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Pharmacology: Pharmacodynamics: Zincofer is the first haematinic offering zinc with iron and other important haemopoietic factors. Zincofer initiates DNA, RNA synthesis and ensures proper foetus formation. Zincofer prevent foetus malformations due to zinc deficiency in pregnancy. Zincofer corrects symptoms like perverted taste, loss of appetite and mental depression often observed during pregnancy. Zincofer corrects anaemia.
There is evidence that a daily dose of 100mg of elemental iron in the ferrous form is adequate to prevent development of iron deficiency in expectant mothers. If a mild iron deficiency is present when Zincofer administration is started, this will be corrected by increased absorption of iron. The daily folate requirement rises steeply during the final trimester of pregnancy, and evidence of maternal depletion may be found. To ensure normal tissue folate levels in the mother after delivery a daily supplement of about 300 micrograms is required during the second and third trimester of pregnancy. This does not obscure the blood picture of addisonian pernicious anaemia.
Pharmacokinetics: Iron is absorbed chiefly in the duodenum and jejunum, absorption being aided by the acid secretion of the stomach and being more readily effected when the iron is in the ferrous state.
Folic acid is absorbed mainly from the proximal part of the small intestine. Folate polyglutamates are considered to be de-conjugated to monoglutamates during absorption. Folic acid rapidly appears in the blood, where it is extensively bound to plasma proteins. The amounts of folic acid absorbed from normal diets are rapidly distributed in body tissues and about 4 to 5 micrograms is excreted in the urine daily. When larger amounts are absorbed, a high proportion is metabolised in the liver to other active forms of folate and a proportion is stored as reduced and methylated folate. Larger amounts of folate are rapidly excreted in the urine.
Zincofer is indicated in Iron deficiency anaemia, nutritional deficiency anaemia and anaemia associated with pregnancy, worm infestation etc.
There is evidence that a daily intake of 100mg of elemental iron in the ferrous form is adequate to prevent development of iron deficiency in expectant mothers. If a mild iron deficiency is present when Zincofer Capsules administration is started, this will be corrected by increased absorption of iron.
The daily folate requirement rises steeply during the final trimester of pregnancy, and evidence of maternal depletion may be found. To ensure normal tissue folate levels in the mother after delivery a daily supplement of about 300 micrograms is required during the second and third trimester of pregnancy. This does not obscure the blood picture of addisonian pernicious anaemia. Zincofer Capsules are indicated during the second and third trimester of pregnancy for prophylaxis against iron deficiency and megaloblastic anaemia of pregnancy. Pregaday Tablets are not intended as a treatment for established megaloblastic anaemia.
One capsule a day after meals or as prescribed by the Physician.
Adults: It is usual to begin therapy with Zincofer Capsules about the thirteenth week of pregnancy (see Precautions) either as routine prophylaxis or selectively if the haemoglobin concentration is less than 11g/100 ml (less than 75% normal).
One Capsule should be taken daily by mouth.
Children: Not applicable.
Route of administration: Oral route.
Acute overdose of oral iron requires emergency treatment. In young children 200-250 mg/kg ferrous fumarate is considered to be extremely dangerous.
Symptoms and signs of abdominal pain, vomiting and diarrhoea appear within 60 minutes. Cardiovascular collapse with coma may follow. Some improvement may occur after this phase which, in some patients, is followed by recovery. In others, after about 16 hours, deterioration may occur involving diffuse vascular congestion, pulmonary oedema, convulsions, anuria, hypothermia, severe shock, metabolic acidosis, coagulation abnormalities and hypoglycaemia.
Vomiting should be induced immediately, followed as soon as possible by parenteral injection of desferrioxamine mesylate, and then gastric lavage. In the meantime, it is helpful to give milk and/or 5% sodium bicarbonate solution by mouth.
Dissolve 2 g desferrioxamine mesylate in 2 to 3 ml of water for injections and give intramuscularly. A solution of 5 g desferrioxamine in 50 to 100 ml of fluid may be left in the stomach. If desferrioxamine is not available, leave 300 ml of 1 % to 5 % sodium bicarbonate in the stomach. Fluid replacement is essential.
Recovery may be complicated by long-term sequelae such as hepatic necrosis, pyloric stenosis or acute toxic encephalitis which may lead to CNS damage.
Known hypersensitivity to the product, Vitamin B12 deficiency, paroxysmal nocturnal haemoglobinuria, haemosiderosis, haemochromatosis, active peptic ulcer, repeated blood transfusion, regional enteritis and ulcerative colitis.
Zincofer Capsules must not be used in the treatment of anaemias other than those due to iron deficiency.
The label will state "Important warning: Contains Iron. Keep out of reach and sight of children, as overdose may be fatal". This will appear on the front of the pack within a rectangle in which there is no other information.
Some post-gastrectomy patients show poor absorption of iron. Care is needed when treating iron deficiency anaemia in patients with treated or controlled peptic ulceration. Caution should be exercised when administering folic acid to patients who may have folate dependent tumours.
Since anaemia due to combined iron and vitamin B12 or folate deficiencies may be microcytic in type, patients with microcytic anaemia resistant to therapy with iron alone should be screened for vitamin B12 or folate deficiency.
Zincofer Capsules should be kept out of the reach of children.
Since Zincofer Capsules are haematinic, safely given during pregnancy and lactation. Administration of Zincofer Capsules during the first trimester of pregnancy may be undesirable. A minority of pregnant women are not protected by physiological doses of folic acid. The development of anaemia despite prophylaxis with Zincofer Capsules calls for investigation.
Gastro-intestinal disorders have been reported including gastro-intestinal discomfort, anorexia, nausea, vomiting, constipation, diarrhoea. Darkening of the stools may occur.
Rarely allergic reactions may occur.
Concurrent administration with antacids.
Iron reduces the absorption of penicillamine. Iron compounds impair the bioavailability of fluoroquinolones, levodopa, carbidopa, thyroxine and bisphosphonates.
Absorption of both iron and antibiotic may be reduced if Zincofer is given with tetracycline.
Absorption of both iron and zinc are reduced if taken concomitantly.
Concurrent administration of antacids may reduce absorption of iron. Co-trimoxazole, chloramphenicol, sulphasalazine, aminopterin, methotrexate, pyrimethamine or sulphonamides may interfere with folate metabolism.
Serum levels of anticonvulsant drugs may be reduced by administration of folate.
Oral chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Some inhibition of iron absorption may occur if it is taken with cholestyramine, trientine, tea, eggs or milk.
Administration of oral iron may increase blood pressure in patients receiving methyldopa.
Coffee may be a factor in reducing iron bioavailability.
Neomycin may alter the absorption of iron.
Store below 25°C in a dry place. Protect from light.
Shelf-Life: 24 Months.
B03AE02 - iron, multivitamins and folic acid ; Belongs to the class of iron in other combinations. Used in the treatment of anemia.