Tolerability

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The gastrointestinal side effects associated with oral iron therapy can be an unwelcome accompaniment to treatment for iron deficiency anemia. Ferralet® 90 with Ferr-Ease™* has been created to make iron therapy as gentle and comfortable as possible while adding to the patient's vital iron stores.

Ferrous gluconate, with a lower elemental iron rate than other ferrous salts, is considered to be the ferrous salt with the lowest incidence of gastrointestinal side effects.1 In fact, "switching to ferrous gluconate may help some people with severe gastrointestinal problems."2

Carbonyl iron, with its gentle and prolonged rate of solubilization and absorption, has demonstrated a dramatically lower rate of gastrointestinal side effects in a randomized, double-blind trial comparing standard doses of carbonyl iron and ferrous sulfate.3

Ferralet 90 also contains 50 mg docusate sodium, a gentle and effective stool softener that helps prevent the constipation that might occur in patients sensitive to iron therapy.

Important Safety Information

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Warning

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

Precautions

Administration of Drug
  • General: Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with Ferralet® 90 tablets. Ensure Hgb, Hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated. This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
  • Folic Acid: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anemia.
  • Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
  • Geriatric Use: Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.

This material is intended to provide basic information. Patients should discuss all medical advice, diagnosis, and treatment with their healthcare provider.

Please see full Prescribing Information

* US Patent no. 6,521,247 B1

  1. Shah A. Iron deficiency anemia--Part III. Indian J Med Sci. 2004 May;58(5):214-6.
  2. Anemia-Treatment [Internet]. University of Maryland Medical Center Web site; [cited 2009 17 Mar]. Available from http://www.umm.edu/patiented/articles/anemia_000057.htm.
  3. Gordeuk VR, Brittenham GM, Hughes M, Keating LJ, Opplt JJ. High-dose carbonyl iron for iron deficiency anemia: a randomized double-blind trial. Am J Clin Nutr. 1987 Dec;46(6):1029-34.