Data from FDA - Curated by EPG Health - Last updated 27 July 2017

Indication(s)

INDICATIONS AND USAGE TRICON™ is a multifactor preparation effective in the treatment of anemias that respond to oral hematinics, including pernicious anemia and other megaloblastic anemias and also irondeficiency anemia. Therapeutic quantities of hematopoietic factors that are known to be important are present in the recommended daily dose.

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Advisory information

contraindications
CONTRAINDICATIONS Hemochromatosis and hemosiderosis are contraindications to iron therapy.
Special warnings and precautions
PRECAUTIONS General Anemia is a manifestation that requires appropriate investigation to determine its cause or causes. Folic acid alone is unwarranted in the treatment of pure vitamin B12 deficiency states, such as pernicious anemia. Folic acid may obscure pernicious anemia in that the blood picture may revert to normal while neurological manifestations remain progressive. As with all preparations containing intrinsic factor, resistance may develop in some cases of pernicious anemia to the potentiation of absorption of physiologic doses of vitamin B12. If resistance occurs, parenteral therapy or oral therapy with so-called massive doses of vitamin B12 may be necessary for adequate treatment of the patient. No single regimen fits all cases, and the status of the patient observed in follow-up is the final criterion for adequacy of therapy. Periodic clinical and laboratory studies are considered essential and are recommended. Pregnancy Teratogenic Effects Pregnancy Category C: Animal reproduction studies have not been conducted with TRICON™ Capsules. It is also not known whether TRICON™ Capsules can cause fetal harm when administered to pregnant women or can affect reproduction capacity. TRICON™ Capsules should be given to pregnant women only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRICON™ is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients below the age of 10 have not been established. Geriatric Use Geriatric Use: Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.
Adverse reactions
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.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION One capsule twice a day. (Two capsules daily produce a standard response in the average uncomplicated case of pernicious anemia.)
Pregnancy and lactation
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRICON™ is administered to a nursing woman.

More information

Category Value
Agency product number PQ6CK8PD0R
Orphan designation No
Product NDC 63044-635
Date Last Revised 17-12-2009
Type HUMAN PRESCRIPTION DRUG
RXCUI 999799
Marketing authorisation holder Nnodum Pharmaceuticals