{"adverse_reactions":["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."],"boxed_warning":["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."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["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 D 3 (cholecalciferol) 400 IU Vitamin E (di-alpha tocopherol acetate) 10 IU Vitamin B 1 (thiamine mononitrate) 3 mg Vitamin B 2 (riboflavin) 3.4 mg Niacinamide 20 mg Vitamin B 6 (pyridoxine NCI) 20 mg Vitamin B 12 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)."],"description_table":["
Folate 1 mg
","
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
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One tablet daily or as directed by a physician."],"drug_interactions":["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."],"effective_time":"20170804","general_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 B 12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B 12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B 12 deficiency. Folate therapy alone is inadequate for the treatment of B 12 deficiency."],"how_supplied":["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]."],"id":"2eff7b9d-e17b-42e6-b546-802533c052f8","indications_and_usage":["INDICATIONS AND USAGE Virt-PN is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation."],"information_for_patients":["PATIENT INFORMATION Virt-PN is a prescription vitamin for use only under the direction and supervision of a licensed physician."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label VIRTUS PHARMACEUTICALS Product Code*: 76439- 241 -90 Virt-PN Tablets Rx 90 Tablets PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label"],"precautions":["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 B 12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B 12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B 12 deficiency. Folate therapy alone is inadequate for the treatment of B 12 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."],"set_id":"842a1c0f-3b06-419c-8537-1bae203052ee","spl_product_data_elements":["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 LEVOMEFOLIC ACID LEVOMEFOLIC ACID PYRIDOXINE PYRIDOXINE .BETA.-CAROTENE .BETA.-CAROTENE CALCIUM CARBONATE CALCIUM CATION ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL .ALPHA.-TOCOPHEROL THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE CYANOCOBALAMIN CYANOCOBALAMIN FERROUS FUMARATE FERROUS CATION POTASSIUM IODIDE IODIDE ION ZINC OXIDE ZINC OXIDE BIOTIN BIOTIN CALCIUM PANTOTHENATE PANTOTHENIC ACID CALCIUM CATION MAGNESIUM OXIDE MAGNESIUM CATION CUPRIC OXIDE CUPRIC CATION Croscarmellose Sodium ANHYDROUS DIBASIC CALCIUM PHOSPHATE Magnesium Stearate MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED Talc Titanium Dioxide Silicon Dioxide Stearic acid V241"],"spl_unclassified_section":["Tablets Rx","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"],"storage_and_handling":["STORAGE Store at 20°-25°C (68°-77°F). Excursions permitted to 15º to 30ºC (59º to 86°F). [See USP Controlled Room Temperature]."],"version":"2"}