Feglo-FZ^®

Feglo-FZ^® is the combined preparation of Ferrous Ascorbate, Folic Acid and Zinc Sulfate Monohydrate. Ferrous Ascorbate when administered is converted to ferric form and immediately is reduced to the ferrous form into the stomach. This reduced ferrous form is then transferred to the duodenum where it is highly absorbed. Ferrous Ascorbate has the advantage of providing both ferrous ion and Ascorbate in the same compound. There is no dissociation on entering GI tract due to the stable chelate of Iron with ascorbate. Folic Acid itself is biochemically inactive, is converted to tetrahydrofolic acid and methyltetrahydrofolate by dihydrofolate reductase in liver. These Folic Acid congeners are transported across cells by receptor-mediated endocytosis where they are needed to maintain numerous body functions. Folic Acid enhances chemical reactions that contribute to the production of red blood cells, the manufacture of DNA needed for cell replication and the metabolism of amino acids (compounds necessary for the manufacture of proteins). Zinc is essential to numerous physiological processes, including the function of many enzymes in the body. Deficiency may lead to poor night vision, slow healing of wounds, poor sexual development and function in males, poor appetite (perhaps owing to a decrease in the sense of taste and smell), a reduced ability to ward off infections, diarrhea, dermatitis and in children, retarded growth.

Feglo-FZ^® is indicated for the treatment of iron deficiency especially when inadequate diet calls for supplementary zinc and iron during pregnancy and anemia.

Route of administration: Feglo-FZ^® is taken in oral route.

Adult and elderly: The recommended dose of Feglo-FZ^® is one tablet a day before or after meal or as directed by the physician. In more severe cases, two tablets a day may be required as prescribed by the physician.

Contraindication
This combination is contraindicated in patients with known hypersensitivity to ferrous ascorbate, folic acid and zinc sulfate monohydrate or any components of this product. This combination is also contraindicated in patients with hemolytic anemia.

Pregnancy: Administration in first trimester of pregnancy should be avoided unless definite evidence of iron deficiency is observed. Prophylaxis of iron deficiency is justified during the remainder of pregnancy specifically when zinc supplementation is required.

Lactation: If currently breastfeeding then please contact the physician, before taking or continuing the drug.

Use in children and adolescents
Safety and effectiveness in pediatric patients have not been established.

Warning and precaution
Care should be taken in patients who may develop iron overload, such as those with hemochromatosis, hemolytic anemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anemia and should be further investigated.

Side effects
The most common side effects of this combination are mild and transient. These include epigastric pain, heart burn, nausea, vomiting, diarrhea and constipation. Other side effect is allergic sensitization.

It is contraindicated in patients with a history of hypersensitivity to rifampicin, isoniazid or any of its components. It is also contraindicated in patients with severe renal impairment (creatinine clearance< 25 ml/min) & a history of drug-induced hepatitis and in patients with acute liver diseases and porphyria. Concomitant use with voriconazole and protease inhibitors, except ritonavir when given at full dose or 600 mg twice daily is also contraindicated.

Drug Interaction with medication: Iron chelates with tetracycline. Since oral iron products interfere with absorption of oral tetracycline antibiotics, this product should not be taken within two hours of each other. Occasional gastrointestinal discomfort may be minimized by taking with meals. Absorption of iron may be impaired by concurrent administrations of penicillamine and antacid. In patients with renal failure, a risk of zinc accumulation may exist.

Drug interaction with food and others: Not applicable.

The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.

Feglo-FZ^® tablet: Each coated tablet contains Ferrous Ascorbate INN equivalent to 48 mg elemental Iron, Folic Acid BP 0.50 mg and Zinc Sulfate Monohydrate USP equivalent to 22.50 mg elemental Zinc.

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Storage
Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children.

Packing
Feglo-FZ^® tablet: Carton of 60 tablets in blister pack.