FerraPlus 90

TRIGEN Laboratories, Inc.

FerraPlus 90Tablets with 90 mg Carbonyl Iron

FULL PRESCRIBING INFORMATION: CONTENTS*

• FERRAPLUS 90 DESCRIPTION:
  • Inactive Ingredients:
• CLINICAL PHARMACOLOGY:
• FERRAPLUS 90 INDICATIONS AND USAGE
• FERRAPLUS 90 CONTRAINDICATIONS
• WARNING
• WARNING
• PRECAUTIONS
  • General:
  • Folic Acid:
  • Pediatric Use:
  • Geriatric Use:
• FERRAPLUS 90 ADVERSE REACTIONS:
• DRUG INTERACTIONS:
• OVERDOSAGE:
• FERRAPLUS 90 DOSAGE AND ADMINISTRATION:
• HOW SUPPLIED:
  • STORAGE:
• PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

FULL PRESCRIBING INFORMATION

R_x Only

DESCRIPTION:

FerraPlus 90 is a dark grey, oval, film-coated tablet, debossed "TL012".

Each dark grey film-coated tablet for oral administration contains:

Inactive Ingredients:

Microcrystalline Cellulose, Di Calcium Phosphate, TriPotassium Citrate, Sodium Carboxymethyl Cellulose, Acacia, Povidone K30, Croscarmellose Sodium, Fumed Silica, Stearic Acid, Magnesium Stearate, Citric Acid, Dextrin, Dextrose, Lecithin, and Sodium Citrate.

CLINICAL PHARMACOLOGY:

Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport, energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic macrocytic anemias. Vitamin B₁₂ is essential to growth, cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.

FERRAPLUS 90 INDICATIONS AND USAGE

FerraPlus 90 is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, post-surgical convalescence, and dietary needs.

FERRAPLUS 90 CONTRAINDICATIONS

Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.

WARNING

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

WARNING

PRECAUTIONS

General:

Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with FerraPlus 90 tablets. Ensure Hgb, Hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated.

Folic Acid:

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anemia.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.

ADVERSE REACTIONS:

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

DRUG INTERACTIONS:

Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.

OVERDOSAGE:

Symptoms: Abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.

DOSAGE AND ADMINISTRATION:

One tablet daily or as directed by a physician.

NOTICE:Contact with moisture can discolor or erode the tablet. Do not chew tablet.

HOW SUPPLIED:

FerraPlus 90 is packaged in bottles of 90 tablets.

Product Code: 13811-012-90

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 container with a child-resistant closure.

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

KEEP OUT OF THE REACH OF CHILDREN.

R_x Only

All prescriptions using this product shall be pursuant to 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. 07/13

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

13811-012-90
R_x Only

FerraPlus 90
Tablets
WITH 90 MG CARBONYL IRON

90 COATED TABLETS

TRIGEN
LABORATORIES