FCM INJECTION 500MG/10ML

Indications

• Iron deficiency anemia
• Chronic kidney disease
• Pregnancy-related anemia
• Post-surgical anemia
• Anemia in patients with inflammatory bowel disease

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines in pediatric populations.

Adults: Refer to the BNF for specific dosing information, as doses may vary based on the severity of iron deficiency and clinical condition.

Mechanism of action

Carboxymaltose is a carbohydrate-coated iron complex. Upon administration, it dissociates in the body, releasing ferric ions that are subsequently taken up by transferrin, a plasma protein that transports iron in the bloodstream. This mechanism facilitates iron delivery to erythroid precursors in the bone marrow, promoting hemoglobin synthesis and red blood cell production.

Pharmacodynamics

The pharmacodynamic effects of carboxymaltose are primarily centered on its role in correcting iron deficiency and improving hemoglobin levels. Following administration, the iron is incorporated into hemoglobin, leading to increased oxygen-carrying capacity of the blood, reduced symptoms of anemia, and overall improvement in physical performance and exercise tolerance.

Pharmacokinetics

Carboxymaltose is administered intravenously, allowing for rapid absorption and onset of action. The distribution half-life is relatively short, while the elimination half-life can vary based on individual patient factors. Iron from carboxymaltose is gradually released into the bloodstream, with a portion of the iron stored in ferritin, the body's iron storage protein. The total iron content and the patient's iron status will influence the pharmacokinetic profile, including the duration of action and the need for subsequent doses.

Contra-indications

• Hypersensitivity to carboxymaltose or any component of the formulation
• Severe anemia not due to iron deficiency
• Conditions associated with iron overload or disturbances in iron utilization

Adverse effects

• Hypotension
• Nausea
• Vomiting
• Abdominal pain
• Headache
• Dizziness
• Allergic reactions including rash and anaphylaxis

Interactions

• May interact with oral iron supplements, reducing their absorption and effectiveness
• Concomitant use with other intravenous iron preparations should be approached with caution

Precautions

• Monitor iron levels and signs of iron overload in patients receiving multiple doses
• Use with caution in patients with a history of allergic reactions to iron preparations
• Consider cardiovascular status in patients with underlying heart disease

Pregnancy

Carboxymaltose is generally considered safe during pregnancy, but should be used only if clearly needed and after assessing risks versus benefits.

Breast-feeding

Carboxymaltose is excreted in breast milk, but is unlikely to affect the breastfeeding infant when used in therapeutic doses.

Storage

Store in a cool, dry place away from light. Do not freeze. Keep out of reach of children.

Formulations

• Intravenous infusion solution

Indications

• Iron deficiency anemia
• Chronic blood loss
• Nutritional iron deficiency
• Pregnancy-related anemia

Dosage

Children: Refer to the BNF for Children for specific dosing information as it may vary based on the formulation and clinical context.

Adults: Refer to the BNF for specific dosing information as it may vary based on the formulation and clinical context.

Mechanism of action

Ferric ions participate in various biological processes, including oxygen transport and electron transfer. They facilitate the formation of hemoglobin in red blood cells, allowing for efficient oxygen delivery throughout the body. Ferric compounds can also promote the absorption of iron from the gastrointestinal tract by providing a more bioavailable form of iron.

Pharmacodynamics

Ferric compounds exhibit their effects primarily through the restoration of iron levels in the body. This leads to improved synthesis of hemoglobin and overall enhancement of oxygen-carrying capacity. The pharmacological action is dose-dependent, with higher doses leading to more pronounced effects on hemoglobin levels and erythropoiesis. Additionally, ferric ions can influence various metabolic pathways involved in cellular respiration and energy production.

Pharmacokinetics

Ferric is absorbed in the gastrointestinal tract, with absorption rates influenced by dietary factors and the presence of other substances in the gut. Once absorbed, ferric ions are transported in the bloodstream bound to transferrin, a transport protein. The body regulates iron levels primarily through absorption rather than excretion, and excess iron can be stored in the liver, spleen, and bone marrow. The elimination of ferric compounds is generally slow, as they are incorporated into various biological systems or stored for future use.

Contra-indications

• Hypersensitivity to ferric compounds
• Iron overload conditions such as haemochromatosis or haemosiderosis
• Chronic liver disease
• Active peptic ulcer disease

Adverse effects

• Gastrointestinal disturbances including nausea, vomiting, and constipation
• Diarrhea
• Abdominal pain
• Black stools
• Allergic reactions including rashes and anaphylaxis
• Staining of teeth (with oral formulations)

Interactions

• Antacids may reduce the absorption of oral ferric preparations
• Tetracyclines and quinolone antibiotics may have reduced absorption when taken with iron
• Ascorbic acid may enhance the absorption of iron

Precautions

• Caution in patients with a history of gastrointestinal disease
• Monitor for signs of iron overload in patients receiving repeated doses
• Use with caution in patients with renal impairment

Pregnancy

Ferric compounds are generally considered safe in pregnancy when used as directed to treat iron deficiency, but should be used under medical supervision.

Breast-feeding

Ferric compounds are excreted in breast milk in small amounts, usually considered safe but should be used under medical supervision.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

• Oral tablets
• Oral solution
• Intravenous injection