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Virt-PN Plus

Generic Name: folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent
Dosage Form: capsule, gelatin 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.

Virt-PN Plus
Softgels

Rx Only

Virt-PN Plus Description

Virt-PN Plus is a prescription prenatal/postnatal multivitamin/mineral softgel with an essential fatty acid.

Each softgel has the following active ingredient:
Folate
(L-methylfolate, or 6(S)-5-MTHF 600 mcg)
(folic acid, USP 400 mcg)
1 mg
*
from at least 340 mg omega-3s from at least 390 mg purified fish oils.
Each softgel also contains the following ingredients
for nutritional supplementation:
Vitamin C 85 mg
Vitamin D3 200 IU
Vitamin E 10 IU
Vitamin B6 25 mg
Vitamin B12 12 mcg
Biotin 250 mcg
Calcium (calcium carbonate) 140 mg
Iron (ferrous fumarate) 28 mcg
Iodine (potassium iodide) 150 mcg
Magnesium (magnesium oxide) 45 mg
Docosahexaenoic Acid (DHA) 300 mg*
Eicosapentaenoic Acid (EPA) 40 mg*

Inactive Ingredients:

Yellow Beeswax, Lecithin, Soybean Oil, Gelatin (Bovine), Glycerin, DI Water, Titanium Dioxide, FD&C Yellow #5, FD&C Blue #1 and Ethyl Vanillin.

Warning: This product contains FD&C Yellow #5 and FD&C Blue #1.

Indications and Usage for Virt-PN Plus

Virt-PN Plus is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.

Warning

Daily ingestion of more than 3 g per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids − including DHA, should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.

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.

This product contains soybean oil and fish oil.

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Precautions

General:
Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.

PATIENT INFORMATION

Virt-PN Plus is a prescription vitamin for use only under the direction and supervision of a licensed physician.

INTERACTIONS

Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

Drugs which may interact with folate include:

  • Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of this AED in the blood and allowing breakthrough seizures to occur.
  • Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
  • Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
  • Colestipol: Reduces folic acid absorption and reduces serum folate levels.
  • Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
  • Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
  • Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
  • Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.
  • Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
  • Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
  • Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts.
  • Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
  • Smoking and Alcohol: Reduced serum folate levels have been noted.
  • Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
  • Metformin treatment in patients with type 2 diabetes decreases serum folate.
  • Warfarin can produce significant impairment in folate status after a 6-month therapy.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates – including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.

Virt-PN Plus Dosage and Administration

Before, during, and/or after pregnancy, one softgel daily or as directed by a physician.

How is Virt-PN Plus Supplied

Virt-PN Plus is supplied as oblong, green soft gelatin capsules imprinted with ‘243’, dispensed in bottles of 30 softgels.

NDC 76439-243-30

STORAGE

Store at 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx Only

Reserved for Professional Recommendation
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured For:
Virtus Pharmaceuticals, LLC.
Tampa, FL 33619
www.virtusrx.com

Virtus
PHARMACEUTICALS

Rev. 04/13

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76439-243-30         Rx Only

Virt-PN
Plus

Softgels

Virtus
PHARMACEUTICALS

Rx

30 Softgels

Virt-PN Plus 
folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-243
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 85 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 200 [iU]
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 10 [iU]
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 25 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
BIOTIN (BIOTIN) BIOTIN 250 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 140 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 28 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 150 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 45 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 300 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 40 mg
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX  
LECITHIN, SOYBEAN  
SOYBEAN OIL  
GELATIN  
GLYCERIN  
WATER  
TITANIUM DIOXIDE  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
ETHYL VANILLIN  
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code 243
Contains         
Packaging
# Item Code Package Description
1 NDC:76439-243-30 30 CAPSULE, GELATIN COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/01/2013
Labeler - Virtus Pharmaceuticals LLC (969483143)
Revised: 05/2013
 
Virtus Pharmaceuticals LLC
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