FERROUS GLUCONATE 300 mg TABLETS - LENNON
(and dosage form):
FERROUS GLUCONATE 300 mg TABLETS - LENNON
Each tablet contains 300 mg Ferrous Gluconate equivalent to 34,75 mg elemental iron.
A 8.3 Erythropoietics (haematinics).
The treatment or prophylaxis of iron-deficiency anaemia.
Ferrous Gluconate should not be given to patients receiving repeated blood transfusions, or in cases of existing haemochromatosis, haemosiderosis or other anaemic conditions, unless accompanied by iron deficiency. It should not be administered concomitantly with parenteral iron.
Prolonged administration of doses in excess of those recommended may result in iron overload. This product contains FD and C Yellow No 5 (Tartrazine) which may cause allergic-type reactions (including Bronchial Asthma) in certain susceptible individuals. Although the overall incidence of Tartrazine sensitivity in the general population is currently thought to be low, it is frequently seen in patients who also have aspirin sensitivity.
DOSAGE AND DIRECTIONS FOR USE:
Therapeutic adult dose: 600 mg (two tablets) three times daily after food, as needed and tolerated. Prophylactic adult dose: 600 mg (two tablets) daily after food.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Stools often become dark green or black in colour. Frequently occurring side-effects include abdominal pain, nausea and vomiting. Other gastro-intestinal effects may include diarrhoea or constipation. These effects may be reduced by administering the tablets with or after food, or by beginning therapy with a small dose and increasing gradually.
Side-effects occurring less frequently are those caused by contact irritation such as chest or throat pain, especially when swallowing, and stools containing fresh or digested blood. Darkened urine or heartburn are other less frequent side-effects.
Care should be taken when given to patients with iron-storage or iron-absorption diseases, haemoglobinopathies or existing gastro-intestinal disease. Ferrous Gluconate should be used with caution when the following medical problems exist: alcoholism; allergies; asthma; hepatitis or hepatic function impairment; kidney disease; intestinal tract inflammatory conditions, such as enteritis, colitis, diverticulitis, and ulcerative colitis; peptic ulcer; rheumatoid arthritis; sensitivity to iron.
The absorption of both Ferrous Gluconate and tetracyclines is diminished when they are taken concomitantly by mouth. If treatment with both drugs is required, a time interval of 2 - 3 hours should be allowed between each administration. Some antacids may also decrease the absorption of Ferrous Gluconate. The response to iron may be delayed in patients receiving concomitant chloramphenicol therapy. Ferrous Gluconate has also been reported to decrease the absorption and thus bioavailability and clinical effect of levodopa with carbidopa, methyldopa, penicillamine and the fluoroquinolones ciprofloxacin and ofloxacin.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Acute iron overdosage can be divided into four stages. In the first phase, which occurs up to 6 hours after oral ingestion, gastro-intestinal toxicity, notably vomiting and diarrhoea, predominates. Other effects may include cardiovascular disorders such as hypotension and tachycardia, metabolic changes including acidosis and hyperglycaemia, and CNS depression ranging from lethargy to coma. Patients with only mild to moderate poisoning do not generally progress past this first phase. The second phase may occur at 6 to 24 hours after ingestion and is characterised by a temporary remission or clinical stabilisation. In the third phase gastro-intestinal toxicity recurs together with shock, metabolic acidosis, convulsions, coma, hepatic necrosis and jaundice, hypoglycaemia, coagulation disorders, oliguria or renal failure, and pulmonary oedema. The fourth phase may occur several weeks after ingestion and is characterised by gastro-intestinal obstruction and possibly late hepatic damage.
An overdose of ingested Ferrous Gluconate tablets may be fatal, especially in small children, and immediate treatment is therefore essential. Inducing emesis with syrup of ipecac to prevent absorption from the alimentary tract is recommended if the patient is conscious. If the patient is comatose or convulsing then lavaging with sodium bicarbonate is advised. Laboratory studies on heparinized blood should include serum iron, haemoglobin, haematocrit, electrolytes, blood gases and blood glucose, total iron-binding capacity, complete blood count and blood type. Fluid and electrolyte balance must be maintained. Acidosis may be corrected with intravenous sodium bicarbonate. Other measures include the symptomatic management and therapy of metabolic and cardiovascular disorders. The patient must be observed for at least 24 hours after becoming asymptomatic to rule out delayed effects such as shock and severe gastro-intestinal bleeding. Gastro-intestinal obstruction may occur weeks or even months later. Residual damage may be ruled out by liver and upper gastro-intestinal studies.
Green, biconvex, sugar-coated tablets.
Packs of 500, 1000 and 5000 tablets.
Store in a cool place below 25°C. Store in an airtight container and protect from light.
KEEP OUT OF REACH OF CHILDREN.
H830 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited, 7 Fairclough Road, Port Elizabeth, 6001
DATE OF PUBLICATION:
KOHLER C&P P.E.
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