Baromalt 500 mg Ingredients and Usage

The active ingredient is Ferric Carboxymaltose, an iron (III) hydroxide complex with a carbohydrate polymer. The 500 mg strength is commonly diluted and administered via slow intravenous (IV) infusion.

Ferric Carboxymaltose is clinically used for the treatment of IDA in various high-risk populations, including:

• Patients with Intolerance to Oral Iron: Including those with gastrointestinal side effects from oral supplements.
• Post-Bariatric Surgery Patients: Where absorption of oral iron is severely compromised.
• Chronic Kidney Disease (CKD) Patients: Who are not on dialysis.
• Certain Heart Failure Patients: To improve exercise capacity in NYHA Class II/III heart failure with iron deficiency.

How Does Baromalt Work?

Ferric Carboxymaltose works as a source of iron that is delivered directly into the circulation, bypassing the gastrointestinal tract. The mechanism of action is designed for controlled release:

1. Colloidal Complex: The iron (III) hydroxide is tightly bound within a carboxymaltose carbohydrate shell, forming a stable complex.
2. Iron Delivery: Once administered, the complex is taken up by the cells of the reticuloendothelial system (e.g., macrophages in the liver and spleen).
3. Controlled Release: The complex slowly releases elemental iron, which then binds to circulating transferrin or is stored as ferritin (the body’s iron storage protein). This process minimizes the risk of releasing high concentrations of free iron, reducing toxicity risks.

Baromalt 500 mg Side Effects and Warnings

Intravenous iron products, including Baromalt, carry a risk of serious reactions and require specific monitoring.

Black Box Warnings and Critical Precautions:

1. Hypersensitivity Reactions: Parenteral iron can cause severe, life-threatening anaphylactic/anaphylactoid reactions. Patients must be observed for at least 30 minutes after each injection, and staff must be prepared to manage a severe allergic reaction (e.g., with epinephrine, antihistamines).
2. Hypophosphatemia (HPP): Baromalt can cause a clinically significant, sometimes symptomatic, decrease in serum phosphate levels (Hypophosphatemia). This risk is higher with repeated administration and may require phosphate monitoring.
3. Hypertension: A temporary increase in blood pressure (Hypertension) may occur immediately after the infusion. Blood pressure monitoring is required during and shortly after administration.
4. Injection Site Reaction: Caution must be exercised to avoid paravenous leakage (leakage outside the vein). Leakage can cause severe irritation and potentially long-lasting brown discoloration of the skin at the injection site.

Baromalt 500 mg Storage Conditions

Baromalt Injection should be stored under controlled conditions:

• Store the unopened vials at controlled room temperature, typically between 20°C and 25°C (68°F and 77°F). Do not freeze.
• Keep the vials in the original carton to protect them from light.
• Administration: The dose can be administered as an undiluted slow IV push or diluted in up to 250 mL of 0.9% Sodium Chloride solution for IV infusion (infused over at least 15 minutes).
• Discard any unused portion, as the vial is single-use.