TL-Icon

TRIGEN Laboratories, Inc.

TL Icon Capsule Hematinic Concentrate with Intrinsic Factor

FULL PRESCRIBING INFORMATION: CONTENTS*

• TL-ICON DESCRIPTION
  • Inactive Ingredients
• RECOMMENDED USE
• CLINICAL PHARMACOLOGY
  • Vitamin B with Intrinsic Factor
  • Folic Acid
  • Iron
• Ascorbic Acid
• TL-ICON INDICATIONS AND USAGE
• TL-ICON CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Pregnancy
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use
• TL-ICON ADVERSE REACTIONS
• OVERDOSAGE
  • Symptoms
  • Treatment
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - 60 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

Rx Only

TL-ICON DESCRIPTION

TL Icon are opaque red capsules, imprinted "TL051."

Inactive Ingredients

Microcrystalline Cellulose, Capsules (Gelatin, Titanium Dioxide, FD&C Red #40, FD&C Blue #1), Fumed Silica, Magnesium Stearate, Tripotassium Citrate, Citric Acid.

RECOMMENDED USE

One capsule twice a day. (Two capsules daily produce a standard response in the average uncomplicated case of pernicious anemia.)

CLINICAL PHARMACOLOGY

Vitamin B with Intrinsic Factor

When secretion of intrinsic factor in gastric juice is inadequate or absent (e.g., Addisonian pernicious anemia or 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 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 concentrate with intrinsic factor and the Vitamin B₁₂ contained in two TL Icon Capsules provide 1 ½ 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 TL Icon (hematinic concentrate with intrinsic factor) Capsule furnishes 110 mg of elemental iron (as ferrous fumurate) 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.

TL-ICON INDICATIONS AND USAGE

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

TL-ICON CONTRAINDICATIONS

Hemochromatosis and hemosiderosis are contraindications to iron therapy.

WARNINGS

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 TL Icon Capsules. It is also not known whether TL Icon Capsules can cause fetal harm when administered to pregnant women or can affect reproduction capacity. TL Icon 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 TL Icon 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

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.

TL-ICON 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 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.

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.

HOW SUPPLIED

TL Icon Capsules are supplied in bottles of 60 capsules.

Product Code: 13811-528-60

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.

Rx Only

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Manufactured For:
TRIGEN Laboratories, Inc.
Sayreville, NJ 08872
www.trigenlab.com

Rev. 03/13

PRINCIPAL DISPLAY PANEL - 60 Capsule Bottle Label

13811-528-60
R_x Only

TL Icon
Capsules

Hematinic Concentrate
with Intrinsic Factor

TRIGEN
LABORATORIES

60 CAPSULES