Taron Forte

TRIGEN Laboratories, Inc.

Taron Forte Capsules

FULL PRESCRIBING INFORMATION: CONTENTS*

• TARON FORTE DESCRIPTION
• RECOMMENDED USE
• CLINICAL PHARMACOLOGY
• TARON FORTE INDICATIONS AND USAGE
• TARON FORTE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Pediatric Use
  • Information for Patients
• TARON FORTE ADVERSE REACTIONS
• TARON FORTE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

R_x Only

TARON FORTE DESCRIPTION

Taron Forte Capsules are orange, imprinted with "TL042."

Inactive Ingredients:

Microcrystalline Cellulose, Capsules (Gelatin, Titanium Dioxide, FD&C Yellow #6, FD&C Red #3), Magnesium Stearate.

RECOMMENDED USE

One (1) capsule daily or as prescribed by a physician.

CLINICAL PHARMACOLOGY

Iron is an essential component in the formation of hemoglobin. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes, that are involved in electron transport.

Folic Acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is converted in the liver and plasma to its metabolically active form, tetrahydrofolic acid, by dihydrofolate reductase.

Vitamin B₁₂ is required for the maintenance of normal erythropoiesis, nucleoprotein and myelin synthesis, cell reproduction and normal growth. Intrinsic factor, a glycoprotein secreted by the gastric mucosa, is required for active absorption of vitamin B₁₂ from the gastrointestinal tract.

TARON FORTE INDICATIONS AND USAGE

Taron Forte Capsules are indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.

TARON FORTE CONTRAINDICATIONS

Taron Forte Capsules are contraindicated in patients with a known hypersensitivity to any of the components of this product.

Hemochromatosis and hemosiderosis are contraindications to iron therapy.

WARNINGS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B₁₂ is deficient.

PRECAUTIONS

General

The type of anemia and the underlying cause or causes should be determined before starting therapy with Taron Forte Capsules. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.

Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Pediatric Use

Safety and effectiveness in pediatric patients has not been established.

Information for Patients

As with all oral iron preparations, Taron Forte Capsules should be stored out of the reach of children to guard against accidental iron poisoning. Patients should not exceed the recommended dosage unless directed by a physician. Patients should be informed that iron therapy can cause black or dark stools.

TARON FORTE ADVERSE REACTIONS

Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools, and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

The clinical cause of acute iron overdosage can be variable. Initial symptoms may include: abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock, and coma.

The oral LD₅₀ of polysaccharide-iron complex was estimated to be greater than 5000 mg iron/kg in rats. Chronic toxicity studies in rats and dogs administered polysaccharide-iron complex showed that a daily dosage of 250 mg iron/kg for three months had no adverse effects.

TARON FORTE DOSAGE AND ADMINISTRATION

One (1) capsule daily or as prescribed by a physician.

HOW SUPPLIED

Taron Forte Capsules are packaged in child-resistant bottles of 100 capsules.

PRODUCT CODE 13811-042-10.

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature]. Protect from light and moisture. Dispense in a tight, light resistant container with a child-resistant closure as defined in the USP/NF.

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

KEEP OUT OF REACH OF CHILDREN

R_x Only

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

Rev. 05/13

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

13811-042-10
R_x Only

100 Capsules

Taron Forte
CAPSULES

TRIGEN
LABORATORIES