PREPLUS- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide and cupric oxide tablet
Virtus Pharmaceuticals LLC
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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NDC: 76439-258-10 (100 ct. bottle/100 tablets)
NDC: 76439-258-50 (500 ct. bottle/500 tablets)
Rx
PRENATAL / POSTNATAL
Prescription Folate
DESCRIPTION: PrePLUS tablet (PNV-Ca with 27 mg Fe; 1 mg FA) is an orally administered PRENATAL / POSTNATAL prescription folate specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels.
PrePLUS tablet (PNV-Ca with 27 mg Fe; 1 mg FA) should be administered under the supervision of a licensed medical practitioner.
Each beige tablet contains the following dietary ingredients:
VITAMINS: | Amount per Tablet |
---|---|
Vitamin A (as Acetate and Beta Carotene) | 4,000 IU |
Vitamin C (Ascorbic Acid) | 120 mg |
Vitamin D-3 (Cholecalciferol) | 400 IU |
Vitamin E (dl-Alpha Tocopheryl Acetate) | 22 mg |
Thiamine (Vitamin B-1 from Thiamine Mononitrate) | 1.84 mg |
Riboflavin (Vitamin B-2) | 3 mg |
Niacin (Niacinamide) | 20 mg |
Vitamin B-6 (as Pyridoxine HCI) | 10 mg |
Folic Acid | 1 mg |
Vitamin B-12 (Cyanocobalamin) | 12 mcg |
MINERALS: | |
Calcium (Calcium Carbonate) | 200 mg |
Iron (Ferrous Fumarate) | 27 mg |
Zinc (Zinc Oxide) | 25 mg |
Copper (Cupric Oxide) | 2 mg |
Other Ingredients: Calcium Sulfate Granular (25% Calcium), Microcrystalline Cellulose Kosher, Stearic acid Kosher, Croscarmellose Sodium Kosher, Magnesium Stearate Kosher, Silicon Dioxide Kosher, FD&C Red # 40 (Lakes), FD&C Blue No. 2 Aluminum Lake, FD&C Yellow Lake No. 5, and other ancillary ingredients as needed to ensure product stability.
Caution: Contains FD&C Red # 40 (Lakes), FD&C Blue No. 2 Aluminum Lake and FD&C Yellow Lake No. 5.
Since additives, preservatives, bioavailability enhancers, colors and/or flavors of natural origin, etc. are preferred over synthetics, it may be the case that product color, appearance and/or taste may vary slightly over time; and it may be necessary to substitute excipients during the manufacturing process as needed to preserve product appearance and continuity in order to avoid confusion in the marketplace and ensure the highest therapeutic target, safety and quality.
ALLERGY STATEMENT: This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Individuals with allergic tendencies to these substances should use discretion.
PHARMACOLOGY: FOLATE - Folates are best known for reducing the incidence of fetal neural tube defects (NTDs).2 NTDs are congenital malformations produced by failure of the neural tube to form and close properly during embryonic development.2 During the first four weeks of pregnancy - when many women do not even realize that they have conceived, adequate maternal folate intake is essential to reduce the risk of NTDs. As the postnatal period approaches there is increased demand again for folate regardless of lactation status. Folate is involved in transformylation and methylation metabolism as well as - indirectly, succinylation metabolism (through the "methyl trap" hypothesis). Folate plays a central role in the formation of nucleic acid precursors, such as thymidylic acid and purine nucleotides, which are essential for nucleic acid synthesis and cell division. IOM/NAS (1998) noted that the evidence for a protective effect from folate supplements is much stronger than that for food folate3. Other dietary ingredients are added to folate as cofactors, coenzymes and co-metabolites; in studies by Czeizel and Dudas (1992) and Berry et al. (1999), factors other than folate intakes may affect the magnitude of risk reduction or participate in a co-protective effect with folate.3
FOLATE MECHANISM OF ACTION: FOLATE is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoiesis. It also promotes white blood cell (WBC) and platelet production in folate-deficiency anemia. Folate is associated with methylation and transformylation biochemistry.4
FOLATE REGULATION: The Federal Register Notices from 1971 to 1973 established that increased folate was proper therapy in megaloblastic anemias of tropical and nontropical sprue, nutritional origin, pregnancy, infancy and childhood.5,6,7 Folate metabolism can be affected by malabsorption issues which differ widely among population groups. The March 5, 1996 Federal Register Notice (61 FR 8760) states that "The agency concluded that the scientific literature did not support the superiority of any one source of folate over others, and that the data were insufficient to provide a basis for stating that a specific amount of folate is more effective than another amount [emphasis added].8" The actual amount and source of folate require a licensed medical practitioner's supervision to achieve a satisfactory maintenance level, and may exceed the 0.8 mg UL. 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. Oral preparations supplying more than 0.8 mg of folate per dosage unit would be restricted to prescription dispensing and that a dietary supplement furnishing 0.8 mg could be prescribed when a maintenance level of 0.8 mg per day was indicated ... When clinical symptoms have subsided and the blood picture and/or CSF folate levels have become normal, a maintenance level should be used. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent. In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased [emphasis added]9." However, once the level of active folate exceeds 0.8 mg - as prescribed dosages, then the product is no longer a medical food but a dietary management / prescription (Rx)-folate regardless of pregnancy/lactation status in spite of the fact that 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).10,11 In the Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029) dated November 28, 2000, FDA wrote "... high intakes of folate may partially and temporarily correct pernicious anemia while the neurological damage of vitamin B12 deficiency progresses. IOM/NAS (1998) set the UL for all adults of 1 mg per day because of devastating and irreversible neurological consequences of vitamin B12 deficiency, the data suggesting that pernicious anemia may develop at a younger age in some racial or ethnic groups, and the uncertainty about the extent of the occurrence of vitamin B12 deficiency in younger age groups (IOM/NAS, 1998) [emphasis added].12" Summary: This product is a dietary management product that - due to advanced folate levels, requires administration under the care of a licensed medical practitioner, and the most appropriate way to do that is to provide the product as prescription for pedigree reporting and safety monitoring. The ingredients, indication or claims of this product are not to be construed to be drug claims.
ADVERSE REACTIONS: Allergic reactions have been reported following the use of oral and parenteral folate.
Call your medical practitioner about side effects.
Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cobalamin.
Paresthesia, somnolence, nausea, and headaches have been reported with pyridoxine.
PATIENT INFORMATION: This product is a dietary management / prescription (Rx) folate supplement to be used only under licensed medical supervision. Your licensed medical practitioner may choose to prescribe this product along with other medications.
INDICATIONS AND USAGE: This product is indicated for the distinct nutritional requirements of individuals who have suboptimal folates levels in the cerebrospinal fluid, plasma and/or red blood cells, and require a maintenance level. Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias,13 (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin,14 pregnancy, infancy, childhood or other related folate-malabsorption complications of an inborn or environmental origin.
KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.
INTERACTIONS: Always talk to your healthcare practitioner and/or pharmacist before taking or using any prescription or over-the-counter medicines or herbal/health supplements alongside this product.
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.
PATIENT INFORMATION: PrePLUS tablet (PNV-Ca with 27 mg Fe; 1 mg FA) is a PRENATAL / POSTNATAL prescription folate to be used only under licensed medical supervision.
Drugs which may interact with folate include but are not limited to:
Drugs which may interact with vitamin B6 include but are not limited to:
Drugs which may interact with vitamin B12 include but are not limited to:
CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. This product is contraindicated for individuals with conditions for which any of the ingredients are contraindicated.
WARNINGS: 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 also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group.
Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF 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
Patients undergoing cancer treatment should consult their licensed medical practitioner for advice.
PREGNANCY and NURSING MOTHERS: PrePLUS tablet (PNV-Ca with 27 mg Fe; 1 mg FA) is intended for use as a prescription PRENATAL folate before, during, and after pregnancy regardless of lactation status.
PRECAUTIONS: Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress.
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.
HOW SUPPLIED: PrePLUS tablet (PNV-Ca with 27 mg Fe; 1 mg FA) is supplied as beige tablets debossed on one side with "V258", dispensed in bottles of 100 and 500 tablets.
NDC: 76439-258-10 (100 ct. bottle/100 tablets)
NDC: 76439-258-50 (500 ct. bottle/500 tablets)
This product may - under certain circumstances, be dispensed through a certified mail-order program so long as there is record of prescription AND confirmation that the patient is under licensed medical supervision. This product is not an Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable.
++This product is a prescription-folate with or without other dietary ingredients that - due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) - or similar product code, as required by pedigree reporting requirements and supply-chain control as well as - in some cases, for insurance-reimbursement applications.
Call your medical practitioner about side effects. You may report side effects by calling (813) 283- 1344.
Rx
PREPLUS
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide and cupric oxide tablet |
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Labeler - Virtus Pharmaceuticals LLC (969483143) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Nutramed | 053745811 | MANUFACTURE(76439-258) |