ferric ammonium citrate

Action and Spectrum

Actions and spectrum:

ammonium ferric citrate is a complex iron salt that contains both ammonium and ferric ions. Its action is primarily related to its iron content, as it serves as a source of supplemental iron in the body. Iron is the essential component of hemoglobin for the oxygen transport. By providing iron, ammonium ferric citrate helps in the treatment of iron deficiency anemia. It has a spectrum of action that involves improving the oxygen-carrying capacity of the blood, thereby alleviating the symptoms of anemia and supporting normal physiological processes that depend on adequate oxygenation.

Drug Interaction

Adverse Reaction

Frequency defined

1-10%

• abdominal pain
• Vomiting
• Hyperkalemia
• Cough

>10%

• Discolored feces (22%)
• constipation (18%)
• diarrhea (21%)
• nausea (11%)

Frequency not defined

• Confusion
• irregular heartbeat
• nervousness
• stomach pain
• weakness
• difficulty breathing
• numbness
• dark-colored stools

difficulty in bowel movement

Black Box Warning

Black Box Warning:

There were no specific black box warnings associated with ammonium ferric citrate

Contraindication / Caution

Contraindication/Caution:

Contraindication:

• Hypersensitivity: ammonium ferric citrate should not be used in individuals who have a known hypersensitivity or allergy to the active ingredient or any of the components of the medication.
• Severe Iron Overload: ammonium ferric citrate is an iron-containing compound and should not be used in patients with severe iron overload conditions, such as hemochromatosis or other iron storage disorders.
• Renal Impairment: Caution is advised when using ammonium ferric citrate in patients with renal impairment, as it may increase the risk of adverse effects in these individuals.

Caution:

• Gastrointestinal Disorders: Caution should be exercised when administering ammonium ferric citrate to patients with gastrointestinal disorders, such as ulcerative colitis, Crohn’s disease, or peptic ulcers, as it may exacerbate these conditions.
• Renal Impairment: Patients should be monitored closely while receiving ammonium ferric citrate, as it may potentially lead to an accumulation of iron and exacerbate kidney function.
• Liver Dysfunction: Patients with liver dysfunction should be closely monitored while on ammonium ferric citrate, as it may affect liver function tests and may lead to increased iron storage in liver.
• Iron Overload: While ammonium ferric citrate is used to treat iron deficiency anemia, excessive use or misuse may lead to iron overload, especially in patients with certain conditions that predispose them to iron accumulation.
• Drug Interactions: ammonium ferric citrate may interact with other medications, especially those containing iron or other minerals.
• Pregnancy and Lactation: The use of ammonium ferric citrate during pregnancy and lactation should be done under the supervision of a healthcare professional.
• Pediatric Use: The safety & efficacy of ammonium ferric citrate in pediatric patients have not been well-established. Use in this population should be carefully considered and monitored by a healthcare professional.

Comorbidities:

• Gastrointestinal Disorders: Chronic gastrointestinal bleeding, such as from peptic ulcers, inflammatory bowel disease, or gastrointestinal tumors, can lead to iron deficiency anemia.
• Chronic Kidney Disease: Patients may develop iron deficiency anemia due to reduced erythropoietin production, a hormone that stimulates red blood cell production, or due to frequent blood losses in dialysis.
• Menstrual Disorders: Women with heavy menstrual bleeding may be at risk of iron deficiency anemia.
• Pregnancy: Pregnant women are susceptible to iron deficiency anemia due to its increased demand for iron during pregnancy.
• Chronic Infections: Certain chronic infections or inflammatory conditions can interfere with iron absorption and utilization, potentially leading to anemia.
• Malabsorption Syndromes: Conditions affecting nutrient absorption in the gastrointestinal tract, such as celiac disease, can result in iron deficiency anemia.

Pregnancy / Lactation

Pregnancy consideration: US FDA pregnancy category: Not assigned

Lactation: Excreted into human milk: unknown

Pregnancy category:

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
• Category N: There is no data available for the drug under this category.

Pharmacology

Pharmacology:

ammonium ferric citrate is a pharmaceutical compound used primarily as an iron replacement therapy to treat iron deficiency anemia. Upon administration, the citrate component chelates the ferric iron, forming a stable complex that enhances its solubility and absorption in the gastrointestinal tract. Once absorbed, the iron is transported by transferring to various tissues, where it plays a crucial role in the synthesis of hemoglobin and other heme-containing proteins involved in oxygen transport and cellular respiration. By replenishing iron levels, ammonium ferric citrate helps improve red blood cell production and overall oxygen-carrying capacity in the body. It is typically available as an oral solution and is prescribed by healthcare professionals to patients with iron deficiency anemia, aiming to alleviate symptoms associated with the condition and restore normal iron balance.

Pharmacodynamics:

• Chelation and Solubilization: ammonium ferric citrate contain ferric iron, which is chelated by the citrate component, forming a stable complex. This chelation enhances the solubility of iron in the gastrointestinal tract, allowing for better absorption.
• Iron Replenishment: After absorption, the iron-citrate complex is transported by transferring to various tissues, where it plays a vital role in iron replenishment.
• Hemoglobin Synthesis: Iron is essential for the synthesis of hemoglobin for carrying oxygen from the lungs to tissues. Adequate iron levels are crucial for proper red blood cell formation and oxygen delivery.
• Oxygen Transport: By replenishing iron levels, ammonium ferric citrate improves the oxygen-carrying capacity of red blood cells. This ensures efficient oxygen transport, supporting various physiological processes and preventing symptoms associated with iron deficiency anemia, such as fatigue and weakness.
• Normalization of Iron Balance: ammonium ferric citrate’s pharmacodynamics aim to restore normal iron balance in the body, correcting iron deficiency anemia and maintaining adequate iron stores for overall health and well-being.

Pharmacokinetics:

Absorption

ammonium ferric citrate is administered orally and undergoes dissolution in the stomach. The ferric iron-citrate complex is absorbed in the small intestine. The presence of the citrate component enhances the solubility of iron, facilitating its absorption.

Distribution

After absorption, the iron-citrate complex is transported through the bloodstream bound to transferrin, a plasma protein that carries iron. Transferrin delivers iron to various tissues, including bone marrow, where it is used for hemoglobin synthesis and other essential functions.

Metabolism

ammonium ferric citrate is primarily a carrier of iron, and it undergoes minimal metabolism itself. The iron component is utilized in various biochemical processes, including the synthesis of hemoglobin and other iron-containing enzymes.

Elimination and excretion

Iron levels in the body are tightly regulated, and excess iron is usually excreted to maintain iron homeostasis. Some iron is excreted via feces, while a small amount may be lost through urine and sweat

Adminstartion

Administration:

ammonium ferric citrate is typically administered orally as a medicinal supplement or in the form of an iron-fortified food product. The dosage and frequency depend on the individual’s iron requirements and the severity of iron deficiency.

It is essential to follow the healthcare professional’s instructions regarding the correct dosage and timing for taking ammonium ferric citrate. Usually, it is recommended to take it with food to improve absorption & reduce the risk of gastrointestinal side effects.

For individuals with diagnosed iron deficiency anemia or as directed by a healthcare provider, ammonium ferric citrate can be taken as a single dose or in divided multiple doses throughout the day. The treatment duration may vary based on the individual’s response to therapy and the underlying cause of iron deficiency.

Patient Information Leaflet

Patient information leaflet

Generic Name: ferric ammonium citrate

Why do we use ferric ammonium citrate?

ferric ammonium citrate is primarily used as a source of iron in dietary supplements and fortified food products to prevent or treat iron deficiency anemia. Iron plays an important role in the formation of hemoglobin for carrying oxygen. Iron deficiency may lead to anemia which characterized by fatigue, weakness, and impaired cognitive function.

ferric ammonium citrate provides a bioavailable form of iron which is easily absorbed by the body. It is commonly used to fortify iron-fortified foods, such as cereals and infant formulas, to improve iron intake in populations at risk of iron deficiency.