Iron polymaltose
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| Surname | Iron polymaltose | |||||||||
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| Molecular formula | C 12 H 25 FeO 14 | |||||||||
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| Drug class |
oral iron supplements |
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| Molar mass | variable | |||||||||
| Physical state |
solid or liquid |
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| As far as possible and customary, SI units are used. Unless otherwise noted, the data given apply to standard conditions . | ||||||||||
Iron (III) hydroxide polymaltose complex ( iron polymaltose ) is a macromolecular complex, consisting of iron (III) hydroxide (trivalent iron, Fe 3+ ) and polymaltose . The iron complex is used as a medicinal substance for the oral treatment of iron deficiency without anemia ( latent iron deficiency ) or with anemia ( manifest iron deficiency , iron deficiency anemia ). Before use, the iron deficiency should be confirmed diagnostically and in the laboratory (e.g. deep ferritin , deep transferrin saturation ).
The drug has been on the market since 1978 and is approved in over 85 countries.
pharmacology
Mode of action
The active ingredient is absorbed in the small intestine, mainly in the duodenum and the jejunum. The absorption takes place via a controlled, active mechanism. There is no passive diffusion, which ensures that practically no iron that is not bound to transferrin gets into the blood. The absorbed iron is mainly stored in the liver as ferritin (storage iron ) and from there is made available to the body for various functions, mainly for incorporation into hemoglobin in the red blood cells, where it is used to transport oxygen in the blood.
The uptake in the erythrocytes of the iron supplied orally via the iron polymaltose complex correlates with the absorption in the intestine, the relative absorption decreasing with increasing dosage and the higher it is, the more pronounced the iron deficiency. As with all oral iron supplements, only approx. 10–15% of the iron is absorbed. A dose of 100 mg iron is therefore necessary for 10 mg to be absorbed.
Pharmacokinetics
After administration, the maximum absorption capacity is already reached after 30 minutes and a continuously increasing absorption can be observed over 24 hours. The iron that is not absorbed is excreted in the stool.
Clinical efficacy and safety
The efficacy and safety have been studied and documented in numerous clinical studies and in various populations, including children, adolescents, adults and the elderly, as well as pregnant women and nursing mothers.
In the study by Ortiz et al. Iron polymaltose 100 mg twice daily was compared with iron sulfate 100 mg twice daily in a randomized , open, multicenter, controlled study design in pregnant women with iron deficiency anemia. The study duration was 90 days. There was an improvement in hemoglobin after 90 days of 2.16 g / dl (iron polymaltose) and 1.93 g / dl (iron sulfate). The ferritin levels after 90 days were 179 ng / ml (iron polymaltose) and 157 ng / ml (iron sulfate). Side effects occurred in 29.3% of the patients on iron polymaltose and in 56.4% on iron sulfate.
The randomized, open study in children with iron deficiency anemia by Yasa et al. investigated iron polymaltose 5 mg / kg body weight in one administration per day in comparison with iron sulfate 5 mg / kg body weight, divided into 2 administrations per day, the duration of the study was 4 months. There was an improvement in hemoglobin after 4 months of 2.3 g / dl (iron polymaltose) and 3 g / dl (iron sulfate). Fewer gastrointestinal side effects were observed with iron polymaltose and the mean acceptance value after 4 months was higher with iron polymaltose than with iron sulfate.
The randomized, multicenter, double-blind study in adults with iron deficiency anemia by Langstaff et al. tested iron polymaltose 100 mg twice a day in comparison with iron sulfate 60 mg three times a day for 9 weeks. An improvement in hemoglobin was observed in both groups after 3, 6 and 9 weeks, with the improvement being more pronounced after 3 and 6 weeks in the iron sulfate group. After 9 weeks the improvement was comparable in both groups. Side effects occurred in 22% of patients on iron polymaltose and in 25% of patients on iron sulfate.
Contraindications and restrictions on use
If there is a known hypersensitivity or intolerance to the active substance or one of the auxiliary substances, iron polymaltose must not be used. Iron supplements are not given for anemia that has a cause other than iron deficiency. Iron supplements are also not allowed to be administered in the case of known iron overload or iron utilization disorders.
Iron polymaltose must not be given at the same time as parenteral iron supplements. There are no known interactions with other drugs or with food.
Side effects
Common side effects observed at a frequency between 1% and 10% include stool discoloration, diarrhea , nausea and dyspepsia . Unusual side effects with a frequency between 0.1% and 1% included constipation , vomiting , abdominal pain , tooth discoloration , itching, and headache , among others . Allergic reactions have been described as very rare side effects with a frequency between 0.1% and 0.01%.
Trade names and dosage forms
Ferrum Hausmann (D), Maltofer (CH), Ferrosig
Iron polymaltose is available as a film or chewable tablet and in liquid form as a syrup, drink solution or drops.
Individual evidence
- ↑ This substance has either not yet been classified with regard to its hazardousness or a reliable and citable source has not yet been found.
- ^ Entry on iron polymaltose in the ChemIDplus database of the United States National Library of Medicine (NLM), accessed on April 7, 2017.
- ↑ P. Geisser: Safety and efficacy of iron (III) -hydroxide polymaltose complex / a review of over 25 years experience. In: drug research. Volume 57, number 6A, 2007, pp. 439-452, doi: 10.1055 / s-0031-1296693 , PMID 17691594 (review).
- ↑ P. Geisser, S. Burckhardt: The pharmacokinetics and pharmacodynamics of iron preparations. In: Pharmaceutics. Volume 3, number 1, January 2011, pp. 12-33, doi: 10.3390 / pharmaceutics3010012 , PMID 24310424 , PMC 3857035 (free full text).
- ↑ JP Kaltwasser, E. Werner, M. Niechzial: Bioavailability and therapeutic efficacy of bivalent and trivalent iron preparations. In: drug research. Volume 37, Number 1A, January 1987, pp. 122-129, PMID 3566867 .
- ↑ P. Geisser, S. Burckhardt: The pharmacokinetics and pharmacodynamics of iron preparations. In: Pharmaceutics. Volume 3, number 1, January 2011, pp. 12-33, doi: 10.3390 / pharmaceutics3010012 , PMID 24310424 , PMC 3857035 (free full text).
- ↑ JE Toblli, R. Brignoli: Iron (III) hydroxide polymaltose complex in iron deficiency anemia / review and meta-analysis. In: drug research. Volume 57, number 6A, 2007, pp. 431-438, doi: 10.1055 / s-0031-1296692 , PMID 17691593 (review).
- ↑ R. Ortiz, JE Toblli, JD Romero, B. Monterrosa, C. Frer, E. Macagno, C. Breymann: Efficacy and safety of oral iron (III) Polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia: a multicenter, randomized, controlled study. In: J. Matern. Fetal. Neonatal. Med. Volume 24, number 11, November 2011, pp. 1347-1352, doi: 10.3109 / 14767058.2011.599080 , PMID 21859366 .
- ↑ B. Yasa, L. Agaoglu, E. Unuvar: Efficacy, Tolerability, and Acceptability of Iron Hydroxide Polymaltose Complex versus Ferrous Sulfate: A Randomized Trial in Pediatric Patients with Iron Deficiency Anemia. In: Int J Pediatr. Volume 2011, 2011, p. 524520, doi: 10.1155 / 2011/524520 , PMID 22121379 , PMC 3206382 (free full text).
- ↑ RJ. Langstaff, P. Geisser, WG. Heil, JM. Bowdler. Treatment of iron-deficiency anemia: a lower incidence of adverse effects with Ferrum Hausmann than ferrous sulphate. In: British Journal of Clinical Research. Volume 4, 1993; 191-198.
