Tricon

Name: Tricon

Tricon Description

Each Tricon™ Capsule contains:

Special liver-stomach concentrate

(containing intrinsic factor). . . . . . . . . . . . . . . . 240 mg

Vitamin B12 (activity equivalent) . . . . . . . . . . . .15 mcg

Iron, elemental (ferrous fumarate) . . . . . . . . . .110 mg

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

Folic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 mg

with other factors of vitamin B complex present in the liver-stomach concentrate.

Inactive ingredients: Citric acid, D&C Yellow No. 10, ethylcellulose, FD&C Blue No. 1, FD&C Red #28, gelatin, lecithin, magnesium stearate, pharmaceutical glaze, silicon dioxide, simethicone, sodium benzoate, sodium citrate, sorbic acid, starch, and titanium dioxide.

CLINICAL PHARMACOLOGY Vitamin B12 with Intrinsic

Factor: when secretion of intrinsic factor in gastric juice is inadequate or absent (e.g., Addisonian pernicious anemia or after gastrectomy), vitamin B12 in physiologic doses is absorbed poorly, if at all. The resulting deficiency of vitamin B12 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 B12. Strict vegetarianism and malabsorption syndromes may also lead to vitamin B12 deficiency. In the latter case, parenteral therapy or oral therapy with so-called massive doses of vitamin B12 may be necessary for adequate treatment of the patient.

Potency of intrinsic factor concentrates is determined physiologically, i.e., by their use in patients with pernicious anemia. The liver-stomach concetrate with intrinsic factor and the vitamin B12 contained in two Tricon™ Capsules provide 1½ times the minimum amount of therapeutic agent that, when given daily in an uncomplicated case of pernicious anemia, will produce a satisfactory 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.

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 B12 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 B12 interrelationship: (1) B12 influences the storage, absorption, and utilization of folic acid, and (2) as a deficiency of B12 progresses, the requirement for folic acid increases. However, folic acid does not change the requirements for vitamin B12.

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 Tricon™ (hematinic concentrate with intrinsic factor) 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.

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.

For the Consumer

Applies to multivitamin with iron: oral capsule, oral miscellaneous, oral solution reconstituted, oral tablet, oral tablet extended release

Other dosage forms:

  • oral powder, oral tablet chewable
  • oral capsule, oral elixir, oral liquid, oral miscellaneous, oral solution, oral tablet
  • oral liquid, oral solution, oral suspension

For Healthcare Professionals

Applies to multivitamin with iron: injectable solution, oral capsule, oral capsule extended release, oral liquid, oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet extended release

Gastrointestinal

Gastrointestinal side effects associated with oral iron therapy have included nausea, constipation, anorexia, heartburn, vomiting, and diarrhea. These effects are generally dose-related. In addition, stools may appear darker in color in patients taking products containing iron. Iron oral preparations may rarely cause Hemoccult-positive stools, patients with positive tests generally require further work-up.[Ref]

Other

Stained teeth have primarily occurred following ingestion of iron liquid preparation.

Iron overload (i.e., hemosiderosis) has been reported in patients genetically predisposed, or have underlying disorders, that augment the absorption of iron. It has also occurred following administration of excessive parenteral iron therapy, combination of oral and parenteral iron, or in patients with hemoglobinopathies that were erroneously diagnosed as iron deficiency anemia. Hemosiderosis is treated with repeated phlebotomy or long-term administration of deferoxamine. The liver is particularly susceptible to toxicity in iron-overload states.[Ref]

Other side effects associated with oral iron products have included stained teeth and iron overload (hemosiderosis). Secondary hemochromatosis due to prolonged iron ingestion has been reported rarely.[Ref]

Metabolic

Metabolic side effects associated with iron have included decreased absorption of thyroxine (T4).[Ref]

Some side effects of Tricon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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