VP-CH-PNV- calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, doconexent, and icosapent capsule
Virtus Pharmaceuticals
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.
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VP-CH-PNV is an orally administered PRENATAL/POSTNATAL prescription folate / obstetrics medical food specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels.
VP-CH-PNV should be administered under the supervision of a licensed medical practitioner.
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Each oblong, purple softgel contains the following dietary ingredients: | |
Calcium (citrate) | 104 mg |
Iron (carbonyl) | 30 mg |
Vitamin D3 (cholecalciferol) | 400 IU |
Vitamin E (dl-alpha tocopherol acetate) | 30 IU |
Vitamin B6 (pyridoxine HCl) | 25 mg |
Folic Acid | 1 mg |
Docusate Sodium | 50 mg |
Docosahexaenoic acid (DHA) | 260 mg* |
Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.
Other Ingredients: Carmine, Ethyl Vanillin, FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Natural Creamy Orange Flavor, Purified Water, Soybean Oil, Soy Lecithin, Titanium Dioxide, Yellow Beeswax.
This product contains fish (tuna) and soy. This product also contains carmine and bovine gelatin.
The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, l-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate.
Individuals with genetic polymorphisms for the genes coding methylenetetrahydrofolate reductase (MTHFR) may not be capable of utilizing or metabolizing folic acid adequately for the vitamin B12 dependent methylation cycle.
Folic acid, including reduced forms1 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision of a licensed medical practitioner.
The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern while establishing that increased folate was proper therapy in megaloblastic anemias - specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that:
Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription.
Folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345).
VP-CH-PNV is indicated for the distinct nutritional requirements of patients in need of PRENATAL/POSTNATAL dietary supplementation as determined by a licensed medical practitioner.
VP-CH-PNV should be administered under the supervision of a licensed medical practitioner.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.
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.
Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.
Folate, when administered as a single agent in doses about 0.1 mg daily, may obscure the detection of vitamin 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). Folate therapy alone is inadequate for treatment of a vitamin B12 deficiency.
Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
VP-CH-PNV is a PRENATAL/POSTNATAL prescription folate / obstetrics medical food to be used only under licensed medical supervision.
Drugs which may interact with folate2 include:
Drugs which interact with vitamin B6:
Drugs which may interact with vitamin D3:
Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate. Paresthesia, somnolence, nausea and headaches have been reported with vitamin B6.
Before, during, and after pregnancy, one softgel capsule, taken by mouth daily, or as directed by a licensed medical practitioner.
Store at Controlled Room Temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.
NOTICE: Contact with moisture can discolor or erode the capsule.
VP-CH-PNV is supplied as oblong, purple soft gelatin capsules imprinted with "V224", dispensed in bottles of 30 softgel capsules.
NDC3 : 76439-224-30
KEEP THIS OUT OF REACH OF CHILDREN.
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Call your medical practitioner about side effects. You may report side effects by calling (813) 283-1344.
VP-CH-PNV
calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, doconexent, and icosapent capsule |
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Labeler - Virtus Pharmaceuticals (969483143) |