Virt-Pn

Virtus Pharmaceuticals

Virt-PN

FULL PRESCRIBING INFORMATION: CONTENTS*

• VIRT-PN DESCRIPTION
  • Inactive Ingredients
• VIRT-PN INDICATIONS AND USAGE
• VIRT-PN CONTRAINDICATIONS
• PRECAUTIONS
  • General
  • PATIENT INFORMATION
  • INTERACTIONS
• VIRT-PN ADVERSE REACTIONS
• VIRT-PN DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
  • STORAGE
• PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

FULL PRESCRIBING INFORMATION

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:

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

Each tablet also contains the following ingredients for nutritional supplementation:

Inactive Ingredients

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

VIRT-PN INDICATIONS AND USAGE

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

VIRT-PN CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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.

VIRT-PN 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 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