Orofer Tablet 47 mg+0.5 mg+22.5 mg

Uses

Treatment of latent and manifest iron deficiency and prevention of iron and folic acid deficiency during and after pregnancy (during lactation). It is also used for folic acid and zinc deficiencies.

Orofer Tablet 47 mg+0.5 mg+22.5 mg is also used to associated treatment for these conditions: Anaemia folate deficiency, Folate deficiency, Iron Deficiency (ID), Iron Deficiency Anemia (IDA), Latent Iron Deficiency, Neural Tube Defects (NTDs), Vitamin Deficiency, Methotrexate toxicity, Nutritional supplementationDry Eyes, Local itching, Localized pain, Localized swelling, Nutritional supplementation

How Orofer Tablet 47 mg+0.5 mg+22.5 mg works

Folic acid, as it is biochemically inactive, is converted to tetrahydrofolic acid and methyltetrahydrofolate by dihydrofolate reductase (DHFR). 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.

Zinc inhibits cAMP-induced, chloride-dependent fluid secretion by inhibiting basolateral potassium (K) channels, in in-vitro studies with rat ileum. This study has also shown the specificity of Zn to cAMP-activated K channels, because zinc did not block the calcium (Ca)-mediated K channels. As this study was not performed in Zn-deficient animals, it provides evidence that Zn is probably effective in the absence of Zn deficiency. Zinc also improves the absorption of water and electrolytes, improves regeneration of the intestinal epithelium, increases the levels of brush border enzymes, and enhances the immune response, allowing for a better clearance of the pathogens.

Dosage

Orofer Tablet 47 mg+0.5 mg+22.5 mg dosage

One tablet daily. Two tablets may be required a day in severe cases or as recommended by the physician. The daily dose can be divided into separate doses or can be taken at one time. Iron Polymaltose Complex tablet should be taken during or immediately after a meal.

May be taken with or without food.

Side Effects

Occasionally gastrointestinal irritations such as a sensation of repletion, pressure in the epigastric region, nausea, obstipation or diarrhoea can occur. A dark colouration of the stool due to iron is of no clinical significance. Iron Polymaltose Complex tablet does not cause teeth staining.

Toxicity

IPR-MUS LD₅₀ 85 mg/kg,IVN-GPG LD₅₀ 120 mg/kg, IVN-MUS LD₅₀ 239 mg/kg, IVN-RAT LD₅₀ 500 mg/kg, IVN-RBT LD₅₀ 410 mg/kg

Human : TDLo ( Oral) 45mg/kg/7D-C : Normocytic anemia, pulse rate increase without fall inBP Human: TDLo (oral) 106mg/kg : Hypermotylity, diarrhea Mouse ; LD50 Oral : 245mg/kg Mouse : LD50 : subcutaneous : 781mg/kg

Precaution

Treatment resistance may occur in patients with depressed haematopoiesis, alcoholism, deficiencies of other vitamins. Neonates.

As with all iron preparations, a dark coloration of the stool may occur which is without clinical significance.

Interaction

Until now interactions have not been observed. Since, the iron is complex bound, ionic interactions with food components (phytin, oxalates, tannin etc.) and concomitant administration of medicaments (tetracyclines, antacids) are unlikely to occur. The haemoccult test (selective for Hb) for the detection of occult blood is not impaired and therefore there is no need to interrupt iron therapy.

Volume of Distribution

Tetrahydrofolic acid derivatives are distributed to all body tissues but are stored primarily in the liver.

After absorption zinc is bound to protein metallothionein in the intestines. Zinc is widely distributed throughout the body. It is primarily stored in RBCs, WBCs, muscles, bones, Skin, Kidneys, Liver, Pancreas, retina, and prostate.

Elimination Route

Folic acid is absorbed rapidly from the small intestine, primarily from the proximal portion. Naturally occurring conjugated folates are reduced enzymatically to folic acid in the gastrointestinal tract prior to absorption. Folic acid appears in the plasma approximately 15 to 30 minutes after an oral dose; peak levels are generally reached within 1 hour.

Approximately 20 to 30% of dietary zinc is absorbed, primarily from the duodenum and ileum. The amount absorbed is dependent on the bioavailability from food. Zinc is the most bioavailable from red meat and oysters. Phytates may impair absorption by chelation and formation of insoluble complexes at an alkaline pH. After absorption, zinc is bound in the intestine to the protein metallothionein. Endogenous zinc can be reabsorbed in the ileum and colon, creating an enteropancreatic circulation of zinc.

Half Life

3 hours

Elimination Route

After a single oral dose of 100 mcg of folic acid in a limited number of normal adults, only a trace amount of the drug appeared in the urine. An oral dose of 5 mg in 1 study and a dose of 40 mcg/kg of body weight in another study resulted in approximately 50% of the dose appearing in the urine. After a single oral dose of 15 mg, up to 90% of the dose was recovered in the urine. A majority of the metabolic products appeared in the urine after 6 hours; excretion was generally complete within 24 hours. Small amounts of orally administered folic acid have also been recovered in the feces. Folic acid is also excreted in the milk of lactating mothers.

Primarily fecal (approximately 90%); to a lesser extent in the urine and in perspiration.

Pregnancy & Breastfeeding use

Pregnancy category A. Reproduction studies in animals did not show any foetal risk. Controlled studies in pregnant women after the first trimester have not shown any undesirable effects on the mother and neonates. There is no evidence of risk during the first trimester and a negative influence on the foetus is unlikely. The administration of Iron Polymaltose Complex tablet is unlikely to cause undesirable effects on the nursed child. During pregnancy and lactation Iron Polymaltose Complex tablet should be used only after consulting a medical doctor or pharmacist.

Contraindication

In conditions with iron overload (e.g. haemocromatosis, haemosiderosis) or disturbances of iron utilization (e.g, lead anaemia, sidero-achrestic anaemia, thalassaemias) and anaemia not caused by iron deficiency (e.g, haemolytic amaemia). Precautions: In cases of anaemia due to infection or malignancy, the substituted iron is stored in the reticulo-endothelial system, from which it is mobilized and utilized only after curing the primary disease.

Acute Overdose

Incase of overdosage neither intoxication nor iron overload have been reported to date. Pharmaceutical precautions Store in a cool and dry place, protected from light.

Storage Condition

Store in a cool and dry place, protected from light.

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