidence of Iron overload, hypersensitivity to Iron Sucrose, or anaemia not caused by Iron deficiency. The drug has potential side effects, including hypotension, gastrointestinal symptoms, and hypersensitivity reactions, and caution should be exercised in patients with tissue Iron overload. It is generally stored in a cool, dry place, protected from light, and should not be frozen.

Attributes

• Indications:
  • Treatment of Ferimax deficiency
  • Rapid Ferimax supply
  • Patients unable to tolerate oral Ferimax therapy
  • Active inflammatory bowel disease
  • Chronic kidney disease patients
  • Patients undergoing surgical procedures
  • Postpartum patients
• Pharmacology:
  • Iron Sucrose is a haematinic
  • Sterile, aqueous, complex of Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use
  • Contains approximately 30% Sucrose w/v and has a pH of 10.5-11.1
  • Dissociates into Iron and Sucrose in the body
  • Iron distributes 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 once to three times a week
  • Limited data on children, not to exceed 0.15 ml Iron Sucrose Injection per kg body weight
• Administration:
  • Intravenous injection at recommended rate
  • Maximum of 10 ml Iron Sucrose Injection (200 mg Iron) per injection
  • Preferably administered by drip infusion to reduce risk of hypotensive episodes
• Interaction:
  • Not studied for drug-drug interactions
  • Not to be administered concomitantly with oral iron preparations
  • Oral Ferimax therapy should not be given until 5 days after last injection
• Contraindications:
  • Patients with evidence of Iron overload
  • Known hypersensitivity to Iron Sucrose or its inactive components
  • Anaemia not caused by Iron deficiency
  • History of allergic disorders, asthma, eczema, anaphylaxis, liver disease, and infections
• Side Effects:
  • Hypotension
  • Cramps/leg cramps
  • Nausea
  • Headache
  • Vomiting
  • Diarrhea
  • Fever
  • Pain
  • Hypertension
  • Abdominal pain
  • Dizziness
  • Pruritus
  • Hypersensitivity reactions
• Pregnancy & Lactation:
  • Pregnancy Category-B
  • Caution advised during nursing
• Precautions & Warnings:
  • Periodic monitoring of hematologic and haematinic parameters required
  • Ferimax therapy should be withheld in patients with evidence of Ferimax overload
  • Caution advised for hypersensitivity reactions and hypotension
• Use in Special Populations:
  • Safety and effectiveness in pediatric patients not established
  • No overall differences in safety observed between elderly and younger subjects
• Overdose Effects:
  • May lead to accumulation of Ferimax in storage sites
  • Discontinue when serum ferritin levels equal or exceed established guidelines
  • Symptoms include hypotension, headache, vomiting, nausea, dizziness, joint aches, and cardiovascular collapse
• Therapeutic Class:
  • Parenteral Iron Preparations
• Storage Conditions:
  • Store in a cool, dry place (15°C-30°C)
  • Protected from light
  • Not to be frozen

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