Ferrostrane 0.68%

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Ferrostrane 0.68%

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Ferrostrane 0.68%

Property Description
Active ingredient Ferric Sodium Edetate (Sodium Feredetate)
Form Oral Liquid Solution
Pharmacological class Antianemic Preparation (Iron Supplement)
Common use Treating and preventing iron deficiency
Origin Synthetic Chelate Compound

What Type of Medicine is Ferrostrane 0.68%?

Ferrostrane 0.68% is categorized as an antianemic preparation, utilized as a therapeutic iron supplement designed to correct or prevent the body’s depletion of iron stores. Its classification falls under the World Health Organization's ATC group for Iron Trivalent, oral preparations.

This medication works primarily by replacement therapy, supplying the essential mineral iron that the body requires. Iron is critical for producing hemoglobin, which is key for oxygen transport. Iron supplementation is used as a foundational treatment for replenishing iron stores and correcting iron-deficiency anemia.


What is the Active Ingredient in Ferrostrane 0.68%?

The key active ingredient in this liquid preparation is Ferric Sodium Edetate, internationally recognized as sodium feredetate. The 0.68% concentration specifies the precise strength of this active compound within the overall solution.

Ferric Sodium Edetate is a unique, synthetic chelated iron compound distinguished by its high water solubility and stability in the digestive tract. This chelated structure is designed to maximize the amount of iron available for absorption. The European Medicines Agency (EMA) classifies this compound for use in iron replacement therapy.


Why is Ferrostrane 0.68% an Oral Liquid Solution?

Ferrostrane 0.68% is supplied as an oral solution, meaning it is a liquid medicine intended to be taken by mouth. This physical form is a core feature of the brand and offers practical advantages for patient adherence compared to solid pills.

The liquid form allows for highly precise and flexible dose adjustment by a healthcare provider, which is often essential when treating varying severity levels of iron deficiency. Moreover, the liquid route of administration is beneficial for individuals who have difficulty swallowing, such as young children or the elderly, ensuring consistent and comfortable intake.

Regulatory References

  1. [EMA Assessment Reports](https://www.ema.europa.eu/)

What side effects are possible with Ferrostrane 0.68%?

Possible side effects and safety information

Ferrostrane 0.68% is an oral liquid medicine containing sodium feredetate, a form of iron supplement. The official safety profile for this medicine is established based on its active ingredient and its general class of treatment.

Adverse Reactions and System Classes

The following types of side effects have been associated with oral iron preparations, including sodium feredetate:

System Organ Class (SOC) Adverse Reactions Frequency
Gastrointestinal disorders Nausea, mild diarrhea, abdominal discomfort, constipation Unknown/Not known*
Immune system disorders Hypersensitivity (e.g., allergic reactions) Unknown/Not known*

*The frequency of these reactions is often officially classified as "Unknown" or "Not known" because the precise incidence cannot be estimated from available post-marketing data.

Serious Adverse Reactions and Contraindications

Serious adverse reactions are not commonly reported but can include allergic reactions (such as swelling of the face, lips, tongue, or throat). It is documented that iron preparations are contraindicated (should not be used) in patients with conditions that lead to iron overload, such as hemochromatosis or hemosiderosis, or in patients with anemias that are not caused by iron deficiency.

Safety-Related Restrictions and Considerations

  • High Regulatory Assessment: Regulatory authorities have assessed the efficacy-to-adverse effects ratio of this product as high.
  • Population Specificity: Specific safety consideration is given to the use of related sodium feredetate preparations in infants and children.
  • Warnings: Caution is advised in patients with existing gastrointestinal diseases or haemolytic anaemia. Prolonged or high-dose use in children may lead to toxic iron accumulation in the body.
  • Other Notes: Iron preparations cause the stools to turn black, which is harmless but can interfere with tests used for detecting blood in the stools.

This information reflects the formal safety statements and classifications documented by official government regulatory bodies.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose involving Ferrostrane 0.68% (Ferric Sodium Edetate) requires immediate emergency attention, as stated in official regulatory documentation. Accidental ingestion of iron-containing products is recognized as a leading cause of fatal poisoning in children under six, underscoring the critical nature of these warnings.


Documented Clinical Manifestations

Overdose may initially present with severe gastrointestinal signs including nausea, vomiting (which may contain blood/haematemesis), diarrhoea, abdominal pain, and lethargy. These initial symptoms can be followed by a period of apparent recovery before the onset of severe systemic effects.

Severe Outcomes and Required Actions

Life-threatening complications documented in regulatory sources include circulatory collapse, shock, coma, metabolic acidosis, and hyperglycemia. Due to the high risk of severe toxicity:

  • Seek immediate medical attention for any suspected overdose, even if symptoms are not yet apparent.
  • The official guidance for children who appear very unwell or drowsy is to call for an ambulance straight away.

Official Management Measures

The specific management described in regulatory documents involves supportive measures for shock and the administration of the chelating agent Desferrioxamine (Deferoxamine), which binds the excess iron. Continuous monitoring of serum iron levels is required throughout the clinical treatment period to guide the intervention. Prolonged or excessive use of iron in children is noted as potentially leading to toxic accumulation.

Therapeutic Uses of Ferrostrane 0.68%

What Ferrostrane 0.68% Treats: Main Uses and Benefits

Ferrostrane 0.68% is an oral iron preparation commonly used to help address health issues related to iron deficiency and is relevant in contexts involving heightened systemic burden. The core therapeutic goal is to address the mineral imbalance in patients presenting with symptoms related to systemic discomfort. The medication is generally indicated for conditions such as iron deficiency anemia and for prophylactic use in specific high-risk groups.


Therapeutic Focus and Benefits

This medication is applied across domains where additional symptomatic support is needed. It is relevant for managing conditions characterized by periods of heightened symptoms, including iron-deficiency anemia. The common symptomatic manifestations it is used for managing are symptoms related to physical discomfort such as tiredness, general lethargy, weakness, and associated headaches and dizziness.

It is often used during phases when symptoms become more noticeable, such as managing the increased iron requirements during pregnancy and preventing iron deficiency in infants and young children during periods of rapid growth. This strategic use may assist with maintaining functional stability during these critical phases.


Quick Fact: Supportive Relief

Ferrostrane may contribute to improved comfort during symptomatic periods by helping to ease the overall symptom burden of fatigue, weakness, and lightheadedness. This assists with maintaining functional stability when symptoms interfere with routine activities.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Ferrostrane 0.68% — Official Regulatory Information

The eligibility profile for Ferrostrane 0.68% is strictly defined by regulatory documents, targeting a specific patient population and set of conditions.

Eligibility Scope

Classification Eligible Population Condition/Restriction
Allowed Use Infants Curative treatment of iron-deficiency anaemia.
Allowed Use Infants Prophylaxis (prevention) of iron deficiency.
Restricted Use Infants (for prophylaxis) Must be preterm, a twin, or born to a mother with iron deficiency, and an adequate dietary iron intake cannot be guaranteed.

Key Eligibility Summary

This medicine is officially intended for use exclusively in infants based on the authorized regulatory information. It is indicated for the curative treatment of existing iron-deficiency anaemia. For prophylaxis (preventive use), the eligibility is limited to infants with high-risk factors for iron deficiency when dietary intake alone is insufficient. No formal contraindications or prohibitions for use in adult populations are listed because the drug's approved scope is limited to the infant population. Use outside of the officially designated age group and stated conditions is not established by regulatory authorization.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Ferrostrane 0.68% (Ferric Sodium Edetate) is primarily defined by the regulatory requirements for mitigating absorption interference in the gastrointestinal tract. This interference can reduce the systemic exposure of both the iron supplement and co-administered drugs, necessitating mandatory separation of administration.

Contraindicated Combinations

Co-administration of Ferrostrane with Parenteral Iron Preparations is strictly prohibited in regulatory labeling due to the risk of systemic iron toxicity.

Interactions Requiring Timing Separation

Oral iron significantly reduces the systemic exposure of certain medicines, a reduction that must be mitigated by timing rules. These rules are explicitly documented in official prescribing information.

Interacting Substance/Class Official Interaction Outcome Administration Timing Constraint
Levothyroxine (Thyroid Hormone) Reduced systemic exposure Must be separated by at least 4 hours
Quinolone & Tetracycline Antibiotics Reduced systemic exposure Must be separated by at least 2 to 4 hours
Antacids, Calcium, or Zinc Salts Reduced iron absorption Must be separated by at least 1 to 2 hours

Drug–Substance and Drug–Food Interactions

The absorption of Ferrostrane is officially reduced by specific dietary components. Beverages such as tea and coffee, which contain tannins, and foods high in phytates (like whole grains) inhibit iron absorption. Co-administration with Ascorbic Acid (Vitamin C), however, may be documented to enhance iron absorption.

Mechanism of Action

Ferrostrane 0.68% (Sodium Feredetate) employs its unique EDTA chelate structure to form a stable, protective complex with ferric iron ( Fe^3+) in the gut. This mechanism prevents the iron from binding to dietary inhibitors like phytates, facilitating high systemic absorption of bioavailable iron delivered to the intestinal mucosal cells via transport mechanisms, such as DMT1.

Once absorbed, the iron is immediately utilized in the Erythropoiesis Pathway by the bone marrow, serving as the essential cofactor for synthesizing heme and subsequently Hemoglobin. This action facilitates the synthesis of Hemoglobin, influencing the blood’s oxygen-carrying capacity, and enables iron-dependent cellular energy metabolism by supplying iron for cytochrome enzymes. Furthermore, it facilitates the incorporation of iron into cellular storage proteins, enabling fundamental metabolic processes dependent on iron cofactors.

While absorption is efficient, the drug’s ultimate physiological effect (the eventual increase in Hemoglobin) is kinetically constrained by the fixed multi-week maturation cycle of red blood cells. Additionally, high levels of the regulatory hormone hepcidin, often present during inflammation, can constrain the mechanism by blocking the export of iron from the intestinal cells into the systemic circulation.

Dosage and Administration Information

Instruction Map: How to use Ferrostrane 0.68% — General Administration Guidelines

This section outlines the usage instructions for Ferrostrane 0.68% (Sodium Feredetate oral solution).

Instruction Detail
Route of administration The medicine is for oral administration only, as an oral solution or syrup.
Dosing schedule (Adult Treatment) The total daily dose for adults is typically divided, ranging from 80 mg to 120 mg of elemental iron, administered in two to three divided doses daily.
Timing in relation to meals Doses should preferably be taken between feeds or before meals for optimal absorption, though they may be taken after some food to improve digestive tolerance.
Preparation requirements The correct volume must be measured using a calibrated dosing device (such as the oral syringe provided); a standard kitchen teaspoon must not be used to ensure accurate dosing.
Age-group administration rules Pediatric Treatment: Dosing is calculated based on body weight, using an elemental iron dose of 3 mg/kg to 6 mg/kg per day, given in two to three divided doses. Prophylaxis in Pregnancy: A specific prophylactic daily elemental iron dose is recommended during the last two trimesters.
Missed-dose rules If a scheduled dose is missed, it should be skipped. A double dose must never be taken to compensate for the missed amount.
Course duration Use must be continued for a sufficient period, typically at least three months, to ensure the full replenishment of the body's iron stores.

Resulting Procedural Structure

The administration protocol requires the precise volumetric measurement of the oral solution, typically in two to three spaced daily doses, to meet the elemental iron requirement set by the prescribing clinician. Dosing should be timed to minimize interference from food or dairy products that reduce iron uptake. This regimen must be followed consistently for the multi-month duration specified in the guidelines to fully restore iron reserves.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Ferrostrane 0.68%


Evidence for the Treatment of Iron Deficiency Anemia

Ferrostrane 0.68% (Sodium Feredetate) was studied for its use in patients diagnosed with confirmed iron-deficiency anemia (IDA). Research utilized Randomized Controlled Trials (RCTs), where patients were given the solution, a placebo, or a different iron supplement, allowing researchers to examine the compound’s results in comparison. Studies focused on monitoring physiological strain by measuring key hematological and iron storage biomarkers, such as changes in hemoglobin and ferritin levels over a defined period.

Research highlighted changes measured during the study period in these markers. Findings described patterns observed in the studies where individuals receiving the iron preparation exhibited measured changes in both hemoglobin and ferritin levels. These observed patterns were consistent across studies involving adults and certain populations of children with IDA.


Evidence for Preventing Iron Deficiency (Prophylaxis)

Research explored study populations that included groups with increased physiological demand for iron, such as pregnant women and infants. Studies aimed to examine the maintenance of mineral balance in at-risk populations. Research describes patterns where monitored iron parameters evolved in the supplemented groups during these high-demand phases.

However, the existing research is limited by the fact that many prophylactic trials utilize multi-micronutrient formulations rather than the iron component in isolation.


Research on Symptomatic Relief

Research also examined patient-reported outcomes describing perceived discomfort related to iron deficiency. Symptoms studied included fatigue, general physical weakness, and headaches. Studies report how symptoms evolved in the observed populations, and often the change in symptoms was observed in some studies following the correction of the primary iron storage biomarkers.

Dedicated research focusing exclusively on symptomatic scales, independent of biomarker correction, is less numerous. Since symptom assessment is inherently subjective, certainty remains low when trying to quantify a direct symptomatic change.


Key Limitations and Areas of Research Uncertainty

Research contributes to the broader evidence landscape, but several research limitation frames apply. The evidence quality varies across studies, and many trials examined this form of iron as part of a multi-nutrient formulation, which creates uncertainty about the effects of Sodium Feredetate alone. Furthermore, data for certain groups remain insufficient or comparative evidence is lacking regarding different oral iron preparations. Follow-up durations were limited in many studies, meaning long-term effects are not fully established.

Key Studies & References

  1. Effect of Ferric Sodium EDTA in Combination with Vitamin C, Folic Acid, Copper, Zinc, and Selenium, for Prevention of Iron Deficiency Anemia during Pregnancy
  2. Efficacy of sodium feredetate versus ferrous sulfate in iron deficiency anemia in preganant women

Frequently Asked Questions (FAQ)

Common questions about Ferrostrane 0.68% (FAQ)


Q: What is the main difference between Ferrostrane and other iron supplements?

A: Official documentation for this specific form of iron (Sodium feredetate) indicates that it is officially stated to have a low incidence of gastrointestinal side effects in comparison with some other iron salts. A key distinction noted in product information is that this preparation is also stated to not discolour teeth, which can be a concern with some other liquid iron supplements.

Q: Is Ferrostrane 0.68% the same as Ferrostrane Infants?

A: Ferrostrane 0.68% is the oral solution containing the active ingredient sodium feredetate. The name 'Ferrostrane Infants' is used in some regions for a product with the same active ingredient that is specifically authorized for use in infants for both treatment and prevention of iron deficiency anemia.

Q: Is the Ferrostrane liquid supposed to be a dark color?

A: The official product documentation describes the oral solution as a red, cherry-flavoured liquid. The concentration and formulation may contribute to this specific appearance.

Q: Can Ferrostrane syrup stain teeth or other things?

A: Official product information is explicit that this specific form of iron (Sodium feredetate) is stated to not discolour teeth. This is a feature noted in the product's description.

Q: Does Ferrostrane need to be stored in the refrigerator?

A: Regulatory requirements state that the medicine must be stored at a temperature not exceeding 25 C and protected from freezing. The medicine must be stored under these conditions to maintain its stability.

Q: Are there certain foods that should be avoided when taking Ferrostrane?

A: Yes, certain foods and beverages are officially described as substances that may interfere with iron absorption and whose co-administration near the time of dosing is not recommended. These commonly include items like tea, coffee, eggs, and milk.

Q: How long does it usually take to see improvement after starting Ferrostrane?

A: Official product information suggests that a measurable improvement in the patient's condition may be observed after 3 to 4 weeks of regular administration, as the medicine works to replenish iron stores and build hemoglobin levels.

Q: Is it normal to have dark stools while using Ferrostrane?

A: This change is frequently reported with iron supplements. Official safety warnings state that iron preparations commonly colour the faeces black because iron is a common substance in the product.

Q: Is Ferrostrane considered safe to use during pregnancy?

A: The use of this medicine during pregnancy is documented in official sources. Administration instructions outline a specific prophylactic daily dose for use during the last two trimesters, indicating its use is documented and authorized in this context.

Q: Can Ferrostrane affect the results of blood tests?

A: While the medicine does not directly affect the chemical results of most blood tests, official safety warnings mention that iron preparations colour the faeces black. This change can therefore interfere with laboratory tests used for detecting occult blood in the stools.

Q: Is there a maximum time someone can safely use Ferrostrane?

A: For infants receiving the medicine for prevention (prophylaxis), the maximum duration is specified in regulatory documents as up to one year of age. Regulatory warnings advise caution if the medicine has been taken for a long time or at high doses as this may lead to toxic iron accumulation.

Q: Does Ferrostrane 0.68% contain any sugar or sweeteners?

A: Official documents specify that the product is formulated as 'sugar free' but contains alternative sweeteners. These sweeteners include saccharin sodium and sorbitol.

Q: Can Ferrostrane be mixed with water or juice for easier consumption?

A: Official documentation for infant use mentions that the supplement can be mixed with feeds from a practical standpoint. The product stability profile also defines a use-by period of 14 days if diluted with water. Administration with liquids that interfere with absorption, such as milk or coffee, is noted in regulatory documents as reducing its effectiveness.

Q: Is Ferrostrane available in a tablet or capsule form?

A: The approved pharmaceutical form of this product is consistently listed as an oral solution or syrup in regulatory documents. Official information does not describe a tablet or capsule form for this specific brand name product.

Q: Does taking Ferrostrane with food reduce stomach upset?

A: Official administration instructions state that although iron is generally better absorbed on an empty stomach, it may help to give each dose after some food to improve digestive tolerance. This may be done to potentially reduce gastrointestinal discomfort.

Q: Are there any reported interactions between Ferrostrane and over-the-counter pain relievers?

A: Regulatory patient information explicitly states that it is generally permissible to give the medicine with those containing common over-the-counter pain relievers like paracetamol or ibuprofen, unless otherwise directed by a physician.

Q: Can Ferrostrane be used by people with certain kidney conditions?

A: Official medical references, such as local formularies, sometimes list this form of iron (Sodium Feredetate) as an available formulary option for iron deficiency management, including in certain patient populations such as those with Chronic Kidney Disease (CKD).

Q: How is the amount of iron in Ferrostrane measured?

A: The amount is measured in two ways in official documents. It is quantified by the concentration of the active substance, sodium feredetate trihydrate, and by the equivalent amount of elemental iron. Elemental iron represents the bioavailable component of the active substance.

Q: Is it safe to drink alcohol while using Ferrostrane?

A: The official interaction section does not list a specific interaction with ingested alcohol. However, the medicine is documented to contain a small amount of ethanol (alcohol) as an inactive ingredient.

Q: Do official sources describe any incompatibilities for mixing Ferrostrane with liquids?

A: Official warnings describe that liquids such as tea, coffee, and milk may interfere with the medicine by reducing its absorption and should therefore be avoided close to dosing.

Q: Can certain vitamins or supplements affect how Ferrostrane works?

A: Regulatory documents list interactions with certain minerals, such as calcium and zinc, which can reduce iron absorption. Additionally, iron-containing vitamin preparations should not be taken with this medicine, as co-administration is noted as a risk factor for excessive total iron intake.

Q: What is the typical time frame official information suggests for checking iron levels after starting Ferrostrane?

A: General patient information relating to iron supplementation often suggests checking blood levels, such as hemoglobin and ferritin, 2 to 4 weeks after the start of treatment to monitor for a response.

Q: Does Ferrostrane cause sleepiness or affect energy levels?

A: Sleepiness is not listed as a known or expected adverse effect in the official safety classification sections for this medicine. Research studies have examined changes in symptoms like fatigue and general physical weakness, which are often associated with the underlying iron deficiency.

Q: Are there any limitations on who can use Ferrostrane based on age?

A: Yes, the authorized regulatory documentation primarily indicates this medicine for use in infants for curative treatment and prophylaxis of iron deficiency. Use outside of the officially designated age group and conditions is not established by regulatory authorization.

Q: Is the safety profile of Ferrostrane well-established in long-term use?

A: Research documents note that while the safety profile is established for the required treatment duration, the available research evidence has generally involved limited follow-up periods. This indicates that the long-term effects are not fully established based on the limited availability of long-term research.

How should Ferrostrane 0.68% be stored and disposed of?

Ferrostrane 0.68% (sodium feredetate oral solution) must be stored and handled according to the following official requirements to maintain its stability and ensure safety.

Storage & Disposal Scope

Scope Area Official Regulatory Requirement
Labeled storage temperature requirements: Store at a temperature that does not exceed 25 C (77°F).
Stability after opening/reconstitution: Once opened, the solution must be used within 3 months. If diluted with water, use within 14 days.
Handling requirements: Must be protected from freezing.
Disposal instructions (as documented in government sources): Do not throw away unused medicines via wastewater or household waste.
Child-protection storage requirements (if stated): Must be kept out of the sight and reach of children due to the serious risk of iron overdose.

Connection to the overall storage/disposal profile: Regulatory documents mandate that the liquid solution is stored below 25 C and protected from freezing. The stability profile dictates that the product must be discarded after 3 months of opening. Due to the danger of iron overdose, the medicine must be strictly stored out of the sight and reach of children. Unused or expired products require disposal via a pharmaceutical waste protocol (consult a pharmacist) to protect the environment.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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