Iberet Folic-500

Iberet Folic-500

Manufacturer:

Abbott

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Multivitamins and minerals.
Description
Each tablet contains ferrous sulfate 525 mg (equivalent to elemental iron 105 mg), vitamin C 500 mg, niacinamide 30 mg, calcium pantothenate 10 mg, thiamine mononitrate (vitamin B1) 6 mg, riboflavin (vitamin B2) 6 mg, pyridoxine HCl (vitamin B6) 5 mg, cyanocobalamin (vitamin B12) 25 mcg and folic acid 800 mcg.
Action
Pharmacology: Iberet-Folic 500 is a hematinic containing iron in a sustained-release system, vitamin C for enhancement of iron absorption, and the vitamin B complex including folic acid.
Iron: Iron is required for hemoglobin (Hb) production so that iron deficiency will cause production of smaller red cells, which contain lower level of Hb and can cause microcytic hypochromic anemia.
Vitamin C: Vitamin C supports the body's metabolism and helps absorption of iron from the duodenal level.
Folic Acid: Folic acid is influencing hematopoietic system like vitamin B12 deficiency does.
Pharmacodynamics: Iron, an essential mineral, is a component of hemoglobin and myoglobin and a number of enzymes. The total body content of iron is approximately 50 mg/kg in man and 35 mg/kg in women.
Iron is primarily stored in the body as hemosiderin or ferritin, found in the reticuloendothelial cells of the liver, spleen and bone marrow. Approximately 2/3 of total body iron is in the circulatory red blood cell mass in hemoglobin, the major factor in oxygen transport. Concentration of plasma iron and the total iron-binding capacity of plasma vary greatly in different physiological conditions and disease states.
Approximately 2/3 of folic acid is bound to plasma proteins. Half of the folic acid stored in the body is found in the liver. Folic acid is also concentrated in spinal fluid.
Pharmacokinetics: Absorption: The absorption is increased when iron stores are depleted or red blood cell production is increased. Conversely, high iron blood concentrations decrease absorption. The average dietary intake of iron is 18-20 mg/day. Approximately 10% of this iron is absorbed in healthy individuals and about 20-30% in iron deficient individuals.
Folic acid and iron are absorbed in the proximal small intestine, particularly the duodenum. Folic acid is absorbed maximally and rapidly at this site, and iron is absorbed in a descending gradient from the duodenum distally. After absorption, folic acid is rapidly converted into its metabolically active forms. Except for the folates ingested in liver, yeast and egg yolk, the percentage of absorption of food folates averages about 10%. The ferrous salt form is absorbed 3 times more readily than the ferric form. The common ferrous salts (sulfate, gluconate, fumarate) are absorbed almost on a milligram-for-milligram basis, but differ in the content of elemental iron. Ferrous sulfate comprises 20% of elemental iron content.
Oral iron is absorbed most efficiently when it is administered between meals. However, conventional iron preparations frequently cause gastric irritation when taken on an empty stomach. Although food can decrease the absorption of iron by 40-66%; gastric intolerance may necessitate administering the drug with food. Studies with iron in the Gradumet have indicated that relatively little iron is released in the stomach, gastric intolerance is seldom encountered and hematologic response ranks with that obtained from plain ferrous sulfate. Therefore, potential gastric irritation is minimized when iron is administered in the Gradumet form in comparison with conventional oral iron preparations.
Large amounts of ascorbic acid administered orally with ferrous sulfate have been shown to enhance iron absorption. This is apparently due to the ability of ascorbic acid to prevent the oxidation of ferrous iron to the less effectively absorbed ferric form.
The B-complex vitamins are absorbed by an active transport process; they are rapidly eliminated and therefore are not stored in the body. Calcium pantothenate is absorbed readily from the gastrointestinal tract and distributed to all body tissues.
Distribution: Ferrous iron passes through gastrointestinal mucosal cells directly into the blood and is immediately bound to transferrin. Transferrin, a glycoprotein B1-globulin, transports iron to the bone marrow where it is incorporated into the hemoglobin.
Small excesses of iron within the villous epithelial cells are oxidized to the ferric state. Ferric iron combines with the protein apoferritin to yield ferritin and is stored in mucosal cells which are exfoliated at the end of their life span and excreted in the feces.
Elimination: Iron metabolism occurs in a virtually closed system. The majority of iron liberated by destruction of hemoglobin is conserved and reused by the body. The daily excretion of iron from urine, sweat and sloughing of intestinal mucosal cells amounts to approximately 0.5-1 mg in healthy men and 1-2 mg in menstruating women. The half-life of ferrous sulfate is approximately 6 hrs.
Indications/Uses
Anemia due to iron deficiency, megaloblastic anemia where there is an associated deficiency of vitamins C and B-complex particularly in pregnancy.
Dosage/Direction for Use
Adults and Pregnant Women: Treatment of Iron and Folic Acid Deficiency: Recommended Dose: 1 tab daily or according to the doctor's directions.
Iberet-Folic 500 is administered orally and may be taken on an empty stomach. Do not chew or crush tablet, swallow whole.
Overdosage
In overdosage, efforts should be made to hasten the elimination of tablet; an emetic should be administered as soon as possible. If necessary, gastric lavage followed by a saline cathartic should be used to speed passage through the intestinal tract. X-ray examination may be then considered to determine the position of Gradumet remaining in the gastrointestinal tract.
Contraindications
Patients with hypersensitivity to any of the ingredients of Iberet-Folic 500 and patients with pernicious anemia.
Special Precautions
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemia where vitamin B12 is deficient.
Where anemia exists, its nature should be established and underlying causes determined. Folic acid especially in doses >0.1 mg daily may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. Concomitant parenteral therapy with vitamin B12 may be necessary in patients with vitamin B12 deficiency. Pernicious anemia is rare in women of childbearing age and the likelihood of its occurrence along with pregnancy is reduced by the impairment of fertility associated with vitamin B12 deficiency.
In older patients and those with conditions tending to lead to vitamin B12 depletion, serum B12 levels should be regularly assessed during treatment with Iberet-Folic 500.
Do not exceed the recommended dose.
There is the possibility of dark feces.
Do not give to patients who received repeated blood transfusion or non-iron deficiency anemia.
Long-term usage may cause iron accumulation.
Side Effects
Rare, occasionally with nausea, vomiting, constipation or diarrhea, gastric pain at high doses.
Drug Interactions
Absorption of iron is inhibited by magnesium trisilicate and antacids containing carbonates. Ferrous sulfate may interfere with the absorption of tetracyclines. The antiparkinsonism effect of levodopa may be reversed by pyridoxine. Iron absorption is inhibited by the ingestion of eggs or milk.
Storage
Store at room temperature not exceeding 30°C.
ATC Classification
B03AE03 - iron and multivitamins ; Belongs to the class of iron in other combinations. Used in the treatment of anemia.
Presentation/Packing
Filmtab (film-seal coating, oblong, elongated shape, red, smooth, imprinted with Abbott logo on one side) 10 x 30's.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in