Filofer 30: An Oral Iron Preparation for Iron Deficiency

Filofer 30 contains Ferric Maltol, an oral iron preparation indicated for the treatment of iron deficiency in adults. It works by delivering iron for absorption and subsequent utilization in the body.

How Filofer 30 Works (Pharmacology)

Ferric Maltol delivers iron in a form that is readily absorbed across the intestinal wall. Once absorbed, this iron is then transferred to transferrin (a protein that transports iron in the blood) and ferritin (a protein that stores iron in the body). By increasing serum iron parameters, including ferritin levels and transferrin saturation (TSAT), Filofer 30 helps to replenish the body's iron stores and alleviate iron deficiency.

Key Indications & Benefits

Filofer 30 is indicated for:

• Treatment of iron deficiency in adults.

Dosage & Administration

Filofer 30 capsules are taken orally. To optimize absorption, they should preferably be taken on an empty stomach, at least 1 hour before or 2 hours after meals. Do not open, break, or chew the capsule.

• Recommended Dosage: 30 mg twice daily.
• Treatment Duration: The duration of treatment depends on the severity of the iron deficiency. Generally, at least 12 weeks of treatment are required. Treatment should continue until ferritin levels are within the normal range.

Use in children and adolescents: The safety and effectiveness of ferric maltol have not been established in pediatric patients.

Always consult a registered physician for medication use.

Important Considerations & Warnings

It is crucial to discuss your full medical history with your doctor before taking Filofer 30.

Contraindications:

• Known hypersensitivity to ferric maltol or any other components of this product.
• History of hemochromatosis and other iron overload syndromes.
• Patients receiving repeated blood transfusions (as this can lead to iron overload).

Side Effects:

The most common side effects are:

• Flatulence
• Diarrhea
• Constipation
• Feces discolored (darkening of stool is common with iron supplements)
• Abdominal pain
• Nausea
• Vomiting

Pregnancy & Lactation:

• Pregnancy: Ferric maltol is not absorbed systemically as an intact complex following oral administration, so maternal use is not expected to result in fetal exposure to the drug.
• Lactation: There are no specific data on the presence of ferric maltol in human milk, its effects on the breastfed child, or its effects on milk production. However, as it's not absorbed systemically as an intact complex by the mother, breastfeeding is not expected to result in exposure of the child to ferric maltol.

Precautions & Warnings:

• Inflammatory Bowel Disease (IBD): Avoid use of Filofer in patients with an active inflammatory bowel disease (IBD) flare, as there is a potential risk of increased inflammation in the gastrointestinal tract.
• Iron Overload: Do not administer to patients with evidence of iron overload or patients receiving intravenous iron.
• Monitoring Iron Parameters: Assess iron parameters (e.g., serum iron, ferritin, TSAT) prior to initiating Filofer and monitor these parameters while on therapy to ensure appropriate dosing and prevent overload.
• Accidental Overdose in Children:Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. In case of accidental overdose, immediate medical treatment is essential.

Drug Interactions:

• Dimercaprol: Concomitant use of iron products with dimercaprol may increase the risk of nephrotoxicity (kidney damage).Avoid concomitant use.
• Reduced Bioavailability of other drugs: Concomitant use of Filofer may decrease the bioavailability of some drugs, including:
  • Mycophenolate
  • Ethynyl estradiol
  • Ciprofloxacin
  • Doxycycline
  • For oral drugs where reductions in bioavailability may cause clinically significant effects on safety or efficacy,separate the administration of Filofer by at least 4 hours.
• Food Interaction: Food has been shown to decrease the bioavailability of iron after administration of Filofer. Hence, it is advised to take it on an empty stomach.

Overdose Effects:

• No specific data is available regarding overdose of Filofer in patients.
• Early signs and symptoms of iron overdose: Nausea, vomiting, abdominal pain, and diarrhea.
• More serious cases: Evidence of hypoperfusion (reduced blood flow), metabolic acidosis, and systemic toxicity.
• Chronic Overdose: Dosages of Filofer in excess of iron needs may lead to accumulation of iron in storage sites, potentially leading to hemosiderosis (excess iron accumulation in tissues).

Storage Conditions

Store in a cool (below 25°C) and dry place, protected from light. Keep away from the reach of children.