FERRAPLUS 90- docusate sodium, folic acid, iron, cyanocobalamin and ascorbic acid tablet, film coated
Trigen Laboratories, Inc.
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.
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FerraPlus 90
Tablets with 90 mg Carbonyl Iron
DESCRIPTION
FerraPlus 90 is a dark grey, oval, film-coated tablet, debossed "TL012".
Each dark grey film-coated tablet for oral administration contains:
| Docusate Sodium | 50 mg |
| Folic Acid | 1 mg |
| Iron (Carbonyl iron) | 90 mg |
| Vitamin B12 (Cyanocobalamin) | 12 mcg |
| Vitamin C (Ascorbic acid) | 120 mg |
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.
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.
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
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
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.
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.
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.
HOW SUPPLIED
FerraPlus 90 is packaged in bottles of 90 tablets.
NDC 13811-012-90
Dispense in a tight container with a child-resistant closure.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Rx Only
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. 07/11
| FERRAPLUS 90
docusate sodium, folic acid, iron, cyanocobalamin, and ascorbic acid tablet, film coated |
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| Labeler - Trigen Laboratories, Inc. (830479668) |