DESCRIPTION

Supplement Facts

Serving size 1 capsule

Each Capsule Contains:

Vitamin C (as ascorbic acid)………………………………………………………………….75 mg

Folic Acid………………………………………………………………………………………….500 mcg

Vitamin B-12 ( as cyanocobalamin)…………………………………………………….15 mcg

Iron (as ferrous fumarate)………………………………………………………………….110 mg

Liver Stomach Concentrate (containing Intrinsic Factor).......................240 mg

Inactive Ingredients:

D&C Red #28, Dicalcium Phosphate, FD&C Blue #1, FD&C Green #3, FD&C Red #40, Gelatin, Magnesium Stearate, Pharmaceutical Glaze, and Titanium Dioxide.

INDICATIONS AND USAGE

This capsule (hematinic concentrate with intrinsic factor) is a multifactor preparation effective in the treatment of anemias that respond to oral hematinics, including pernicious anemia and other megaloblastic anemias and also iron deficiency anemia.  Therapeutic quantities of hematopoietic factors that are known to be important are present in the recommended daily dose.

CLINICAL PHARMACOLOGY

Vitamin B-12 with Intrinsic Factor - When secretion of intrinsic factor in gastric juice is inadequate or absent (e.g., in Addisonian pernicious anemia or after gastrectomy), vitamin B-12 in physiologic doses is absorbed poorly, if at all. The resulting deficiency of vitamin B-12 leads to the clinical manifestations of pernicious anemia.  Similar megaloblastic anemias may develop in fish tapeworm (Diphyllobothrium latum) infection or after a surgically created small-bowel blind loop; in these situations, treatment requires freeing the host of the parasites or bacteria that appear to compete for the available vitamin B-12.  Strict vegetarianism and malabsorption syndromes may also lead to vitamin B-12 deficiency.  In the latter case, parenteral therapy, or oral therapy with so-called massive doses of vitamin B-12, may be necessary for adequate treatment of the patient.

Potency of intrinsic factor concentrates is determined physiologically, ie., by their use in patients with pernicious anemia. The liver-stomach concentrate with intrinsic factor and the vitamin B-12 contained in two Ferotrin Capsules provide 1 1/2 times the minimum amount of therapeutic agent, which, when given daily in an uncomplicated case of pernicious anemia, will produce a satisfactory reticulocyte response and relief of anemia and symptoms.

Concentrates of intrinsic factor derived from hog gastric, pyloric and duodenal mucosa have been used successfully in patients who lack intrinsic factor. For example, Fouts et al maintained patients with pernicious anemia in clinical remission with oral therapy (liver extracts or intrinsic factor concentrate with vitamin B-12) for as long as 29 years.

After total gastrectomy, Ficarra found multifactor preparations taken orally to be "just as effective in maintaining blood levels as any medication that has to be administered parenterally." His study was based on 24 patients who had survived for five years after total gastrectomy for cancer and who had been taking two Ferotrin Capsules daily.

Folic Acid - Folic acid deficiency is the immediate cause of most, if not all, cases of nutritional megaloblastic anemia and of the megaloblastic anemias of pregnancy and infancy; usually, it is also at least partially responsible for the megaloblastic anemias of malabsorption syndromes, e.g., tropical and nontropical sprue.

It is apparent that in vitamin B-12 deficiency (e.g., pernicious anemia), lack of this vitamin results in impaired utilization of folic acid.  There are other evidences of the close folic acid-vitamin B-12 interrelationship: (1) B-12 influences the storage, absorption, and utilization of folic acid, and (2) as a deficiency of B-12 progresses, the requirement for folic acid increases.  However, folic acid does not change the requirement for vitamin B-12.

Iron - A very common anemia is that due to iron deficiency.  In most cases, the response to iron salts is prompt, safe, and predictable.  Within limits, the response is quicker and more certain to large doses of iron than to small doses.  Each Ferotrin Capsule furnishes 110 mg. of elemental iron (as ferrous fumarate) to provide a maximum response.

Ascorbic Acid - Vitamin C plays a role in anemia therapy.  It augments the conversion of folic acid to its active form, folinic acid.  In addition, ascorbic acid promotes the reduction of ferric iron in food to the more readily absorbed ferrous form.  Severe and prolonged vitamin C deficiency is associated with an anemia that is usually hypochromic but occasionally megaloblastic in type.

CONTRAINDICATIONS

Hemochromatosis and hemosiderosis are contraindications to iron therapy.

PRECAUTIONS

ADVERSE REACTIONS

Rarely, iron in therapeutic doses produces gastrointestinal reactions, such as diarrhea or constipation. Reducing the dose and administering it with meals will minimize these effects in the iron-sensitive patient.

In extremely rare instances, skin rash suggesting allergy has been noted following the oral administration of liver-stomach material.  Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

OVERDOSAGE

Symptoms: Those of iron intoxication, which may include pallor and cyanosis, vomiting, hematemesis, diarrhea, melena, shock, drowsiness, and coma.

Treatment: For specific therapy, exchange transfusion and chelating agents.  For general management, gastric and rectal lavage with sodium bicarbonate solution or milk, administration of intravenous fluids and electrolytes, and use of oxygen.

DOSAGE AND ADMINISTRATION

One capsule twice a day.  (Two capsules daily produce a standard response in the average uncomplicated case of pernicious anemia.)

HOW SUPPLIED

Boxes of 60 capsules.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL