Iron (III) hydroxide polymaltose complex, folic acid.
Each capsule contains: Iron (III) Hydroxide Polymaltose Complex eq. to Elemental Iron 100 mg, %RDI 666.66; Folic acid 0.55 mg, %RDI 275.00.
Pharmacology: Pharmacodynamics: FERCIROL contain Iron (III) hydroxide polymaltose complex, which is absorbed into reticulo-endothelial system cells where it is ionized to Fe3+, transported to the bone marrow via transferrin, and incorporated into hemoglobin. A minor amount of Fe3+ is stored as hemosiderin and ferritin or incorporated into myoglobin or heme-containing enzymes.
Folic acid, which is an exogenous source of folate is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is not metabolically active as such, but is the precursor of tetrahydrofolic acid which is involved as a cofactor for 1-carbon transfer reactions in the biosynthesis of purines and thymidylates of nucleic acids. Impairment of thymidylate synthesis in patients with folic acid deficiency is thought to account for the defective DNA synthesis that leads to megaloblast formation and megaloblastic and macrocytic anemias. Folate is involved in amino acid interconversions (e.g., catabolism of histidine to glutamic acid, interconversion of serine and glycine, conversion of homocysteine to methionine), and generation of formate.
Pharmacokinetics: Iron (III) hydroxide polymaltose complex: Iron (III) hydroxide polymaltose complex has rapid absorption. Following absorption, it is minimally excreted in feces, skin and gastrointestinal epithelial cell exfoliation, perspiration, bile, urine. Women experience iron loss during menstruation.
Folic acid: Folic acid is absorbed rapidly from the GI tract. Following oral administration, peak folate activity in blood occurs within 30-60 minutes. Synthetic folic acid is almost 100% bioavailable when administered in fasting individuals, bioavailability of synthetic folic acid consumed with a meal ranges from 85-100%. Tetrahydrofolic acid and its derivatives are distributed into all body tissues. Folic acid is distributed into milk. Following absorption of 1 mg or less, folic acid is largely reduced and methylated in the liver to N5-methyltetrahydrofolic acid, which is the main transport form of folate in the body. The excess folate is excreted unchanged in urine after maximum renal tubular reabsorption.
Treatment of iron deficiency or anemia including patients who need supplement for iron such as pregnant, breastfeeding, anemia due to postpartum hemorrhage.
Recommended dose: Adult & Geriatric: Treatment and prevention: 100 to 300 mg once daily or in divided doses for 1 to 2 months for prevention, or 3 to 5 months for treatment. For iron treatment should increase hemoglobin levels by 1 g/week. Dosing may be decreased to 100 mg daily when desired hemoglobin is reached.
Pregnant patients: 200 to 300 mg once daily or in divided doses until target hemoglobin is reached; maintenance: 100 mg once daily continued at least until the end of pregnancy.
Children >12 years and adolescents: Treatment and prevention: Refer to adult dosing.
Renal impairment: Use with caution in renal impairment patient.
Hepatic impairment: Use with caution in hepatic impairment patient.
Mode of administration: FERCIROL is orally administered during or immediately after a meal.
Symptoms may present when 30 to 60 mg/kg is ingested. Acute poisoning will produce symptoms i.e. Lethargy, abdominal pain, nausea, vomiting, hypotension, weak-rapid pulse, fever, dyspnea, and coma. If not immediately fatal, symptoms may subside survives for ~24 hours. If patient survives, hepatic cirrhosis, antral stenosis or CNS damage may be seen.
Known hypersensitivity to any ingredient.
Iron overload.
Thalassemia.
Non-Iron deficiency anemia (like hemolytic anemia).
Should not use this drug frequently unless there is iron deficiency.
Use with caution in patients with cardiovascular disease.
Use with caution in patients with gastrointestinal disorders, such as peptic ulcers, chronic ulcerative colitis.
Use with caution in patients with preexisting liver impairment.
Use with caution in patients with inflammatory disorders.
Use with caution in patients with paroxysmal nocturnal hemoglobinuria; increased risk of exacerbation and hemolysis.
Use with caution in patients with preexisting renal insufficiency.
Use with caution in patient with undiagnosed anemia.
An accidental overdose of iron containing product is a leading cause of fetal poisoning in children younger than 6 years.
Pregnancy: Pregnancy category A.
RDA of iron in pregnant women is 27 mg/day.
Lactation: FERCIROL is excreted in breast milk due to folate, concentrations are not affected by dietary intake unless the mother has a severe deficiency. RDA of iron in breast-feeding women is 9 to 10 mg/day.
GI: Abdominal pain, constipation, diarrhea, GI irritation, nausea, vomiting. Stools may appear darker in color. GI effects including anorexia, nausea, abdominal distention, flatulence, and a bitter/bad taste have been reported rarely in patients receiving 15 mg of folic acid daily for one month.
CNS: Altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgment have been reported rarely in patients receiving 15 mg of folic acid daily for one month.
Hypersensitivity: erythema, rash, itching, general malaise, and bronchospastic respiratory difficulty has been reported.
Miscellaneous: decreased vitamin B
12 serum levels.
Avoid concomitant use of FERCIROL with any of the following, dimercaprol, raltitrexed.
The level of FERCIROL may be increased by ACEIs, dimercaprol, ascorbic acid, chloramphenicol.
FERCIROL may decrease the level of bictegravir, iron salts, captopril, cephalosporins, fluoroquinolones, levodopa, levothyroxine, methyldopa, mycophenolate mofetil, penicillamine, fosphenytoin, phenobarbital, phenytoin, primidone.
The level of FERCIROL may be decreased by antacid, calcium salts, digestive enzymes, H2 antagonists, proton pump inhibitors, sulfasalazine.
B03AD - Iron in combination with folic acid ; Used in the treatment of anemia
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