COMPOSITION: A non-alcholic aqueous solution of ferrous lactate equivalent to 25 mg iron per mL.
PHARMACOLOGICAL CLASSIFICATION: A 8.3 Erythropoietics (haematinics).
PHARMACOLOGICAL ACTION: Ferrous lactate provides a supplementary source of iron which is necessary for haemoglobin formation. It is absorbed chiefly in the duodenum and jejenum, absorption being aided by the acid secretion of the stomach.
INDICATIONS: The prophylaxis and treatment of iron deficiency anaemia in infants under 1 year of age.
DOSAGE AND DIRECTIONS FOR USE:
0,3-0,6 mL daily based on a dosage of 1 - 2 mg iron per kg body mass.
1 - 2 mL daily in three divided doses based on a dosage of 5 mg iron per kg body mass.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Gastro-intestinal irritation with vomiting and diarrhoea, which may be reduced by administration immediately after food.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Iron poisoning occurs in distinct stages. Stage 1: Ten minutes to two hours or longer after ingestion, nausea and severe vomiting of brown or black, often bloody, fluid begins, accompanied by severe gastric pain. There is often watery and later blackish, bloody and sometimes violent diarrhoea. The patient may be pale or cyanotic.
Respiration and pulse are usually rapid and weak, although the patient may breathe deeply and rapidly as the result of metabolic acidosis. The patient is cold, and the blood pressure is low. Drowsiness, hyporeflexia, and dilated pupils may be seen. Shock may ensue, especially if there is severe gastro-intestinal haemorrhage. This shock may be fatal in four to five hours. About a quarter of the fatalities occur in this stage according to one author. Stage 2: Hours or even days may pass, giving the impression that everything is all right. The Stage 2 is heralded by black and offensive smelling diarrhoea. Signs and acute encephalopathy may develop - severe headache, confusion delirium, convulsions and loss of consciousness. Pneumonia may develop. Profound metabolic acidosis is often seen during this stage. Cardiovascular collapse may occur. In severe acute poisoning, this is usually the stage at which death occurs. Stage 3: Even though the patient survives Stages 1 and 2, recovery cannot be assured. Acute hepatic necrosis may develop, as evidenced by jaundice. This may progress to hepatic coma and death. Treatment: In the treatment of acute iron poisoning desferrioxamine given both intramuscularly and by mouth after gastric lavage is recommended. Shock, dehydration and acid-base abnormalities should be treated in the conventional manner. Speed of diagnosis and treatment is important.
IDENTIFICATION: Dark, greenish brown liquid.
PRESENTATION: Vials of 10 mL with dropper.
STORAGE INSTRUCTIONS: Store in a cool place (15°C to 25°C). KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: P/8.3/38
NAME AND BUSINESS ADDRESS OF APPLICANT: Pharmacare Limited
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 13 July 1982
Updated on this site: November 2005
Source: Hospital Pharmacy