IRORICH INJECTION
Iron Sucrose Injection
Strength: 20 mg/mL
Dosage Form: Injection
Route of Administration: Intravenous (IV) use only
Family: Iron Replacement Therapy / Parenteral Iron Preparation
Composition: Each mL contains Iron Sucrose equivalent to 20 mg of elemental iron.
Indications: IRORICH Injection is indicated for the treatment of iron deficiency anemia when oral iron therapy is ineffective, poorly tolerated, or clinically unsuitable. It is particularly used in patients with chronic kidney disease when intravenous iron replacement is required. Other indications depend on the locally approved product information.
Mode of Action: Iron sucrose is a complex of ferric iron and sucrose. Following intravenous administration, it is processed by the body's iron-handling system, making iron available for incorporation into ferritin and hemoglobin. This supports red blood cell production and replenishment of depleted iron stores.
Pharmacological Action: Iron is an essential component of hemoglobin, myoglobin, and several iron-dependent enzymes. By providing bioavailable iron, IRORICH supports red blood cell formation and helps restore iron stores in patients with iron deficiency.
Clinical Benefits: IRORICH helps replenish iron stores, supports hemoglobin synthesis, and improves iron availability for red blood cell formation. Successful treatment may help relieve fatigue, weakness, reduced exercise tolerance, and other symptoms associated with iron deficiency anemia.
Therapeutic Benefits: Intravenous administration bypasses gastrointestinal absorption, making iron sucrose a useful option for patients who cannot tolerate oral iron or do not respond adequately to it. Clinical response depends on the severity of iron deficiency, the underlying cause, and the prescribed treatment regimen.
Dosage and Administration: Each mL contains 20 mg of elemental iron. The total iron requirement, dose per administration, and treatment schedule depend on body weight, hemoglobin level, iron stores, clinical condition, and the approved prescribing information. Administer by slow intravenous injection or intravenous infusion according to the product instructions and a qualified healthcare professional's prescription. Do not administer intramuscularly.
Iron Content Calculation:
1 mL = 20 mg elemental iron
2.5 mL = 50 mg elemental iron
5 mL = 100 mg elemental iron
10 mL = 200 mg elemental iron
These calculations indicate iron content only and are not individual dosing recommendations. The permitted dose and administration rate must be verified against the approved product leaflet.
Side Effects: Possible adverse effects include nausea, vomiting, diarrhea, headache, dizziness, itching, muscle cramps, joint pain, back pain, low blood pressure, and injection-site reactions. Infusion-related reactions and temporary changes in blood pressure may also occur.
Serious Adverse Effects: Rare but potentially severe hypersensitivity reactions can occur. Difficulty breathing, facial or throat swelling, fainting, or severe dizziness require immediate medical attention. Administration should take place in a setting equipped to manage serious allergic reactions.
Contraindications: Do not use in patients with known hypersensitivity to iron sucrose or its components, or in patients with iron overload. Iron deficiency should be confirmed before initiating treatment.
Precautions: Administer only under medical supervision. Monitor the patient for hypersensitivity reactions and changes in blood pressure during administration and for at least 30 minutes afterward. Use caution in patients with a history of drug allergies or other conditions that may increase the risk of adverse reactions.
Monitoring During Treatment: Hemoglobin, hematocrit, serum ferritin, and transferrin saturation should be assessed as clinically appropriate. Monitoring helps evaluate treatment response, guide further dosing, and reduce the risk of excessive iron accumulation.
Drug Interactions: Concurrent oral iron therapy may require adjustment. The timing of oral iron initiation or resumption should follow the approved product instructions and the prescriber's advice.
Use During Pregnancy: IRORICH may be considered during pregnancy when intravenous iron replacement is clinically necessary. Treatment should be based on an assessment of maternal need, gestational age, and potential benefits and risks, in accordance with the approved prescribing information.
Use During Breastfeeding: Treatment may be considered when clinically indicated. The mother's iron requirements, the benefits of breastfeeding, and available product-specific safety information should be considered by a healthcare professional.
Storage and Handling: Store according to the manufacturer's approved product instructions. Inspect the ampoule before use and do not use it if damaged or if the solution shows visible abnormalities. This is a single-dose presentation; any unused portion should be handled or discarded according to the approved instructions.
Product Presentation: Single-dose ampoule containing Iron Sucrose Injection 20 mg/mL for intravenous administration.
Product Summary: IRORICH Injection is a parenteral iron replacement preparation designed to restore iron availability, support hemoglobin synthesis, and replenish iron stores in patients with confirmed iron deficiency when intravenous treatment is appropriate.
Company: LINCOLN