Ferodex

Injection: Each 5 mL ampoule of Iron Dextran contains: Iron Dextran complex 250 mg, Water for Injection q.s. to 5 mL.

Pack size: 10 X 5mL.

Injectable ampoules for deep intramuscular use.

PHARMACOTHERAPEUTIC CATEGORY

Antianaemic

MODE OF ACTION

Iron Dextran is absorbed after intra-muscular injection primarily through the lymphatic system. About 60% of iron dextran is absorbed after 3 days and up to 90% after 1 to 3 weeks. The reticuloendothelial cells gradually separate iron from the Iron dextran complex and ferric iron is then incorporated into haemoglobin or stored as ferritin and haemosiderin.

Iron Dextran is used in the treatment of iron-deficiency anaemia (sideropenic anaemia) where oral therapy is ineffective or impracticable.

Haemochromatosis, hemolytic anaemia, hypoplastic and pernicious anaemia, acute infections or tumours without iron deficiency, dermatitis and bronchitis tendency; pyelonephritis and hepatophaty; history of hypersensitivity to the product.

Incidence of side-effects increases if oral iron therapy is administered concomitantly with parenteral iron. Care should be taken when given to patients with iron-storage or iron-absorption diseases or haemoglo-binopathies.

SPECIAL PRECAUTIONS

Iron overload, with increased storage of iron in various tissues, may occur as a result of excessive parenteral therapy, causing severe adverse effects. Special care is also required when evaluating dosage of iron to be administered with respect to body weight particularly in the under-weight patients.

Severe anaphylactoid reactions may occur after parenteral use of iron complex and carbohydrates and fatalities have been reported. It is therefore recommended that administration takes place where are facilities for immediate treatment. Iron dextran should not be used in pregnant women.

Incidence of side-effects increases if oral iron therapy is administered concomitantly with parenteral iron. Care should be taken when given to patients with iron-storage or iron-absorption diseases or haemoglo-binopathies.

Local reactions: intramuscular Injection is associated with local reactions, pain, and staining at the site of injection. A metallic taste may also occur rarely.

Systemic reaction: headache, nausea, vomiting, fever, dyspnoea, and face flush; cardiac palpitation, thorax oppression and arterial hypotension may rarely occurred. The systemic reaction commonly occur when doses higher than recommended are administered or when oral Iron is given concomitantly.

Similar reactions may occur even with recommended doses in sensitive and extrimely weaken patients. In such cases the single dose should adequately be reduced. The risk of adverse effects increases in case of high free iron plasma concentration that may occur when other iron therapy is concomitantly instituted or in pathological complications.

Reactions rarely occured: Only one case has been reported of hematuria. Severe reactions such as cardiovascular disturbances with cardiac arrhythmia have been observed. A physician or pharmacist should be accordingly adviser about possible advised effects not reported in this leaflet and episodes which may be attributed to iron dextran.

Iron Dextran is given by deep intramuscular injection into the upper outer quadrant of the buttock; to prevent leakage along the injection tract, the subcutaneous tissue is drawn to one side before a 5 cm long needle is inserted.

Total dosage is calculated according to haemoglobin concentration, body-weight, and usually the sex of the patient. The total dose requirement may be administered as a series of intramuscular injection daily or once or twice a week in inactive patients.

A suggested daily dosage per intramuscular injection for children is: less than 5 kg body-weight, up to 0.5 mL (25 mg): 5 to 9 kg up to 1 mL (50 mg).

Adults normally receive 2 mL up to a maximum of 5 mL per injection.

STORE AT A TEMPERATURE NOT EXCEEDING 30°C.

DO NOT USE THE PRODUCT AFTER EXPIRY DATE KEEP THE PRODUCT OUT OF THE REACH OF CHILDREN