General

Anemia is a manifestation that requires appropriate investigation to determine its cause or causes. Folic acid alone is unwarranted in the treatment of proof 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

Pregnancy Category C: Animal reproduction studies have not been conducted. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can effect reproduction capacity. It should be given to a pregnant woman 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 this product is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 10 have not been established.

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