Ferric Maltol

Ferric Maltol delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin. It has been shown to increase serum iron parameters, including ferritin and transferrin saturation (TSAT).

Ferric Maltol capsule should be taken orally, preferably on an empty stomach, at least 1 hour before or 2 hours after meals.

• Iron Deficiency Anemia: Used for the treatment of iron deficiency in adults.

Oral Iron preparations

Iron Replacement (Oral)

Ferric Maltol delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin. It has been shown to increase serum iron parameters, including ferritin and transferrin saturation (TSAT).

Ferric Maltol supplements iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin.

Adult Dose (Oral):

• 30 mg twice daily.
• Continue as long as necessary until ferritin levels are within normal range.
• Treatment duration depends on severity of iron deficiency but generally at least 12 weeks of treatment is required.

Take 1 hour before or 2 hours after a meal. Do not open, break or chew the capsule. Swallow whole.

If you miss a dose of Ferric Maltol, take it as soon as possible; however, if it is almost time for your next dose, skip the missed dose.

Common Side Effects (1-10%):

• Flatulence (4.6%)
• Diarrhea (4%)
• Constipation (4%)
• Discolored feces (4%)
• Abdominal pain (2.9%)
• Nausea (1.7%)
• Vomiting (1.7%)
• Abdominal discomfort (1.1%)
• Abdominal distension (1.1%)

Precautions:

• Avoid use in patients with active inflammatory bowel disease (IBD) flare (risk of increased GI inflammation).
• Do not administer to patients with evidence of iron overload or patients receiving IV iron.
• Assess iron parameters before initiating treatment and monitor during therapy.
• Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years; keep out of reach of children.

Contraindications:

• Hypersensitivity
• Hemochromatosis and other iron overload syndromes
• Patients receiving repeated blood transfusions

Drug Interactions:

• Dimercaprol: May increase risk of nephrotoxicity; avoid concomitant use.
• Mycophenolate, Ethynyl estradiol, Ciprofloxacin, Doxycycline: May decrease bioavailability; separate by at least 4 hours.

Food Interactions: Food decreases bioavailability of iron; take on empty stomach.

Use in Pregnancy: Not absorbed systemically as an intact complex following oral administration; fetal exposure not expected.

Use in Lactation: No data on presence in human milk; not absorbed systemically as an intact complex following maternal oral administration.

Pediatric Use: Safety and effectiveness not established.

Geriatric Use: No specific dosage adjustment is necessary for elderly patients.

Renal Impairment: Safe for patients with kidney disease.

Hepatic Impairment: Safe for patients with liver disease.

Overdose: Early signs: nausea, vomiting, abdominal pain, diarrhea; serious cases: hypoperfusion, metabolic acidosis, systemic toxicity; excess dosages may lead to hemosiderosis.

Storage: Store below 25 degree C in a cool and dry place protected from light. Keep away from reach of children.

Ferric Maltol