Iron sucrose

⚠️ SCOPE — READ FIRST: the page is a general IV-iron page (specialties Haematology and Renal & Nephrology). The indication and route match — intravenous iron for iron deficiency anaemia — but THE FETCHED LABEL DOSES ONLY CKD POPULATIONS. It gives no regimen for iron deficiency anaemia outside CKD (post-partum, gastrointestinal blood loss, malabsorption, pre-operative optimisation, heart failure), no total-iron-deficit / Ganzoni-type calculation, and no maximum weekly dose. || WHY maxDose IS EMPTY: no adult maximum-dose cue appears anywhere in the fetched label. The 1000 mg figure is a usual total COURSE ('The usual total treatment course of iron sucrose injection is 1000 mg'), not a per-dose or weekly ceiling; the 'not to exceed 100 mg per dose' cap belongs to the paediatric regimen and is carried there. || VERBATIM (§2 summary table): 'Adult patients — Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD): 100 mg slow intravenous injection or infusion. Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD): 200 mg slow intravenous injection or infusion. Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD): 300 mg or 400 mg intravenous infusion.' || HDD-CKD (§2.2, verbatim): 'Administer iron sucrose injection 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session. Administer iron sucrose injection early during the dialysis session (generally within the first hour). The usual total treatment course of iron sucrose injection is 1000 mg. Iron sucrose injection treatment may be repeated if iron deficiency reoccurs.' || NDD-CKD (§2.3, verbatim): 'Administer iron sucrose injection 200 mg undiluted as a slow intravenous injection over 2 to 5 minutes or as an infusion of 200 mg in a maximum of 100 mL of 0.9% NaCl over a period of 15 minutes. Administer on 5 different occasions over a 14 day period. There is limited experience with administration of an infusion of 500 mg of iron sucrose injection, diluted in a maximum of 250 mL of 0.9% NaCl, over a period of 3.5 to 4 hours on Day 1 and Day 14.' — note that the 500 mg infusion is explicitly described as limited experience, not as a recommended dose. || PDD-CKD (§2.4, verbatim): 'Administer iron sucrose injection in 3 divided doses, given by slow intravenous infusion, within a 28 day period: 2 infusions each of 300 mg over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. Dilute iron sucrose injection in a maximum of 250 mL of 0.9% NaCl.' || STRENGTHS (§3, verbatim): 'Injection: 50 mg Elemental Iron/2.5 mL (20 mg/mL), 100 mg Elemental Iron/5 mL (20 mg/mL), or 200 mg Elemental Iron/10 mL (20 mg/mL) in single-dose vials.' All doses are expressed as elemental iron. || ADMINISTRATION SAFETY: §5.1 requires that iron sucrose is given 'when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions', with observation 'for at least 30 minutes and until clinically stable following completion of each administration'.

THIS IS A PER-DOSE FIGURE, NOT A DAILY TOTAL — 0.5 mg/kg is given once every two weeks (HDD-CKD) or once every four weeks (NDD-CKD/PDD-CKD), and the same 0.5 mg/kg per-dose figure applies to both regimens; only the interval differs. It is capped at 100 mg per dose. || ⚠️ INDICATION SCOPE: this is IRON MAINTENANCE treatment in children with CKD, and only that. §2.5, verbatim: 'The dosing for iron replacement treatment in pediatric patients with HDD-CKD has not been established.' §2.6 repeats this for NDD-CKD and PDD-CKD. §8.4: 'Safety and effectiveness of iron sucrose for iron replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established.' Do not use this figure for iron replacement, or for iron deficiency anaemia outside CKD. || VERBATIM (§2.5, HDD-CKD, iron maintenance): 'Administer iron sucrose injection at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every two weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 0.9% NaCl at a concentration of 1 mg/mL to 2 mg/mL and administered over 5 to 60 minutes. Do not dilute to concentrations below 1 mg/mL.' §2.6 (NDD-CKD or PDD-CKD on erythropoietin therapy) is identical except 'every four weeks for 12 weeks'. || AGE LIMITS (§2.5/§2.6 headings and §8.4, verbatim): the regimen is for 'Pediatric Patients (2 Years of Age and Older)'; 'Iron sucrose has not been studied in patients younger than 2 years of age.' §8.4 also records a safety signal in the very young: 'In a country where iron sucrose is available for use in children, at a single site, five premature infants (weight less than 1,250 g) developed necrotizing enterocolitis and two of the five died during or following a period when they received iron sucrose, several other medications and erythropoietin. Necrotizing enterocolitis may be a complication of prematurity in very low birth weight infants. No causal relationship to iron sucrose or any other drugs could be established.' || DOSE-RANGING CONTEXT (§8.4): 'Iron sucrose at doses of 0.5 mg/kg, 1 mg/kg, and 2 mg/kg was administered. All three doses maintained hemoglobin between 10.5 g/dL and 14.0 g/dL in about 50% of subjects over the 12-week treatment period with stable EPO dosing.' Only 0.5 mg/kg appears in the dosing section and only that is published here. || CONCENTRATION: 20 mg/mL of elemental iron, pinned by §2.1 ('Each mL contains 20 mg of elemental iron') and §3 ('20 mg/mL' for all three vial sizes). That is the UNDILUTED vial strength — the volume it yields is the volume to inject undiluted, or to dilute further to 1–2 mg/mL for infusion. || Verify any paediatric dose against a children's formulary.