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Virt-PN

Generic Name: prenatal/postnatal multivitamin/mineral
Dosage Form: tablet, 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

Tablets
Rx

Virt-PN Description

Virt-PN is a prescription prenatal/postnatal multivitamin/mineral tablet. Virt-PN are oblong, white tablets with "V241" debossed on one side.

Each tablet has the following active ingredient:

Folate 1 mg

(L-methylfolate, or 6(S)-5-MTHE 600 mcg)
(folic acid, USP 400 mcg)

Each tablet also contains the following ingredients for nutritional supplementation:

Vitamin A (100% as beta-carotene) 2500 IU
Vitamin C (ascorbic acid) 80 mg
Vitamin D3 (cholecalciferol) 400 IU
Vitamin E (di-alpha tocopherol acetate) 10 IU
Vitamin B1 (thiamine mononitrate) 3 mg
Vitamin B2 (riboflavin) 3.4 mg
Niacinamide 20 mg
Vitamin B6 (pyridoxine NCI) 20 mg
Vitamin B12 12 mcg
Biotin 300 mcg
Pantothenic acid (calcium pantothenate) 6 mg
Calcium (calcium carbonate) 120 mg
Iron (ferrous fumarate) 27 mg
Iodine (potassium iodide) 150 mcg
Magnesium (magnesium oxide) 30 mg
Zinc (zinc oxide) 15 mg
Copper (copper oxide) 2 mg

Inactive Ingredients

Microcrystalline Cellulose, Dicalcium Phosphate, Croscarmellose Sodium, Magnesium Stearate, Silicon Dioxide, Stearic Acid, Film Coating (Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc).

Indications and Usage for Virt-PN

Virt-PN 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.

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

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 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
  • 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 Dosage and Administration

One tablet daily or as directed by a physician.

How is Virt-PN Supplied

Virt-PN is dispensed in bottles of 90 tablets.
Product Code 76439-241-90

STORAGE

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

Call your medical practitioner about side effects.
You may report side effects by calling 813-283-1344.

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

Rx

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, Florida 33619

Rev. 07/12

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

Product Code*: 76439-241-90
Virt-PN
Tablets

Rx
90 Tablets

Virt-PN 
levomefolic acid, pyridoxine, .beta.-carotene, calcium carbonate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacinamide, cyanocobalamin, ferrous fumarate, potassium iodide, zinc oxide, biotin, calcium pantothenate, magnesium oxide, and cupric oxide tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-241
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMEFOLIC ACID (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 1 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 20 mg
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 2500 [iU]
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 120 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 80 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 10 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE MONONITRATE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
FERROUS FUMARATE (FERROUS CATION) FERROUS FUMARATE 27 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 150 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15 mg
BIOTIN (BIOTIN) BIOTIN 300 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) CALCIUM PANTOTHENATE 6 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 30 mg
CUPRIC OXIDE (CUPRIC OXIDE) CUPRIC OXIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
Croscarmellose Sodium  
Calcium Phosphate, Dibasic, Anhydrous  
Magnesium Stearate  
Cellulose, Microcrystalline  
Polyethylene Glycols  
Polyvinyl Alcohol  
Talc  
Titanium Dioxide  
Silicon Dioxide  
Stearic acid  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 10mm
Flavor Imprint Code V241
Contains         
Packaging
# Item Code Package Description
1 NDC:76439-241-90 90 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 07/12/2012
Labeler - Virtus Pharmaceuticals (969483143)
Revised: 08/2012
 
Virtus Pharmaceuticals
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