Each film-coated tablet contains iron, elemental (as dried ferrous sulfate 187 mg) 60 mg, folic acid 600 mcg, pyridoxine HCl (vitamin B6) 20 mg and cyanocobalamin (vitamin B12) 25 mcg.
Excipients/Inactive Ingredients: Microcrystalline cellulose, copolyvidone, sodium starch glycolate, sodium lauryl sulfate, magnesium stearate and opadry.
ODIRON film-coated tablet (Iron + B-Complex) is specially formulated to meet the highly increased demands of pregnant women for iron, folic acid, vitamin B6 and B12 - nutrients necessary for healthy blood to prevent anemia and to prevent neural tube defects (NTDs). Studies show that anemia is highly prevalent during pregnancy.
Aside from iron deficiency, pregnant women are also prone to folate, vitamins B6 and B12 deficiency which could lead to NTDs and hyperhomocysteinemia. The combination of folate, vitamins B6 and B12 in ODIRON may help lower plasma homocysteine. Recent data show that elevated plasma homocysteine is associated with common pregnancy complications (e.g., preeclampsia) and adverse pregnancy outcomes (e.g., prematurity, very low birth weight). Hyperhomocysteinemia has been reported to result in NTDs and is also identified as a risk factor for atherosclerosis and thrombosis.
ODIRON combines anti-anemia and antihomocysteine nutrients: Iron-essential in the formation of blood, transport and storage of oxygen and a co-factor required for the proper functioning of cells.
Folic Acid-required for the prevention of neural tube defects (NTDs) in infants characterized by malformation of neural tube including spina bifida which can lead to a variety of physical disabilities (i.e., paralysis and hydrocephalus). Adequate folate nutrition offers protection against complications of pregnancy, including premature detachment of the placenta, hemorrhage, low birth weight and fetal malformation. Folate deficiency is a major concern during pregnancy because during this period, there is a notable decrease in the efficiency of folate absorption and an increase in the rate of urinary folate excretion.
Vitamin B6 and B12-help in the synthesis of hemoglobin and formation of red blood cells. These nutrients also facilitate energy metabolism and may help relieve anorexia, muscle weakness, nausea, and vomiting.
Folic acid, Vitamins B6 and B12, synergistically facilitate homocysteine metabolism to prevent hyperhomocysteinemia.
For the prevention and treatment of iron deficiency anemia in pregnant and lactating women.
To reduce the risk of having a baby with neural tube defect due to folate deficiency.
To help lower plasma homocysteine.
For increased iron-requirement in the following cases: menstrual periods, malnutrition, post-operation, haemorrhage, ankylostomosis, convalescence period of severe diseases, vegetarian diets, etc.
Orally, one film-coated tablet daily, or as recommended by a physician.
The symptoms of acute iron toxicity have been reported with ingestion of 200 to 250 mg/kg of body weight of ferrous sulfate in adults and 20 mg/kg of elemental iron in children.
Initial manifestations of acute toxicity include diarrhea, sometimes containing blood, fever, nausea, severe stomach pain or cramping, vomiting, sometimes containing blood. Late symptoms may include bluish-colored lips, fingernails, palms of hands; drowsiness; pale, clammy skin; seizures; shallow and rapid breathing; unusual tiredness or weakness; weak and fast heartbeat.
Acute overdose of iron requires immediate medical treatment that should be completed as soon as possible following ingestion. In the event of acute overdose, induce emesis with syrup of ipecac or lavaging with sodium bicarbonate may be used, depending on the patient's condition. Antidote - deferoxamine, administered slowly, intravenously or intramuscularly, is used in more severe iron toxicity. Dialysis is indicated in renal failure. Rehydration and correction of electrolyte imbalance if they occur. Elevation of blood pressure with dopamine if necessary.
Hypersensitivity to any component in the formulation.
Having malignant tumour or having doubts about tumour.
Iron: Primary hemochromatosis, peptic ulcer, regional enteritis or ulcerative colitis.
Iron: Should not use iron to treat hemolytic anemia unless an iron deficient state also exists.
Should not administer parenteral iron together with oral iron to avoid iron overload.
Should not administer iron to patients receiving repeated blood transfusions, since there is considerable amount of iron in the hemoglobin of transfused erythrocytes.
Pyridoxine: Data on exposed pregnancies indicate no adverse effects of pyridoxine in therapeutic doses on pregnancy or the health of the foetus or newborn child, or during lactation.
Caution should be exercised when prescribing to pregnant women.
Cyanocobalamin: For pernicious anaemia, an adequate dose must be used and the blood picture must be examined regularly at least every three months for 18 months until stabilised, and then annually.
Indiscriminate administration of this medicine may mask precise diagnosis.
This medicine should not be used to treat megaloblastic anaemia of pregnancy because this is due to folate deficiency.
Effects on ability to drive and use machines: There is no relevant information.
Gastrointestinal side effects are usually related to the amount of elemental iron taken rather than the type of preparation. Other effects may include diarrhea or constipation. Side effects may be reduced by administration with or after food or by starting therapy with a small dose and increasing gradually.
May cause temporary staining of teeth.
Stool may appear darker in color.
Pyridoxine is normally non-toxic. Prolonged use of pyridoxine in a dose of 10 mg daily is considered safe but the long-term use of pyridoxine in a dose of 200 mg or more daily can cause neuropathy.
Central nervous system:
Headache, sleepiness, convulsion.
Endocrinology & metabolism:
Acidosis, low serum folic acid level.
Muscular and nervous system:
High doses of pyridoxine (200 mg per day) taken for several months have caused a severe sensory neuropathy, progressing from unstable gait and numb feet to numbness and clumsiness of hands. This condition seems to be reversible on withdrawal of pyridoxine, although some residual weakness has been observed.
Allergic reactions may occur, including burning and itching skin sensations.
Anaphylactic shock, fever, headache, bronchospasm, pharyngeal angioedema.
Skin reactions include acne, urticaria, erythema,itching.
Secondary cardiac dysrhythmia due to hypokalemia during initial treatment.
Please inform the doctor for any side-effect during treatment.
Iron: Concurrent administration of antacids with oral iron may decrease iron absorption.
When taken concomitantly, absorption of both iron salts and tetracyclines is diminished.
Responses to iron may be delayed when receiving concomitant chloramphenicol therapy.
Iron salts have also been reported to decrease absorption and thus reduce the bioavailability and clinical effect of levodopa with carbidopa, methyldopa, penicillamine, and some quinolones (ciprofloxacin, norfloxacin, ofloxacin). Oral iron preparations should not be ingested concomitantly with or within two hours of a dose of these medications.
Folic Acid: Folic acid may increase phenytoin metabolism, resulting in decreased phenytoin serum concentration.
Concurrent administration of chloramphenicol and folic acid in folate-deficient patients may antagonize hematopoietic response to folic acid.
Pyridoxine: Pyridoxine hydrochloride may reduce the effect of levodopa, a drug used in the treatment of Parkinsons disease.
Cyanocobalamin: Absorption of vitamin B12 may be reduced with the concurrent use of neomycin, aminosalicylic acid, histamine H2-receptor antagonists and colchicine.
Serum B12 concentrations may be decreased by concurrent administration of oral contraceptives. Chloramphenicol may decrease the hematologic effects of vitamin B12 in patients with anemia.
Effects of cyanocobalamin may be reduced when co-administered with omeprazole.
Store in a dry place, at temperatures not exceeding 30°C, protect from light.
Shelf-Life: 24 months from manufacturing date.
B03XA - Other antianemic preparations ; Used in the treatment of anemia.
Film-coated tab 25 x 4's, 3 x 10's.