PHARMACOLOGICAL CLASSIFICATION: A 8.3 Erythropoietics (haematinics)
PHARMACOLOGICAL ACTION: Iron is an essential constituent of the body, being necessary for haemoglobin formation and for the oxidative processes of living tissue. Ferrous Sulphate is one of the most widely used iron salts in the treatment of iron-deficiency anaemia.
INDICATIONS: Iron-deficiency anaemia
CONTRA-INDICATIONS: Patients receiving repeated blood transfusions.
Anaemia is not produced by iron deficiency unless iron deficiency is also present.
DOSAGE AND DIRECTIONS: Adults: The usual initial therapeutic dose is three to five tablets daily in divided doses followed by a maintenance dose of two tablets daily.
Children 6 to 12 years: Three tablets daily in divided doses. Side-effects can be reduced by taking tablets with or immediately after food.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS Side-effects include gastro-intestinal discomfort, diarrhoea and vomiting.
Continued administration may cause constipation and faeces may be black.
Care should be taken when given to patients with iron-storage or iron-absorption diseases, haemoglobinopathies, or existing gastro-intestinal disease.
Ferrous Sulphate diminishes the absorption of tetracycline taken concomitantly by mouth. If treatment with both drugs is required, the Ferrous Sulphate should be administered three hours before or two hours after the tetracycline. The absorption of iron is decreased in the presence of antacids or when taken with tea.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Symptoms of overdosage include gastro-intestinal irritation and necrosis, perforation may occur and stricture formation may subsequently follow.
Symptoms, which may not appear for several hours, include epigastric pain, diarrhoea, vomiting and haematemesis. If haemorrhage and diarrhoea are severe circulatory failure may follow, convulsions and coma may occur.
In treating iron poisoning, speed is essential to block absorption of iron from the alimentary tract. A dose of as little as 1 g should be considered toxic in children.
If desferrioxamine is not available, empty the stomach immediately by emesis and lavage using a 1 to 5% solution of Sodium Bicarbonate, and leave about 300 mL of the solution in the stomach.
Fluid loss should be replaced by intravenous administration of Compound Sodium Lactate Injection or Sodium Chloride and Dextrose Injection. Exchange transfusion may be necessary in severe cases.
The following procedure has been recommended if desferrioxamine is available:
Intramuscularly inject 2 g desferrioxamine mesylate, dissolved in Water for Injection; wash out the stomach with a 1% solution of Sodium Bicarbonate; give 5 g desferrioxamine mesylate, in 50 tot 100 mL water, by mouth or by stomach tube; give desferrioxamine mesylate by intravenous infusion at a rate of not more than 15 mg per kilogram body mass per hour, maximum dosage 80 mg/kg in 24 hours; repeat intramuscular injections of 2 g desferrioxamine mesylate every 12 hours if necessary.
IDENTIFICATION: A white sugar coated tablet.
PRESENTATION: Patient Ready Packets of 28 and 84 tablets
Plastic containers of 100, 500, 1 000 and 5 000 Tablets
STORAGE DIRECTIONS: Store below 25ºC. Keep well closed. Protect from light.
Keep out of reach of children.
REGISTRATION NUMBER: H0825 (Act 101 of 1965)
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION: GULF DRUG COMPANY (PTY) LTD.
22 BURNSIDE DRIVE
OLD MILL INDUSTRIAL PARK
MOUNT EDGECOMBE, 4300
DATE OF PUBLICATION OF PACKAGE INSERT 01/06/2000
New addition to this site: July 2010
Source: Pharmaceutical Industry