Iron Sucrose Injection USP
Iron Sucrose Injection USP
For intravenous Injection only
Therapeutic Category: Iron Supplement
Each ml contains :
Ferric Hydroxide in Complex with Sucrose
equivalent to elemental iron 20 mg
Water for Injections IP q.s.
I-Key (Iron Sucrose injection, USP) is a brown, sterile, aqueous,
complex of polynuclear Iron (III)-hydroxide in Sucrose for intravenous use.
Iron Sucrose injection has a molecular weight of approximately 34,000 – 60,000
Each ml contains 20 mg elemental Iron as Iron Sucrose in water for injection.
I-Key is available in 5 ml single dose ampoules (100 mg elemental Iron
per 5 ml)
The drug product contains approximately 30% Sucrose w/v (300mg/ml) and has a
pH of 10.5-11.1. The product contains no preservatives. The osmolarity of the
injection in not less than 1150 & not more than 1350 mOsmol/L.
Following intravenous doses of Iron Sucrose, its Iron component exhibits first
order kinetics with an elimination half-life of 6 h, total clearance of 1.2
L/h. non-steady state apparent volume of distribution of 10.0 L and steady
state apparent distribution of 7.9 L. Since Iron disappearance from serum
depends on the need for Iron in the Iron stores and Iron utilizing tissues of
the body, serum clearance of Iron is expected to be more rapid in Iron
deficient patients treated with I-Key as compared to healthy
individuals. Following intravenous doses of Iron Sucrose, its Iron component
appears to distribute mainly in blood and to some extent in extra vascular
A study evaluating I-Key containing 100 mg Iron labeled with 52Fe/59Fe
in patients with Iron deficiency shows that a significant amount of the
administered Iron distributes in the liver, spleen, and bone marrow and that
the bone marrow is an Iron trapping compartment and not a reversible volume of
distribution. Following intravenous doses of Iron Sucrose, its Iron component
dissociated into Iron and Sucrose by the reticuloendothelial system. The
Sucrose component is eliminated mainly by urinary excretion.
I-Key is indicated for the treatment of Iron deficiency anemia in cases
where rapid and reliable substitution of Iron is required.
The use of I-Key is contraindicated in patients with evidence of Iron
overload, in patients with known hypersensitivity to Iron preparations or any
of its inactive components, and in patients with anemia not caused by Iron
PRECAUTIONS & WARNINGS
Hypersensitivity reactions have been reported with injectable
Iron products. Serious hypersensitivity reactions have been rarely reported in
patients receiving Iron Sucrose. In the event of an allergic or anaphylactoid
reactions administered of Iron Sucrose must be stopped, intramuscular
adrenaline should be administered immediately and other supportive measures
initiated in line with the established cardio-pulmonary resuscitation
procedures of the clinic or hospital. Hypotension has been reported in
patients receiving intravenous Iron. Hypotension following administration of
Iron Sucrose may be related to rate of administration and the total dose
administered. Caution should be taken to administer Iron Sucrose according to
recommended guidelines. Because body Iron excretion is limited and excess
tissues Iron can be hazardous, caution should be exercised to withhold Iron
administration in the presence of evidence of tissue Iron overload. Patients
receiving Iron Sucrose require periodic monitoring of hematologic and
hematinic parameters, Iron therapy should be withheld in patients with
evidence of Iron overload. Transferrin saturation values increase rapidly
after IV administration of Iron Sucrose, thus, serum Iron values may be
reliably obtained 48 hours after IV dosing.
USAGE IN PREGNANCY, LACTATION & CHILDREN
No adequate and well controlled studies with Iron Sucrose Injections in
pregnant women have been reported. This drug should therefore not be used in
pregnant women. It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
when Iron Sucrose is administered to a nursing woman. Safety and effectiveness
of Iron Sucrose in pediatric patients have not been established.
Each white tablet contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol.
The pink tablets do not contain any hormones and are included to help remember
to start the new strip on time.
Iron Sucrose should not be administered concomitantly with oral Iron
preparation since the absorption of oral Iron is reduced.
DOSAGE AND ADMINISTRATION
The dosage of I-Key is expressed in terms of mg of elemental Iron. Each ml
contains 20 mg elemental Iron.
DOSAGE IN HEMODIALYSIS PATIENTS
The recommended dosage of I-Key for the repletion of Iron deficiency in
hemodialysis patients is 5 ml of Iron sucrose (100 mg of elemental Iron)
delivered intravenously during the dialysis sessions. Most patients require a
minimum cumulative dose of 1,000 mg elemental Iron, administered over 10
sequential dialysis sessions, to achieve a favorable hemoglobin or hematocrit
response. Frequency of dosing should not be more than three times weekly.
Patients may continue to require therapy with Iron Sucrose or other
intravenous Iron preparations at the lowest dose necessary to maintain target
levels of hemoglobin, hematocrit and laboratory parameters of Iron storage
within acceptable limits.
Calculation of doses in other patients with Iron deficiency anemia
The total cumulative dose of I-Key equivalent to the total Iron deficit
(mg), is determined by the hemoglobin level and body weight. The dose and the
dosage schedule has to be individually adapted according to the total Iron
deficit calculated with the following formula:
Total Iron deficit (mg) = body weight (kg) x (target Hb-actual Hb) (g/l) x
0.24* + depot Iron (mg).
Up to 35 kg body weight. Target Hb = 130 g/l & depot Iron = 15 mg/kg body
Above 35 kg body weight. Target Hb = 150 g/l & depot Iron = 500 mg
*Factor 0.24 = 0.0034 x 0.07 x 1000 (Iron content of hemoglobin = 0.34%
Blood volume = 7% of the body weight: Factor 1000 = conversion from g to mg).
Total amount of I-Key to be administered (in ml) = Total Iron
If the total necessary dose exceeds the maximum allowed single dose, then the
administration has to be split. If no response in the hematological parameters
is observed after 1 to 2 weeks, the original diagnosis should be reconsidered.
I-Key must only be administered intravenously either by slow injection or
by infusion. However administration by intravenous drip infusion is the
preferred route of administration as this may help reduce the risk of
hypotensive episodes and paravenous leakage.
I-Key is a strongly alkaline solution and must never be administered by
the subcutaneous or Intramuscular route.
SLOW INTRAVENOUS INJECTION
I-Key may be administered undiluted by slow intravenous Injection at
rate of 1 ml (20 mg Iron) solution per minute (i.e. 5 minutes per ampoule) not
exceeding one ampoule I-Key ( 100 mg Iron) per Injection. Discard any
I-Key may also be administered by infusion. The contents of each ampoule
must be diluted exclusively in a maximum of 100 ml of 0.9% NaCl, immediately
prior to infusion. The solution should be infused at rate of 100 mg of Iron
over a period of at least 15 minutes. Unused diluted solution should be
INJECTION INTO DIALYSER
I-Key may be administered during the middle of a haemodialysis session
directly into the venous limb of the dialyses under the same procedures as
those outlined for Intravenous administration.
Do not mix I-Key with other medications or add to parenteral nutrition
solutions for intravenous solution. Parenteral drug products should be
inspected visually for particulate matter and discoloration prior to
administration, whenever the solution and container permit.
Side effects of I-Key (Iron Sucrose injection, USP) in excess of Iron
needs may lead to accumulation of Iron storage sites leading to hemosiderosis.
Periodic monitoring of Iron parameters such as serum ferritin and transferring
saturation may assist in recognizing Iron accumulation. Iron Sucrose should
not be administered to patients with Iron overload and should be discontinued
when serum ferritin levels equals or exceeds established guidelines.
Particular caution should be exercised to avoid Iron overload where anemia
unresponsive to treatment has been incorrectly diagnosed as Iron deficiency
anemia. Symptoms associated with overdosage or infusing Iron Sucrose too
rapidly included hypotension, headache, vomiting, nausea, dizziness, joint
aches, parenthesis, abdominal and muscle pain, edema and cardiovascular
collapse. Most symptoms have been successfully treated with IV fluids,
hydrocortisone and/or antihistamines. Infusing the solution as recommended or
at a slower rate may also alleviate symptoms.
STORAGE: Store at controlled room temperature. Protect from light. Do
Keep medicine out of reach of children.
Pack of 2.5 ml Ampoule & Pack of 5 ml Ampoule.