Ferrous fumarate, folic acid, cyanocobalamin.
Each controlled release capsule contains: Ferrous Fumarate B.P. 150 mg (equivalent to 49.5 mg of Elemental Iron), Folic Acid B.P. 1 mg, Cyanocobalamin B.P. (Vitamin B12) 15 mcg.
Permitted colours used in capsule shell.
Pharmacology: Iron, an essential mineral, is a component of hemoglobin, myoglobin and a number of enzymes (e.g. cytochromes, catalase, peroxidase). The total body content of iron is approximately 50 mg/kg in men (3.5 g in the average 70 kg man), and 37 mg/kg in women. Iron is primarily stored as hemosiderin or aggregated ferritin, found in the reticuloendothelial system and hepatocytes. Approximately two thirds of the total body iron is in circulating red blood cell mass in hemoglobin, the major factor in oxygen transport.
Iron deficiency can affect muscle metabolism, heat production, and catecholamine metabolism and has been associated with behavioral or learning problems in children.
Ferrous Fumarate contains 33% elemental iron.
Folic Acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrolic acid, which is involved as co-factor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic macrocytic anaemias. Vitamin B12 is essential to growth, cell reproduction, hematopoiesis, nucleic acid and myelin synthesis. Deficiency may result in megaloblastic or pernicious anaemia.
Pharmacokinetics: Iron is primarily absorbed from the duodenum and jejunum. The ferrous salt form is absorbed 3 times more readily than the ferric form. The common ferrous salts (e.g. sulfate, gluconate, fumarate) are absorbed almost on a milligram-for-milligram basis but differ in the content of elemental iron. The amount of iron absorbed increases progressively with larger doses; however, the percentage absorbed decreases. Food can decrease the absorption of iron by at least 50%; however, gastric intolerance may often necessitate administering the drug with food.
Iron is transported via the blood and bound to transferrin. The daily loss of iron from urine, sweat, and sloughing of intestinal mucosal cells amounts to approximately 0.5 to 1 mg in healthy men. In menstruating women, approximately 1 to 2 mg is the normal daily loss.
Folic acid is absorbed rapidly from the intestine, primarily from the proximal portion. Cerebrospinal fluid levels are several times greater than serum level of the drug. Folic acid is metabolized in the liver to 7, 8-dihydrofolic acid and eventually to 5, 6, 7, 8-tetrahydrofolic acid. Tetrahydrofolic acid derivatives are distributed to all body tissues but are stored primarily in the liver. A majority of the metabolic products appeared in the urine after 6 hours; excretion was generally complete within 24 hours. Small amounts of orally administered folic acid have also been recovered in the feces. Folic is also excreted in the milk of lactating mothers.
The parietal cells of the stomach secrete intrinsic factor, which regulates the amount of vitamin B12 absorbed in the terminal ileum. Vitamins B12 is primarily stored in the liver. Enterohepatic circulation plays a key role in recycling vitamin B12 from bile and other intestinal secretions. If plasma-binding proteins are saturated, excess free vitamin B12 will be excreted in the kidney.
It is indicated for prevention and treatment of all anaemias that are responsive in oral iron therapy.
Iron deficiency: For the prevention and treatment of iron deficiency and iron deficiency anaemias.
Iron supplement: As a dietary supplement for iron.
Symptoms of iron overdosage may be present when 20 mg/kg is ingested. Acute poisoning will produce symptoms like abdominal pain, diminished tissue perfusion, fever, dyspnea, hyperglycemia, hypotension, lethargy, leukocytosis, metabolic acidosis, nausea, blackened stools, vomiting, rapid pulse, and/or comatose. If not immediately fatal, symptoms may subside within 12 to 24 hours. Symptoms may return in 12 to 48 hours after ingestion and may include the following: anuria, convulsion, death, diffuse vascular congestion, hyperthermia, metabolic acidosis, pulmonary edema, shock.
Treatment of Overdosage: Maintain proper airway, respiration, and circulation. Perform gastric lavage in patients who are candidates for GI decontamination. Systemic chelation therapy with deferoxamine is generally recommended for patients with serum iron levels greater than 350 to 500 mcg/dL or in patients with symptoms of iron toxicity.
It is contraindicated in individuals with hypersensitivity to any of the ingredients. Hemolytic anaemia, hemochromatosis and hemosiderosis are contraindications to iron therapy.
Folic acid alone is improper therapy in the treatment of pernicious anaemias and other megaloblastic anaemias where Vitamin B12 is deficient.
Intolerance: Discontinue use if symptoms of intolerance appear.
GI effects: Occasional GI discomfort, such as nausea, may be minimized by taking with meals and by slowly increasing to the recommended dosage.
Folic Acid: Folic acid in doses above 0.1 mg daily may obscure pernicious anaemias in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anaemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anaemia.
Use in Children: Safety and effectiveness in paediatric patients have not been established.
Use in Elderly: Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease of other drug therapy, dosing should start at the lower end of the dosing range.
Adverse reactions with iron therapy may include GI irritation, constipation, diarrhoea, nausea, vomiting and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Iron salts interact with drugs including antacids, tetracyclines, fluoroquinolones, calcium salts, proton pump inhibitors etc.
Store at a temperature not exceeding 30°C.
B03AE02 - iron, multivitamins and folic acid ; Belongs to the class of iron in other combinations. Used in the treatment of anemia.