Ferromalt (Drops) Instructions for Use

Marketing Authorization Holder

Alvils, LLC (Russia)

Manufactured By

Vifitech, CJSC (Russia)

ATC Code

B03AB05 (Iron polyisomaltose)

Active Substance

Iron polymaltose (BP British Pharmacopoeia)

Dosage Form

Ferromalt

Oral drops 50 mg/ml: 30 ml, 50 ml, or 100 ml bottle.

Dosage Form, Packaging, and Composition

Oral drops dark brown in color with a characteristic odor.

Excipients : sucrose – 50.00 mg, sodium methylparaben – 2.00 mg, sodium propylparaben – 0.22 mg, flavor “Caramel-Cream 761” – 3.00 mg, sodium hydroxide – to pH 5.5-7.0, purified water – to 1.00 ml.

30 ml – dark glass bottles (1) – cardboard packs.
50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Antianemic drug

Pharmacotherapeutic Group

Iron preparation

Pharmacological Action

Anemia treatment agent. The polynuclear centers of Fe3+ hydroxide are surrounded externally by many non-covalently bound polymaltose molecules, forming a complex with a total molecular weight of 50 kDa, which is so large that its diffusion through the intestinal mucosa membranes is approximately 40 times less than that of Fe2+ hexahydrate.

This macromolecular complex is stable, does not release iron in the form of free ions, and is similar in structure to the natural compound of iron and ferritin. Due to this similarity, Fe3+ ions from the intestine enter the blood only through active absorption, which explains the impossibility of overdose (and intoxication) unlike simple iron salts, the absorption of which occurs along a concentration gradient.

The absorbed iron is deposited in a form bound to ferritin, mainly in the liver. Later, in the bone marrow, it is incorporated into hemoglobin. The iron that is part of the Fe3+-hydroxide polymaltose complex does not have pro-oxidant properties (which are inherent in simple Fe2+ salts), which leads to a reduction in the oxidation of LDL and VLDL.

Rapidly replenishes iron deficiency in the body, stimulates erythropoiesis, and restores hemoglobin.

Pharmacokinetics

The degree of absorption after oral administration depends on the degree of iron deficiency (the greater the deficiency, the higher the absorption) and on the dose of the drug (the higher the dose, the worse the absorption). It is absorbed primarily in the duodenum and small intestine. The unabsorbed portion is excreted in the feces.

After intramuscular administration, it enters the bloodstream through the lymphatic system. The time to reach C_max is 24 hours. In the reticuloendothelial system (RES), the complex is broken down into iron (III) hydroxide and polymaltose (metabolized by oxidation). In the bloodstream, iron binds to transferrin, in tissues it is deposited as part of ferritin, in the bone marrow it is incorporated into hemoglobin and used in the process of erythropoiesis.

Indications

For oral administration: treatment of iron deficiency anemia of various origins and latent iron deficiency in infants and young children; increased need for iron (pregnancy, lactation, blood donation, period of intensive growth, vegetarianism, old age).

For parenteral administration: treatment of iron deficiency anemia when oral iron-containing drugs are ineffective or cannot be used (including in patients with gastrointestinal diseases, malabsorption syndrome).

ICD codes

Dosage Regimen

Determine the dosage individually based on the degree of iron deficiency, patient age, and clinical situation.

For oral administration, administer the drops directly into the mouth or mix with fruit or vegetable juice. Do not mix with tea, coffee, or milk.

For infants and children, calculate the daily dose as 5 mg of iron (III) per kg of body weight. Administer the calculated dose once daily or in divided doses.

For adults and adolescents, the typical daily dose is 100-200 mg of iron (III), equivalent to 2-4 ml of oral drops. Administer once daily or in divided doses.

For pregnant women, the typical daily dose for treating anemia is 100-200 mg of iron (III). For prophylaxis, use 50-100 mg daily.

The duration of treatment for iron deficiency anemia is typically 3-5 months after hemoglobin normalization to replenish iron stores.

For intramuscular administration, calculate the total cumulative dose based on body weight and hemoglobin level. Administer injections deeply into the gluteal muscle, alternating sides. Do not exceed the maximum single dose.

Continue treatment for the full prescribed duration even after clinical improvement and hemoglobin normalization.

Adverse Reactions

When taken orally: dyspepsia (feeling of fullness and pressure in the epigastric region, nausea, constipation or diarrhea), dark coloration of stool (due to the excretion of unabsorbed iron and has no clinical significance).

With intramuscular injection: in rare cases – arthralgia, lymph node enlargement, fever, headache, malaise, dyspepsia (nausea, vomiting); very rarely – allergic reactions. Local reactions (with incorrect injection technique): skin staining, pain, inflammation.

Contraindications

Excess iron in the body (hemochromatosis, hemosiderosis); anemia not associated with iron deficiency (hemolytic anemia or megaloblastic anemia caused by cyanocobalamin deficiency, aplastic anemia); impaired iron utilization mechanisms (lead anemia, sideroblastic anemia, thalassemia, cutaneous porphyria tarda); hypersensitivity to the active substance.

Only for intramuscular administration (additionally): Rendu-Osler-Weber disease; chronic polyarthritis; acute stage of infectious kidney diseases; uncontrolled hyperparathyroidism; decompensated liver cirrhosis; infectious hepatitis; children under 4 months of age; first trimester of pregnancy.

Use in Pregnancy and Lactation

No negative effect on the fetus has been established when using oral forms during pregnancy (including in the first trimester).

Intramuscular administration is contraindicated in the first trimester of pregnancy.

In small amounts, unchanged iron from the polymaltose complex may be excreted in breast milk; however, the occurrence of adverse effects in breastfed infants is unlikely.

Pediatric Use

Contraindicated for use in children under 4 months of age.

Special Precautions

Iron supplementation should be continued even after hemoglobin normalization.

Does not cause staining of tooth enamel.

Parenteral iron preparations can cause allergic and anaphylactic reactions. In case of moderately severe allergic reactions, antihistamines should be prescribed; if a severe anaphylactic reaction develops, immediate administration of epinephrine is necessary. Cardiopulmonary resuscitation equipment should be available. Caution should be exercised when administering iron preparations to patients with allergies, as well as hepatic and renal insufficiency. Side effects occurring in patients with cardiovascular diseases may exacerbate the underlying disease. Patients with bronchial asthma or those with low serum iron-binding capacity and/or folic acid deficiency are at high risk of developing allergic or anaphylactic reactions.

In children, parenteral iron preparations may adversely affect the course of an infectious process.

Drug Interactions

Oral forms: no interactions with other medicinal products have been identified.

Solution for injection: ACE inhibitors enhance systemic effects. Should not be used concurrently.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.