Data from FDA - Curated by EPG Health - Last updated 27 July 2017

Indication(s)

INDICATIONS: The treatment of iron deficiency anemia, which may occur due to an increased need for iron, a deficient intake of iron, or an excessive loss of iron.

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Advisory information

contraindications
CONTRAINDICATIONS: All iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis and hemolytic anemias.
Special warnings and precautions
PRECAUTIONS: Existing gastrointestinal diseases, i.e. peptic ulcers, regional enteritis, ulcerative colitis may be aggravated by causing the iron not to be absorbed and therefore, be ineffective in patients with steatorrhea or those with a partial gastrectomy. It is important to determine and treat the underlying cause of the anemia, in addition to the administration of IntegraTM. Indefinite administration of iron should be avoided.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age), One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12. TIME AND DURATION: The hematologic response to orally administered iron is indicated by reticulocytosis of 2% to 10% depending on the severity of the anemia, beginning five to ten days after initiation of therapy. A rise in hemoglobin value is observable at the end of the second week. When therapy is adequate, hemoglobin value increases 0.1 to 0.2 gm per 100 ml of blood a day and usually becomes normal in two months. However, to improve body iron stores, treatment may be continued from 3 to 12 months, after the hemoglobin has returned to normal. If no satisfactory response is noted after three weeks of therapy, consideration should be given to (1) whether dosage recommendations have been followed, (2) blood loss is occurring simultaneously, (3) whether there are complicating causes, such as infection, defects in absorption or utilization, (4) whether diagnosis or iron-deficiency was correct. WARNING: Do not administer to pediatric patients. Do not exceed recommended dosage. Keep this and all drugs out of reach of pediatric patients. If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

More information

Category Value
Agency product number 25X51I8RD4
Orphan designation No
Product NDC 52747-900,52747-901,52747-902
Date Last Revised 29-12-2009
Type HUMAN PRESCRIPTION DRUG
RXCUI 1314685
Marketing authorisation holder US Pharmaceutical Corporation