Fezin-CI

Uses

Fezin-CI is used for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency. It is used for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

Fezin-CI 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 Fezin-CI 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

Fezin-CI dosage

One capsule daily. In more severe cases, 2 capsules a day may be required or as directed by the physician.

May be taken with or without food.

Side Effects

Generally well tolerated. However, a few allergic reactions may be seen.

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 anemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.

Interaction

No such drug interactions have been reported.

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

Recommended. Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of iron during the first trimester requires definite evidence of iron deficiency. Prophylaxis of iron deficiency where inadequate diet calls for supplementary zinc and folic acid is justified during the remainder of pregnancy.

Contraindication

Fezin-CI is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Acute Overdose

Symptoms of carbonyl iron include decreased energy, nausea, abdominal pain, tarry stool; a weak, rapid pulse, fever; coma; seizures.

Storage Condition

Store in a dry place below 25°C. Protect from light.

Innovators Monograph

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