VP-CH-PNV
VP-CH-PNV Softgels
FULL PRESCRIBING INFORMATION: CONTENTS*
- VP-CH-PNV DESCRIPTION
- VP-CH-PNV INDICATIONS AND USAGE
- VP-CH-PNV CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- VP-CH-PNV ADVERSE REACTIONS
- VP-CH-PNV DOSAGE AND ADMINISTRATION
- STORAGE
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
FULL PRESCRIBING INFORMATION
PRENATAL/POSTNATAL
Prescription Folate / Obstetrics Medical Food
VP-CH-PNV DESCRIPTION
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.
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.
FOLATE REGULATION
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 forms
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 INDICATIONS AND USAGE
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.
VP-CH-PNV CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.
WARNINGS
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.
WARNING
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.
PRECAUTIONS
General
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.
CAUTION
Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
PATIENT INFORMATION
VP-CH-PNV is a PRENATAL/POSTNATAL prescription folate / obstetrics medical food to be used only under licensed medical supervision.
DRUG INTERACTIONS
Drugs which may interact with folate
- Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, 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 the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin and other anticonvulsants.
- Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of capecitabine.
- Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
- 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.
- L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels.
- 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, such as pancreatin and pancrelipase.
- Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
- Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine.
- 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.
- Heme-iron: Can compete for transport and reduce folate absorption.
- Folinic acid may enhance the toxicity of fluorouracil.
- Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate.
- Caution should be exercised with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.
Drugs which interact with vitamin B6:
- Vitamin B6 should not be given to patients receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
- Isoniazid can produce a vitamin B6 deficiency.
Drugs which may interact with vitamin D3:
- Certain thiazide diuretics, such as hydrochlorothiazide, as well as antacids, bile acid sequestrants (such as cholestyramine), mineral oil, orlistat, olestra, cimetidine, and anticonvulsant medications may reduce the absorption or increase the catabolism of vitamin D.
- Vitamin D supplementation should not be given with calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.
PREGNANCY and NURSING MOTHERS
VP-CH-PNV is intended for use before, during and after pregnancy for lactating and non-lactating mothers. Talk with your medical practitioner to ensure adequate prenatal/postnatal supplementation.
VP-CH-PNV ADVERSE REACTIONS
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.
VP-CH-PNV DOSAGE AND ADMINISTRATION
Before, during, and after pregnancy, one softgel capsule, taken by mouth daily, or as directed by a licensed medical practitioner.
STORAGE
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.
HOW SUPPLIED
VP-CH-PNV is supplied as oblong, purple soft gelatin capsules imprinted with "V224", dispensed in bottles of 30 softgel capsules.
NDC
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.
Rx
Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619
MADE IN CANADA
Rev. 4/2012
PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
VIRTUS
PHARMACEUTICALS
NDC*: 76439-224-30
VP-CH-PNV
PRENATAL / POSTNATAL
Prescription Folate / Obstetrics Medical Food
Rx
30 Softgels
VP-CH-PNVCALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, DOCONEXENT, and ICOSAPENT CAPSULE
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