| NDC | 69543-243-30 |
| Set ID | 93b9b0c7-6cbc-4f61-bb9d-c199cfe146d5 |
| Category | DIETARY SUPPLEMENT |
| Packager | Virtus Pharmaceuticals |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- HEALTH CLAIM
- DESCRIPTION
-
DIRECTIONS FOR USE
Before, during, and/or after pregnancy, one softgel daily or as directed by a licensed healthcare practitioner.
Supplement Facts Serving Size: 1 Softgel Amount Per Serving % Daily Value for Pregnant & Lactating Women Vitamin C 85 mg 142% Vitamin D (Vitamin D3 as cholecalciferol) 200 IU 50% Vitamin E 10 IU 33% Vitamin B6 25 mg 1000% Folate (L-methylfolate, or 6(S)-5-MTHF 600 mcg) (Folic acid, USP 400 mcg) 1 mg 125% Vitamin B12 12 mcg 150% Biotin 250 mcg 83% Calcium (calcium carbonate) 140 mg 11% Iron (ferrous fumarate) 28 mg 156% Iodine (potassium iodide) 150 mcg 100% Magnesium (magnesium oxide) 45 mg 10% Docosahexaenoic Acid (DHA) 300 mg* † Elcosapentaenoic Acid (EPA) 40 mg* † Other Ingredients: Gelatin (Bovine), Glycerin, DI Water, Yellow Beeswax, Lecithin, Soybean Oil, Titanium Dioxide, FD&C Yellow #5, and FD&C Blue #1.
Contains FD&C Yellow #5, FD&C Blue #1, fish and soy.
- ALLERGY STATEMENT
- CONTRAINDICATIONS
- WARNINGS
-
CAUTIONS
High levels of folic acid may, especially in older adults, hide signs of vitamin B-12 deficiency (such as pernicious anemia, a condition that can cause nerve damage).
Patients undergoing cancer treatment should consult their licensed medical practitioner for advice.
Caution should be exercised when using folate with folate antagonists (e.g. methotrexate, trimethoprim). Patients should not be given folate simultaneously with a folate antagonist for the purpose of reducing or preventing clinical toxicity, as the therapeutic effect of the antagonist may be nullified. Exercise caution with the concomitant use of folate and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as this has been associated with increased rates of treatment failure and mortality.1
Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-tetrahydrofolate and fluorouracil; accompanying granulocytopenia and fever were present in some but not all of the patients.
The concomitant use of formyl-tetrahydrofolate with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study.1
Caution is recommended in patients with a history of bipolar illness as mood elevation is possible following coadministration of folate with antidepressant therapy.
Caution is recommended in patients taking anticonvulsant medications, because folate may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism.
Ingestion of more than 2 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) as dietary supplements may have antithrombotic effects and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding predisposition, including those taking anticoagulants.
- SIDE EFFECTS
-
DRUG INTERACTIONS
Drug interactions with folate include
- Folate may decrease serum levels of first generation anticonvulsants (carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate).
- Folic acid absorption (and consequent reduction in serum folate levels) may be reduced by cholestyramine, colestipol, and cycloserine. Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine. Sulfasalazine inhibits absorption and metabolism of folic acid.
- Plasma folate levels may be decreased by colchicine, levodopa, dihydrofolate reductase inhibitors (including aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim). Serum folate levels may be depressed by smoking and/or drinking alcohol, oral contraceptive therapy, methylprednisolone, and metformin treatment of patients with type 2 diabetes. Reduced folate levels have occurred in some patients taking pancreatic extracts (e.g. pancreatin and pancrelipase), isotretnoin, or prolonged intravenous pentamidine.
- Folate may enhance the toxicity of fluorouracil.
- Concurrent administration of chloramphenicol and folate in folate-deficient patients may result in antagonism of the hematopoietic response to folate.
Drug interactions with Vitamin B6 include
- Cycloserine increases urinary excretion of pyridoxine, which may exacerbate seizures and neurotoxicity associated with cycloserine.
- Some antiepileptic medications, including valproic acid, carbamazepine, and phenytoin, increase the catabolism rate of Vitamin B6. This can result in increased homocysteine levels, which in antiepileptic drug users can increase the risk of epileptic seizures and vascular events like stroke.
- Theophylline is associated with low pyridoxal 5' phosphate concentrations, which could contribute to neurological and central nervous system side effects associated with theophylline use.
- Vitamin B6 should not be given to patients receiving the drug levodopa because the action of levodopa may be antagonized by Vitamin B6. Vitamin B6 may or may not interfere with levodopa even when used concurrently with carbidopa.
Drug interactions with Vitamin B12 include
- Arsenic trioxide, an antineoplastic drug, can cause QT interval prolongation and complete atrioventricular block; theoretically, use of arsenic trioxide during intensive Vitamin B12 treatment may potentiate risk of cardiac arrhythmias, because of the hypokalemia that may develop duing the early phase of Vitamin B12 therapy.
- Metformin may reduce the absorption of Vitamin B12 through alterations in gastric motility, bacterial overgrowth, or alterations in calcium-dependent intestinal uptake of the Vitamin B12 intrinsic factor complex.
- Chloramphenicol may interfere with Vitamin B12 activity.
- SPECIFIC POPULATIONS
- HOW SUPPLIED
-
STORAGE
Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and moisture. Dispense in a tight, light-resistant container.
Call your medical practitioner about side effects. You may report side effects by calling Virtus at 1-888-848-3593 or FDA at 1-800-FDA-1088.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
-
REFERENCES
- 1.
- Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. J Infect Dis. 1994 Oct; 170(4):912-7.
- 2.
- De-Regil LM, Fernández-Gaxiola AC, Dowswell T, et al. Effects and safety of periconceptional folate supplementation for preventing birth defects. Cochrane Database Syst Rev. 2010 Oct 6;(10): CD007950. doi: 10.1002/14651858.CD007950.pub2.
- 3.
- Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H). October 10, 2000.
- 4.
- Hendler SS, Rorvik D. PDR for Nutritional Supplements. 2nd ed. Montvale, NJ. Physicians' Desk Reference Inc; 2008.5.
- 10.
- Code of Federal Regulations Title 21 Section 172.345.
- 11.
- Code of Federal Regulations Title 21 Section 101.9(j)(8).
- 12.
- Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029). November 28, 2000.
- 13.
- Hallert C, Tobiasson P, Walan A. Serum folate determinations in tracing adult coeliacs. Scand J Gastroenterol. 1981;16:263-67.
- 14.
- Wu A, Chanarin I, Levi AJ. Macrocytosis of chronic alcoholism. The Lancet. 1974;1:829-31.
Rx
Manufactured for
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619
1-888-848-3593Made in USA
Rev. 10/2015 - PRINCIPAL DISPLAY PANEL - 30 Softgels Bottle Label
-
INGREDIENTS AND APPEARANCE
VIRT-PN PLUS
ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, levomefolic acid, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent, and icosapent capsule, gelatin coatedProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69543-243 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 85 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 200 [iU] .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL 10 [iU] PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 25 mg LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 600 ug FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 400 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 250 ug CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 140 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 28 mg POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 150 ug MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 45 mg DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 300 mg ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT 40 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) YELLOW WAX (UNII: 2ZA36H0S2V) SOYBEAN OIL (UNII: 241ATL177A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:69543-243-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 12/08/2015 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 24 mm imprint Labeler - Virtus Pharmaceuticals (079659493)
