DESCRIPTION
EACH CAPSULE CONTAINS:
Vitamin C (Ascorbic Acid)........................................................................75 mg.
Folic Acid.............................................................................................500 mcg.
Vitamin B-12 (Cyanocobalamin)............................................................15 mcg.
Iron (Ferrous Fumarate)........................................................................110 mg.
Liver Stomach Concentrate (containing Intrinsic Factor)......................240 mg.
Inactive Ingredients: D&C Red #28, Dicalcium Phospate, FD&C Blue #1, FD&C Green # 3, FD&C Red # 40, Gelatin, Magnesium Stearate, Pharmaceutical Glaze, and Titanium Dioxide.
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.
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.
CONTRAINDICATIONS
Hemochromatosis and hemosiderosis are contraindications to iron therapy.
WARNINGS
Accidental overdose of iron-containing products is a
leading cause of fatal poisoning in children under six. Keep this
product out of reach of children. In case of accidental overdose,
call a doctor or Poison Control Center immediately.
PRECAUTIONS
General
General: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that
hematologic remission can occur while neurological manifestations remain progressive. 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 B-12. If
resistance occurs, parenteral therapy or oral therapy with so-called massive doses of vitamin
B-12 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.
Interactions
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
Teratogenic Effects
Pregnancy Category C: Animal reproduction studies have not been conducted
with this product. It is also not known whether this product can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity. This product 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.
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
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.
DRUG ABUSE AND DEPENDENCE
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.
STORAGE
Store at controlled room temperature 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].
KEEP OUT OF THE REACH OF CHILDREN.
Information for patients
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Rx Only
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
