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
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.
Ferralet® 90 is a prescription iron supplement approved for treating anemias that respond to oral iron therapy. Your doctor may prescribe Ferralet® 90 if you have certain anemias associated with pregnancy, blood loss, or metabolic disease, or if you are recovering from surgery or do not have enough iron in your diet.
Important Safety Information
Ferralet® 90 has not been tested in children. Dosing for elderly patients should begin at the lower end of the dosing range.
Talk to your doctor before taking Ferralet® 90 if you have a known sensitivity to any of its ingredients.
Because some medications may interact with Ferralet® 90, you should tell your doctor about any medications you are taking, including antacids and antibiotics.
Before prescribing iron therapy, your doctor will need to determine the type of anemia you have and identify its underlying causes. You should not take this product if you have been diagnosed with hemolytic anemia or an iron overload disorder such as hemochromatosis or hemosiderosis.
If you have certain forms of anemia associated with vitamin B12 deficiency (i.e. pernicious anemia), the Folic acid contained in Ferralet® 90 is not enough to treat your condition. Doses of more than 0.1 mg Folic acid per day can hide the symptoms of these anemias, so your doctor must rule them out before prescribing this product.
Once you begin iron therapy with Ferralet® 90, take the product 2 hours after meals, and do not exceed the recommended dose.
When taking Ferralet® 90, you may experience temporary side effects such as GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools.
Some patients taking Folic acid have reported allergic reactions. Additionally, Ferralet® 90 contains FD&C Yellow No. 5 (tartrazine), which may cause allergic reactions (including bronchial asthma) in certain susceptible people. Although uncommon, tartrazine sensitivity is often seen in patients who also have aspirin hypersensitivity. Contact your doctor and discontinue use if you develop any unusual symptoms.
Keep this product out of reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. Symptoms of overdose include abdominal pain, metabolic acidosis, decline or absence of urine production, nerve damage, coma, convulsions, death, dehydration, congestion of blood vessels, cirrhosis of the liver, low blood pressure, hypothermia, fatigue, nausea, vomiting, diarrhea, black or tarry stools, vomiting blood, rapid heart rate, high blood sugar, drowsiness, abnormal pale or bluish skin color, lack of energy, seizures, and shock. In case of accidental overdose, call a doctor or poison control center immediately.
To report negative side effects, contact Mission Pharmacal Company at 1-800-298-1087 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
* 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.
