Iron(III)-hydroxide polymaltose complex is a medication used to treat iron deficiency / iron deficiency anemia and belongs to the group of oral iron preparations. The preparation is a macromolecular complex, consisting of iron(III) hydroxide (trivalent iron, Fe³⁺, Fe(OH)₃·H₂O) and the carrier polymaltose and is available in solid form as a film-coated or chewable tablet and in liquid form as a syrup, drinkable solution, or drops. It is used for treating

iron deficiency Iron deficiency, or sideropenia, is the state in which a body lacks enough iron to supply its needs. Iron is present in all cells in the human body and has several vital functions, such as carrying oxygen to the tissues from the lungs as a key ...

without anemia (latent iron deficiency) or with

anemia Anemia (also spelt anaemia in British English) is a blood disorder in which the blood has a reduced ability to carry oxygen. This can be due to a lower than normal number of red blood cells, a reduction in the amount of hemoglobin availabl ...

(apparent iron deficiency). Prior to administration, the iron deficiency should be diagnostically established and verified via laboratory tests (e.g., low

ferritin Ferritin is a universal intracellular and extracellular protein that stores iron and releases it in a controlled fashion. The protein is produced by almost all living organisms, including archaea, bacteria, algae, higher plants, and animals. ...

concentration, low

transferrin saturation Transferrin saturation (TS), measured as a percentage, is a medical laboratory value. It is the value of serum iron divided by the total iron-binding capacity of the available transferrin, the main protein that binds iron in the blood, this value t ...

). The drug has been on the market since 1978 and is approved in over 85 countries. In many countries it is known with brand name Maltofer.

Pharmacology

Mode of action

The drug is absorbed in the small intestine, primarily in the

duodenum The duodenum is the first section of the small intestine in most vertebrates, including mammals, reptiles, and birds. In mammals, it may be the principal site for iron absorption. The duodenum precedes the jejunum and ileum and is the shortest p ...

and

jejunum The jejunum is the second part of the small intestine in humans and most higher vertebrates, including mammals, reptiles, and birds. Its lining is specialized for the absorption by enterocytes of small nutrient molecules which have been pr ...

. Absorption occurs via a controlled, active mechanism. No passive diffusion takes place, which ensures that practically no unbound (to

transferrin Transferrins are glycoproteins found in vertebrates which bind and consequently mediate the transport of iron (Fe) through blood plasma. They are produced in the liver and contain binding sites for two Iron(III), Fe3+ ions. Human transferrin is ...

) iron reaches the blood. The absorbed iron is primarily stored in the

liver The liver is a major metabolic organ (anatomy), organ exclusively found in vertebrates, which performs many essential biological Function (biology), functions such as detoxification of the organism, and the Protein biosynthesis, synthesis of var ...

as ferritin (protein used for iron storage) and subsequently made available to the body for various functions, primarily for incorporation into the red blood cells'

hemoglobin Hemoglobin (haemoglobin, Hb or Hgb) is a protein containing iron that facilitates the transportation of oxygen in red blood cells. Almost all vertebrates contain hemoglobin, with the sole exception of the fish family Channichthyidae. Hemoglobin ...

, thereby transporting oxygen in the blood.

Pharmacodynamics

The utilization and absorption by the erythrocytes of the iron administered orally in the form of iron polymaltose complex is correlated with the absorption in the intestines, whereby the relative absorption decreases with increased dosage and the more severe the iron deficiency, the greater the Absorption. As with ascorbate and sulfate oral iron preparations, only about 10-15% of the iron is absorbed. A dose of 100 mg of iron is thus necessary in order for 10 mg to be absorbed.

Pharmacokinetics

After administration, the maximum absorption capacity is reached already after 30 minutes and continuously increasing absorption can be observed over 24 hours. The non-absorbed iron is excreted via the stool.

Effectiveness, safety

The effectiveness and safety have been investigated and documented in numerous clinical studies and in various patient populations. This has included children, young people, adults, and the elderly, in addition to pregnant women and breastfeeding mothers.

Important clinical studies

= Study in pregnant women

= Randomized, open, multicenter, controlled study in pregnant women affected by iron deficiency anemia. INTERVENTION: Iron polymaltose 100 mg 2x a day in comparison to iron sulfate 100 mg 2x a day. STUDY DURATION: 90 days. RESULTS: hemoglobin improvement after 90 days by 2.16g/dL (iron polymaltose) and 1.93g/dL (iron sulfate). Ferritin levels after 90 days: 17.9 ng/mL (iron polymaltose), 15.7 ng/mL (iron sulfate). Side-effects observed in 29.3% of patients receiving iron polymaltose and 56.4% of those receiving iron sulfate.

= Study in children

= Randomized, open study in children affected by iron deficiency anemia. INTERVENTION: Iron polymaltose 5 mg/kg body weight in one administration a day, compared to iron sulfate 5 mg/kg body weight, divided up over 2 administrations a day. STUDY DURATION: 4 months. RESULTS: hemoglobin improvement after 4 months by 2.3g/dL (iron polymaltose) and 3g/dL (iron sulfate). Fewer gastrointestinal side-effects with iron polymaltose. The mean acceptance value after 4 months was higher with iron polymaltose than with iron sulfate.

= Study in adults

= Randomized, multicenter, double-blind study in adults affected by iron deficiency anemia. INTERVENTION: Iron polymaltose 100 mg 2x a day in comparison to iron sulfate 60 mg 3x a day. STUDY DURATION: 9 weeks. RESULTS: hemoglobin improvement in both groups after 3, 6, and 9 weeks, whereby after 3 and 6 weeks, a significant improvement was observed in the iron sulfate group. After 9 weeks, comparable improvement in both groups. Side-effects occurred in 22% of patients receiving iron polymaltose and 25% of those receiving iron sulfate.

Contraindications

Iron polymaltose must not be used in the event of known

hypersensitivity Hypersensitivity (also called hypersensitivity reaction or intolerance) is an abnormal physiological condition in which there is an undesirable and adverse immune response to an antigen. It is an abnormality in the immune system that causes Imm ...

or intolerance to the active ingredient or one of the excipients. Iron preparations are not administered to treat anemia that is not associated with iron deficiency. Furthermore, iron preparations must not be used in the event of known iron overload or iron utilization disorders.

Interactions

Iron polymaltose must not be administered at the same time as parenteral iron preparations. No interactions with other medications or foods are known.

Side-effects

Commonly observed side-effects, occurring in 1 to 10% of cases, include stool discoloration,

diarrhea Diarrhea (American English), also spelled diarrhoea or diarrhœa (British English), is the condition of having at least three loose, liquid, or watery bowel movements in a day. It often lasts for a few days and can result in dehydration d ...

nausea Nausea is a diffuse sensation of unease and discomfort, sometimes perceived as an urge to vomit. It can be a debilitating symptom if prolonged and has been described as placing discomfort on the chest, abdomen, or back of the throat. Over 30 d ...

, and

dyspepsia Indigestion, also known as dyspepsia or upset stomach, is a condition of impaired digestion. Symptoms may include upper abdominal fullness, heartburn, nausea, belching, or upper abdominal pain. People may also experience feeling full earlier ...

. Uncommon side-effects, occurring in 0.1 to 1% of cases, include

constipation Constipation is a bowel dysfunction that makes bowel movements infrequent or hard to pass. The Human feces, stool is often hard and dry. Other symptoms may include abdominal pain, bloating, and feeling as if one has not completely passed the ...

vomiting Vomiting (also known as emesis, puking and throwing up) is the forceful expulsion of the contents of one's stomach through the mouth and sometimes the nose. Vomiting can be the result of ailments like food poisoning, gastroenteritis, pre ...

, stomachache,

tooth discoloration Tooth discoloration is abnormal tooth color, hue or translucency. External discoloration is accumulation of stains on the tooth surface. Internal discoloration is due to absorption of pigment particles into tooth structure. Sometimes there are se ...

itch An itch (also known as pruritus) is a sensation that causes a strong desire or reflex to scratch. Itches have resisted many attempts to be classified as any one type of sensory experience. Itches have many similarities to pain, and while both ...

iness, and

headache A headache, also known as cephalalgia, is the symptom of pain in the face, head, or neck. It can occur as a migraine, tension-type headache, or cluster headache. There is an increased risk of Depression (mood), depression in those with severe ...

. As very rare side-effects, occurring in 0.1 to 0.01% of cases,

allergic Allergies, also known as allergic diseases, are various conditions caused by hypersensitivity of the immune system to typically harmless substances in the environment. These diseases include hay fever, food allergies, atopic dermatitis, alle ...

reactions have been observed.

Dosage and administration

The preparation is available in various galenic formulations: syrup, drops, drinkable solution, film-coated tablets, and chewable tables. The syrup, drops, or drinkable solution are preferable for children. The preparation is dosed according to age. The following general dosage guidelines apply (for iron deficiency with anemia): * Premature babies: 2.5–5 mg/kg body weight * Children up to 1 year of age: 25–50 mg * Children 1–12 years of age: 50–100 mg * Young people age 12 and up and adults: 100–300 mg * Pregnant women: 100–300 mg The quantity of active ingredient per unit is 100 mg of iron per chewable or film-coated tablet, 50 mg of iron per 1mL of drops, 10 mg of iron per 1mL of syrup, 100 mg of iron per 1 drinkable solution (5mL). Iron polymaltose should be taken with food, as this improves absorption.

Excipients

The preparation contains different excipients depending upon the galenic formulation. * Chewable tablets: cyclamate, vanillin, fersip, aromatica, excip. pro compr. * Drops: conserv.: E217, E219; sucrose, vanillin, aromatica, excip. ad solut. * Syrup: conserv.: E216, E218; sucrose, vanillin, aromatica, excip. ad solut. * Drinkable solution: conserv.: E217, E219; sucrose, vanillin, aromatica, fersip, excip. ad solut. * Film-coated tablets: excip. pro compr.

Packaging, storage

The preparation should be stored in its original packaging at room temperature (15-25 °C) and consumed by the date printed on the packaging.

Chemical properties

General information

Information regarding active ingredient, properties

References

{{reflist, refs= {{cite journal, title=Safety and efficacy of iron(III)-hydroxide polymaltose complex / a review of over 25 years experience., last1=Geisser, first1=P., journal=Arzneimittelforschung, year=2007, volume=57, issue=6A, pages=439–452, pmid=17691594, doi=10.1055/s-0031-1296693 {{cite journal, title=The pharmacokinetics and pharmacodynamics of iron preparations., last1=Geisser, first1=P, last2=Burckhardt, first2=S., journal=Pharmaceutics, date=4 January 2011, volume=3, number=1, pages=12–33, pmid=24310424, doi=10.3390/pharmaceutics3010012, pmc=3857035, doi-access=free {{cite journal, title=Efficacy and safety of oral iron(III) polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia: a multicenter, randomized, controlled study, last1=Ortiz, first1=R, others=et al., journal= Journal of Maternal-Fetal and Neonatal Medicine, date=November 2011, volume=24, number=11, pages=1347–52, pmid=21859366, doi=10.3109/14767058.2011.599080, s2cid=25666373 {{cite journal, title=Efficacy, Tolerability, and Acceptability of Iron Hydroxide Polymaltose Complex versus Ferrous Sulfate: A Randomized Trial in Pediatric Patients with Iron Deficiency Anemia, last1=Yasa, first1=B, others=et al., journal=International Journal of Pediatrics, year=2011, volume=2011, page=524520, pmid=22121379, doi=10.1155/2011/524520, pmc=3206382, doi-access=free {{cite journal, last1=Langstaff, first1=RJ, others=et al., title=Treatment of iron-deficiency anaemia: a lower incidence of adverse effects with Ferrum Hausmann than ferrous sulphate, journal=British Journal of Clinical Research, year=1993, volume=4, pages=191–198 {{cite journal, title=Iron(III)-hydroxide polymaltose complex in iron deficiency anemia / review and meta-analysis, last1=Toblli, first1=JE, last2=Brignoli, first2=R, journal=Arzneimittelforschung, year=2007, volume=57, number=6A, pages=431–438, pmid=17691593, doi=10.1055/s-0031-1296692 {{cite journal, title=Bioavailability and therapeutic efficacy of bivalent and trivalent iron preparations, last1=Kaltwasser, first1=JP, last2=Werner, first2=E, last3=Niechzial, first3=M, journal=Arzneimittelforschung, year=1987, volume=37, number=1A, pages=122–129, pmid=3566867 {{cite journal, title=Food interaction of oral uptake of iron / a clinical trial using 59Fe, last1=Lundqvist, first1=H, last2=Sjöberg, first2=F, journal=Arzneimittelforschung, year=2007, volume=57, number=6A, pages=401–416, pmid=17691590, doi=10.1055/s-0031-1296689

External links

PubChem
Iron(III) compounds Drugs acting on the blood and blood forming organs