Ferotrin

Generic Name: ascorbic acid, folic acid, cyanocobalamin, ferrous fumarate, sus scrofa stomach and beef liver
Dosage Form: capsule

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Ferotrin CAPSULES

Ferotrin Description

EACH CAPSULE CONTAINS:

Vitamin C (Ascorbic Acid)........................................................................75 mg.

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

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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.

Ferotrin - 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 for Ferotrin

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.

Information for Patients

Laboratory Tests

Interactions

Drug 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.

Nonteratogenic Effects

Labor and Delivery

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

Controlled Substance

Abuse

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.

Ferotrin Dosage and Administration

One capsule twice a day. (Two capsules daily produce a standard response in the average

uncomplicated case of pernicious anemia.)

How is Ferotrin 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

Ferotrin 
hematinic concentrate with intrinsic factor capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64376-805
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 75 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 500 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 15 ug
FERROUS FUMARATE (IRON) FERROUS FUMARATE 110 mg
SUS SCROFA STOMACH (SUS SCROFA STOMACH) SUS SCROFA STOMACH 24 mg
BEEF LIVER (BEEF LIVER) BEEF LIVER 216 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 28  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
FD&C BLUE NO. 1  
FD&C GREEN NO. 3  
FD&C RED NO. 40  
GELATIN  
MAGNESIUM STEARATE  
SHELLAC  
TITANIUM DIOXIDE  
Product Characteristics
Color RED (Scarlet/Garnet) Score no score
Shape CAPSULE Size 22mm
Flavor LIVER Imprint Code CPC;464
Contains         
Packaging
# Item Code Package Description
1 NDC:64376-805-06 60 CAPSULE (CAPSULE) in 1 BOX
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/02/2009
Labeler - Boca Pharmacal, Inc. (170266089)
Registrant - Contract Pharmacal Corporation (057795122)
Establishment
Name Address ID/FEI Operations
Contract Pharmacal Corporation 057795122 MANUFACTURE
Revised: 04/2010
 
Boca Pharmacal, Inc.
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