Xenofer 50 mg/2.5 ml (IV Injection or Infusion)

Product Title

• Iron Sucrose Injection USP

Product Category

• Medicine
• Pharmaceutical

Indications

• Treatment of Xenofer deficiency in various conditions such as inflammatory bowel disease, chronic kidney disease, anemia in surgical patients, blood donors, and postpartum patients

Pharmacology

• Iron Sucrose Injection is a haematinic therapeutic class, containing approximately 30% Sucrose w/v (300 mg/ml) and has a pH of 10.5-11.1. It is dissociated into Iron and Sucrose by the reticuloendothelial system, with Iron transferring to the liver and bone marrow for utilization in the production of haemoglobin.

Dosage

• 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week for adults and elderly patients
• Limited data available for children, recommended not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week

Administration

• Can be administered via intravenous injection or infusion
• Maximum of 10 ml Iron Sucrose Injection (200 mg Iron) can be injected per injection

Interaction

• Not studied for drug-drug interactions, should not be administered concomitantly with oral iron preparations

Contraindications

• Patients with evidence of Iron overload, known hypersensitivity to Iron Sucrose or any of its inactive components, or anaemia not caused by Iron deficiency

Side Effects

• May include hypotension, cramps/leg cramps, nausea, headache, vomiting, diarrhea, chest pain, hypertension, dyspnea, and hypersensitivity reactions

Pregnancy & Lactation

• Pregnancy Category-B, caution advised during breastfeeding

Precautions & Warnings

• Monitoring of hematologic and haematinic parameters required, caution advised in the presence of evidence of tissue Iron overload, potential for serious hypersensitivity reactions and hypotension

Use in Special Populations

• Safety and effectiveness in pediatric patients not established, caution advised for geriatric use, specific dosage guidelines for dialysis-dependent and non-dialysis dependent chronic kidney disease patients

Overdose Effects

• Excess dosage may lead to accumulation of Iron in storage sites, caution advised to avoid Iron overload, symptoms may include hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, and cardiovascular collapse

Therapeutic Class

• Parenteral Iron Preparations

Storage Conditions

• Store in a cool (15°C - 30°C) & dry place, protected from light, and keep out of reach of children

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