COMPOSITION:
Each ml contains:
Ferric Hydroxide Sucrose eq. to Elemental Iron 20 mg
Description:
Huntred injection is a brown, sterile, aqueous complex of polynuclear iron (III) hydroxide in sucrose. The sterile solution has an osmolarity not less than 1150 mOsmol/L and not greater than 1350 mOsmol/L. It is to be administered by intravenous route.
Pharmacology:
Following intravenous administration of iron sucrose, it is dissociated by the reticulo-endothelial system into iron and sucrose which results in significant increase in hemoglobin iron and serum ferritin.
In healthy adults treated with intravenous doses of Iron sucrose, its iron component exhibits first order kinetics with an elimination half-life of 6 h, total clearance of 1.2 L/h, non-steady state apparent volume of distribution of 10.0 L and steady state apparent volume of distribution of 7.9 L. In healthy adults receiving intravenous doses of Iron sucrose, its iron component appears to distribute mainly in blood and to some extent in extravascular fluid. The sucrose component is eliminated mainly by urinary excretion.
Indications:
Treatment of the iron deficiency anaemia, for which the oral iron therapy is not sufficient, is ineffective or not suitable because of the existence of gastrointestinal disorders. The necessity of treatment with injection must be confirmed with appropriate clinical analysis (such as serum ferritin, haemoglobin, hematocrit and MCW calculated values).
Dosage & Administration:
Slow IV Injection (Bolus) – Inject 1 ampoule (100mg) over 2-5 minutes, wait for 2 minutes and inject another ampoule over 2-5 minutes.
IV Infusion – 1 ampoule (100mg) to be diluted in maximum 100ml of 0.9% normal saline immediately prior to infusion and infuse over a period of 30 minutes.
During Prophylaxis
400mg to be diluted in maximum of 250 ml of 0.9% normal saline and infuse over a period of 2 hrs.
Warnings & Precautions:
General: This medication must only be used under prescription and medical surveillance. Hypersensitivity reactions are reported with parenteral iron products. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. Because body iron excretion is limited and excess tissue iron can be hazardous, caution should be exercised to withhold iron administration in the presence of evidence of tissue iron overload.
Patients require periodic monitoring of hematologic and hematinic parameters. Iron therapy should be withheld in patients with evidence of iron overload. Transferrin saturation values increase rapidly after IV administration of iron sucrose; thus, serum iron values may be reliably obtained 48 hours after IV dosing.
Adverse reactions:
Adverse reactions reported in patients are as follows: hypotension, muscle cramps, itching, nausea, headache, vomiting, dizziness, diarrhea etc.
Drug Interactions:
The parenteral iron preparations should not be administered concomitantly with oral preparations, due to the oral absorption impairment.