FerraPlus 90

Generic Name: docusate sodium, folic acid, iron, cyanocobalamin, and ascorbic acid
Dosage Form: tablet, film coated

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.

FerraPlus 90
Tablets with 90 mg Carbonyl Iron

Rx Only

FerraPlus 90 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

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.

FerraPlus 90 - 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 for FerraPlus 90

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.

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.

FerraPlus 90 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 is FerraPlus 90 Supplied

FerraPlus 90 is packaged in bottles of 90 tablets.

NDC 13811-012-90

Dispense in a tight container with a child-resistant closure.

STORAGE

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP controlled room temperature].

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

PRINCIPAL DISPLAY PANEL - 90 mg Tablet Bottle

NDC 13811-012-90
Rx Only

FerraPlus 90
Tablets

WITH 90 MG CARBONYL IRON

90 COATED TABLETS

TRIGEN
LABORATORIES

FerraPlus 90 
docusate sodium, folic acid, iron, cyanocobalamin, and ascorbic acid tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13811-012
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Docusate Sodium (Docusate) Docusate Sodium 50 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Iron (Iron) Iron 90 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug
Ascorbic acid (Ascorbic acid) Ascorbic acid 120 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline  
Anhydrous Dibasic Calcium Phosphate  
Potassium Citrate Anhydrous  
Carboxymethylcellulose Sodium  
Acacia  
Povidone K30  
Croscarmellose Sodium  
Silicon Dioxide  
Stearic Acid  
Magnesium Stearate  
Citric Acid Monohydrate  
Icodextrin  
Dextrose  
Sodium Citrate  
Product Characteristics
Color GRAY (dark grey) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code TL012
Contains         
Packaging
# Item Code Package Description
1 NDC:13811-012-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/01/2011
Labeler - TRIGEN Laboratories, Inc. (830479668)
Revised: 09/2011
 
TRIGEN Laboratories, Inc.
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