Xenofer

INDICATIONS Condition listed above or as directed by the physician

DOSAGE Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

The therapeutic class of Iron Sucrose is haematinic. Iron Sucrose Injection USP is a brown, sterile, aqueous, complex of Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use. The drug product contains approximately 30% Sucrose w/v (300 mg/ml) and has a pH of 10.5-11.1. Following intravenous administration, Iron Sucrose Injection is dissociated into Iron and Sucrose by the reticuloendothelial system, and Iron is transferred from the blood to a pool of Iron in the liver and bone marrow. Ferritin, an Iron storage protein, binds and sequesters Iron in a nontoxic form, from which Iron is easily available. Iron binds to plasma transferrin, which carries Iron within the plasma and the extracellular fluid to supply the tissues. The transferrin receptor, located in the cell, and the transferrin-receptor complex is returned to the cell membrane. Transferrin without Iron (apotransferrin) is then released to the plasma. The intracellular Iron becomes (mostly) haemoglobin in circulating red blood cells (RBCs). Transferrin synthesis is increased and ferritin production reduced in Iron deficiency. The converse is true when Iron is plentiful. Its elimination halflife is 6 h, total clearance is 1.2 L/h, non-steady state apparent volume of distribution is 10.0 L and steady state apparent volume of distribution is 7.9 L. In Iron Sucrose, its Iron component appears to distribute mainly in blood and to some extent in extravascular fluid. 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 distribution. The sucrose component is eliminated mainly through urinary excretion.

Adverse reactions, whether or not related to Iron Sucrose injection are as follows: hypotension, cramps/leg cramps, nausea, headache, vomiting, and diarrhea. Some of these symptoms may be seen in patients with chronic renal failure or on hemodialysis not receiving intravenous iron. Body as a Whole: headache, fever, pain, asthenia, unwell, malaise, accidental injury. Cardiovascular Disorders General: hypotension, chest pain, hypertension, hypervolemia. Gastrointestinal Disorders: nausea, vomiting, abdominal pain, elevated liver enzymes. Central and Peripheral Nervous System: dizziness. Musculoskeletal System: cramps/leg cramps, musculoskeletal pain. Respiratory System: dyspnea pneumonia, cough. Skin and appendages: pruritus, application site reaction. Hypersensitivity reactions: In safety studies, several patients experienced mild or moderate hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. Anaphylactoid reactions including patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with Iron Sucrose administration can occur. So, patients should be given a small test dose initially.

Do not use if capseal is broken or missing. Close the cap tightly after use.

WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional. As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product. Keep this and all medication out of reach of children Do not use if capseal is broken or missing. Close the cap tightly after use.

Drug-drug interactions involving Iron Sucrose have not been studied. Iron Sucrose Injection should not be administered concomitantly with oral iron preparations since the absorption of oral Iron is reduced. Even oral Iron therapy should not be given until 5 days after last injection.