Polymax

The chemical name of iron hydroxide polymaltose is iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide with the empirical formula C₁₂H₂₅FeO₁₄ and a molecular weight of 449.16.
Each capsule contains: Iron 100 mg (Equivalent to 333.33 mg Iron (III) Hydroxide Polymaltose Complex), Folic Acid (Vitamin B₉) BP 550 mcg.
Appropriate overages of vitamin added to compensate for loss on storage.
Approved colours used in the capsule shell.

Anti-Anemia.
Pharmacology: Mechanism of action: In the IPC, the polynuclear iron (III) hydroxide core is superficially surrounded by a number of non-covalently bound polymaltose molecules, which leads to an average total molecular weight of approximately 50kDa. IPC is a stable complex and does not release large amounts of iron under physiological conditions. The polynuclear iron core of the IPC has a structure similar to the physiological iron storage protein ferritin. Because of its size, the extent of diffusion of IPC through the membrane of the mucosa is about 40 times less than in most water-soluble iron (II) salts, existing in aqueous solution as hexaqua-iron (II) ion complex. Iron from IPC is taken up in the gut via an active mechanism.
Folic acid (folate) belongs to the group of B vitamins. It is a precursor to tetrahydrofolate, a coenzyme that is involved in various metabolic processes, including the biosynthesis of purines and thymidylates of nucleic acids. Folic acid is required for nucleoprotein synthesis and to maintain normal erythropoiesis.
The absorbed iron is bound to transferrin and used for Hb synthesis in the bone marrow or stored, primarily in the liver, bound to ferritin.
Folic acid is the precursor of tetrahydrofolic acid which is active and acts as a co-factor for 1-carbon transfer reactions in the biosynthesis of purines and thymidylates of nucleic acids.
Pharmacokinetics: Studies with radiolabeled IPC show a good correlation between iron absorption and the iron incorporation into hemoglobin. The relative amount of absorbed iron correlates with the extent of iron deficiency (i.e. the higher the iron deficiency, the better the iron absorption). In contrast to iron (II) salts, no negative impact of food on the bioavailability of iron from IPC was found: A significantly increased bioavailability of iron with concomitant food intake was demonstrated in one clinical study, while three further studies showed a positive trend but no clinically relevant effects.
Approximately 80% of folic acid is absorbed in the small intestine, with an absorption maximum after 30-60 minutes.
Unabsorbed iron is excreted through the faeces. Folic acid is mainly excreted in the urine.

Iron + Folic Acid (Vitamin B₉) capsule is indicated in the treatment of iron deficiency anemia during pregnancy, lactation, and in anemia which is due to post-partum haemorrhage.
It is also indicated in the prevention of iron deficiency anemia.

Dosage and duration of therapy are dependent upon the extent of iron deficiency.
Treatment of iron deficiency anemia: 1 capsule to be taken orally twice daily.
Prevention of iron deficiency anemia: 1 capsule to be taken orally once daily.
In cases of iron deficiency, the therapy takes about 3-5 months until normalization of the hemoglobin value is achieved. Afterwards, the therapy should be continued for several weeks to replenish the iron stores.
Pediatric population: There are no data on the use of iron hydroxide polymaltose complex in children and adolescents aged 12 years and younger, and therefore it is not recommended.
Method of administration: Oral use.

In case of overdoses, intoxication or iron accumulation are unlikely due to the low toxicity of iron (III) hydroxide polymaltose complex [in mice or rats, the 50% lethal dose (LD50) > 2000 mg Fe/Kg body weight] and the expected saturation of the iron intake is unlikely. There are no known cases of accidental fatal poisoning.
There are reports that an excessive dose of folic acid may cause changes in the central nervous system (namely, mood disorders, changes in sleep patterns, irritability and hyperactivity), nausea, abdominal distension and flatulence.

Known hypersensitivity or intolerance to the active ingredients or to any of the excipients.
Iron overload (e.g., hemochromatosis, hemosiderosis).
Disturbances in iron utilization (lead anemia, sideroblastic anemia, thalassemia).
All anemias not caused by iron deficiency (e.g., hemolytic anemia or megaloblastic anemia due to vitamin B₁₂ deficiency).

Anemia should always be treated under medical supervision.
If the therapy does not succeed (hemoglobin increases by about 2-3 g/dl after 3 weeks), the treatment should be reconsidered.
Iron + Folic Acid (Vitamin B₉) capsules contain folic acid and can mask a vitamin B₁₂ deficiency. Due to the risk of irreversible neurological disorders, a possible vitamin B₁₂ deficiency should be excluded in anemic patients before starting therapy.
During the treatment with iron hydroxide polymaltose, dark discolouration of the faeces (stool) may occur, however this is not of clinical relevance.
Caution should be exercised in patients who receive repeated blood transfusions, since erythrocytes also supply iron, which can lead to iron overload. Infections or tumors may cause anemia. Since iron can be utilized only after correcting the primary disease, a benefit/risk evaluation is advisable.
Effects on ability to drive and use machines: No relevant studies were undertaken. However, iron hydroxide polymaltose complex is unlikely to have any effect on the ability to drive and use machines.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: There are no data on the use of iron hydroxide polymaltose complex in children and adolescents aged 12 years and younger, and therefore it is not recommended.
Use in the Elderly: Clinical experience with iron hydroxide polymaltose in the elderly is limited. For use in elderly patients consult a medical practitioner.

Pregnancy: Iron + Folic Acid (Vitamin B₉) capsules can be used in pregnancy and lactation.
Clinical data from exposed pregnant women showed no adverse effects on pregnancy or the health of the fetus or new-born. There is no experience from epidemiological studies. Studies in animals have not shown reproductive toxicity. As a precautionary measure, iron hydroxide polymaltose complex should only be taken after consulting a medical doctor.
Lactation: It is not known whether iron from the iron (III) hydroxide polymaltose complex passes into breast milk. Human breast milk naturally contains iron, which is bound to lactoferrin. As a precautionary measure, iron hydroxide polymaltose complex should only be taken during breastfeeding after consulting a medical practitioner.

The frequency of the side effects described as follows is divided into very common (≥1/10), common (<1/10 to ≥1/100), uncommon (<1/100 to ≥1/1000) or rare (<1/1000).
Discoloured faeces are a well-known adverse drug reaction of oral iron medications, but this is considered of no clinical relevance and is underreported. Other commonly seen side effects were gastrointestinal disorders (nausea, constipation, diarrhea and abdominal pain).
Very common: faeces discoloration.
Common: diarrhea, nausea, abdominal pain (including dyspepsia, epigastric discomfort, abdominal distension), constipation.
Uncommon: vomiting (including regurgitation), gastritis, tooth discoloration, pruritus, rash (including macular rash, blistered rash), urticaria, erythema, headache.
Rare: muscle spasms (including involuntary muscle contraction, tremor), myalgia.

Interactions of Iron (III) Hydroxide Polymaltose Complex (IPC) with tetracycline or aluminium hydroxide were investigated in three human studies. No significant reduction in the absorption of tetracycline was observed. The plasma tetracycline concentration did not fall below the minimum inhibitory concentration level necessary for bacteriostasis. Iron absorption from IPC was not reduced by aluminium hydroxide and tetracycline. IPC can therefore also be administered simultaneously with tetracyclines or other phenolic compounds and with aluminium hydroxide.
Studies in rats with tetracycline, aluminium hydroxide, acetylsalicylate, sulfasalazine, calcium carbonate, calcium acetate, calcium phosphate in combination with vitamin D₃, bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol and auranofin have not shown any interaction with iron (III) hydroxide polymaltose complex.
In addition, no interactions of iron (III) hydroxide polymaltose complex with food constituents such as phytic acid, oxalic acid, tannin, sodium alginate, choline and choline salts, vitamin A, vitamin D₃ and vitamin E, soya oil and soya flour were observed in in vitro studies. These results suggest that iron hydroxide polymaltose complex can be taken during or immediately after food intake.
The hemoccult test (selective for Hb) for the detection of occult blood is not impaired; and therefore, there is no need to interrupt the therapy.
The simultaneous administration of parenteral iron preparations and iron hydroxide polymaltose complex is not indicated since it would reduce the absorption of the oral iron preparation.
Folic acid could increase phenytoin metabolism, leading to lower serum phenytoin concentrations, especially in folate deficient patients. Some patients may experience an increased frequency of epileptic seizures. Patients who take phenytoin or other antiepileptics/anticonvulsants should consult a doctor before taking a folic acid supplement.
There are reports that concomitant administration of chloramphenicol and folic acid in patients with folic acid deficiency may reduce the hematopoietic response to folic acid. Although the importance and mechanism of this interaction is unclear, the hematopoietic response to folic acid should be carefully monitored in patients receiving both medicines at the same time.

Store at temperatures not exceeding 30°C.

Vitamins & Minerals (Pre & Post Natal) / Antianemics

B03AD - Iron in combination with folic acid ; Used in the treatment of anemia

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