Ferrous Ascorbate Uses, Dosage, Benefits & Side Effects | DrugsAtlas
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Therapeutic Class
Haematinic
Subclass
Oral Iron Supplement (Chelated Iron with Ascorbic Acid)
Speciality
Haematology
Schedule (India)
Not scheduled (OTC — available without prescription)
Routes
Oral
Formulations
| Form | Strengths Available (Elemental Iron) |
|---|---|
| Tablet | 30 mg, 50 mg, 100 mg elemental iron (with ascorbic acid 75–150 mg) |
| Capsule | 100 mg elemental iron + folic acid combinations |
| Oral suspension | 30 mg/5 mL elemental iron |
| Syrup | 50 mg/5 mL, 100 mg/5 mL elemental iron |
| Drops | 15 mg/mL, 25 mg/mL elemental iron |
Note: All doses in this monograph refer to elemental iron content. Ferrous ascorbate is a synthetic molecule of iron with ascorbic acid in 1:2.8 molar ratio, offering enhanced bioavailability compared to conventional ferrous salts.
Adult indications
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Iron Deficiency Anaemia (IDA) — Adults
| Parameter | Dosing |
|---|---|
| Starting dose | 100 mg elemental iron once daily |
| Titration | May increase to 100 mg twice daily if response inadequate at 4 weeks |
| Usual maintenance dose | 100 mg/day (continued for 3–6 months after Hb normalisation to replenish stores) |
| Maximum dose | 200 mg elemental iron/day in divided doses |
Clinical Notes:
- Preferably taken on empty stomach for optimal absorption; may take with food if GI intolerance occurs
- Ascorbic acid component enhances iron absorption — no need for additional Vitamin C supplementation
- Response expected: Hb rise of 1–2 g/dL in 3–4 weeks
- Continue therapy 3–6 months after Hb normalises to restore ferritin
2. Antenatal Iron Supplementation (National Iron Plus Initiative — NIPI)
| Parameter | Dosing |
|---|---|
| Starting dose | 100 mg elemental iron once daily (or 60 mg as per facility protocol) |
| Titration | Not applicable |
| Usual maintenance dose | 60–100 mg elemental iron/day + folic acid 0.5 mg |
| Maximum dose | 200 mg/day (in documented moderate-severe IDA) |
| Duration | From confirmation of pregnancy (ideally 2nd trimester) to 6 months postpartum |
Clinical Notes:
- Part of national IFA supplementation programme
- Weekly iron-folic acid (WIFS) for non-pregnant adolescent girls: 100 mg elemental iron + 0.5 mg folic acid once weekly
3. Postpartum Anaemia
| Parameter | Dosing |
|---|---|
| Starting dose | 100 mg elemental iron twice daily |
| Titration | Not applicable |
| Usual maintenance dose | 100–200 mg elemental iron/day |
| Maximum dose | 200 mg elemental iron/day |
| Duration | 3–6 months or until ferritin normalises |
4. Menorrhagia-Associated Iron Deficiency
| Parameter | Dosing |
|---|---|
| Starting dose | 100 mg elemental iron once daily |
| Titration | May increase to 100 mg twice daily based on severity and response |
| Usual maintenance dose | 100–200 mg/day |
| Maximum dose | 200 mg/day |
| Duration | 3–6 months; reassess iron status periodically |
Clinical Notes:
- Address underlying cause of menorrhagia simultaneously
- Monitor ferritin to guide duration of therapy
Secondary Indications — Adults Only (Off-label)
| Indication | Dose | Duration | Supervision | Evidence |
|---|---|---|---|---|
| Iron deficiency in non-dialysis CKD (oral iron trial before IV) | 100 mg elemental iron twice daily | 1–3 months | Nephrologist; OFF-LABEL | Indian nephrology practice; KDIGO guidelines supportive — oral iron trial before IV iron in non-dialysis CKD |
| Preoperative anaemia optimisation (elective surgery) | 100–200 mg/day | 2–4 weeks pre-surgery | Surgeon/Anaesthetist; OFF-LABEL | Patient Blood Management protocols; RCT evidence supportive |
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
Iron Deficiency Anaemia — Treatment
| Age Group | Starting Dose | Titration | Usual Maintenance | Maximum Dose |
|---|---|---|---|---|
| 6 months – 2 years | 3 mg/kg/day in 1–2 divided doses | Not applicable | 3–6 mg/kg/day | 6 mg/kg/day |
| 2–5 years | 3 mg/kg/day in 1–2 divided doses | May increase to 6 mg/kg/day | 3–6 mg/kg/day | 6 mg/kg/day (max 60 mg/day) |
| 5–12 years | 3 mg/kg/day once or twice daily | Not applicable | 3–6 mg/kg/day | 6 mg/kg/day (max 120 mg/day) |
| >12 years | Adult dosing | As per adult | As per adult | 200 mg/day |
Duration: Minimum 3 months after Hb normalisation to replenish iron stores
Dosing Examples — Oral Suspension/Syrup
| Age/Weight | Typical Daily Dose | Using 30 mg/5 mL suspension |
|---|---|---|
| 6–12 months (8–10 kg) | 25–50 mg/day | 4–8 mL in divided doses |
| 1–3 years (10–15 kg) | 30–60 mg/day | 5–10 mL in divided doses |
| 3–6 years (15–20 kg) | 45–90 mg/day | 7.5–15 mL in divided doses |
| 6–12 years (20–40 kg) | 60–120 mg/day | 10–20 mL in divided doses |
Clinical Notes:
- Use drops or suspension for infants and young children
- Administer between meals for optimal absorption; may give with small meals if GI intolerance
- Sweet taste of most formulations aids compliance
Iron Prophylaxis — As per IAP/MoHFW
| Age Group | Dose | Frequency |
|---|---|---|
| 6–12 months | 2 mg/kg/day | Daily (high-risk) or weekly |
| 1–5 years | 2 mg/kg/day (max 30 mg/day) | As per nutritional status |
| 5–10 years | 30–45 mg/day | Weekly supplementation under WIFS |
Secondary Indications — Paediatric Doses (Off-label)
| Indication | Dose | Age | Supervision | Evidence |
|---|---|---|---|---|
| Prophylaxis in preterm/LBW infants | 2–3 mg/kg/day elemental iron | Start at 2–4 weeks of age | Specialist only; OFF-LABEL | IAP and WHO recommendations supportive |
| ADHD with documented iron deficiency | 3–6 mg/kg/day | School-age children | Specialist only; OFF-LABEL | Limited RCT evidence |
Safety Monitoring — Paediatrics
- Confirm iron deficiency before initiating treatment
- Monitor Hb response at 4 weeks
- Risk of accidental overdose — counsel caregivers on safe storage (keep out of children's reach)
- Iron drops/syrups may stain teeth — rinse mouth after administration
⚠️ CLEAR STATEMENT: Not recommended in infants <6 months except under specialist supervision in confirmed iron deficiency (preterm, LBW, or documented deficiency).
Renal Adjustments
No dose adjustment required for oral ferrous ascorbate.
Additional Notes:
- Oral iron is not nephrotoxic
- In CKD stages 3b–5, oral iron often has limited efficacy due to hepcidin-mediated iron sequestration
- IV iron preferred in dialysis patients and ESA-treated CKD patients
- Avoid in patients with established iron overload
Hepatic adjustment
Contraindications
- Known hypersensitivity to ferrous ascorbate or any component
- Haemochromatosis (primary or secondary)
- Haemosiderosis
- Non-iron-deficiency anaemias (thalassaemia major, sideroblastic anaemia, haemolytic anaemia without concurrent IDA)
- Active peptic ulcer disease with bleeding
- Patients receiving regular blood transfusions with elevated ferritin
- Concurrent parenteral iron therapy
- Iron accumulation states
Cautions
- History of peptic ulcer disease or gastritis — increased GI irritation risk
- Inflammatory bowel disease — may worsen symptoms; consider IV iron
- Elderly with constipation risk
- Chronic liver disease — monitor for iron overload
- History of intolerance to other oral iron preparations
- GI strictures or diverticula — risk of retention
- Concurrent conditions that may mask GI bleeding (dark stools from iron)
- Patients on repeated transfusions — monitor ferritin
Pregnancy
| Aspect | Details |
|---|---|
| Overall safety | Safe; recommended as standard component of antenatal care in India |
| Risk category | Not formally classified; extensive safety data supports routine use |
| First trimester | May defer non-urgent supplementation to second trimester to reduce nausea |
| Second/Third trimester | Routine supplementation recommended per MoHFW/NIPI guidelines |
| Preferred alternatives | Ferrous ascorbate is preferred over ferrous sulphate due to better GI tolerance |
| Monitoring | Hb at booking, 28 weeks, 36 weeks; serum ferritin if available; assess GI tolerance |
Lactation
| Aspect | Details |
|---|---|
| Compatibility | Fully compatible with breastfeeding |
| Levels in breast milk | Very low; iron in breast milk is tightly regulated and not affected by maternal supplementation |
| Preferred alternatives | Not applicable — ferrous ascorbate is acceptable first-line |
| Infant monitoring | Generally not required; no interruption of breastfeeding needed |
Elderly
| Aspect | Recommendation |
|---|---|
| Starting dose | 50–100 mg elemental iron once daily |
| Titration | Increase gradually based on tolerance; avoid high doses |
| Maximum dose | 100–150 mg/day usually sufficient |
| Special risks | Constipation (common and troublesome), GI discomfort, pill-induced gastritis |
| Additional considerations | Investigate underlying cause of IDA (GI malignancy, occult blood loss); IV iron may be preferred if oral not tolerated or poor response |
Major drug interactions
| Tetracyclines (doxycycline, tetracycline) | Reduced absorption of both iron and tetracycline | Chelation in GI tract | Avoid concurrent use; separate by ≥3 hours |
|---|---|---|---|
| Fluoroquinolones (ciprofloxacin, levofloxacin, ofloxacin) | Reduced quinolone absorption (40–50%) | Chelation |
Avoid concurrent use; separate by ≥2 hours (quinolone first)
|
| Levothyroxine | Reduced thyroxine absorption and efficacy | Chelation | Separate doses by ≥4 hours; monitor TSH |
| Levodopa/Carbidopa | Reduced levodopa absorption | Chelation | Separate by ≥2 hours |
| Bisphosphonates (alendronate, risedronate) | Reduced bisphosphonate absorption | Chelation | Separate by ≥2 hours; take bisphosphonate first |
| Mycophenolate | Reduced mycophenolate absorption | Chelation | Separate by ≥4 hours |
| Penicillamine | Reduced absorption of both drugs | Chelation |
Avoid concurrent use
|
| Dimercaprol | Formation of toxic complex | Direct chemical interaction |
CONTRAINDICATED
|
Moderate drug interactions
| Interacting Drug | Effect | Management |
|---|---|---|
| Antacids (aluminium/magnesium hydroxide) | Reduced iron absorption | Separate by ≥2 hours |
| Proton pump inhibitors (omeprazole, pantoprazole) | Reduced iron absorption due to decreased gastric acid | Monitor Hb response; ascorbic acid component partially compensates |
| H2 blockers (ranitidine, famotidine) | Reduced iron absorption | Same as PPIs; monitor response |
| Calcium supplements | Reduced iron absorption | Separate by ≥2 hours; take iron between meals |
| Zinc supplements | Competitive absorption | Separate by ≥2 hours |
| Methyldopa | Reduced antihypertensive effect | Separate by ≥2 hours; monitor BP |
| Cholestyramine | Reduced iron absorption | Separate by ≥4 hours |
| ACE inhibitors | Potential enhancement of iron-induced GI side effects | Monitor GI tolerance |
Common Adverse effects
- Nausea (5–15%)
- Epigastric discomfort, abdominal pain
- Constipation (less common than with ferrous sulphate)
- Diarrhoea (less common)
- Black/dark stools (harmless; may mask melena)
- Metallic taste
- Heartburn
- Teeth staining (with liquid preparations)
Serious Adverse effects'
| Adverse Effect | Clinical Notes |
|---|---|
| Acute iron poisoning (accidental overdose) |
Life-threatening, especially in children; presents with vomiting, bloody diarrhoea, haematemesis, shock — requires immediate hospitalisation and deferoxamine
|
| Hypersensitivity reactions | Rare; rash, pruritus, angioedema — discontinue and treat appropriately |
| GI ulceration/bleeding | Very rare; in setting of pre-existing ulcer disease |
| Iron overload | With prolonged unnecessary use — monitor ferritin; discontinue when stores replete |
Monitoring requirements
| Phase | Parameters |
|---|---|
|
Baseline
|
Hb, MCV, MCH, serum ferritin, transferrin saturation (if available); peripheral blood smear |
|
After 3–4 weeks
|
Hb (expect rise of 1–2 g/dL); reticulocyte count (peaks at 7–10 days) |
|
After 2–3 months
|
Hb (should normalise); serum ferritin to assess store repletion |
|
Long-term (>3 months)
|
Ferritin every 3 months to prevent overload; investigate if inadequate response (occult blood loss, malabsorption, non-compliance, incorrect diagnosis) |
|
Pregnancy
|
Monthly Hb during 2nd and 3rd trimesters |
Brands in India
| Orofer-XT | Emcure | Tablet | FDC with folic acid |
|---|---|---|---|
| Livogen-Z | East India | Tablet | FDC with folic acid, zinc |
| Fefol-Z | GSK | Capsule | FDC with folic acid, zinc |
| Feronia-XT | Eris | Tablet | FDC with folic acid |
| Autrin | Sarabhai | Capsule | FDC with folic acid, B12, zinc |
| Hemfer-XT | Hetero | Tablet,Drops | Plain and FDC variants |
| Orofer-S | Emcure | Syrup,Drops | Paediatric formulations |
| Aciron | Troikaa | Tablet | Plain ferrous ascorbate |
| Ferium-XT | Systopic | Tablet | FDC with folic acid |
| Tonoferon Plus | East India | Drops,Syrup | Paediatric formulations |
Note: Most brands are FDCs with folic acid ± zinc ± Vitamin B12. Always verify elemental iron content per unit when prescribing.
Price range (INR)
| Formulation | Price Range | Notes |
|---|---|---|
| Tablet (100 mg elemental iron) | ₹3–₹8 per tablet | Brand-dependent |
| Tablet with folic acid (FDC) | ₹4–₹10 per tablet | Most common formulation |
| Syrup (100 mL) | ₹60–₹150 per bottle | Unidentified |
| Drops (15–30 mL) | ₹40–₹100 per bottle | Paediatric formulation |
Government Supply: Available free under National Iron Plus Initiative (NIPI) and ANC programmes in many public health facilities. Not specifically listed in NLEM 2022 as single entity (ferrous sulphate is NLEM-listed).
Clinical pearls
- Better tolerability than ferrous sulphate: Ferrous ascorbate causes fewer GI side effects (especially constipation) compared to ferrous sulphate, making it useful in patients who discontinued other iron preparations due to intolerance.
- Built-in absorption enhancer: Ascorbic acid in the formulation improves non-haeme iron absorption by 2–3 fold — no need for additional Vitamin C supplementation.
- Counsel about dark stools: Proactively inform patients that black stools are expected and harmless — prevents unnecessary alarm and workup; however, melenic (tarry/sticky) stools warrant evaluation.
- Confirm deficiency before long-term use: Avoid empirical prolonged iron therapy in undiagnosed anaemia — risk of iron overload in thalassaemia trait, anaemia of chronic disease, or sideroblastic anaemia.
- Drug timing matters: Separate from tetracyclines, quinolones, levothyroxine, antacids, and calcium by 2–4 hours to avoid chelation-related reduced absorption.
- Storage safety in households with children: Iron overdose is a leading cause of fatal poisoning in children <6 years — emphasise safe storage away from children's reach.
Version
RxIndia v1.0 — 05 May 2025
Reference
-
- CDSCO approved product information
- Indian Pharmacopoeia 2022
- API Textbook of Medicine (11th Edition)
- ICMR Guidelines for Control of Nutritional Anaemia
- MoHFW National Iron Plus Initiative (NIPI) Operational Guidelines
- IAP Guidelines on Prevention and Treatment of Iron Deficiency Anaemia in Children
- AIIMS Antenatal Care Protocols
- Goodman & Gilman's The Pharmacological Basis of Therapeutics (pharmacokinetic references)
- WHO Guideline: Daily Iron Supplementation (supportive)
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Clinical Responsibility
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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