Iron / Folic acid / Zinc
Feforex Plus®
Category
Nutritional supplement(mineral); Antianemic.
(USP DI)
Pharmacodynamic and pharmacokinetic properties:
The absorption of iron from the gastrointestinal tract is highly regulated. The body has a limited capacity to excrete iron. Very little iron is excreted by the kidneys or via the biliary route. Some iron losses occur through sloughing of skin and mucosal cells. Folic acid, are transported across the proximal small intestine via a saturable pH-dependent process. Folate is excreted in the urine as folate cleavage products. Intact folate enters the glomerulus and is reabsorbed into the proximal renal tubule. Very little intact folate is excreted in the urine. Folate is excreted in the bile and much of it is reabsorbed via the entero hepatic circulation. Absorption of zinc from the gastrointestinal tract is incomplete, and is reduced in the presence of some dietary constituents such as phytates. Bioavailability of dietary zinc is about 20 to 30%. Zinc is distributed throughout the body with the highest concentrations found in muscle, bone, skin, eye, and prostatic fluids. It is primarily excreted in the faeces, and regulation of faecal losses is important in zinc homoeostasis. Small amounts are lost in urine and perspiration. Folic acid doses of up to 1 milligram daily are well tolerated.
(Martindale)
Indications:
It is used as supplement for iron and folic acid and zinc deficiency. Use in preventing and treating iron-deficiency anemia. Folic acid is indicated for the prevention of some birth defects and appears, as well, to confer significant protection against cardiovascular disease and some forms of cancer. Zinc is an essential element of nutrition and traces are present in a wide range of foods. It is a constituent of many enzyme systems and is present in all tissues. Features of zinc deficiency include growth retardation and defects of rapidly-dividing tissues such as the skin the immune system, and the intestinal mucosa.
(Martindale,USP DI)
Pregnancy and breast feeding
Pregnant women and nursing mothers should not use supplemental doses of iron higher than direct of physician .Women of childbearing age, pregnant women and nursing mothers should ensure that their intake of folic acid from nutritional supplements and/or fortified food is 400 micrograms/day. Doses higher than 1 milligram/day should only be used by the above groups if prescribed by their physicians. Problems in humans have not been documented with intake of normal daily recommended amounts. However adequate and well controlled studies in humans have not been done.
(USP DI)
Contraindications:
Iron supplements are contraindicated in those with hemochromatosis, hemosiderosis and hypersensitive to any component of an iron-containing supplement. Folic acid is contraindicated in those who are hypersensitive to any component of a folic acid-containing product. Zinc supplement contraindicated in copper deficiency.
(USP DI)
Warning and precautions:
Iron supplements should not be used for the treatment of anemias other than iron deficiency anemia. Treatment of iron deficiency anemia must only be undertaken under medical supervision. Those with elevated serum ferritin levels should be extremely cautious in the use of iron supplements. Iron should be used with caution in those with a history of gastritis, peptic ulcer disease or gastrointestinal bleeding. The use of folic acid for the treatment of folate deficiency or for the treatment of any medical condition requires medical supervision. The use of folic acid doses above 1 milligram/day may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. Those who use folic acid doses above 1 milligram/day should only do so under medical supervision. Those with undiagnosed anemia should exercise caution in the use of supplementary folic acid. Doses of folic acid greater than 100 micrograms daily may result in hematologic improvement in those with vitamin B12 deficiency. Prolonged use of high doses of zinc supplements, by mouth or parenterally, leads to copper deficiency with associated sideroblastic anemia and neutropenia; full blood counts and serum cholesterol should be monitored to detect early signs of copper deficiency. Zinc toxicity has occurred after the use of contaminated water in haemodialysis solutions. High serum zinc concentrations may be reduced by using a chelating drug such as sodium calcium edetate. Iron supplements should be used with extreme caution in those with chronic liver failure, alcoholic cirrhosis, chronic alcoholism and pancreatic insufficiency.
(Martindale)
Interactions:
Iron salts are not well absorbed by mouth, and food may further impair their absorption.
Compounds containing calcium and magnesium, including antacids and mineral supplements, and bicarbonates, carbonates, oxalates, or phosphates, may be decreased. The absorption of iron by the formation of insoluble complexes. The absorption of iron and zinc salts and tetracyclines is diminished when taken together by mouth. If treatment with both drugs is required, a time interval of about 2 to 3 hours should be allowed between them. A suitable interval is also advised if an iron supplement is required in patients receiving trientine. Iron is chelated by acetohydroxamic acid, reducing the absorption of both. Iron should not be given with dimercaprol as toxic complexes may form.
The response to iron may be delayed in patients receiving systemic chloramphenicol.
Some agents, such as ascorbic acid and citric acid, may actually increase the absorption of iron. In addition to those already mentioned, iron and zinc salts can also decrease the absorption of other drugs and thus reduce their bioavailability and clinical effect. Drugs so affected include cefdinir, bisphosphonates, entacapone, fluoroquinolones, levodopa, methyldopa, mycophenolate mofetil, coppercphosphorus, containing preparations and penicillamine. Iron salts may reduce the efficacy of levothyroxine. (Martindale)
Adverse reactions:
The most common side effects are gastrointestinal ones and include nausea, vomiting, bloating and other abdominal discomfort, black stools, diarrhea, constipation, anorexia, abdominal pain, dyspepsia, gastric irritation, and gastritis. These are particularly common if these are taken on an empty stomach and may be reduced by giving them with meals.
(Martindale)
Overdose:
Acute iron overdosage can be divided into four stages. In the first stage, which occurs up to six hours after ingestion, the principal symptoms are vomiting and diarrhea, hypotension, tachycardia and CNS depression ranging from lethargy to coma. The second phase may occur at 6-24 hours after ingestion and is characterized by a temporary remission. In the third phase, gastrointestinal symptoms recure accompanied by shock, metabolic acidosis, coma, hepatic necrosis and jaundice, hypoglycemia, renal failure and pulmonary edema. The fourth phase may occur several weeks after ingestion and is characterized by gastrointestinal obstruction and liver damage. There are no reports of folic acid overdosage in the literature. In acute overdosage zinc salts are corrosive, due to the formation of zinc chloride by stomach acid; treatment consists of giving milk or alkali carbonates and activated charcoal. The use of emetics or gastric lavage should be avoided.
(Martindale)
Dosage and administration:
As directly by the physician.
Storage:
Store below 30°c and protect from humidity and direct light.
How supplied:
Feforex plus® is available as Fe++ 47mg / Folic acid 0.5 mg / Zn++ 22.5mg
Hard gelatin capsules (cap: transparent green / body: colorless transparent).
There are blisters of 2×15 in a box of 30's.
Ref:
1- Martindale 2007
2- USP DI 2004