Ferrocyte

Ferrocyte

Manufacturer:

Eisai

Distributor:

DKSH
Full Prescribing Info
Contents
Sodium ferrous citrate.
Description
Each white, gastric-soluble, film-coated cotains 470.9 mg of sodium ferrous citrate (50 mg as elemental iron).
(See Table 1.)

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Nonproprietary name: Sodium Ferrous Citrate (JAN).
Physicochemistry: Chemical name: Tetrasodium biscitrate iron (II).
Molecular formula: C12H10FeNa4O14.
Molecular weight: 526.01.
Sodium ferrous citrate occurs as a greenish white to green-yellowish white, crystalline powder. It is slightly soluble in water, and practically insoluble in ethanol (95). This product dissolves in dilute hydrochloric acid, dilute nitric acid and dilute sulfuric acid. This product gradually turns brown when exposed to light.
It also contains carmellose, microcrystalline cellulose, titanium oxide, calcium stearate, low substituted hydroxypropylcellulose, hydroxypropylcellulose, hypromellose and macrogol 6000 as inactive ingredients.
Action
Pharmacology: Pharmacodynamics: Mechanism of action: Absorbed iron is bound to plasma transferrin and enters the general circulation. Iron bound to transferrin is taken into erythroblasts in bone marrow and used for synthesis of hemoglobin.
Sodium ferrous citrate increases serum iron levels without being affected by gastric acid secretion: Increases in serum iron levels achieved by sodium ferrous citrate were similar to those achieved by ferrous sulfate and ferrous fumarate in normal rabbits and rats, and anemic rabbits. When sodium ferrous citrate was administered to dogs after a meal, it increased serum iron levels.
Sodium ferrous citrate increased serum iron levels in rats whose gastric acid secretion was inhibited, suggesting that gastric acid has relatively little effect on sodium ferrous citrate.
Sodium ferrous citrate improves anemia through recovery of hemoglobin level and iron reserve: The Hemoglobin level showed a marked recovery after administration of sodium ferrous citrate (30 mg/kg/day) for 18 consecutive days to exsanguinated anemia rats fed with iron deficient-food. The Iron content in the liver and spleen was significantly increased compared to the control, suggesting that the drug replenishes the iron reserve. Sodium ferrous citrate also improved lowered serum iron levels and the serum iron saturation index, and increased the total iron-binding capability.
Clinical Studies: Clinical efficacy: Open labeled clinical trials have shown that FERROCYTE improved anemic symptoms (malaise, palpitations, shortness of breath and dizziness) and peripheral hematological findings (hemoglobin content, serum iron concentration, TIBC, serum ferritin concentration, RBC count and hematocrit value) in patients with iron-deficiency anemia. (See Table 2.)

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The rate of improvement of hemoglobin level and usefulness was significantly higher in the 200 mg/day of FERROCYTE group than in the 100 mg/day group. There was no difference in effectiveness between tablets and granules as regards increase in hemoglobin and alleviation of anemic symptoms.
FERROCYTE has also been shown to be useful in a double blind clinical trial.
Reference: In a pilot study on implementation methods for a clinical experience investigation, this was no difference in incidence rate of adverse reactions between pregnant and non-pregnant women in 545 patients.
A follow-up study on fetuses and neonates delivered from mothers who had administered FERROCYTE in drug use investigation showed that there were no problems. (See Table 3.)

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A pilot study was conducted to compare the incidence rate of adverse reactions in elderly patients and non-elderly patients. In 1,254 patients, there was no significant difference in adverse reactions incidence rates between 60 years or over and under 60 for either men or women. However, the incidence rate for women was higher than for men. (See Table 4.)

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Pharmacokinetics: Serum iron concentration: Two tablets of FERROCYTE (100 mg as elemental iron) were administered to 18 healthy adult male volunteers after a meal. The serum iron concentration increased at 1 hr, peaked at 3-4 hr, and returned to the pre-treatment baseline at 12 hr after administration. (See figure and Table 5.)

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The serum iron concentration at 24 hr after administration was lower than the preadministration level. This phenomenon is also seen with other iron preparations and is within daily range of physiological change. It has been suggested that this is due to a high transfer of iron from the serum into the iron reserve pool.
Transfer to the fetus: Sodium ferrous citrate is transferred from the maternal body into the fetus as transferrin iron due to the physiological regulatory function of the placenta. Transferrin iron in the maternal body is converted into placental ferritin after transfer into placental tissues and then into fetal transferrin iron after crossing the placenta. Sodium ferrous citrate was more quickly absorbed and transferred to blood, placenta, fetuses and amniotic fluid than an analog compound (ferrous sulfate) in pregnant rats.
Transfer to the milk: Sodium ferrous citrate is transferred to the blood as transferrin, and thereafter transferrin is transfer to the milk as lactoferrin. Sodium ferrous citrate was more quickly transferred to milk than an analog compound (ferrous sulfate) in nursing rats.
Indications/Uses
Iron-deficiency anemia.
Dosage/Direction for Use
The usual adult dosage for oral use is 100-200 mg as elemental iron (2-4 tablets) daily in one or two divided doses after meals.
The dosage may be adjusted depending on the patient's age and symptoms.
Overdosage
Symptoms: Major symptoms of overdose are gastrointestinal symptoms including nausea, vomiting, abdominal pain, hemorrhagic diarrhea and hematemesis due to gastric mucosal irritation. Tachycardia, decreased blood pressure, cyanosis, elevated GOT, elevated GPT, etc., have also been reported. In the event of a serious disease, coma, shock, liver necrosis and hepatic failure may develop.
Treatment: Therapeutic emesis and gastric lavage are effective in the early stages after administration of FERROCYTE. Other treatments include administration of cathartics, iron chelators (deferoxamine), etc. In cases where decreased blood pressure or circulatory collapse develops, symptomatic treatment using vasopressors, fluid therapy, etc., should be performed.
Contraindications
FERROCYTE is contraindicated in the following patients: Patients who are not iron-deficient.
[Since iron overload may occur, caution should be taken to avoid accidental overdosing].
Special Precautions
Careful Administration (FERROCYTE should be administered with care in the following patients.): Patients with gastrointestinal diseaseas such as peptic ulcer, chronic ulcerative colitis or focal enteritis [FERROCYTE may aggravate such condition.]
Patients with paroxysmal nocturnal hemoglobinuria [FERROCYTE may induce hemolysis and aggravate the condition.]
Patients on therapy with iron-containing preparations (iron preparations, liver-specific contrast media for MRI, etc.) [Iron overload may occur.]
Important Precautions: Hematological tests should be conducted during treatment with FERROCYTE as necessary to avoid accidental overdosing.
Precautions concerning Use: Caution when handling over drug (tablets).
For drugs that are dispensed in a press-through package (PTP), patients should be instructed to remove the drugs from the package prior to use. [Swallowing the PTP sheet by mistake has been reported to cause puncture in the esophageal mucosa due to sharp corners of the sheet, resulting in perforation and in serious complications such as mediastinitis.]
Other Precautions: Stools may become dark due to the use of FERROCYTE.
FERROCYTE may cause temporary discoloration (browning) of the teeth. In the event of this occurence, the teeth should be brushed with sodium bicarbonate, etc.
FERROCYTE coadministered with a large dose of allopurinol has been reported to increase iron reserve in the liver in an animal study.
Effects on Laboratory Tests: Occult blood tests may yield false-positive results.
Use in Children: Safety of FERROCYTE for use in children has not been established (inadequate clinical experience).
Use in Elderly: Since the physiological functions of elderly patients are impaired in general, caution, such as dose reduction, should be exercised in these patients.
Adverse Reactions
Adverse reactions were reported in 487 of 5,939 patients (8.20%). (At the end of the reexamination period). (See Table 6.)

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Drug Interactions
Precautions for coadministration (FERROCYTE should be administered with care when coadministered with the following drugs.) (See Table 7.)

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Storage
STORAGE FOR HANDLING: FERROCYTE should be stored below 30℃.
FERROCYTE should be protected from moisture after opening aluminum bag.
FERROCYTE should be used before the expiration date indicated on the package.
ATC Classification
B03AB01 - ferric sodium citrate ; Belongs to the class of oral iron trivalent preparations. Used in the treatment of anemia.
Presentation/Packing
FC tab 50 mg (white, gastric-soluble) x 100's.
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