Monograph: |
Iron Sorbitol
A complex of ferric iron, sorbitol, and citric acid ;stabilised
with dextrin and sorbitol.
Adverse Effects, Treatment, and Precautions as for iron dextran whose record is given below :
A risk of carcinogenesis may attend the intramuscular injection of iron-carbohydrate complexes. Such complexes have been found under experimental conditions to produce sarcoma when large doses or small doses injected repeatedly at the same site were given to rats, mice, and rabbits, and possibly in hamsters.
The long latent period between the injection of a potential carcinogen and the appearance of a tumor makes it impossible to measure accurately the risk in man. There have, however, been several reports in the literature describing tumors at the injection site in humans who had previously received intramuscular injections of iron-carbohydrate complexes.
Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse effects. The adverse effects frequently are delayed (1-2 days) reactions typified by one or more of the following symptoms; arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting. The onset is usually 24-48 hours after administration and symptoms generally subside within 3-4 days. These symptoms have also been reported following intramuscular injection and generally subside within 3-7 days. The etiology of these reactions is not known. The potential for a delayed reaction must be considered when estimating the risk/benefit of treatment.
The maximum daily dose should not exceed 2 mL undiluted iron dextran.
This preparation should be used with extreme care in patients with serious impairment of liver function.
It should not be used during the acute phase of infectious kidney disease.
Adverse reactions experienced following administration of IMFERON may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease.
PRECAUTIONS
General: Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. Such iron overload is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias.
IMFERON should be used with caution in individuals with histories of significant allergies and/or asthma.
Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Therefore, administration of subsequent test doses during therapy should be considered. (See DOSAGE AND ADMINISTRATION : Administration.)
Epinephrine should be immediately available in the event of acute hypersensitivity reactions. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.)
injection. Patients using beta-blocking agents may not respond adequately to epinephrine. Isoproterenol or similar beta-agonist agents may be required in these patients.
Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of IMFERON.
Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli.
There may be severe systemic reactions with cardiac compli-
cations which may be fatal, such as complete atrioventricular
block, ventricular tachycardia, or ventricular fibrillation. A
transient metallic taste or loss of taste may occur.
The urine of patients treated with iron sorbitol may become
dark on standing.
Iron sorbitol should not be administered intravenously.
A description of adverse events in three patients with the mal-
absorption syndrome treated with intramuscular injections of
iron sorbitol.' Two patients died; in one. findings were con-
sistent with anaphylaxis and in the other cardiac toxicity was
considered to be due to a direct effect. In the third patient
direct cardiac toxicity was also implicated.
Interactions
As for Iron Dextran.
Pharmacokinetics
About 66% of iron sorbitol is absorbed within 3 hours of in-
tramuscular injection, most of it directly into the blood circu-
lation. and some via the lymphatic system. Almost all is
absorbed within about 10 days. Clearance of iron sorbitol
from the plasma is rapid, and is mainly via the reticulo-
endothelial system, as described for Iron Dextran.
Uses and Administration
Iron sorbitol should be used only in the treatment of proven
iron-deficiency anaemia where oral therapy,is ineffective or
impracticable.
It is given by deep intramuscular injection into the upper outer
quadrant of the buttock: to prevent leakage along the injection
track, the subcutaneous tissue is drawn to one side before the
needle is inserted.
Total dosage is calculated according to body-weight and the
haemoglobin concentration of the blood, and tables arc usual-
ly provided with iron sorbitol injections for this purpose. The
recommended single dose is the equivalent of 1.5 mg of iron
per kg body-weight up to a maximum of 100 mg per injec-
tion: these doses are then given daily until the total dosage
has
been achieved. Iron sorbitol is not recommended in children
under 3 kg in body-weight.
Iron sorbitol should not be administered intravenously.
|