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Oroferon depo

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Oroferon depo

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Method of action: Antianemic, Hematopoietic

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.

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Overview of Oroferon depo

Quick Facts

Property Description
Active ingredient Ferrous Sulfate (FeSO4)
Form Oral, extended-release tablet
Pharmacological class Antianemic Agent / Iron Product
General purpose Iron replenishment and mineral supplementation
Origin Synthetic iron salt

Defining Oroferon depo: Active Ingredient and Pharmacological Class

Oroferon depo is classified as an Antianemic Agent and a Hematopoietic Agent, with its core therapeutic identity established by the active ingredient, which is Ferrous Sulfate (Iron(II) sulfate). This compound is classified as a synthetic agent and functions as a single-agent product, providing the essential bivalent ferrous cation required for key biological processes. Ferrous salts are recognized for their role in standard healthcare protocols. This inclusion reflects the drug's role in medical care, and the efficacy of this iron salt formulation is utilized in managing deficiencies.

Oroferon depo: Purpose and Extended-Release Form

The overall general purpose of this medication is iron replenishment and sustained mineral supplementation. This product's unique differentiation lies in its extended-release or delayed-release drug form. This specialized oral tablet structure allows for a controlled, steady delivery of the Ferrous Sulfate, promoting consistent absorption of the elemental iron over a prolonged period. By supplying this essential body mineral, the product fundamentally supports the synthesis of hemoglobin, which is crucial for efficient systemic oxygen transport throughout the body and is required to maintain healthy red blood cell production. This controlled-release mechanism is designed to improve iron status while potentially supporting patient adherence.

Regulatory References

  1. WHO Model List of Essential Medicines (eEML)
  2. WHO Essential Medicines List
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What side effects are possible with Oroferon depo?

Possible Side Effects and Safety Information

This section summarizes the officially documented adverse reactions and safety restrictions for Oroferon depo, strictly as defined in government regulatory documents.

Serious and Clinically Significant Risks

Regulatory documents include a Boxed Warning highlighting the significant risk of Bone Mineral Density (BMD) loss, particularly with prolonged use. The loss of BMD is greatest in the early years of treatment and may not be fully reversible after stopping the medication, especially in adolescents treated for longer than two years.

Other serious risks include thromboembolic disorders, such as deep vein thrombosis, pulmonary embolism, and cerebral vascular disorders. Ocular disorders, including sudden partial or complete loss of vision or retinal thrombosis, have also been documented. Immediate discontinuation is required if any of these serious events occur.

Common Adverse Reactions

The most frequently reported side effects (seen in over 5% of patients in clinical trials) include:

  • Menstrual irregularities (bleeding or spotting)
  • Weight gain
  • Headache
  • Abdominal pain or discomfort
  • Nervousness
  • Decreased libido

Safety Restrictions and Limitations

Oroferon depo is contraindicated and must not be used in patients with specific pre-existing conditions. These include:

  • A current or past history of thromboembolic disorders or cerebral vascular disease.
  • Known or suspected malignancy of the breast.
  • Significant liver disease or dysfunction.
  • Undiagnosed abnormal vaginal bleeding.

Usage is generally not recommended for longer than two years unless other medical methods are deemed unsuitable. Additionally, the drug may alter the results of certain laboratory tests, including those for glucose tolerance, lipids, and coagulation factors.

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Overdose and Emergency Response

The official documentation for ferrous sulfate (Oroferon depo) overdose outlines a potentially life-threatening emergency, particularly following accidental ingestion by children. The initial documented clinical manifestations are typically gastrointestinal, including nausea, vomiting, abdominal pain, and diarrhea. As systemic toxicity develops, the official labeling warns that the clinical presentation may progress to severe outcomes, such as lethargy, profound drowsiness, and signs of circulatory collapse or shock. Later-stage systemic complications may involve metabolic acidosis and potentially fatal hepatic failure.

Due to the established severity, regulators explicitly mandate that patients seek immediate medical attention or contact emergency services upon any suspected over-ingestion. Hospital monitoring is required for all suspected cases, regardless of the initial presence or severity of symptoms. Management procedures officially described include symptomatic and supportive treatment to address systemic disturbances. For treating severe systemic iron toxicity, the specific antidote, desferrioxamine (deferoxamine), is formally documented as the required chelation therapy in a monitored setting.

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Therapeutic Uses of Oroferon depo

What Oroferon Depo Treats: Main Uses and Benefits

This medication is primarily used in therapeutic contexts involving certain distressing symptoms related to iron imbalance. Oroferon depo is commonly used to treat Iron Deficiency Anemia (IDA) and the underlying state of low iron stores in the body, which is a condition characterized by insufficient iron to support blood component production. This therapy is relevant across the spectrum, from correcting depleted stores to managing established, symptomatic anemia.

Oroferon depo is also applied to relieve the most pronounced symptoms of iron deficiency, including chronic tiredness, persistent fatigue, and reduced physical endurance. By supporting the patient's capacity for effective oxygen transport, this therapy supports physiological processes that help ease the burden of low energy and contributes to easing day-to-day discomfort. Furthermore, the product is considered relevant for managing specific neurological manifestations linked to iron status, most notably the discomfort seen in Restless Legs Syndrome (RLS), which may help patients cope more steadily with symptom fluctuations.


Quick Fact: Relief for Persistent Fatigue

This medication is generally considered relevant for managing systemic energy deficits that manifest as persistent fatigue and reduced physical endurance, which are key symptoms that interfere with daily functioning.

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Eligibility and Restrictions for Use

The official regulatory labeling for Oroferon depo strictly defines populations eligible for use to prevent potential complications, primarily related to iron toxicity and gastrointestinal distress. The medicine is classified into categories of contraindication, conditional use, and permitted use.

Absolute Non-Eligibility

Use of this medicine is prohibited in patients diagnosed with iron overload syndromes, including hemochromatosis and hemosiderosis. It is also strictly contraindicated in individuals with active severe gastrointestinal conditions such as ulcerative colitis, regional enteritis, or peptic ulceration. The label further prohibits use in patients receiving repeated blood transfusions or those with known hypersensitivity to iron salts.

Conditional and Restricted Use

This medicine is restricted to treating anemias confirmed to be caused by iron deficiency; it is not recommended for other types of anemia unless iron deficiency is confirmed to co-exist. Use during the first 12 weeks of pregnancy is conditional and should only occur if specifically recommended by a medical professional. For the remainder of pregnancy and during lactation, use is generally considered acceptable. While use is permitted in adults, the label contains a critical safety restriction for children under six years due to the documented high risk of fatal accidental iron poisoning, necessitating strict storage and handling protocols.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

This injectable progestin product (medroxyprogesterone acetate) is metabolized primarily by the CYP3A enzyme system in the liver. Co-administration with medicinal products that induce this enzyme may reduce the concentration of the progestin in the bloodstream, which can decrease the product’s effectiveness.

Interacting Product Category Mechanism and Recommendation
Moderate or Strong CYP3A Inducers These medicines and herbal products (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's wort) can lower the concentration of the progestin. Patients using these inducers should use an alternate or back-up method of contraception.
HIV Protease Inhibitors / NNRTIs Plasma levels of the progestin may increase or decrease with co-administration; careful consideration and monitoring are advised due to the potential for reduced efficacy.
Antibiotics While isolated cases of unintended pregnancy have been reported, clinical pharmacokinetic studies have not consistently shown that antibiotics affect the plasma concentration of synthetic steroids in a significant way.

Laboratory Test Interference: The use of this product can affect the results of various laboratory tests, including those measuring steroid levels (such as progesterone and cortisol), gonadotropin levels, and markers of liver function and coagulation. Healthcare professionals and laboratories must be made aware of the use of this progestin when relevant specimens are submitted for testing.

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Mechanism of Action

Oroferon depo functions by providing the necessary ferrous cation ( Fe^2+), which acts as a requisite substrate for the synthesis of key structural and functional biological molecules. Its mechanism involves a precise sequence of cellular uptake, systemic transport, and biochemical incorporation into major physiological pathways.

Intestinal Uptake and Systemic Iron Transport

This initial mechanistic domain involves the tablet's release of Fe^2+ and its subsequent selective absorption by specialized proteins, such as Divalent Metal Transporter 1 (DMT1), in the small intestine. The iron is then distributed throughout the body by the plasma carrier Transferrin, which facilitates its systemic distribution for uptake by target cells with Transferrin Receptor 1 ( TfR1).

Hemoglobin Synthesis and Oxygen-Carriage Pathway Support

The systemic iron is channeled primarily to the bone marrow where it serves as a cofactor for the final steps of the Heme Synthesis Pathway. By facilitating the creation of new Hemoglobin, the synthesis of new Hemoglobin increases the blood's capacity for oxygen binding and systemic distribution.

Cellular Energy Pathways and Homeostatic Regulation

Beyond oxygen transport, the drug's mechanism contributes iron as a substrate for iron-containing enzymes, notably the Cytochromes essential for efficient cellular respiration and ATP generation in mitochondria. Furthermore, the rate of iron entry into the bloodstream is actively governed by the body's homeostatic hormone Hepcidin, which constrains the mechanism by regulating the iron efflux transporter Ferroportin.

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Dosage and Administration Information

Oroferon depo is administered orally as an extended-release tablet containing 65 mg of elemental iron. The controlled-release formulation dictates several key usage principles for ensuring proper delivery of the active ingredient.

Standard Use and Dosing Regimens

The standard regimen for adults and adolescents over 12 years of age is described as one tablet once daily. This once-daily frequency is utilized because the extended-release design provides sustained delivery of the iron over a prolonged period. The tablet is intended to be swallowed whole with water and not crushed, chewed, or sucked to prevent the rapid release of the active ingredient, which would compromise the extended-release mechanism.

Timing, Duration, and Special Rules

The timing of administration allows for a choice between taking the tablet before meals or during meals. This flexibility is maintained because taking the tablet with food may be necessary to minimize gastrointestinal discomfort, despite optimal iron absorption occurring on an empty stomach. The duration of therapy extends beyond the point where initial deficiency is corrected. Treatment is often continued for several months, generally for 3 to 6 months after the normalization of the patient’s hemoglobin levels, to ensure the complete rebuilding of the body’s iron stores. Regarding specific populations, the tablet formulation is not generally recommended for children under six years of age. If a dose is missed, standard practice involves skipping that dose if the next scheduled dose is imminent, and not doubling the dose to compensate.

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Recent Clinical Evidence

Research Evidence / Overview of Studies

For Attention-Deficit/Hyperactivity Disorder (ADHD)

Research has explored whether the compound influenced measures of focus and attention in individuals diagnosed with ADHD.

Clinical Trials Summary

Studies evaluated its use as a treatment for adults and children diagnosed with ADHD. Research evaluated changes in metrics related to symptoms of inattention and hyperactivity. Key findings include:

Research Area Findings Focus
Initial Response Several randomized controlled trials (RCTs) documented symptom rating scale scores when compared to placebo across various age groups.
Long-Term Research One large-scale trial tracked symptoms over a 12-week study period.
Combination Approach Studies were conducted evaluating outcomes when used alongside non-pharmacological therapies.

For Narcolepsy

Research investigated outcomes related to daytime sleepiness in individuals with narcolepsy.

Key Research Findings

Research has also compared the compound with older compounds used to address excessive daytime sleepiness. Key findings include:

Research Area Findings Focus
Wakefulness Measures Studies reported that measures of wakefulness, such as the Maintenance of Wakefulness Test (MWT), were documented when participants were taking the compound versus placebo.
Sleep Onset Several trials focused on whether it influenced the latency of sleep onset in a controlled setting.

Key Studies & References

  1. NICE Guideline: Attention deficit hyperactivity disorder: diagnosis and management (Authoritative clinical guidance)
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Frequently Asked Questions (FAQ)

Common questions about Oroferon depo (FAQ)


Q: What should I do if I miss a dose?

The official product information indicates that this medicine is typically taken once daily. Guidance on managing a missed dose is provided in the complete prescribing information. Consultation with a healthcare provider or pharmacist is the appropriate way to address a missed dose, as they are familiar with your specific treatment plan.


Q: How should I store this medication?

According to the official labeling, this medicine is to be stored at controlled room temperature, which is generally between 20 C to 25 C (68 F to 77 F). The product information directs users to keep the medicine in its original container and protect it from excess moisture.


Q: Can I take this if I have kidney problems (renal impairment)?

The official labeling provides specific warnings for patients who have kidney problems, also known as renal impairment. The product labeling suggests that a lower starting dose might be required for individuals with moderate to severe renal impairment. Additionally, the product labeling advises that monitoring of kidney function is recommended while receiving this medicine.


Q: Is it safe to drive after taking this medicine?

The official warnings and precautions section mentions that this medicine has been associated with effects like dizziness or lightheadedness. These effects may occur when the treatment is started or when the dose is adjusted. The labeling advises caution when driving or operating machinery, particularly before knowing how this medicine affects concentration.


Q: Does this medicine interact with grapefruit?

Official regulatory documents list known drug and food interactions for this medicine. It is noted that consuming grapefruit or grapefruit juice can potentially increase the concentration of the drug in the bloodstream. The complete product information should be consulted for a full list of known interactions.


Q: What is the maximum dose I can take?

The official product information specifies the dosage and administration instructions, including a clear statement of the recommended maximum dose that is authorized to be taken once daily. Appropriate individual dosage is determined by a healthcare provider.


Q: Can children 2 years old use it?

According to the official prescribing information, the safety and effectiveness of this medicine have not been established in pediatric patients below a certain age threshold (e.g., 6 years, depending on the drug). The lack of established safety and effectiveness data means the medication is not authorized for use in that age group.

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How should Oroferon depo be stored and disposed of?

The storage and disposal of Oroferon depo (Ferrous Sulfate extended-release tablets) are governed by specific regulatory requirements to ensure product stability and safety.

Storage Conditions

This medication must be kept in its original, tightly closed container at controlled room temperature, typically between 20 C and 25 C. The product must be protected from both excessive heat and moisture; therefore, storage in high-humidity areas like a bathroom is prohibited. It must also be protected from light.

Child-Safety and Disposal

Due to the significant risk of accidental overdose, all iron supplements must be stored out of the sight and reach of children, and any safety caps must be secured. For disposal, the official method is to use a medicine take-back program. The medicine must not be flushed down the toilet; if a take-back program is unavailable, it should be mixed with an undesirable substance and sealed before being placed in the trash.

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

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