Fefa TR

Uses

This is used for the treatment and prophylaxis of iron, folic acid and zinc deficiency specially during pregnancy and lactation.

Fefa TR 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 supplementation

How Fefa TR 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.

Dosage

Fefa TR dosage

Adults or Elderly: 1 capsule or tablet daily. In more severe cases, 2 capsulesor table daily may be required.

Children: Aged over 1 year: 1 capsuleor tablet daily. The capsule may be opened and the pellets to be mixed with soft, cool food, but they must not be chewed.

May be taken with or without food.

Side Effects

Dark stools are usual during iron therapy, and nausea and other symptoms of gastrointestinal irritation, such as anorexia, vomiting, discomfort, constipation and diarrhoea are sometimes encountered. Zinc may also produce gastrointestinal upset. These timed release capsules are designed to reduce the possibility of gastrointestinal irritation. There have been rare reports of allergic reactions.

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

Precaution

Care should be taken in patients who may develop iron overload, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. In patients with renal failure, a risk of zinc accumulation may exist.

Interaction

Iron and zinc chelate with tetracycline and absorption of all three agents may be impaired. The absorption of zinc may be reduced in the presence of iron. Absorption of iron may be impaired by penicillamine and by antacids. Such potential interactions can be reduced by separating administration of each product by several hours. In patients with renal failure a risk of zinc accumulation could exist.

Volume of Distribution

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

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.

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.

Pregnancy & Breastfeeding use

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.

Contraindication

It is contraindicated in patients with haemolytic anaemia and in conditions with hypersensitivity to any of its components and increased body iron content.

Acute Overdose

Iron overdosage is dangerous, particularly in children, and requires immediate attention. Gastric lavage should be carried out in the early stages, or if this is not possible, vomiting should be induced. These procedures should not be undertaken where signs of the corrosive effects of zinc are present. Give oral desferrioxamine (2 g for a child or 5 g for an adult and demulcent. If serum iron levels at 4 hours or more post-ingestion are over 5 mg/l in a child or 8 mg/l in an adult, or if the patient is in shock of coma, intravenous desferrioxamine should be used. Zinc sulphate in gross overdosage is corrosive. Symptoms are those of gastrointestinal irritation, leading in severe cases to haemorrhage, corrosion of the mucosa and possible later stricture formation. Gastric lavage or emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as dimercaprol, penicillamine or edetic acid have been recommended. Symptomatic and supportive measures should be given as required. The timed release capsule presentation may delay excessive absorption of iron and zinc and allow more time for initiation of appropriate counter measure.

Storage Condition

Store in a dry place below 25˚C and protect from light. Keep out of children’s reach to avoid accidental iron poisoning.

Innovators Monograph

You find simplified version here Fefa TR