FeUp^®

FeUp is a preparation of Ferric Citrate. Ferric Iron binds dietary phosphate in the GI tract and precipitates as Ferric Phosphate. This compound is insoluble and is excreted in the stool. By this process and by decreasing absorption, Ferric Citrate lowers the phosphate concentration in the serum. Ferric Iron is transformed from the ferric to the ferrous form by ferric reductase in the GI tract. After being transported through the enterocytes into the blood, oxidized Ferric Iron bound to the plasma protein transferrin and can be incorporated into hemoglobin.

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FeUp is indicated for-

• The control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis.
• The treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.

Route of administration: FeUp should be taken in oral route with food. FeUp tablet should be swallowed whole and must not be chewed or crushed.

Recommended dose for hyperphosphatemia in chronic kidney disease on dialysis The recommended starting dose is two FeUp® tablets three times daily. Monitor serum phosphorus level and titrate the dose in decrements or increments of 1 to 2 tablets per day as needed up to a maximum dose of 12 tablets daily. Dose can be titrated at 1 week or longer intervals.

Recommended dose for iron deficiency anemia in chronic kidney disease not on dialysis
The recommended starting dose is one FeUp tablet three times daily. Titrate the dose as needed to achieve and maintain hemoglobin at target levels up to a maximum dose of 12 tablets daily.

Pregnancy: There are no adequate and well-controlled studies on use of ferric citrate in pregnant women.

Lactation: There is no information regarding the presence of ferric citrate in human milk, the effects on the breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects on the breastfed infant from ferric citrate or from the underlying maternal condition.

Use in children and adolescents
Safety and effectiveness of ferric citrate in children and adolescents have not been established.

There's a risk of iron overload and overdosage in children due to accidental ingestion. Caution should be taken.

The most common side effects are discolored feces, diarrhea, constipation, nausea, vomiting, cough, abdominal pain and hyperkalemia.

It is contraindicated in patients with history of known hypersensitivity to ferric citrate or any other components of this product. It is also contraindicated in patients with iron overload syndromes (e.g., hemochromatosis).

Drug interaction with medication: No significant drug interaction has been reported so far.

Drug interaction with food and others: Not applicable.

In case of overdose proper monitoring and general supportive measures should be initiated.

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Each coated tablet contains Iron 210 mg as Ferric Citrate INN.

Storage
Store below 30°C in a dry place, protected from light. Keep away from the reach of children.

Packing
FeUp^® tablet: Carton of 30 tablets in blister pack.