Full Prescribing Info
Iron (III)-Hydroxide Polymaltose Complex, folic acid.
Each hard gelatin capsule contains: Iron (III)-Hydroxide Polymaltose Complex 40% equivalent to Elemental Iron 100 mg; Folic Acid USP 550 mcg as erythropoeitics (haematinics).
Appropriate overages of vitamin added to compensate for loss on storage.
Approved colours used in the capsule shell.
Excipients/Inactive Ingredients: Colloidal Anhydrous Silica BP and Lactose BP.
Pharmacology: Pharmacodynamics: Iron (III)-Hydroxide Polymaltose Complex: Mechanism of Action: Iron is used metabolically in the formation of haemoglobin & is necessary for the oxidative processes of living tissue.
The absorption of ferric Iron from Iron (III)-Hydroxide Polymaltose Complex is controlled by a feedback mechanism. When Iron (III)-Hydroxide Polymaltose Complex comes in contact with the Iron binding sides at the mucosal surface, a physiological exchange is assumed to occur. Iron (III)-Hydroxide Polymaltose Complex releases the required amount of ferric iron, which is actively transported into the mucosal cell by a carrier protein & from there released for binding to ferritin or transferrin.
Folic Acid: Mechanism of Action: Folic Acid supplementation prevents the development of folate deficiency Megaloblastic Anaemia particularly during the third trimester of pregnancy.
Folic acid, as it is biochemically inactive, is converted to tetrahydrofolic acid and methyltetrahydrofolate by dihydrofolate reductase. These folic acid congeners are transported across cells by receptor-mediated endocytosis where they are needed to maintain normal erythropoiesis, synthesize Purine and Thymidylate nucleic acids, interconvert amino acids, methylate tRNA, and generate and use formate. Using vitamin B12 as a cofactor, folic acid can normalize high homocysteine levels by remethylation of homocysteine to Methionine via Methionine synthetase.
Pharmacokinetics: Iron (III)-Hydroxide Polymaltose Complex: The efficiency of absorption depends on the salt form, the amount administered, the dosing regimen and the size of iron stores. Subjects with normal iron stores absorb 10% to 35% of an iron dose. Those who are iron deficient may absorb up to 95% of an iron dose.
Folic Acid: Protein Binding: Very high to plasma protein.
Route of Elimination: Folic Acid is metabolized in the liver to 7, 8-dihydrofolic acid and eventually to 5, 6, 7, 8- tetrahydrofolic acid with the aid of reduced diphosphopyridine nucleotide (DPNH) and folate reductases. A majority of the metabolic products appeared in the urine after 6 hours; excretion was generally complete within 24 hours. Folic Acid is also excreted in the milk of lactating mothers.
Toxicology: Preclinical Safety Data: Preclinical data reveal no special hazard for humans based on conventional studies of pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Prophylaxis of Iron deficiency; including Megaloblastic Anaemia during pregnancy resulting from a folic acid deficiency.
Dosage/Direction for Use
1-2 capsules per day OR as directed by the Physician.
Route of Administration: Oral.
Symptoms: Initially epigastric pain, diarrhoea & vomiting & may include metabolic acidosis; convulsions & coma after apparent recovery.
Treatment (Antidote): Speed is essential for effective treatment which is dependent upon removing excess Iron from the alimentary tract prior to absorption. Initially an emetic should be given, followed by gastric lavage with 1% sodium bicarbonate & oral administration of Desferrioxamine to complex with residue. Fluid loss may be corrected with IV normal saline or Dextrose solution.
Megaloblastic anaemia stemming from Vitamin B12 deficiency, pernicious anaemia, haemolytic anaemia, haemochromatosis.
Special Precautions
Occasional GI discomfort e.g. nausea, may be minimised by taking with meals & by slowly increasing to the recommended dosage. To discontinue use if symptoms of intolerance occur.
Effects on Ability to Drive and Use Machines: None.
Use In Pregnancy & Lactation
Iron: U.S. Food and Drug Administration's Pregnancy Category C for iron Dextran by the manufacturer and U.S. Food and Drug Administration's Pregnancy Category B for sodium ferric gluconate by the manufacturer.
Australian Drug Evaluation Committee's (ADEC) Category A (Batagol, 1993).
Folic Acid: U.S. Food and Drug Administration's Pregnancy Category A if administered in doses below 0.8 mg / day or Category C if doses higher than 0.8 mg / day (Briggs et al, 1990).
Australian Drug Evaluation Committee's (ADEC) Category A (ADEC, 1996).
Although few teratogenic or adverse effects during pregnancy have been reported following administration of FOLIC ACID, some data indicate that FOLIC ACID deficiency during pregnancy can result in infants with lower birth weights (Giles et al, 1971; Iyengar & Rajalakshmi, 1975; Briggs et al, 1986).
Adverse Reactions
Nausea, epigastric distress, diarrhoea, constipation, black stools.
Drug Interactions
Iron (III)-Hydroxide Polymaltose Complex Equivalent to Elemental Iron: Drug-Drug Interactions: Alendronate: Formation of non-absorbable complexes.
Ciprofloxacin: Formation of non-absorbable complexes.
Doxycycline: Formation of non-absorbable complexes.
Antacids: GI absorption of iron reduced.
Ascorbic Acid: GI absorption of iron enhanced.
Chloramphenicol: Serum Iron levels may be increased.
Cimetidine: GI absorption may be reduced.
Levodopa: Decreased Levodopa serum levels.
Methyldopa: May result in decreased efficacy of Methyldopa.
Quinolones: GI absorption of Quinolones decreased.
Penicillamine: Marked reduction in GI absorption of Penicillamine.
Tetracyclines: Decreased in the absorption of both Tetracycline & Iron salts.
Food-Drug Interactions: Eggs & milk inhibit Iron absorption. Administration of calcium & Iron supplementation reduces Ferrous sulfate absorption by one third. If combined Iron & calcium supplementation is required, then calcium carbonate should be used & the supplementation taken between meals.
Folic Acid: Drug-Drug Interactions: Amobarbital: Folic acid decreases the effect of anticonvulsant, Amobarbital.
Aprobarbital: Folic acid decreases the effect of anticonvulsant, Aprobarbital.
Butabarbital: Folic acid decreases the effect of anticonvulsant, Butabarbital.
Dihydroquinidine barbiturate: Folic acid decreases the effect of anticonvulsant, Dihydroquinidine barbiturate.
Heptabarbital: Folic acid decreases the effect of anticonvulsant, Heptabarbital.
Hexobarbital: Folic acid decreases the effect of anticonvulsant, Hexobarbital.
Methohexital: Folic acid decreases the effect of anticonvulsant, Methohexital.
Methylphenobarbital: Folic acid decreases the effect of anticonvulsant, Methylphenobarbital.
Pentobarbital: Folic acid decreases the effect of anticonvulsant, Pentobarbital.
Phenytoin: Folic acid may decrease the levels of Phenytoin.
Primidone: Folic acid decreases the effect of anticonvulsant, Primidone.
Quinidine barbiturate: Folic acid decreases the effect of anticonvulsant, Quinidine barbiturate.
Caution For Usage
Incompatibilities: None.
Store in a cool, dark & dry place.
Shelf life: 24 Months from the date of manufacturing.
ATC Classification
B03AD - Iron in combination with folic acid ; Used in the treatment of anemia
Cap (red/red hard gelatin with GENO' & Eleron' printed & containing brown coloured powder) 3 x 10's.
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