Hemoron100 ml

Hemoron is an oral iron replacement therapy indicated for:

• Established use: Treatment of iron-deficiency anemia in adults, children, and infants, including cases where conventional ferrous iron salts (e.g., ferrous sulfate) are poorly tolerated due to gastrointestinal side effects.
• Established use: Prevention (prophylaxis) of iron-deficiency anemia in at-risk groups, including low-birth-weight infants, young children, and pregnant women, under medical supervision.
• Guideline-supported adjunct use: Iron-deficiency anemia occurring in pregnancy, particularly when standard oral iron formulations cause intolerable gastrointestinal upset.
• Adjunct use: Anemia secondary to chronic inflammatory conditions such as rheumatoid arthritis, where iron deficiency has been confirmed, used alongside treatment of the underlying disease.

Hemoron is not indicated for anemias not caused by iron deficiency (e.g., hemolytic anemia, anemia of chronic disease without confirmed iron deficiency, or megaloblastic anemia due to vitamin B12/folate deficiency).

Each dose of Sodium Feredetate Trihydrate oral solution provides elemental iron in the form of a ferric-sodium chelate of edetate (sodium iron edetate), typically standardized to deliver approximately 27.5 mg of elemental iron per 5 mL. The formulation may also contain pharmaceutical excipients such as sweetening and flavoring agents, preservatives, and coloring agents; patients with known sensitivity to these excipients should review the product label.

The exact strength and formulation of Sodium Feredetate Trihydrate may vary by manufacturer; always check the product packaging for the precise elemental iron content per dose.

Hemoron (sodium iron edetate) is an iron-chelate compound used as an oral hematinic agent for the treatment and prevention of iron-deficiency anemia. It is formulated to release iron in a chelated form that is generally associated with better gastrointestinal tolerability, less tooth/gum staining, and a milder metallic taste compared with some conventional ferrous iron salts.

Hemoron is typically supplied as an oral liquid solution, making it suitable for use in infants, young children, and patients who have difficulty swallowing tablets or capsules, as well as in adults who cannot tolerate other iron preparations.

Hemoron belongs to the therapeutic class of hematinic agents / oral iron replacement therapy, used to correct and prevent iron-deficiency states.

Mechanism of Action

Sodium Feredetate Trihydrate supplies elemental iron in a chelated (ferric-edetate) form. Once ingested, iron is released from the chelate and absorbed predominantly in the duodenum and proximal jejunum. Absorbed iron binds to transferrin for transport to the bone marrow, where it is incorporated into hemoglobin within developing red blood cells, and to other tissues for storage as ferritin.

Pharmacodynamics

By replenishing body iron stores, Sodium Feredetate Trihydrate restores normal hemoglobin synthesis and corrects the anemia and associated symptoms (fatigue, pallor, weakness) caused by iron deficiency. Hematological improvement (reticulocytosis, then rising hemoglobin) is typically seen within 1-2 weeks of adequately dosed therapy.

Pharmacokinetics

Iron from Sodium Feredetate Trihydrate is absorbed from the upper small intestine, with absorption influenced by iron stores, erythropoietic activity, and concurrent food or medications. Unabsorbed iron is excreted in the feces; absorbed iron is conserved by the body with minimal physiological excretion.

Hemoron oral solution may be taken directly or diluted with water or juice as directed on the product label. It can be taken with or after food if it causes stomach upset, although absorption is generally best on an empty stomach; a physician can advise on the best timing for an individual patient.

To avoid reduced absorption, Hemoron should be taken at least 2 hours apart from antacids, proton pump inhibitors, calcium or zinc supplements, and tetracycline or fluoroquinolone antibiotics. Use the measuring device provided with the product for accurate dosing, especially in infants and children. Do not exceed the dose prescribed by the physician.

Clinically Significant Interactions

• Tetracyclines and fluoroquinolone antibiotics: Hemoron forms complexes with these antibiotics, reducing absorption of both the iron and the antibiotic; separate dosing by at least 2 hours.
• Levothyroxine (thyroxine): Iron can reduce absorption of levothyroxine; separate administration by at least 4 hours and monitor thyroid function if co-administered with Hemoron.
• Bisphosphonates and penicillamine: Concurrent use with Hemoron can reduce absorption of these drugs; separate dosing times.
• Antacids and proton pump inhibitors: Reduce gastric acidity needed for optimal iron absorption from Hemoron; separate dosing where possible.
• Dimercaprol: Should not be given with Hemoron, as the combination can form a toxic complex.
• Mycophenolate mofetil: Oral iron, including Hemoron, may reduce its absorption; separate administration times.
• Chloramphenicol: May delay the hematological response to Hemoron in some patients.
• Vitamin C (ascorbic acid) and other iron-fortified products: Ascorbic acid can enhance iron absorption from Hemoron; concurrent use of other iron-containing products with Hemoron should be avoided unless directed by a physician, to prevent excess iron intake.

This is not an exhaustive list. Inform your physician or pharmacist of all medicines you are taking before starting Hemoron.

Most side effects of Hemoron are gastrointestinal and generally milder than with conventional ferrous iron salts, though they can still occur:

• Nausea
• Mild diarrhea or, less commonly, constipation
• Abdominal discomfort
• Dark or black-colored stools (a harmless but expected effect of unabsorbed iron)
• Rarely, hypersensitivity reactions (skin rash, itching)

If severe abdominal pain, persistent vomiting, black tarry stools accompanied by dizziness, or signs of an allergic reaction (swelling, difficulty breathing) occur while taking Hemoron, seek medical attention promptly.

Hemoron is commonly used to treat and prevent iron-deficiency anemia during pregnancy, particularly when standard oral iron preparations are poorly tolerated, and is generally considered acceptable for use under medical supervision. However, as with any medicine used in pregnancy, Hemoron should be used only if clearly needed, with the dose and duration determined by a physician, and with particular care during the first trimester.

Hemoron has not been associated with reported adverse effects during breastfeeding; nonetheless, a breastfeeding mother should consult her physician before use to confirm the appropriate dose and to weigh the potential benefits and risks for her specific situation.

• Iron overload/storage disorders: Use Hemoron with caution in patients with a history of iron-storage disease or hemolytic conditions where iron overload could occur (see Contraindications for absolute exclusions).
• Gastrointestinal disease: Use with caution in patients with active peptic ulcer disease, ulcerative colitis, diverticulitis, or other significant GI conditions, as iron may aggravate symptoms.
• Effect on stool color and occult blood testing: Hemoron darkens the stool and may interfere with tests for occult (hidden) blood in stool; inform your physician if such testing is planned.
• Excipients: Some formulations of Hemoron contain sorbitol and should be avoided in patients with hereditary fructose intolerance; certain formulations may also contain preservatives or coloring agents that can rarely cause delayed hypersensitivity reactions.
• Children: Accidental ingestion of iron-containing products, including Hemoron, is a recognized cause of serious and potentially fatal poisoning in young children. Always store Hemoron in a childproof container, out of sight and reach of children, and use only the measured dose prescribed (see Overdose Effects for emergency guidance).
• Avoid unsupervised combination with other iron products: Do not take other iron-containing supplements or fortified products together with Hemoron unless advised by a physician, to avoid excessive iron intake.

Overdose of Hemoron is a medical emergency, especially in young children, and can be fatal even with relatively small amounts of concentrated iron products. Symptoms of overdose may include nausea, vomiting, diarrhea, abdominal pain, lethargy, and in severe cases, gastrointestinal bleeding, circulatory collapse, and shock; these symptoms can appear within hours and may be followed by a deceptively symptom-free period before delayed, serious complications develop.

If overdose of Hemoron is suspected or witnessed, seek immediate medical attention or contact emergency services / a poison control center right away - do not wait for symptoms to appear. Management must be carried out by medical professionals and may include gastric decontamination and specific iron chelation therapy (e.g., desferrioxamine) in a hospital setting. Do not attempt to treat a suspected overdose at home.

Store Hemoron at room temperature (below 30°C as specified on the product label), protected from light and moisture. Keep the container tightly closed and out of the sight and reach of children at all times, as an iron overdose can be fatal in a child.

Renal Impairment

No well-established dose adjustment of Hemoron is required for renal impairment; however, iron status should be monitored, particularly in patients with chronic kidney disease who may have altered iron handling.

Hepatic Impairment

Hemoron should be used cautiously in patients with significant liver disease, given the risk of hepatic iron accumulation; monitoring of iron indices is advised.

Elderly

Elderly patients may take Hemoron at the same doses recommended for adults, with attention to gastrointestinal tolerability and any concurrent medications that may interact (see Interactions).

For pediatric use of Hemoron, see Pediatric Uses.

Treatment with Hemoron for iron-deficiency anemia is typically continued for at least 2-3 months after hemoglobin levels normalize, in order to replenish the body's iron stores. The total duration should be individualized by the physician based on follow-up hemoglobin and ferritin levels and the underlying cause of the iron deficiency.

Sodium Feredetate Trihydrate belongs to the hematinic agent / oral iron replacement therapy class, specifically the iron-chelate (sodium iron edetate) subclass of iron supplements.

Sodium Feredetate Trihydrate works by supplying elemental iron in a chelated form that is absorbed from the small intestine and delivered to the bone marrow via plasma transferrin. There, the iron is incorporated into protoporphyrin to form heme, which combines with globin chains to produce hemoglobin in developing red blood cells. By restoring adequate iron substrate, Sodium Feredetate Trihydrate corrects the impaired hemoglobin synthesis that underlies iron-deficiency anemia, improving oxygen-carrying capacity and resolving related symptoms such as fatigue and pallor.

Hemoron is commonly used in infants and children for both the treatment and prevention of iron-deficiency anemia, and its oral liquid formulation makes it convenient for pediatric dosing.

• Treatment dose: Approximately 3-6 mg/kg/day of elemental iron, divided into 2-3 doses (maximum around 200 mg/day), adjusted by the pediatrician based on the child's weight and severity of anemia.
• Preventive (prophylactic) dose: Varies by age - from about 5 mg/day (up to 2 mg/kg/day in some low-birth-weight infants) in exclusively breastfed low-birth-weight infants, rising to about 12.5 mg/day at 6-24 months, 20-30 mg/day at 2-5 years, 30-60 mg/day at 6-11 years, and about 60 mg/day in adolescents.

As with all iron products, Hemoron must be stored safely out of children's reach, since accidental overdose in a child can be fatal (see Overdose Effects). Use only the dosing device supplied with the product to ensure accurate dosing in infants and young children.