Therapeutic Class: Oral Iron preparations
Indications:
Iron Polymaltose Complex is indicated for the-
syrup: Each 5 ml of syrup contains Iron (III) Hydroxide Polymaltose Complex INN 200 mg equivalent to 50 mg of elemental iron.
paediatric syrup: Each ml syrup contains Iron (III) Hydroxide Polymaltose Complex INN 40 mg equivalent to 10 mg of elemental iron.
paediatric drops: Each ml drop contains Iron (III) Hydroxide Polymaltose Complex INN 200 mg equivalent to 50 mg of elemental iron.
Indications:
Iron Polymaltose Complex is indicated for the-
- Treatment of latent iron deficiency and iron deficiency anaemia including macrocytic anaemia, nutritional anaemia of infants, anaemia due to excessive haemorrhage and anaemia associated with infections and malignant disease.
- Prevention and treatment of iron deficiency anaemia before, during and after pregnancy and during lactation.
- For prophylactic therapy of iron deficiency to cover the recommended daily dietary allowances (RDA).
syrup: Each 5 ml of syrup contains Iron (III) Hydroxide Polymaltose Complex INN 200 mg equivalent to 50 mg of elemental iron.
paediatric syrup: Each ml syrup contains Iron (III) Hydroxide Polymaltose Complex INN 40 mg equivalent to 10 mg of elemental iron.
paediatric drops: Each ml drop contains Iron (III) Hydroxide Polymaltose Complex INN 200 mg equivalent to 50 mg of elemental iron.
Description:
Iron Polymaltose Complex is a polysaccharide-iron complex, which is a novel iron preparation used in the treatment of iron deficiency anaemia. Iron, an essential constituent of the body, is necessary for haemoglobin formation and for the oxidative process of living tissue. This preparation contains non-ionic ferric iron and polymaltose in a stable complex. This facilitates a controlled absorption of the ferric iron when it comes in contact with the mucosal cell surface. Being non-ionic, it does not release any free radicals and thus takes care of all the toxic effects found due to the release of free radicals by the traditional ionized iron salt preparations. It does not interact with the food components and other medications and so, unlike ferrous salts, there is no decrease in bioavailability of Iron Polymaltose Complex. This makes sure that with the consumption of this complex, iron gets utilized at a faster rate in the haemoglobin and myoglobin synthesis.
Generally, no interactions have been observed. Since the iron is complex bound, ionic interactions with foodstuff components (phytates, oxalates, tannin, etc.) and concomitantly administered medicaments (tetracycline, antacids) are unlikely to occur.
Contraindications:
This preparation is well tolerated. However, a few side effects of oral iron preparations, including nausea, vomiting, constipation, or diarrhoea may occur.
Pregnancy & Lactation:
Administration of drugs during the first trimester of pregnancy requires careful assessment of potential risk versus benefits to be gained and should not be administered unless clearly indicated. For the remainder of the pregnancy, iron therapy may be indicated but only on the advice of a physician. Iron is excreted in breast milk but not in clinically significant concentrations.
Precautions & Warnings:
Initially, epigastric pain, diarrhea, and vomiting; and may include metabolic acidosis, convulsions, and coma after apparent recovery. 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, and oral administration of desferrioxamine to complex with residue.
Overdose:
In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur and may include metabolic acidosis, convulsions, and coma after apparent recovery. Should seek emergency medical attention in case of overdose. Initially, an emetic should be given and then gastric lavage and general supportive measures should be employed.
Storage:
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Iron Polymaltose Complex is a polysaccharide-iron complex, which is a novel iron preparation used in the treatment of iron deficiency anaemia. Iron, an essential constituent of the body, is necessary for haemoglobin formation and for the oxidative process of living tissue. This preparation contains non-ionic ferric iron and polymaltose in a stable complex. This facilitates a controlled absorption of the ferric iron when it comes in contact with the mucosal cell surface. Being non-ionic, it does not release any free radicals and thus takes care of all the toxic effects found due to the release of free radicals by the traditional ionized iron salt preparations. It does not interact with the food components and other medications and so, unlike ferrous salts, there is no decrease in bioavailability of Iron Polymaltose Complex. This makes sure that with the consumption of this complex, iron gets utilized at a faster rate in the haemoglobin and myoglobin synthesis.
Dosage & Administration:
Dosage and duration of therapy are dependent upon the extent of iron deficiency and should be taken as directed by the physician.- Adults: 10 ml once or twice daily
- Children (6-12 years): 10 ml daily
- Children (2-6 years): 5 ml daily
- Premature infants & Infants: 3.33 mg of elemental iron/kg body weight.
Generally, no interactions have been observed. Since the iron is complex bound, ionic interactions with foodstuff components (phytates, oxalates, tannin, etc.) and concomitantly administered medicaments (tetracycline, antacids) are unlikely to occur.
Contraindications:
- In conditions where there is a risk of iron overload e.g. haemochromatosis, thalassemia or
- haemosiderosis.
- In case of hypersensitivity to iron or any other ingredients of the syrup.
This preparation is well tolerated. However, a few side effects of oral iron preparations, including nausea, vomiting, constipation, or diarrhoea may occur.
Pregnancy & Lactation:
Administration of drugs during the first trimester of pregnancy requires careful assessment of potential risk versus benefits to be gained and should not be administered unless clearly indicated. For the remainder of the pregnancy, iron therapy may be indicated but only on the advice of a physician. Iron is excreted in breast milk but not in clinically significant concentrations.
Precautions & Warnings:
Initially, epigastric pain, diarrhea, and vomiting; and may include metabolic acidosis, convulsions, and coma after apparent recovery. 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, and oral administration of desferrioxamine to complex with residue.
Overdose:
In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur and may include metabolic acidosis, convulsions, and coma after apparent recovery. Should seek emergency medical attention in case of overdose. Initially, an emetic should be given and then gastric lavage and general supportive measures should be employed.
Storage:
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.