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Natalvirt FLT

Generic Name: ferrous gluconate, folic acid, cyanocobalamin, ascorbic acid and docusate sodium
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.

NATALVIRT™ FLT

90 mg Dual-Iron Delivery

Natalvirt FLT Description

Each green film-coated tablet for oral administration contains:

Iron (Carbonyl Iron, Ferrous Gluconate) 90 mg
Folic Acid 1 mg
Vitamin B12 (Cyanocobalamin) 12 mcg
Vitamin C (Ascorbic Acid) 120 mg
Docusate Sodium 50 mg

Inactive Ingredients: Citric Acid, Croscarmellose Sodium, Fumed Silica, Green Color Coating (FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #5 Aluminum Lake, Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, Talc, Titanium Dioxide, Triacetin), Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Stearic Acid and TriPotassium Citrate.

This product contains FD&C Yellow No. 5 (tartrazine) Aluminum Lake.

This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, shellfish, milk, eggs, wheat, and soy. Individuals with allergic tendencies to these substances should use discretion.

Natalvirt FLT - 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 Natalvirt FLT

NATALVIRT™ FLT 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 THE 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 NATALVIRT™ FLT 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. This product contains FD&C Yellow No. 5 (tartrazine) Aluminum Lake which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons.

Although the overall incidence of FD&C Yellow No. 5 (tartrazine) Aluminum Lake sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

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 this product 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.

Natalvirt FLT 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 Natalvirt FLT Supplied

NATALVIRT™ FLT (NDC 76439-247-90) is a green, rectangle shaped, film-coated tablet, debossed with “576” on one side and blank on the other, and packaged in bottles of 90. Store at 25°C (77°F). Excursions permitted to 15°- 30°C (59°-86°F). (See USP Controlled Room Temperature).

To report a serious adverse event or obtain product information, call (813) 283-1344.

KEEP THIS OUT OF REACH OF CHILDREN.

This is not an Orange Book product.

All prescriptions using this product should be pursuant to state statutes as applicable.

Rx Only

VIRTUS
PHARMACEUTICALS

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, FL 33619

Made in Canada

Revised 4/13

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VIRTUS
PHARMACEUTICALS

NDC 76439-247-90

NATALVIRTTM FLT
90 mg Dual-Iron Delivery

Rx Only

90 Coated Tablets

Natalvirt FLT 
ferrous gluconate, folic acid, cyanocobalamin, ascorbic acid and docusate sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-247
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERROUS GLUCONATE (FERROUS CATION) FERROUS CATION 90 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
CROSCARMELLOSE SODIUM  
SILICON DIOXIDE  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
FD&C YELLOW NO. 5  
HYPROMELLOSES  
POLYVINYL ALCOHOL  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
GELATIN  
STEARIC ACID  
POTASSIUM CITRATE ANHYDROUS  
Product Characteristics
Color GREEN Score no score
Shape RECTANGLE Size 10mm
Flavor Imprint Code 576
Contains         
Packaging
# Item Code Package Description
1 NDC:76439-247-90 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 04/01/2013
Labeler - Virtus Pharmaceuticals LLC (969483143)
Revised: 05/2013
 
Virtus Pharmaceuticals LLC
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