Irondext (Solution) Instructions for Use

Marketing Authorization Holder

Pharmaceutical Projects, LLC (Russia)

Manufactured By

Gland Pharma, Limited (India)

ATC Code

B03AC (Parenteral preparations of trivalent iron)

Active Substance

Iron sucrose (BAN)

Dosage Form

Irondext

Solution for intravenous administration 20 mg/1 ml: amp. 5 ml 5 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration colloidal, brown in color.

Excipients: sodium hydroxide – q.s. to adjust pH to 10.9-11.0, water for injections – up to 1 ml.

5 ml – glass ampoules (5) – trays (1) – cardboard packs.

Clinical-Pharmacological Group

Antianemic drug for parenteral administration

Pharmacotherapeutic Group

Iron preparation

Pharmacological Action

A drug for the treatment of iron deficiency conditions. The polynuclear iron (III) hydroxide centers are surrounded on the outside by numerous non-covalently bound sucrose molecules.

As a result, a complex is formed with a molecular weight of approximately 43 kDa, which makes its excretion by the kidneys in unchanged form impossible. This complex is stable and does not release iron ions under physiological conditions.

The iron in this complex is bound to structures similar to natural ferritin.

Pharmacokinetics

After a single intravenous administration of a dose containing 100 mg of iron, the C_max of iron, averaging 538 µmol, is reached 10 minutes after the injection.

The V_d of the central chamber almost completely corresponds to the volume of serum – about 3 L. The V_d at steady state is approximately 8 L (indicating low distribution of iron in body fluids).

Due to the low stability of iron sucrose compared to transferrin, a competitive exchange of iron in favor of transferrin is observed. As a result, about 31 mg of iron (III) is transferred within 24 hours.

T_1/2 is about 6 hours. Less than 5% of iron from the total clearance is excreted by the kidneys in the first 4 hours. After 24 hours, the serum iron level returns to the initial (pre-administration) value, and approximately 75% of the sucrose leaves the vascular bed.

Indications

Iron deficiency conditions: when rapid iron replenishment is necessary; in case of intolerance to oral iron preparations or non-compliance with the treatment regimen; in the presence of active inflammatory bowel diseases when oral iron preparations are ineffective.

ICD codes

Dosage Regimen

Administered only intravenously (by slow drip or bolus) or into the venous portion of the dialysis system. Not intended for intramuscular administration. Simultaneous administration of the full therapeutic dose is not permissible.

Before administering the first therapeutic dose, a test dose must be prescribed. If intolerance phenomena occur during the observation period, the administration should be stopped immediately.

The dose is calculated individually according to the total iron deficiency in the body using a special formula.

Adverse Reactions

Nervous system disorders very rarely – dizziness, headache, loss of consciousness, paresthesia.

Cardiovascular system disorders very rarely – palpitations, tachycardia, decreased blood pressure, collapse-like conditions, feeling of heat, flushing.

Respiratory system disorders very rarely – bronchospasm, dyspnea.

Digestive system disorders very rarely – diffuse abdominal pain, epigastric pain, diarrhea, taste perversion, nausea, vomiting.

Skin and subcutaneous tissue disorders very rarely – erythema, itching, rash, pigmentation disorder, increased sweating.

Musculoskeletal and connective tissue disorders very rarely – arthralgia, back pain, joint swelling, myalgia, limb pain.

Allergic reactions very rarely – anaphylactoid reactions, facial edema, laryngeal edema.

General disorders and administration site conditions very rarely – asthenia, chest pain, feeling of heaviness in the chest, weakness, peripheral edema, malaise, pallor, fever, chills.

Local reactions very rarely – pain and swelling at the injection site.

Contraindications

Anemia not associated with iron deficiency; signs of iron overload (hemosiderosis, hemochromatosis); impaired iron utilization process; first trimester of pregnancy; hypersensitivity to the active substance.

Use in Pregnancy and Lactation

Contraindicated for use in the first trimester of pregnancy.

Limited experience with use during pregnancy has shown no adverse effects of iron sucrose on the course of pregnancy and the health of the fetus/newborn. To date, no well-controlled studies have been conducted in pregnant women.

In experimental studies on reproductive effects in animals, no direct or indirect harmful effects on embryo/fetal development, childbirth, or postnatal development were identified.

The passage of non-metabolized iron sucrose into breast milk is unlikely. This medicinal product is considered not to pose a risk to breastfed infants.

Special Precautions

Use with caution in patients with bronchial asthma, eczema, polyvalent allergy, allergic reactions to other parenteral iron preparations; in patients with low serum iron-binding capacity and/or folic acid deficiency; patients with hepatic insufficiency, with acute or chronic infectious diseases, with elevated serum ferritin levels, because parenterally administered iron may have an adverse effect in the presence of bacterial or viral infection.

Use only after confirmation of the anemia diagnosis with appropriate laboratory data (e.g., results of serum ferritin determination or hemoglobin and hematocrit levels, red blood cell count and their parameters – mean corpuscular volume, mean corpuscular hemoglobin).

Intravenous iron preparations can cause allergic or anaphylactoid reactions, which can be potentially life-threatening.

A higher frequency of adverse reactions (especially decreased blood pressure), which can also be severe, is associated with an increase in dose.

Drug Interactions

Should not be used concurrently with oral iron dosage forms, as the absorption of iron from the gastrointestinal tract is reduced. Treatment with oral iron preparations can be started no earlier than 5 days after the last injection.

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.