In anemic patients, the rate of iron absorption is different from that in healthy patients. In the anemic, iron absorption increases significantly within minutes of its administration.1 Since intestinal enterocytes can only absorb iron when it is in the ferrous state,2 Ferralet® 90 includes Ferr-Ease™*, a unique, patented way to deliver oral iron therapy.
Ferr-Ease contains both ferrous gluconate and carbonyl iron. Since ferrous gluconate enters the body in the ferrous state, it is ready for quick dissolution and ready absorption.2 Of all the ferrous salts, ferrous gluconate was chosen for Ferr-Ease because it is associated with fewer side effects than other ferrous salts.3
Carbonyl iron, the keystone formulation associated with Ferralet 90, provides gentle and prolonged solubilization and absorption. The patient's own production of gastric acid determines the rate of carbonyl iron conversion from the particulate to the soluble ionized form.4 As a result of this gentle and prolonged action, carbonyl iron demonstrates excellent tolerability and safety.
The patient's system defines the rate of absorption1
- (a) Ferrous gluconate enters the body ready for immediate absorption (b)Particulate carbonyl iron is converted to soluble ionized iron at a rate determined by the rate of gastric acid production4
- Overall bioavailability is similar for carbonyl iron and ferrous salts5
- Ferralet 90 provides both the initial bolus of ferrous iron and the more prolonged absorption of carbonyl iron
It has been demonstrated that the bioavailability of carbonyl iron is similar to that of ferrous iron. Uptake by the intestinal mucosa and absorption of carbonyl iron were also similar to iron sulfate, except that the process occurred over a longer interval with carbonyl iron.2
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
- Rimon E, Kagansky N, Kagansky M, Mechnick L, Mashiah T, Namir M, Levy S. Are we giving too much iron? Low-dose iron therapy is effective in octogenarians. Am J Med. 2005 Oct;118(10):1142-7.
- Donovan A, Roy CN, Andrews NC. The ins and outs of iron homeostasis. Physiology (Bethesda). 2006 Apr;21:115-23.
- Huebers HA, Brittenham GM, Csiba E, Finch CA. Absorption of carbonyl iron. J Lab Clin Med. 1986 Nov;108(5):473-8.
- Shah A. Iron deficiency anemia--Part III. Indian J Med Sci. 2004 May;58(5):214-6.
- 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.
